PAxlovid loNg cOvid-19 pRevention triAl With recruitMent In the Community in Norway
Phase: PHASE3
Conditions: Post COVID-19 Condition, Unspecified, SARS-CoV2 Infection, COVID-19
Sponsor: Haukeland University Hospital

1 
 
 
 
 
PAxlovid loNg cOvid-19 pRevention triAl with recruitMent In 
the Community in Norway 
 
 
 
 
Short title: PANORAMIC Norway 
Ethics Ref:  578741 
 
EudraCT Number: 2022-003244-27 
 
 
Study phase: 3 
 
 
Sponsor Name:  
 
Department of Medicine 
Haukeland University Hospital (HUH) 
Helse Bergen HF 
Jonas Lies Vei 87 
N5021 Bergen, 
Norway 
 
 
 
 
 
 
 
Professor Nina Langeland 
 
Date and Version No Norwegian protocol: 23rd March 2023 Version 2.3 
 

 
2 
 
 
 
 
This Clinical Study Protocol has been reviewed and approved by the Sponsor in order to ensure 
compliance with Good Clinical Practice. This Clinical Study Protocol has been reviewed and 
approved by the Principle investigator in order to ensure compliance with Good Clinical 
Practice. 
 
Signature of Sponsor representative 
 
Title: Trial Title: PAxlovid loNg cOvid-19 pRevention triAl with recruitMent In the 
Community in Norway 
 
 
 
Professor Nina Langeland 
Haukeland University Hospital, Helse Bergen HF 
Department of Medicine 
Helse Bergen HF 
Jonas Lies Vei 87 
N5021 Bergen, 
Norway 
 
 
 
 
 
 
Signature: 
 
Date:  
23rd March 2023 
 
 
 
 

 
3 
 
 
 
Sponsor  
Department of Medicine 
Haukeland University Hospital (HUH) 
Helse Bergen HF 
Jonas Lies Vei 87 
N5021 Bergen, 
Norway  
Chief Investigator and trial leader:  
Professor Nina Langeland 
Department of Medicine, HUH/  
Department of Clinical Science (K2), University of 
Bergen (UiB) 
Nina.langeland@uib.no /+47 416 16 450 
Co-Principal Investigator and Co-trial lead:  
Assoc. Professor Bjørn Blomberg  
Department of Medicine, HUH/ 
K2, UiB 
bjorn.blomberg@uib.no/ +47 932 62 119 
Co-Principal Investigator and Co-trial lead:  
Assoc. Professor Oddvar Oppegaard  
Department of Medicine, HUH/  
K2, UiB 
O.Oppegaard@uib.no /+47 975 85 709 
Medical Monitor 
Professor Camilla Tøndel 
Department of Research and Development, HUH 
/K2, UiB 
camilla.tondel@helse-bergen.no/ +47 924 68 362 
Investigators:  
Professor Rebecca Jane Cox 
Influenza Centre K2, UiB/  
Department of Microbiology, HUH 
Professor Rolv Terje Lie 
Department of Global Public Health and Primary 
Care (IGS), UiB 
Professor Kjell Haug,  
Bergen Municipality/ IGS UiB 
Dr. Arild Iversen,  
Bergen Municipality 
Professor Axel Sandvig 
St Olavs Hospital/Norwegian University of Science 
and Technology (NTNU)  
Assoc. Professor Vibeke Devold Valderhaug,  
Helse Midt 
Professor Pål Aukrust,  
Oslo University Hospital (OUS)/University of Oslo 
(UiO) 
Professor Peter Szodoray 
OUS/UiO 
Assoc. Professor Maja Wilhelmsen 
University Hospital of Northern Norway (UNN)/ 
Arctic University of Norway (UiT) 
Assoc. Professor Bjørn Eivind S Kirsebom 
Arctic University of Norway (UiT) 
 
 

 
4 
 
 
Protocol Summary 
 
PAxlovid loNg cOvid-19 pRevention triAl with recruitMent In the Community in Norway 
  
 
Background: Despite high uptake of vaccination against COVID-19, the disease remains 
prevalent in Norway and in many countries around the world, with many patients continuing 
to experience considerable morbidity and requiring hospital treatment. There is therefore an 
urgent need to identify treatments for COVID-19 for use in the community early on in the 
illness that speeds recovery and prevents the need for hospital admission. A considerable 
burden of long term complications has been reported after COVID (named long COVID) even 
after home isolation of mild cases, but are particularly associated with more severe disease, 
and an early therapeutic intervention could potentially also prevent this COVID-19 related 
morbidity. 
 
Aims and objectives: The study hypothesis is that antiviral treatment for acute Covid can 
prevent occurrence of persisting symptoms at 3 months and beyond. The primary objective is 
to assess whether a 5-day course of nirmatrelvir/ritonavir (Paxlovid ®) treatment for patients 
with acute Covid verified by positive SARS-CoV-2 PCR test result or positive lateral flow test, 
can reduce the prevalence of persistent symptoms at 3 months compared to placebo. The 
overall aim of the research is to identify a tool to prevent long COVID, and reduce its burden 
on society.  
 
Interventions: This is a randomized clinical trial assessing whether healthy adults (P) treated 
with Paxlovid (I) for acute Covid versus those treated with placebo (C) will have reduced 
probability of suffering persistent symptoms at 3 months and beyond (O). Participants will be 
randomized 1:1 to two arms of the trial. Participants in the intervention arm will receive a 
standard 5-day treatment course Paxlovid (nirmatrelvir plus ritonavir) in addition to standard  
of care. Participants in the control arm will receive a 5-day course of placebo tablets, with the 
same appearance and quantity, in addition to standard of care. Participants will be 
randomised to receive either the antiviral agent Paxlovid (nirmatrelvir plus ritonavir) in 
addition to standard of care or Placebo plus standard of care.  
 
Eligibility: Participants who meet the following inclusion criteria may be eligible to take part 
in the trial:  
- 
Symptoms attributable to COVID-19 starting within the past 5 days and ongoing  
- 
A positive PCR SARS-CoV-2 test or a positive lateral flow test. Any positive PCR test or 
a lateral flow test taken between two days before symptom onset and randomisation 
qualifies 
- 
Age  ≥ 18 years and <65 years 
- 
Participant is able and willing to provide informed consent, and able to comply with all 
study visits 
- 
Patient not currently admitted to hospital  
- 
No comorbidity which constitutes an indication for active antiviral treatment with 
Paxlovid as judged by the investigator 
- 
No chronic renal impairment 
- 
No chronic liver disease or liver impairment 
- 
No previous randomisation in the PANORAMIC Norway trial  
- 
Not currently participating in a clinical trial of a therapeutic agent 

 
5 
 
 
- 
Not currently taking Paxlovid 
- 
No known allergy to Paxlovid 
- 
No use of concomitant medication contraindicated for the treatment of Paxlovid* 
- 
Not currently pregnant or lactating 
- 
Willingness to take a pregnancy test prior to starting study treatment (Participants of 
childbearing potential)  
- 
Willingness to use highly effective contraceptive until 7 days after completing Paxlovid 
(Participants of childbearing potential or have a partner of childbearing potential)  
 
 
Outcomes: The primary endpoint will be presence of pre-defined symptoms of long COVID at 
3 months from randomisation). The secondary outcome will be all-cause, non-elective 
hospitalisation or death within 28 days of randomisation. Secondary outcomes will further 
include time to self-reported recovery; participant reported illness severity; duration of 
symptoms and symptom recurrence; healthcare service use; participant reported household 
infection rate; safety outcomes and cost-effectiveness outcomes; symptoms and well-being 
at six months (with determination of proportion with Long Covid) from randomisation. See 
Table 1 for details of objectives and outcome measures. 
 
Study design: This is a two-arm 1:1 randomized double-blinded placebo-controlled clinical 
trial. The study is designed to assess whether healthy adults (P) treated with Paxlovid (I) for 
acute Covid versus those treated with placebo (C) will have reduced probability of suffering 
persistent symptoms at 3 months and beyond (O).  An external statistician will produce a 
randomization list prior to the start of the trial. At the time of inclusion in the study, study 
personnel will blindly allocate participants to receive active ingredient or placebo according 
to the randomization list. All enrolment (screening, eligibility review, informed consent and 
baseline data) will be conducted by the trial team, with follow-up procedures (electronic diary) 
conducted remotely with participants or their chosen support person (Study Partner) using 
the trial website or a telephone call with the trial team. Any hospitalisations and deaths will 
be recorded.  
 
Recruitment: A central trial team will recruit and allocate participants to the next 
medication/Placebo number. A participant pack containing Paxlovid or Placebo will be given 
to the participant or their Study Partner, which is a person appointed by the participant to act 
on their behalf, for instance to collect study medication at the central study site. During the 
study period, further recruitment sites and PraksisNett collaboration will be considered. 
 
Data to be recorded: Demographic features including age, gender, comorbidity, allergies, 
medication history and present medication, COVID vaccine history and previous COVID-19 will 
be captured at baseline. In the online diary (completed each day for 7 days, weekly for 28  
days, and at 3 and 6 months) and during telephone calls, participants or their Study Partners 
will rate the severity of symptoms including how well they are feeling, record contacts with 
the health services (including hospital admission), record study medication use, resource use, 
sick leave, and new infections in the household. Follow-up beyond 28 days after 
randomisation will be by accessing medical registries and by participant questionnaire for 
information relevant to the longer-term consequences of COVID-19 at three and six months 
from randomisation. To investigate the impact of trial interventions on the longer-term effects 
of COVID-19, we will also remotely follow-up participants, for up to 1 year.  
 

 
6 
 
 
Exploratory subprojects: 1. A subgroup of up to 500 patients will be asked to attend a face-
to-face visit or to donate a microbiological or blood sample for the purpose of the study, at 3, 
6 and 12 months after inclusion. 2. A smaller group of 100 patients, with and without 
symptoms at 3 months will be included in a study on brain damage, including neurocognitive, 
EEG and MRI investigations. 
 
Numbers to be randomised: An estimated maximum of approximately 1000 participants per 
arm will be required to provide approximately 90% power for detecting a 20% relative 
reduction in long COVID symptoms in an experimental arm relative to Placebo, based on the 
assumption of an underlying 30% prevalence of long COVID at 3 months in the placebo arm, 
and an intervention lowering the long COVID rate to 22%.  
 
Estimated study timelines for data collection: 
 
Start of study: 01-Apr-2023 
First patient in (FPI): 01-Apr-2023 
Last patient in (LPI): 01-Aug-2024 
Last patient out (LPO): 01-Aug-2025   
 
 
 
 

 
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Table of Contents 
 
 
Table of Contents ............................................................................................................... 7 
1. 
BACKGROUND and RATIONALE .................................................................................. 10 
1.1 Aims and Objectives ..................................................................................................... 10 
1.2 Risk Benefit assessment ............................................................................................... 14 
2. 
TRIAL DESIGN AND PROCEDURES ............................................................................... 14 
2.1 Participant Identification ............................................................................................. 14 
2.1.1 Trial Participants .................................................................................................... 14 
2.1.2 Inclusion Criteria .................................................................................................... 15 
2.1.3 Exclusion Criteria ................................................................................................... 15 
2.2 Trial procedures ............................................................................................................ 16 
2.2.1 Recruitment ........................................................................................................... 16 
2.2.2 Screening and eligibility ......................................................................................... 16 
2.2.3 Informed Consent .................................................................................................. 17 
2.2.4 Randomisation ....................................................................................................... 17 
2.2.5 Blinding and code-breaking ................................................................................... 17 
2.2.6 Participants of child-bearing potential .................................................................. 18 
2.2.7 Follow-up Procedures ............................................................................................ 19 
2.2.8 Exploratory subgroup studies ................................................................................ 20 
2.3 Economic evaluation .................................................................................................... 21 
2.4 Early Discontinuation/Withdrawal of Participants ..................................................... 22 
2.5 Definition of End of Trial .............................................................................................. 22 
2.6 Early termination .......................................................................................................... 23 
3. 
TRIAL INTERVENTIONS ............................................................................................... 23 
3.1 Study interventions administered ............................................................................... 23 
3.2 Preparation, Handling, Storage, and Accountability ................................................... 23 
a. 
Encapsulation and labelling ....................................................................................... 23 
b. 
Medication Distribution ............................................................................................. 23 
c. 
Storage ........................................................................................................................ 24 
d. 
Drug accountability .................................................................................................... 24 
e. 
Drug Destruction/Returns .......................................................................................... 24 
3.3 Medication adherence ................................................................................................. 24 
3.4 Overdose ....................................................................................................................... 24 
4. 
SAFETY REPORTING .................................................................................................... 24 
4.1 Procedures for Reporting Adverse Events (AE) and Serious Adverse Events ............. 26 

 
8 
 
 
4.1.1. Other events exempt from immediate reporting as SAEs ................................... 29 
4.1.2. Procedure for immediate reporting of Serious Adverse Events .......................... 29 
4.1.3 Expectedness  ......................................................................................................... 29 
4.1.4 Assessment of Causality ........................................................................................ 29 
4.2 SUSAR Reporting .......................................................................................................... 29 
4.3 Annual Report ............................................................................................................... 30 
5. 
STATISTICS ................................................................................................................. 30 
5.1 Statistical Analysis Plan (SAP) ...................................................................................... 30 
5.2 Research hypothesis ..................................................................................................... 30 
5.3 Outcome definitions ..................................................................................................... 30 
5.3.1 Primary efficacy endpoints .................................................................................... 30 
5.3.2 Secondary endpoints ............................................................................................. 31 
5.4 Randomization and allocation ..................................................................................... 31 
5.5 Primary Analysis Population ........................................................................................ 31 
5.6 Withdrawal / follow-up ................................................................................................ 31 
5.7 Analysis methods .......................................................................................................... 31 
5.8 Reporting of statistical results ..................................................................................... 32 
5.9 Sample size justification ............................................................................................... 33 
5.10 Interim analysis and stopping guidance .................................................................... 33 
5.11 Procedures for Reporting Unplanned Deviation(s) from the Master Statistical 
Analysis Plan ....................................................................................................................... 33 
6. 
DATA MANAGEMENT ................................................................................................. 33 
6.1 Source Data ................................................................................................................... 33 
6.2 Access to Data ............................................................................................................... 34 
6.3 Data Recording and Record Keeping ............................................................................ 34 
7. 
QUALITY ASSURANCE PROCEDURES ........................................................................... 34 
7.1 Risk assessment and Monitoring ................................................................................. 35 
7.2 Trial committees ........................................................................................................... 35 
8. 
PROTOCOL DEVIATIONS ............................................................................................. 35 
9. 
SERIOUS BREACHES .................................................................................................... 36 
10. ETHICAL AND REGULATORY CONSIDERATIONS ........................................................... 36 
10.1 Declaration of Helsinki ............................................................................................... 36 
10.2 Guidelines for Good Clinical Practice ......................................................................... 36 
10.3 Approvals  ................................................................................................................... 36 
10.4 Reporting .................................................................................................................... 36 
10.5 Participant Confidentiality ......................................................................................... 36 
10.6 Expenses and Benefits ................................................................................................ 37 

 
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11. FINANCE AND INSURANCE ......................................................................................... 37 
11.1 Funding ....................................................................................................................... 37 
11.2 Insurance .................................................................................................................... 37 
11.3 Contractual arrangements ......................................................................................... 37 
12. PUBLICATION POLICY ................................................................................................. 37 
13. DEVELOPMENT OF A NEW PRODUCT/ PROCESS OR THE GENERATION OF 
INTELLECTUAL PROPERTY .................................................................................................. 37 
14. ARCHIVING ................................................................................................................ 37 
15. REFERENCES ............................................................................................................... 37 
16. APPENDIX A: SCHEDULE OF PROCEDURES .................................................................. 39 
17. APPENDIX B: AMENDMENT HISTORY ......................................................................... 42 
18. APPENDIX C: SUPPLEMENTARY MATERIAL ................................................................. 43 
19 APPENDIX D: CASE REPORT FORMS .............................................................................. 48 
 

 
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1.  BACKGROUND and RATIONALE  
 
Despite high uptake of vaccination against COVID-19, the disease remains prevalent in Norway 
and in many countries around the world, with many people continuing to be infected and 
requiring hospital admission. COVID-19 causes considerable suffering, including loss of ability 
to perform activities of daily living, loss of educational and work opportunities, and inability 
to perform caring duties, with far reaching personal and societal consequences1,2. A 
considerable burden of long term complications has been reported after COVID (named long 
COVID) affecting more than 50% of cases after home isolation of mild cases, but are 
particularly associated with more severe disease where up to 80% have symptoms after six 
months (2). Nearly half of home isolated individuals still had persisting symptoms 12 months 
after COVID-19, with high risk of fatigue, memory problems, concentration problems and 
dyspnea3. Worryingly, the prevalence of memory problems increased overall from 6 to 18 
months. Reports have shown some reduction of persisting symptoms when patients have 
been vaccinated before SARS-CoV-2 infection, but the degree of protection is yet to be 
established1. People with underlying health conditions, unvaccinated people, and those in 
whom the vaccine is not effective are at increased risk of more severe disease4. Moreover, 
new ‘vaccine escaping’ variants may yet emerge, potentially expanding the population at risk 
of persisting and/or relapsing symptoms of COVID-19. Early treatment with antiviral agents 
may prevent progression to the later phase of COVID-19. Therefore, there is an urgent need 
to identify treatments for COVID-19 for use in the community early on in the illness that 
prevent the need for hospital admission, improves time to recovery and potentially reduce 
long term sequelae5, 6. Antiviral agents may reduce viral load and shedding, and use of antiviral 
agents may lead to the emergence of resistance to novel antiviral agents, but the impact of 
novel antiviral agents on shedding and resistance is not yet known7. In a placebo controlled 
trial, treatment of symptomatic Covid-19 with Paxlovid (nirmatrelvir plus ritonavir) was safe 
and reduced the risk of progression to severe Covid-19 by 89% compared to placebo8. 
However, any effect of Paxlovid on long term complications after COVID-19 has yet to be 
shown.  
 
1.1 Aims and Objectives  
The primary objective is to to investigate if early treatment with Paxlovid (nirmatrelvir plus 
ritonavir) for patients with acute COVID (confirmed PCR or lateral flow test) can reduce long 
term complications (long COVID).  
 
Long COVID will be defined as one or more of the new-onset symptoms fatigue, dyspnoea and 
cognitive difficulties. 
 
The secondary objective is to determine whether early COVID treatment with Paxlovid will 
reduce all-cause, non-elective hospitalisation or death within 28 days of randomisation. 
Secondary objectives will further include to examine Paxlovid treatment affects time to self-
reported recovery; participant reported illness severity; duration of symptoms and symptom 
recurrence; healthcare service use; participant reported household infection rate; safety 
outcomes and cost-effectiveness outcomes; symptoms and well-being at six months (with 
determination of proportion with Long Covid) from randomisation. See Table 1 for details of 
objectives and outcome measures. 
 
 
Table 1. Objectives and Outcome Measures 

 
11 
 
 
 
Objectives 
Outcome Measures  
Timepoint (s)  
Primary  
To determine whether 
Paxlovid treatment in 
the community 
reduces risk of long-
term complications of 
COVID-19 (long COVID) 
Presence of long-
COVID 
 3 months after 
randomisation 
Secondary  
To determine whether 
Paxlovid treatment in 
the community safely 
reduces non-elective 
overnight 
hospitalisations/ 
deaths in  
symptomatic patients 
with confirmed COVID-
19  
 
 
 
To explore whether 
Paxlovid treatment 
affects  
 
1) Time to recovery 
(defined as the first 
instance that a 
participant report of 
feeling recovered from 
the illness)  
 
2) Participant reported 
illness severity, 
reported by daily 
rating of how well 
participant feels, 
enabling identification 
of sustained recovery.  
 
3) Duration of 
symptoms and 
symptom recurrence 
 
 
 
4) To determine 
whether Paxlovid 
treatment in the 
community safely 
reduces contacts with 
the health services  
All cause, non-elective 
hospitalisation and/or 
death, within 28 days 
of randomisation 
 
 
 
 
 
 
 
 
 
 
 
 
 
1-3) Participant 
reported symptoms 
daily for 7 days, weekly 
for 28 days and at 3 
and 6 months. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
4) Contacts with health 
services reported by 
participants and/or 
Within 28 days of 
randomisation  
Participant report, 
review of health 
registry data for up to 
1 year (Norwegian 
Patient Registry, 
Norwegian Pandemic 
Registry and 
Norwegian Cause of 
Death Registry) 
 
 
 
 
 
 
1-3) Online participant 
report daily for 7 days, 
weekly for 28 days and 
at 3 and 6 months.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
4) Online participant 
report daily for 7 days, 
weekly for 28 days and 
at 3 and 6 months. 

 
12 
 
 
 
 
 
 
 
 
 
 
 
5) To determine 
whether Paxlovid 
treatment in the 
community safely 
reduces new infections 
in household  
 
 
 
6) To investigate the 
safety of Paxlovid 
 
 
 
 
7) To investigate the 
longer term effects  
 
 
 
 
8) To investigate the 
cost effectiveness  
 
captured by review for 
health registries 
 
 
 
 
 
 
 
 
5) New infections in 
the household 
reported by the 
participants 
 
 
 
 
 
6) Evaluation of overall 
safety of drugs by the 
monitoring of adverse 
events  
 
 
7) Well-being, 
symptoms and health 
care utilisation  
 
 
 
8) Resource use and 
cost data   
Review of health 
registry data for up to 
one year (Norwegian 
Patient Registry, 
Norwegian Pandemic 
Registry and Norwegian 
Registry for Primary 
Health Care) 
 
5) Online participant 
report day 0 – 6, 
weekly for 28 days  
 
 
 
 
 
 
6) For the duration of 
the antiviral course 
and 3 months after 
inclusion 
 
 
7) Online participant 
report at six months, 
health registry search 
for up to one year  
 
 
8) Baseline, Day 28 and 
at 3 months.  
 
 
Exploratory subproject 
1.  
Primary 
1) To investigate the 
relationship between 
long COVID, 
neurocognitive 
dysfunction and 
alterations in the brain 
neural connectome. 
1) Data from fMRI, EEG 
and 
neuropsychological 
assessment.  
1) 3 and 6 months 

 
13 
 
 
Secondary 
To document long 
COVID associated 
changes in 
 
1) The brain volume 
 
 
2) The brain resting 
state activity 
 
 
3) The neural 
connectome 
 
 
4) The brain activity 
during cognitive tasks 
 
 
5) Cognitive domain 
functions 
 
 
 
 
 
1) Volumetric data 
from MRI 
 
2) Data from fMRI 
 
 
 
3) Diffusion tensor MRI 
data 
 
 
4) Alfa and theta 
frequencies registered 
with EEG 
 
5) Neuropsychological 
assessment 
 
 
 
 
1) 3 and 6 months 
 
 
2) 3 and 6 months 
 
 
 
3) 3 and 6 months 
 
 
 
4) 3 and 6 months 
 
 
 
5) 3 and 6 months 
Exploratory subproject 
2 
Primary 
1) To investigate the 
relationship between 
long COVID and 
persistent 
inflammation, and 
identify biological, 
immune and 
inflammatory  
markers 
 
1) study duration up to 
12 months  
Secondary 
1) SARS CoV-2 specific 
antibodies 
2) SARS-CoV-2 specific 
B cells 
3) Markers of immune 
activation and cellular 
exhaustion  
4) SARS CoV-2 specific 
T-cell responses  
5) 
phenotyping 
of 
leukocyte subsets  
1) SARS CoV-2 specific 
binding 
and 
neutralising 
antibodies 
2) SARS-CoV-2 specific 
B cells by ELISpot and 
flow cytometry 
3) Immune activation, 
cellular 
exhaustion, 
extracellular 
matrix 
and 
markers 
of 
impaired blood-brain-
barrier function  
4) SARS CoV-2 specific 
T-cell memory and 
exhaustion responses 
5) deep phenotyping 
1-5) baseline, 3-12 
months 

 
14 
 
 
of leukocyte subsets 
by mass cytometry,  
 
 
1.2 Risk Benefit assessment 
The available safety data in the EU risk management plan for paxlovid (pf-
07321332/ritonavir)  indicates that PF-07321332/ritonavir has a favourable safety profile in 
the population studied. No safety signals have been identified. PF-07321332/ritonavir was 
well tolerated for 5 days of dosing in high-risk COVID-19 individuals. Overall, no previously 
unknown important risks have been identified.  
The most important known risk factors are hepatic impairment, and  renal impairment, as 
well as women who are pregnant and lactating. These patients groups are excluded from 
this study. Any ongoing or new symptoms are systematically collected at all study time 
points. 
Studies to date have not identified any new major risks. 
The potential benefit to the participant is early treatment of COVID-19, thereby avoiding 
serious disease, hospitalisation and death. 
2. TRIAL DESIGN AND PROCEDURES  
PANORAMIC Norway is a two-arm 1:1 randomized double-blind, placebo-controlled 
prospective, clinical trial in community care. Trial arms will include:  
 
Intervention arms: The antiviral agent Paxlovid (nirmatrelvir plus ritonavir) in addition to 
standard of care 
 
Comparator arm: Placebo plus standard of care.  
 
Any use of over-the-counter medication as well as key medications such as inhaled steroids 
and monoclonal antibodies will be captured, and changing outcomes and treatment 
modalities over time will be accounted for in the analysis.  
 
2.1 Participant Identification  
 
2.1.1 Trial Participants  
The trial includes participants who test positive for SARS-CoV-2 infection, and with ongoing 
symptoms consistent with COVID-19, who are not hospitalised, and who are aged between 18 
years and 65 years of age. 
 

 
15 
 
 
2.1.2 Inclusion Criteria  
• Symptoms attributable to COVID-19 started within the past 5 days and ongoing  
• Positive PCR or lateral flow SARS-CoV-2 test. Any positive PCR test or a lateral flow test 
taken between two days before symptom onset and randomisation qualifies. 
• Age between 18 and 65 years 
• Participant is able and willing to provide informed consent  
• Willingness to take a pregnancy test prior to starting study treatment (Participants of 
childbearing potential)  
•  
 
2.1.3 Exclusion Criteria  
• Patients that are not able to comply with all study visits 
• Patient currently inpatient at hospital  
• Comorbidity which requires active antiviral treatment as judged by the investigator 
• Any chronic renal impairment 
• Any chronic liver disease or liver impairment 
• Previous randomisation in the PANORAMIC Norway trial  
• Currently participating in a clinical trial of a therapeutic agent  
• Currently taking Paxlovid 
• Known allergy to Paxlovid 
• Use of concomitant medication contraindicated for the treatment of Paxlovid* 
• Pregnant and lactating women 
• Participants of childbearing potential (participants who are anatomically and 
physiologically capable of becoming pregnant), or have a partner of childbearing 
potential, not willing to use highly effective contraceptive until 7 days after completing 
Paxlovid.  
 
* Concomitant medications that are contraindicated for the treatment of Paxlovid  
 
• Medicinal products that are highly dependent on CYP3A for clearance and for which 
elevated concentrations are associated with serious and/or life-threatening reactions.  
• Medicinal products that are potent CYP3A inducers where significantly reduced 
nirmatrelvir/ritonavir plasma concentrations may be associated with the potential for 
loss of virologic response and possible resistance.  
• Paxlovid cannot be started immediately after discontinuation of any of the following 
medicinal products due to the delayed offset of the recently discontinued CYP3A 
inducer.  
 
Medicinal products listed below are a guide and not considered a comprehensive list of all 
possible medicinal products that are contraindicated with Paxlovid. Further guidance on 
contraindicated concomitant medication is provided in the SmPC. 
 • Alpha1-adrenoreceptor antagonist: alfuzosin  
 • Analgesics: pethidine, piroxicam, propoxyphene  
 • Antianginal: ranolazine  
 • Anticancer drugs: neratinib, venetoclax  
 • Antiarrhythmic: amiodarone, bepridil, dronedarone, encainide, flecainide, propafenone, 
 quinidine  
 • Antibiotics: fusidic acid, rifampicin  

 
16 
 
 
 • Anticonvulsants: carbamazepine, phenobarbital, phenytoin  
 • Anti-gout: colchicine  
 • Antihistamines: astemizole, terfenadine  
 • Antipsychotics/neuroleptics: lurasidone, pimozide, clozapine, quetiapine  
 • Ergot derivatives: dihydroergotamine, ergonovine, ergotamine, methylergonovine  
 • GI motility agents: cisapride  
 • Herbal products: St. John’s wort (Hypericum perforatum)  
 • Lipid-modifying agents:  
  
o HMG Co-A reductase inhibitors: lovastatin, simvastatin  
  
o Microsomal triglyceride transfer protein (MTTP) inhibitor: lomitapide  
 • PDE5 inhibitor: avanafil, sildenafil, vardenafil  
 • Sedative/hypnotics: clorazepate, diazepam, estazolam, flurazepam, oral midazolam and 
 triazolam 
 
 
 
2.2 Trial procedures 
 
2.2.1 Recruitment 
Potential participants can present directly to the trial team via the trial website or telephone. 
Dissemination of trial information and recruitment of potential trial participants will 
commence through several channels: 
 
I. 
All health professionals (including primary care physicians and Test and Trace staff, 
pharmacy staff, etc.) will be able to provide information about participation and direct 
potential participants to the online trial information and the trial website.  
II. 
Media campaigns will use television, radio and social media platforms to generate 
awareness of the trial and to sign-post to the trial.  
III. 
All facilities including testing centres and municipality centres will be able to inform 
potentially eligible participants about the trial, and refer them to the trial website 
and/or trial team.  
IV. 
Clinicians can reach out to potentially eligible participants identified by receiving SARS-
CoV-2 test results from Test and Trace and laboratories, and by regular searches for 
patients with a positive SARS-CoV-2 test result in their clinical database. Contact can 
be made with potential participants verbally or by text, email, and telephone.  
V. 
PraksisNett, a data extraction service for primary care data, and analogous general 
practice clinical record facilities, will be able to reach out to potentially eligible 
participants and signpost them to the PANORAMIC Norway website to explore their 
participation.  
 
2.2.2 Screening and eligibility 
Remote screening and eligibility procedures will be used.  
Screening information will be completed during a telephone call with a member of the trial 
team. A member of the trial team (medically qualified clinician or appropriately trained 
research nurse) will then confirm eligibility. 
 
Eligibility can be assessed by eliciting medical history and relevant information directly from 
the participant, and the participant can be randomised if there is no contraindication to the 

 
17 
 
 
study drugs currently in the trial. Where necessary, eligibility checking will be assessed 
additionally through direct access to the participant’s Medical Record (or similar medical 
record summary), or by reference to relevant medical information obtained from the 
participant’s primary care medical practice.  
 
For participants who are too unwell or unable to respond to surveys themselves, a Study 
Partner who they identify will be able to assist their participant in completing screening, 
baseline, and follow up online forms and/or calls and provide information to them on their 
behalf where necessary.  
 
2.2.3 Informed Consent  
 
Eligible participants will be asked to physically attend the study central site for enrolment in 
the study.  Written informed consent will be provided after a two-way discussion between a 
member of the trial team and the participant, where the risks and benefits of taking part and 
follow-up procedures will be explained.  Adults who lack capacity to consent will not be 
recruited.  
 
Prior to consent, written and summary versions of the Patient Information Sheet (PIS), and 
Informed Consent Form (ICF) will be available to participants detailing no less than: the exact 
nature of the trial; and the known side-effects and risks involved in taking part. It will be clear 
that the participant is free to withdraw from the study at any time. Adequate time will be 
given to the participant to consider the information and to ask any questions about the trial 
before deciding whether to participate.  
 
After informed consent is signed, participants will enter online baseline information, including 
demographics, comorbidities, concomitant medication, allergies, COVID vaccine history and 
previous COVID-19, residual symptoms of past COVID-19-infection, as well as their contact 
details and those of a Study Partner. Identifying a Study Partner is not a requirement of study 
participation.  
 
2.2.4 Randomisation  
A randomisation list will be generated by a qualified person not involved in the trial and 
forwarded directly to the company producing placebo capsules. Prior to the initiation of the 
study, the pharmaceutical company performing the encapsulation of the IMPs (Paxlovid and 
placebo) will assign study IDs to the medicinal packages based on the randomisation list. At 
inclusion, the trial team will allocate the participants to the next available study ID number 
and the corresponding Paxlovid/placebo medicinal package. No study procedures will occur 
until informed consent is signed.  
 
2.2.5 Blinding and code-breaking  
PANORAMIC Norway is a double-blinded placebo-controlled trial. If unblinding or code 
breaking is required, as requested by the protocol or the Data and Safety Monitoring 
Committee (DSMC) this will be made available to the DSMC. However, those managing the 
data will be blind to participant allocation.  
The trial team and recruiting clinicians will be blinded to emerging results of interim analyses. 
During the course of the trial, only the unblinding statisticians and the independent members 
of the DSMC will have access to the unblinded interim results.  
 

 
18 
 
 
2.2.6 Participants of child-bearing potential  
For the purpose of this document, a woman is considered of childbearing potential following 
menarche and until becoming post-menopausal unless permanently sterile. Permanent 
sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral 
oophorectomy. A postmenopausal state is defined as no menses for 12 months without an 
alternative medical cause.  
 
Paxlovid is not recommended during pregnancy and in women of childbearing potential not 
using contraception unless the clinical condition requires treatment with Paxlovid. 
 
To mitigate the risk of pregnancy in the trial, all participants of child-bearing potential will be 
required to take a urine pregnancy test prior to commencing trial treatment. Thus, they should 
indicate willingness to take such a pregnancy test at screening. Before starting the trial 
treatment the clinician/research nurse will explain to the participant that pregnancy is an 
exclusion criterion, and explain the contraception requirements during the trial. If the 
participant confirms that there is a possibility that they may be pregnant during this call, they 
will be excluded from taking part. The pregnancy test will be supplied in the participant pack 
with the antiviral agent, for women of childbearing potential. The pregnancy test must be 
completed prior to starting the trial treatment, and we will confirm a negative test result 
during the Day 1 telephone call with a member of the trial team.   
 
Highly effective contraception* is advised during the period of medication for women of 
childbearing potential. All male participants will also be required to use contraception as a 
precautionary measure for 7 days after completing Paxlovid if they have a partner of 
childbearing potential. This will be clearly explained prior to randomisation (see section 2.2.7 
Follow-up procedures for details regarding confirmation of a negative test result). Use of 
ritonavir may reduce the efficacy of combined hormonal contraceptives. Patients using 
combined hormonal contraceptives will be advised to use an effective alternative 
contraceptive method or an additional barrier method of contraception during treatment with 
Paxlovid, and until one menstrual cycle after stopping Paxlovid. 
 
Participants themselves will be asked on day 14,  day 28, and 3 months ECRF whether they 
have become pregnant since enrolling into the trial. These responses will be monitored and if 
a participant does become pregnant during the trial, follow-up information regarding the 
outcome of the pregnancy and any postnatal sequelae in the infant will be obtained. The CI or 
delegated individual will liaise with the relevant obstetrician or equivalent healthcare 
professional throughout the pregnancy until delivery to monitor for congenital abnormality or 
birth defect, at which the pregnancy would fall under the definition of serious and require 
reporting as an SAE. The DMSC will be informed of any pregnancies in this treatment group, 
in weekly safety reports. Pregnancies and outcomes will be included in annual safety reports. 
 
*Highly effective methods have typical-use failure rates of less than 1% and include 
sterilisation and long-acting reversible contraceptive (LARC) methods (intrauterine devices 
and implants) OR if a couple are using another method of contraception, such as a combined 
hormonal method, progestogen only pill or injection, they are only eligible if they are willing 
to use an additional barrier method (e.g. male condom). Note: a barrier method on its own is 
not sufficient. 
 

 
19 
 
 
2.2.7 Follow-up Procedures  
Follow-up will be via self-completed questionnaires online or through telephone calls.  
 
All patient-related procedures at Day 0 will occur after the informed consent form is signed. 
After enrolment at the study central site, participants will allocated to receive the trial drug 
(active ingredient or placebo) according to the randomization list (see section 3.1 Medication 
Distribution). The participant pack will contain: IMP (the antiviral agent or Placebo), an 
information booklet; medication card detailing how the medication should be administered, 
precautions and safety guidance; medication appendix providing further information about 
the treatment (available prior to randomisation as part of the PIS); emergency contact card; 
pregnancy test (only for participants of child-bearing potential).  
 
A safety call will be made on Day 1 (day after randomisation) to women of child-bearing 
potential by a member of the trial team. During this Day 1 call, a member of the trial team will 
confirm with participants of childbearing potential, that a pregnancy test has been done and 
that the result is negative before starting the study drug. In the event of a positive test result, 
the participant will be asked not to take any of the study drug, return it, and will be withdrawn 
from the trial. Results will be documented in the Day 1 Call CRF. The pregnancy test must be 
completed prior to taking the study drug and this will be clearly explained prior to 
randomisation.  
 
All participants, irrespective of group allocation, will be contacted on Day 2 (2 days after  
randomisation) to confirm follow-up procedures and answer queries. The contact may be 
either electronic or by phone. At this day 2 contact, compliance will be assessed and 
participants will be also asked if they are experiencing any potential side-effects.  
 
Participants on all arms of the trial will complete an electronic diary each day for 7 days, 
weekly for 28 days, and then at 3, 6, and 12  months from randomisation, where they will rate 
the severity of symptoms, record contacts with the health services (including hospital 
admissions, hospital outpatient visits, accident and emergency attendances, use of specialist 
services and primary care encounters), impact of symptoms on work/study, record study 
medication use and new infections in the household. We will collect the Chalder fatigue scale 
questionnaire and specific questions capturing relevant symptoms. Participants will be 
contacted at three and six months to ascertain wellbeing and longer-term consequences of 
their illness, including proportion with long Covid.  
 
The trial team will retrospectively retrieve relevant information from hospital records, 
Norwegian health registries, for example details concerning COVID-related hospital 
admittance (Norwegian Pandemic Registry), mortality and cause of death (Norwegian Cause 
of Death Registry), contacts with primary care (Norwegian Registry for Primary Health Care 
(KPR), COVID vaccine history (Norwegian Immunisation Registry (Sysvak)), drug prescription 
(Norwegian Prescription Database (NorPD), Norwegian Surveillance System for 
Communicable Diseases (MSIS) and sick leave (The Sickness Absence Registry). 
 
To investigate the impact of trial interventions on the longer-term effects of COVID-19, we will 
also remotely follow-up participants, for up to 1 year. 
 

 
20 
 
 
The research team will call participants/study partners with no internet access or those who 
have not completed their diary for at least two days before day 7. No more than two contact 
attempts will be made at each of these follow-up points. There will be a participant phone 
number accessible on weekdays. The municipality emergency facility (Legevakt), and the 
Emergency department of local hospitals will be made aware of the study and have contact 
information to study medical personnel. Study participants will be informed that they can at 
any time withdraw from the study. 
 
2.2.8 Exploratory subgroup studies  
A subgroup of up to 500 patients will be asked to attend a face-to-face visit or to donate a 
microbiological and/or blood sample for the purpose of the study, and to undergo 
neurocognitive testing and fMRI investigations, at 3, 6 and 12 months after inclusion. 
 
 
 
 
Exploratory Subprojects:  
1. Study on brain damage in long COVID.  
Hypothesis: Neuroimaging can identify brain structural or functional damage in long COVID 
patients that correlate with neuropsychological deficits. This project will include 50 patients 
without symptoms at 3 months and 50 patients with cognitive symptoms at 3 months, and 
they will be followed at 3-, 6- and 12-months post infection. Exploratory endpoints: 
Document the hypothesized relationship between long COVID, neurocognitive dysfunction 
and alterations in the brain neural connectome of patients with acute SARS-CoV-2 infection 
at 3- and-6-month time-points. The exploratory secondary outcomes will be (i) loss of brain 
volume assessed with volumetric MRI; (ii) reduced resting state activity evaluated with fMRI; 
(iii) quantified reduction in the neural connectome using diffusion tensor MRI; (iv) persistent 
slowing of brain activity registered with EEG in the alfa and theta frequencies at rest and 
during 
cognitive 
tasks; 
(v) 
quantification 
of 
cognitive 
domain 
functions 
with 
neuropsychological assessment.   
Data to be recorded Changes in brain volume, and density of white matter fiber tracts. 
Changes in brain activity using resting state fMRI and EEG registration at rest and during 
cognitive tasks. Document deficits in memory, spatial navigation, cortical motor control, 
concentration and focus control, mental endurance and affective processing.  
 
 
2. Immune profiling of COVID-19 patients with no or COVID sequalae.  
Hypothesis: Long COVID appears to be a state of immune dysfunction that involves persistent 
inflammation, and identification of biological, immune and inflammatory parameters of this 
dysfunction will reveal potential additional targets for intervention, risk prediction and 
prevention. 
Methods: Biological samples such as blood and respiratory samples will be collected during 
the acute phase and convalescent phase at appropriate time periods with possible follow up 
to 12 months. From the same group of 100 patients in subproject 1, supplemented with up to 
400 additional patients to a total of maximum 500 participants, follow-up blood samples will 
be collected to allow detailed immune profiling. Serum, EDTA plasma and PaxGene tubes will 
be collected (up to 50 ml). In a subset of subjects, peripheral blood mononuclear cells will be 
collected up to 50ml of blood. We will correlate SARS CoV-2 specific B-and-T cell functions and 
changes in inflammatory and immune markers with the severity of long COVID. We will 

 
21 
 
 
conduct state of the art immunological assays using established protocols to investigate (i) 
SARS CoV-2 specific binding and neutralising antibodies to SARS CoV-2 variants using ELISA 
and neutralisation assays (ii) Detection of SARS-CoV-2 specific B cells by ELISpot and flow 
cytometry, including deciphering B cell receptor signaling and recall responses in SARS CoV-2 
antigen specific B lymphocytes. (iii) Markers of immune activation/cellular exhaustion (e.g., 
TIM-3/LAG-3/CEACAM1), cellular senescence/accelerated aging (e.g., chitotriosidase and 
stathmin1), extracellular matrix remodeling (e.g., GDF-15 and osteopontin), vascular 
inflammation (e.g., von Willebrand Factor, CXCL16 and pentraxin-3) and markers of impaired 
blood-brain-barrier function (e.g., MADCAM, NCAD) will be measured by high-throughput 
ELISA in all participants during follow-up. Proteomics in serum plasma (OLINK Explore panel, 
>1500 analyses) and RNA sequencing and targeted/untargeted proteomic (Mass 
Spectrometry) on immune cells will be used as discovery platforms that among others will 
include analyses of DNA repair mechanisms and  mitochondrial function as well as epigenetic 
and epitransciptomic modifications . (iv) SARS CoV-2 antigen specific T-cell responses 
including memory and exhaustion markers and SARS-CoV-2 Spike specific CD4+ T cells will be 
assessed by ELISpot and multiparametric flow cytometry, (v) deep phenotyping of leukocyte 
subsets by mass cytometry, including T and B cells, monocyte, dendritic cells and NK cell 
subsets. 
 
3. Comparison to the UK PANORAMIC study 
The following comorbidities will specifically be identified: 
o chronic respiratory disease (including chronic obstructive pulmonary disease 
(COPD), cystic fibrosis and asthma requiring at least daily use of preventative 
and/or reliever medication)  
o chronic heart or vascular disease  
o chronic kidney disease  
o chronic liver disease  
o chronic neurological disease (including dementia, stroke, epilepsy)  
o severe and profound learning disability  
o Down’s syndrome  
o diabetes mellitus (Type or Type II)  
o immunosuppression: primary (e.g., inherited immune disorders resulting from 
genetic mutations, usually present at birth and diagnosed in childhood) or 
secondary due to disease or treatment (e.g., sickle cell, human immunodeficency 
virus (HIV), cancer, chemotherapy)  
o solid organ, bone marrow and stem cell transplant recipients  
o morbid obesity (body mass index (BMI) >35)  
o severe mental illness  
 
2.3 Economic evaluation  
A prospective economic evaluation will be embedded within the trial design to assess the cost 
effectiveness of Paxlovid9. We will estimate the resource inputs associated with embedding 
Paxlovid treatment into routine clinical practice, and estimate societal costs. Broader resource 
use will be drawn from General Practice Data (PraksisNett) and linked Hospital Episode 
Statistics – encompassing primary care encounters, hospital inpatient/day case admissions, 
outpatient visits, and accident and emergency attendances. Unit costs will be valued using 
national reference tariffs and attached to resource inputs to generate a compound total 
health care cost per trial participant over the trial time horizon. Secondary expressions of cost-

 
22 
 
 
effectiveness will include incremental cost per hospitalization and/or death prevented over 
28 days and 3 months.  
 
Bivariate regression of costs and measures of health consequence, with multiple imputation 
of missing data, will be conducted to generate within-trial estimates of incremental cost-
effectiveness. Sensitivity analyses will assess the impact of areas of uncertainty surrounding 
components of the economic evaluation. Cost-effectiveness acceptability curves will show the 
probability of cost-effectiveness of each treatment evaluated at alternative cost-effectiveness 
thresholds. Cost-effectiveness threshold values will be informed by guidance from Norwegian 
government departments on the value placed by decision-makers on an additional QALY10 and 
on a statistical life11.  
 
A decision-analytic modelling-based economic evaluation will also be conducted. The baseline 
decision-analytic model will be developed during the early stages of the study, and aim to 
provide a framework for extrapolating the cost-effectiveness of each antiviral beyond the 
parameters of PANORAMIC Norway trial. Accepted guidelines for good practice in decision-
analytic modelling will be followed. The model will consider the progression of symptomatic 
COVID-19 status over time, and the model structure will capture disease progression using 
health states that represent the important natural history and clinical- and event-related 
activity for symptomatic COVID-19 symptomatic status, the appropriate model type (e.g. 
Markov or discrete-event simulation approach) and the appropriate analytical framework (e.g. 
cohort analysis versus individual-level simulation). Parameter inputs into the model will be 
informed by data extracted from PANORAMIC Norway trial, supplemented by data identified 
from external sources following targeted literature searches. As with the within-trial economic 
evaluation, cost-effectiveness will be expressed in terms of incremental cost per QALY gained. 
Multi-parameter uncertainty in the model will be addressed using probabilistic sensitivity 
analysis. Cost-effectiveness acceptability curves will be used to show the probability of cost-
effectiveness of each anti-viral strategy at alternative cost-effectiveness thresholds held by 
decision-makers. Long-term costs and health consequences will be discounted using 
nationally recommended discount rates. Specific plans for the economic evaluation will be 
outlined in a pre-specified health economics analysis plan.  
 
2.4 Early Discontinuation/Withdrawal of Participants  
Each participant has the right to withdraw from the study at any time. In addition, the 
Investigator may discontinue a participant from the study at any time if the Investigator 
considers it necessary for any reason including:  
• Ineligibility (either arising during the study or retrospectively)  
• Withdrawal of consent  
 
The reason for withdrawal will be recorded. Data that has already been collected about the 
participant will be kept and used in the analyses of the trial. Withdrawn participants will not be 
replaced. 
 
2.5 Definition of End of Trial 
The end of the trial will be the timepoint for last controlled data capture of last participant.  
 

 
23 
 
 
2.6 Early termination  
The sponsor reserves the right to terminate the study at any time for any reason at the sole 
discretion of the sponsor. 
 
Further reasons for early discontinuation of the study may include: 
 
• 
Major safety concerns are revealed by the DSMC based on the interim-analysis or 
SAE/SUSAR reports. 
• 
Following a serious breach 
• 
Inadequate or no recruitment (evaluated after a reasonable amount of time) of 
participants by the investigator 
• 
Withdrawal of funding or study medication 
 
If the study is prematurely terminated or suspended, the sponsor shall promptly inform the 
investigators and the regulatory authorities of the reason for termination or suspension. The 
investigator shall promptly inform the participant and assure appropriate participant therapy 
and/or follow-up. 
 
3. TRIAL INTERVENTIONS  
 
3.1 Study interventions administered  
 
IMP: Paxlovid / placebo 
Participants will be randomised to Paxlovid or Placebo for five days. Randomisation will be 
performed by an external statistician prior to the study, by sending the randomisation list to 
the placebo producer where encapsulation of both intervention drug and placebo is 
performed. The placebo producer will label the containers of Paxlovid and placebo with 
numbers according to the randomization list.  
 
Dose  
1 dose Paxlovid contain 2x150 mg nirmatrelvir + 100 mg Ritonavir.  In this study the tablets 
are encapsulated to maintain blinding.  
 
2x150 mg nirmatrelvir + 100 mg Ritonavir for oral administration twice daily (every 12 hours) 
for 5 days 
 
3.2 Preparation, Handling, Storage, and Accountability  
 
a. Encapsulation and labelling 
Kragerø tablettproduksjon AS, Kirkegata 15, 3770 Kragerø will encapsulate and label the IMP 
for trial purposes in accordance with Annex 13.  
 
b. Medication Distribution  
Distribution of trial packs to participants will be performed at the central site at the time of 
enrolment (with appropriate infection control measures).   

 
24 
 
 
 
c. Storage 
Will be stored below 25 °C. Should not be refrigerated or freezed. Will be stored securely at 
clinical site with restricted access. 
 
d. Drug accountability 
Accountability logs will be kept by the distributor, study pharmacy and the study site, central 
monitoring of the logs will allow oversight by the study monitor.   
 
 
e. Drug Destruction/Returns 
Participants will receive IMP for 5 days treatment. Participants withdrawing for trial treatment 
prior to completing the 5 day treatment period be asked to return unused IMP to the site by 
post or in person. Unused study medication will be destroyed by an authorised third party. 
 
 
3.3 Medication adherence  
A safety call will be made to all participants on day 2 to ensure compliance and that the 
medication is used as prescribed. Moreover, medication adherence will be captured daily in 
the electronic diaries or in phone calls with the patient. The research team will call 
participants/study partners who have not completed their diary for at least two days before 
day 7. No more than five contact attempts will be made at each of these follow-up points. 
Deviation(s) from the prescribed dosage regimen will be recorded. 
 
 
3.4 Overdose 
Treatment of overdose with Paxlovid should consist of general supportive measures including 
monitoring of vital signs and observation of the clinical status of the patient. There is no 
specific antidote for overdose with Paxlovid. 
We will monitor potential overdoses by asking in the daily diary Day 1 – 7 whether the 
participant has taken more than the specified dose. A safety alert will be triggered if the 
participant records that they have exceeded the dose. A Doctor from the central clinical team 
will contact the participant immediately and follow-up accordingly, with a minimum of daily 
telephone calls for 7 days to monitor any potential AEs caused by the overdose. 
 
4. SAFETY REPORTING  
Symptoms, adverse events and Serious Adverse Events (SAE) will be collected from participant 
daily diaries, as well as calls to participants/Study Partners.  
 
We will adopt a risk assessed and proportionate approach to safety monitoring. In line with 
the SmPC, we will assess the risks and the safety profile, and detail the mitigation and 
monitoring procedures. All safety procedures will be according to NorCRINs standard 
operating procedures (Safety Reporting SOP).  
 
 
a. Reference Safety Information (RSI)  

 
25 
 
 
Current SmPC will be RSI for this trial 
 
Hazard  
Likelihood  
(L,M,H)  
Impact  
(L,M,H)  
Mitigation  
Monitoring  
1. Pregnancy:  
i. Potential 
teratogenicity  
 
ii. There are no 
human studies of 
use among 
pregnant or 
lactating people.  
 
H  
H  
Requirement for negative 
pregnancy test in participants 
of child-bearing potential, 
prior to starting medication.  
 
We will exclude known 
pregnancy, breastfeeding, and 
require participants to use 
adequate contraception for 
the duration of the treatment 
and 7 days of follow-up, 
including participants with a 
partner with child bearing 
potential.  
 
During the pre-randomisation 
call, 
the 
clinician/research 
nurse 
will 
confirm 
this 
exclusion criteria with the 
participant.  
Confirmation of negative 
pregnancy test documented 
in the Day 1 and/or Day 2 Call 
CRFs and Daily Diary  
 
We will monitor daily 
responses to the question 
‘have you become pregnant 
since starting the trial?’ and 
follow-up as required to 
immediately stop treatment, 
if applicable.  
 
 
 
Pregnancy occurring during 
the 28-day trial follow-up 
period will be reported as an 
AE of Special Interest.  
 
 
As per CTU SOP 
Pharmacovigilance, any 
pregnancy that occurs during 
IMP administration requires 
monitoring and follow-up 
until the outcome of the 
pregnancy is known. The CI or 
delegated individual will  
liaise with the relevant 
Obstetrician throughout the 
pregnancy.  
 
The DMSC will be informed of 
any 
pregnancies 
in 
this 
treatment group, in weekly 
safety reports.  
2. Unknown/other 
potential side- 
effects  
 
M  
M  
All participants will receive a 
call on day 1 to make sure 
that they understand the 
possible risks associated with 
Paxlovid and how to report 
potential side-effects and 
seek medical care if required.  
 
Participants will be provided 
with a 24 hour contact 
telephone line to report any 
AEs that they experience and 
are concerned about, directly 
to a clinician.  
 
We will collect symptoms and 
side effects from symptom 
The DMSC will review weekly 
reports of unblinded 
symptom data to identify 
potential side-effects of 
Paxlovid. Any safety signals 
will be communicated to the 
TSC and TMG.  
 
 
The TMG will monitor SAEs, 
AEs and calls to the 24hr safety 
phone line, for potential safety 
signals,  

 
26 
 
 
diaries 
and 
participant 
telephone calls.  
3. Compliance  
 
 
 
 
Participants will be asked in 
their daily diaries about trial 
medication use 
The trial team will monitor 
daily diary responses where 
the participant indicates that 
they have taken too much 
IMP, and escalate to the 
clinical team to follow-up with 
the participant.  
 
 
 
4.1 Procedures for Reporting Adverse Events (AE) and Serious Adverse Events 
The participant will be asked to rate the severity of a number key COVID-19 symptoms which 
are also possible common medication side effects in their daily diary. Symptoms of COVID-19 
and medication adverse event symptoms may overlap and can be difficult to disentangle. 
Trends in the prevalence in the severity of symptoms between Placebo/Usual Care and 
Paxlovid arms will be compared, for evidence of increased severity of measured symptoms in 
those randomised to receive Paxlovid.  
 
i. 
AE reporting  
 
AE Definition 
• An AE is any untoward medical occurrence in a clinical study participant, temporally 
associated with the use of study intervention, whether or not considered related to 
the study intervention. 
• NOTE: An AE can therefore be any unfavorable and unintended sign (including an 
abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally 
associated with the use of study intervention. 
 
 
AEs will be monitored from the start of treatment for 12 months, and assessed by a clinician 
(independent from the Sponsor) for causality and severity (definitions below).  
 
Participants will be free to withdraw from taking the IMP if they perceive they have an 
intolerable AE. Participants will also be provided with a Trial Wallet Emergency Card detailing 
potential side-effects and a contact telephone line, answered by a clinical team, enabling them 
to report AEs they experience whilst taking the drug. This card will also alert hospital clinicians 
about trial participation, should a participant be admitted to hospital. In the event of a medical 
emergency, trial participants will be instructed to show this card to the clinician they see. 
Based on clinical judgement, the clinician may contact the participant directly within 24 hours 
of becoming aware of an AE reported in their daily diary or on the study-specific telephone 
number, to advise the participant on the appropriate clinical care.  
 
ii. 
AE Severity Assessment (for assessing clinician)  
 
Clinical assessment of severity  

 
27 
 
 
GRADE 1 (Mild)  
Short-lived or mild symptoms; medication 
may be required. No limitation to usual 
activity  
GRADE 2 (Moderate)  
Moderate limitation in usual activity. 
Medication may be required.  
GRADE 3 (Severe)  
Considerable limitation in activity. 
Medication or medical attention required.  
 
 
iii. 
SAEs  
Definition of SAE 
An SAE is defined as any untoward medical occurrence that, at any dose, meets one or more 
of the criteria listed: 
a. 
Results in death 
b. Is life threatening 
The term life threatening in the definition of serious refers to an event in which the participant 
was at risk of death at the time of the event. It does not refer to an event, which hypothetically 
might have caused death, if it were more severe. 
c. 
Requires inpatient hospitalization or prolongation of existing hospitalization 
• In general, hospitalization signifies that the participant has been admitted (usually 
involving at least an overnight stay) at the hospital or emergency ward for observation 
and/or treatment that would not have been appropriate in the physician’s office or 
outpatient setting. Complications that occur during hospitalization are AEs. If a 
complication prolongs hospitalization or fulfills any other serious criteria, the event is 
serious. When in doubt as to whether hospitalization occurred or was necessary, the 
AE should be considered serious. 
• Hospitalization for elective treatment of a pre-existing condition that did not worsen 
from baseline is not considered an AE. 
d. Results in persistent or significant disability/incapacity 
• The term disability means a substantial disruption of a person’s ability to conduct 
normal life functions. 
• This definition is not intended to include experiences of relatively minor medical 
significance such as uncomplicated headache, nausea, vomiting, diarrhea, influenza, 
and accidental trauma (e.g. sprained ankle) that may interfere with or prevent 
everyday life functions but do not constitute a substantial disruption. 
e. Is a congenital anomaly/birth defect 
f. 
Other situations: 
• Medical or scientific judgment should be exercised by the investigator in deciding 
whether SAE reporting is appropriate in other situations such as important medical 
events that that may not be immediately life-threatening or result in death or 
hospitalization but may jeopardize the participant or may require medical or surgical 
intervention to prevent one of the other outcomes listed in the above definition. These 
events should usually be considered serious. 

 
28 
 
 
o Examples of such events include invasive or malignant cancers, intensive 
treatment in an emergency room or at home for allergic bronchospasm, blood 
dyscrasias, convulsions not resulting in hospitalization, or development of 
intervention dependency or intervention abuse. 
 
 
Definition of suspected unexpected serious adverse reaction (SUSAR) 
If an event is not an SAE per definition above, then it cannot be a SUSAR 
SUSAR Definition 
Adverse Reaction: all unwanted and unintended responses to an investigational medicinal 
product related to any dose administered.  
Unexpected Adverse Reaction: an adverse reaction, the nature or severity of which is not 
consistent with the applicable product information.  
Suspected Unexpected Serious Adverse Reaction: Unexpected Adverse Reaction that: 
• Results in death 
• Is immediately life-threatening 
• Requires in-patient hospitalization or prolongation of existing hospitalization 
• Results in persistent or significant disability or incapacity 
• Is a congenital abnormality or birth defect 
Is an important medical event that may jeopardize the subject or may require medical 
intervention to prevent one of the outcomes listed above. 
 
All-cause hospitalisation and death are secondary outcomes, and this data will be captured in 
CRFs. SAEs other than hospitalisation or death due to COVID-19 must be reported for Paxlovid.  
 
SAEs must be reported to sponsor by the person who has discovered the SAE or nominated 
delegate within 24 hours of becoming aware of the event. Some SAEs occurring within the 28-
day follow-up period, may be identified retrospectively from data extracts and not in real-
time. These will be reported within 24 hours of becoming aware of the event. The sponsor or 
delegate will ensure it is reviewed by the medical monitor or other delegated personnel for 
relatedness and expectedness as soon as possible taking into account the reporting time for a 
potential SUSAR according to the relevant competent authority. If the event has not resolved, 
at the 28-day time point the SAE will be reviewed again by the central clinical team, to see if 
resolution has occurred. If the event is considered ‘resolved’ no further follow up is required. 
If not, the event must be followed up until such a time point.  
 
All SAEs that have not resolved by the end of the study or those that are identified 
retrospectively, or that have not resolved upon discontinuation of the participant's 
participation in the study, must be followed until any of the following occurs:  
• The event resolves  
• The event stabilises  
• The event returns to “baseline”, if a “baseline” value/status is available  
• The event can be attributed to agents other than the study intervention or to factors 
unrelated to study conduct  
• It becomes unlikely that any additional information can be obtained (participant or health 
care practitioner refusal to provide additional information, lost to follow-up after 
demonstration of due diligence with follow-up efforts)  

 
29 
 
 
 
See Appendix C. Supplementary Material for definitions of adverse events  
 
4.1.1. Other events exempt from immediate reporting as SAEs  
Hospitalisations will be defined as at least a one-night admission to hospital. Hospitalisation 
for a pre-existing condition, including elective procedures planned prior to study entry, which 
has not worsened, does not contribute to the secondary outcome and does not constitute a 
SAE.  
 
4.1.2. Procedure for immediate reporting of Serious Adverse Events  
• Trial team/responsible clinician/CI will complete an SAE report form, directly into the 
database, for all reportable SAEs.  
• The trial team/RCGP will provide additional, missing or follow up information in a 
timely fashion.  
• If necessary, the participant may be contacted to provide additional, missing or follow 
up information as required.  
 
An investigator, will review the SAE once reported, collect as much information and report 
to the Sponsor delegate within the timeframe according to the NorCRINs Standard 
Operation Procedures (SOPs).  
 
 
4.1.3 Expectedness  
For SAEs that require reporting, expectedness of SAEs will be assessed and determined by the 
Medical Monitor who is unblinded, according to the relevant Reference Safety Information 
(RSI) section of the Summary of Product Characteristics. The RSI will be the current 
NoMA/EMA approved SmPC version at the time of the event occurrence.  
 
4.1.4 Assessment of Causality  
The relationship of each serious adverse event to Paxlovid must be determined by a medically 
qualified individual according to the following definitions:  
• Unrelated – where an event is not considered to be related to Paxlovid  
• Possibly – although a relationship to Paxlovid cannot be completely ruled out, the 
nature of the event, the underlying disease, concomitant medication or temporal 
relationship make other explanations possible.  
• Probably – the temporal relationship and absence of a more likely explanation suggest 
the event could be related to Paxlovid.  
• Definitely – the known effects of Paxlovid, its therapeutic class or based on challenge 
testing suggest that Paxlovid is the most likely cause.  
 
The investigator will make the assessment of causality.  
AEs/SAEs judged possibly, probably or definitely related will be considered as related to the 
antiviral agent.  
 
4.2 SUSAR Reporting  
All SUSARs will be reported by the sponsor delegate to the relevant Competent Authority and 
other parties as applicable. The period for the reporting of suspected unexpected serious 

 
30 
 
 
adverse reactions by the sponsor to the Agency shall take account of the seriousness of the 
reaction and shall be as follows:  
(a) in the case of fatal or life-threatening suspected unexpected serious adverse reactions, as 
soon as possible and in any event not later than seven days after the sponsor became aware 
of the reaction;  
(b) in the case of non-fatal or non-life-threatening suspected unexpected serious adverse 
reactions, not later than 15 days after the sponsor became aware of the reaction;  
(c) in the case of a suspected unexpected serious adverse reaction which was initially 
considered to be non-fatal or non- life threatening but which turns out to be fatal or life-
threatening, as soon as possible and in any event not later than seven days after the sponsor 
became aware of the reaction being fatal or life-threatening. 
 
 
4.3 Annual Report   
The Annual report be developed and submitted annually 60 days after the anniversary date 
that the trial receives Clinical Trial Authorisation. Due to the nature of this trial and the 
importance of sharing the science of COVID-19 and the drug, internationally, we expect to 
produce reports to the Norwegian Government and regulatory agency more frequently upon 
request.  
 
5. STATISTICS  
 
5.1 Statistical Analysis Plan (SAP)  
Details of the statistical design and methods for the PANORAMIC Norway trial and are 
described in the Statistical Analysis Plan (SAP version 1.0, dated 28.2.2023).  
 
5.2 Research hypothesis  
Antiviral treatment of acute Covid can prevent occurrence of persisting symptoms at 3 
months and beyond. 
 
5.3 Outcome definitions  
A total of 13 symptoms will be recorded. The following symptoms are recorded as binary 
variables: fever, tingling sensation, headache, dizziness, altered taste/smell, sleep 
disturbances, chest-pain, muscle/joint pains, nausea. The following will be recorded as 
graded symptoms (better than usual, as usual, worse than usual, much worse than usual): 
fatigue, dyspnea, memory problems, concentration problems, feeling depressed. 
Additionally, we will record, absence from work/school (number of days), hospitalization 
(number of days), any contact with doctor / emergency clinic. 
 
5.3.1 Primary efficacy endpoints 
The primary outcome is a dichotomous variable for presence of any of the three most 
important long-COVID symptoms: (i) fatigue, (ii) dyspnea and (iii) cognitive symptoms 
(defined as memory and/or concentration problems). The outcome is coded 1 for the 
presence of any one or more of these 3 symptoms, and 0 for absence of all the 3 symptoms.  
The primary outcome will first be evaluated at 3-months follow-up, and then re-evaluated at 
6-, 12- and 24-months follow-up. 

 
31 
 
 
 
5.3.2 Secondary endpoints 
Secondary outcomes include assessment of the intervention’s effect on: 
- 
All individual symptoms separately, and grouped by systems (systemic symptoms, 
chest-symptoms, cognitive, other neuropsychiatric symptoms). 
- 
Graded responses for separate symptoms and symptom constellations, including an 
ordinal variable graded 0-3 for the presence of the 3 symptoms in the primary outcome. 
- 
Severity of acute disease using an 8-step scale (ref: Beigel, NEJM) (score) 
- 
Hospitalization (binary) 
- 
Mortality at three months (binary) 
- 
Severe adverse events (binary) 
- 
Absence from work (binary)  
- 
Societal cost / economic analysis, including estimated cost of absence from 
work/school, hospitalizations, deaths, QALYs lost according to EQ-5D-5L, and more. 
 
5.4 Randomization and allocation 
Participants will be randomized to antiviral treatment or placebo using fixed equal allocation 
ratios. An external statistician will produce a randomization list that will be given to the 
pharmaceutical company packaging interventional drugs and placebo. The active drugs and 
placebos will be coated by the company so that they look identical, and packages will appear 
identical. Packages will be labeled with the ID number on the randomization list and patients 
will be allocated with this ID number.  At the time of inclusion in the study, study personnel 
will blindly allocate participants to receive active ingredient or placebo according to the 
randomization list. 
 
5.5 Primary Analysis Population  
The primary analysis will be an “intention to treat” analysis performed on all patients who 
were allocated to receive the investigational medicinal product according to the 
randomisation list.  In addition, per protocol analysis will be performed for patients who 
reported to have adhered to the ingestion of the study product (antiviral or placebo), and on 
other subgroups of the study population. If adherence is incomplete, we will attempt to 
estimate the biological effect of the medication by using instrumental variable analysis.  
 
5.6 Withdrawal / follow-up 
Participation is based on informed voluntary consent. Participants may withdraw at any time 
of the study without giving reasons or justification. Upon withdrawal, no further data will be 
collected. However, data recorded up until the time of withdrawal will be included in the 
analysis. 
 
5.7 Analysis methods 
The primary outcome, i.e. the effect of intervention on a binary variable for the presence of 
any of 3 key long-COVID symptoms, will be analyzed with an appropriate logistic regression 
model. Depending on whether we obtain a good balance of prognostic factors between the 
randomized groups, we may consider adjustment for prognostic factors in the analyses. We 
will typically report an odds ratio with 95% confidence intervals and a p-value from this 
analysis.  
 

 
32 
 
 
In the analysis of follow-up data up to 24 months, we will use appropriate mixed models to 
account for correlation of symptoms over time. We will estimate the main effect of 
treatment and test whether the effect is uniform over time. 
 
Secondary outcomes will be analyzed with appropriate regression models depending on the 
type of outcome variable. For binary outcomes, we will use logistic regression. For number 
of symptom counts, we will consider negative binomial regression and for score outcomes 
we will attempt ordinal logistic regression and quantile regression. Using quantile regression 
models, we will estimate the effect of the intervention also in the tails of the score-
distribution. 
 
Further analysis plans include cost-efficacy analyses and explorative analyses. We will 
estimate the resource inputs associated with providing the antiviral treatment in routine 
clinical practice. Societal costs will be estimated using data on primary care encounters, 
hospital inpatient/day case admissions, outpatient visits, and accident and emergency 
attendances. Loss of quality-adjusted life year (QALY) will be estimated. Unit costs will be 
valued using national reference tariffs. Compound total health care cost per trial participant 
over the trial time horizon will be estimated. Secondary expressions of cost-effectiveness will 
include incremental cost per hospitalization and/or death prevented over 28 and 60 days. 
Relevant data may be obtained from registries, including emergency hospitalization events 
(Norwegian Patient Registry (NPR)) and Norwegian Pandemic Registry (NIPaR), mortality and 
cause of death (Norwegian Cause of Death Registry), contacts with primary care (Norwegian 
Registry for Primary Health Care (KPR)), drug prescription (Norwegian Prescription Database 
(NorPD) and sick leave (The Sickness Absence Registry). Cost-effectiveness will be expressed 
in terms of incremental cost per QALY gained. 
 
Bivariate regression of costs and measures of health consequence, with multiple imputation 
of missing data, will be conducted to generate within-trial estimates of incremental cost-
effectiveness. Sensitivity analyses will assess the impact of areas of uncertainty surrounding 
components of the economic evaluation. The probability of cost-effectiveness at alternative 
thresholds will be measured. Cost-effectiveness threshold values will be informed by 
guidance from government departments on the value placed by decision-makers on an 
additional QALY10 and on a statistical life.   
 
Statistical analysis will be performed in Stata version 17 (StataCorp LLC, College Station, 
Texas) and R version 4.2.2 or higher (The R Foundation for Statistical Computing, Vienna, 
Austria). All the relevant regression models are fully implemented in Stata. If imputation is 
considered necessary or useful, regression analysis with multiple imputation will be 
performed in Stata using the mi-command.  Mixed effects models analysis in R will be 
performed using the “lme4” or “lmerTest” packages, and imputation will be performed using 
the mice.impute.bygroup function in the “mice” and “miceadd” libraries in R. We will 
develop scripts in both systems and check the results for consistency. 
 
5.8 Reporting of statistical results 
Analysis results for the primary outcome will be reported as odds ratio with 95% confidence 
interval with P-value. The standard cut-off of p<0.05 will be used for statistical significance 
levels. For secondary outcomes we will report appropriate effects measures with 95% 
confidence intervals without p-values. Type I error will be controlled at the traditional 0.05 

 
33 
 
 
two-sided level for the hypothesis test. We will perform a hypothesis test only for the 
primary outcome and we will not need to adjust for multiple tests.   
 
5.9 Sample size justification 
We expect to be able to recruit around 2000 patients for randomization in the Norway 
study. The presence of long covid is our primary endpoint. Prior knowledge suggest that long 
covid may be present among approximately 50% of the patients. With a total sample size of 
around 2000 we will be able to detect a 16% treatment effect with a power of 90% (5% 
significance level, Table 1x). If the prevalence of long covid drops to 40% or 30% in the 
placebo-group, we will still have 90% power to detect a 17.5% or 21.7% treatment effect, 
respectively, with a total sample size of approximately 2000. 
 
Table 1x: Sample size scenarios  
90% power and 5% significance level, two-sided test of superiority  
Placebo* 
Treatment* 
Treatment effect 
NNT 
Total sample size 
50% 
42.5% 
16% 
14 
1908 
40% 
33% 
17.5% 
15 
2042 
30% 
23.5% 
21.7% 
16 
2008 
* Expected prevalence of primary outcome 
 
5.10 Interim analysis and stopping guidance 
Interim analysis will be performed when 1000 patients have reached 28 days follow-up 
assessing any deaths and hospitalizations occurring in the study population.   
The study will be stopped if the proportion of deaths at 28 days follow-up is higher in one of 
the groups by a significance of p<0.02 and effect size of odds ratio > 4. 
 
Severe adverse events will be reported consecutively to the DSMB. The DSMB will evaluate 
this independently of the interim analysis.   
 
5.11 Procedures for Reporting Unplanned Deviation(s) from the Master 
Statistical Analysis Plan  
Any deviations from the protocol will be documented in a protocol deviation form and filed in 
the study master file. A NorCRIN SOP is in place describing the procedure for identifying non-
compliances, escalation to the central team and assessment of whether a non-compliance 
/deviation may be a potential Serious Breach. Analyses will be carried out in accordance with 
the SAP. Any additional analysis that is not specified in the SAP or any unplanned deviation(s) 
from the SAP will be specified in the Statistical Analysis Report. Reasons for these changes will 
be documented and authorized by the Chief Investigator. 
6. DATA MANAGEMENT  
The data management aspects of the study are summarised here with details fully described 
in the Data Management Plan.  
 
6.1 Source Data  
Source documents are where data are first recorded. CRF entries will be considered source 
data where no other primary record is documented. The trial team will use Norwegian health 
registries as source data for relevant medical information, including emergency 
hospitalization events (Norwegian Patient Registry (NPR)), details concerning COVID-related 

 
34 
 
 
hospital admittance (Norwegian Pandemic Registry), mortality and cause of death (Norwegian 
Cause of Death Registry), contacts with primary care (Norwegian Registry for Primary Health 
Care (KPR)), COVID vaccine history (Norwegian Immunisation Registry (Sysvak)), drug 
prescription (Norwegian Prescription Database (NorPD), Norwegian Surveillance System for 
Communicable Diseases (MSIS) and sick leave (The Sickness Absence Registry). 
Data collected will include participant identifiable information and will be accessed at the 
Haukeland University Hospital/ University of Bergen according to CTU Information 
Governance policies and Norwegian GDPR. Data will only be held for the duration it is 
required; this will be reviewed annually.  
 
All documents will be stored safely in confidential conditions. On all study-specific documents, 
other than the signed consent, the participant will be referred to by the study participant 
number/code, not by name.  
 
6.2 Access to Data  
Direct access will be granted to authorised representatives from the Sponsor, host institution, 
and the regulatory authorities to permit trial-related monitoring, audits and inspections.  
 
6.3 Data Recording and Record Keeping  
The Investigators will maintain appropriate medical and research records for this trial, in 
compliance with the requirements of the Clinical Trials Regulation, no. 536/, ICH E6 GCP and 
regulatory and institutional requirements for the protection of confidentiality of volunteers. 
The Chief Investigator, Principal Investigator, Co-Investigators, clinical team, including Study 
Nurses, and other authorised members of the trial team will have access to records. The 
Investigators will permit authorised representatives of the sponsor, and regulatory agencies 
to examine (and when required by applicable law, to copy) clinical records for the purposes of 
quality assurance reviews, audits and evaluation of the study safety and progress.  
The data will be entered into CRFs in an electronic format by the participant, trial Partner, or 
trial team using the secure cloud hosted SAFE server located at the University of Bergen, 
Norway. Data will be entered in a web browser and then transferred to the database by 
encrypted (Https) transfer. This includes safety data, laboratory data and outcome data. 
Safety data will be collected through electronic diaries. Risks are mitigated using the ISO97001 
framework.  
An online secure data entry system designed to collect sensitive data, such as participant and 
Study Partner contact details, will be used. All identifiable participant data is encrypted. The 
participant portal will also manage electronic patient reported outcome data. Participant and 
Trial Partner data will be kept and stored securely for as long as it’s required by the study and 
reviewed on annual basis.  
 
7. QUALITY ASSURANCE PROCEDURES 
  
The study will be conducted in accordance with the current approved protocol, ICH-GCP, 
relevant regulations and NorCRIN SOPs. All investigators, coordinating centre staff and site 
staff will receive training in trial procedures according to ICH-GCP where required. Regular 
monitoring will be performed according to ICH-GCP using a risk-based approach. Data will be 
evaluated for compliance with the protocol and accuracy in relation to source documents 
where possible.  
 

 
35 
 
 
The NorCRIN-CTU Trial Management Group will be responsible for the monitoring of all 
aspects of the trial’s conduct and progress and will ensure that the protocol is adhered to and 
that appropriate action is taken to safeguard participants and the quality of the trial itself. The 
TMG will be comprised of individuals responsible for the trial’s day to day management and 
will meet regularly throughout the course of the trial.  
 
7.1 Risk assessment and Monitoring  
A risk assessment and monitoring plan will be prepared before the study opens and will be 
reviewed as necessary over the course of the study to reflect significant changes to the 
protocol or outcomes of monitoring activities. Monitoring will be performed by the monitors 
from NorCRIN. The level of monitoring required will be informed by the risk assessment.  
 
7.2 Trial committees  
The responsibilities of each group are as follows:  
• Data and Safety Monitoring Committee (DSMC) will review the data received from the 
SAC at each interim analysis as described in the Statistical Analysis section, in order to 
ensure that the process is working correctly and to review and monitor the accruing 
data to ensure the rights, safety and wellbeing of the trial participants. Composition, 
and roles and responsibilities of the DSMC are detailed in the DSMC charter. The DSMC 
reviews data from interim analyses and makes recommendations to the TSC if safety 
concerns have emerged.  
• Trial Steering Committee (TSC) will ensure the rights, safety and wellbeing of the trial 
participants. They will make recommendations about how the study is operating, any 
ethical or safety issues and any data being produced from other relevant studies that 
might impact the trial. Composition, and roles and responsibilities of the TSC are 
detailed in the TSC charter. The TSC advises the TMG about the conduct of the study 
and stopping randomisation to study arms (based on recommendations received from 
the DSMC and/or relevant information external to the trial). If national 
recommendations in standard of care changes during the study period, the TSC will 
make recommendations to the TMG regarding potential new risks or benefits. 
• The Statistical Analysis Committee (SAC) will perform interim analysis and report these 
to the DSMC. The TMG will remain blind to these interim analyses until a 
recommendation is received form the TSC about stopping randomisation or safety 
concerns.  
• Trial Management Group (TMG) – will be responsible for the day-to-day running of the 
trial, including monitoring all aspects of the trial and ensuring that the protocol is being 
adhered to. It will include Co-Investigators and will meet weekly in the first instance. 
Composition, and roles and responsibilities of the TMG are detailed in the TMG 
charter.  
• A core project team (PT) from within the TMG will meet weekly or as required for 
operational decision making (meet daily at the start of the trial).  
 
8. PROTOCOL DEVIATIONS  
 
A study related deviation is a departure from the ethically approved study protocol or other 
study document or process (e.g. consent process or administration of study intervention) or 
from Good Clinical Practice (GCP) or any applicable regulatory requirements. Any deviations 

 
36 
 
 
from the protocol will be documented in a protocol deviation form and filed in the study 
master file.  
A NorCRIN SOP is in place describing the procedure for identifying non-compliances, 
escalation to the central team and assessment of whether a non-compliance /deviation may 
be a potential Serious Breach.  
 
9. SERIOUS BREACHES  
 
A “serious breach” is a breach of the protocol or of the conditions or principles of Good Clinical 
Practice which is likely to affect to a significant degree –  
 
a) the safety or physical or mental integrity of the trial subjects; or  
b) the scientific value of the research.  
 
In the event that a serious breach is suspected the Sponsor must be contacted within one 
working day. In collaboration with the CI, the serious breach will be reviewed by the Sponsor 
and, if appropriate, the Sponsor will report it to the approving Norwegian Medicines Agency 
(NoMA) within seven calendar days.  
 
10. ETHICAL AND REGULATORY CONSIDERATIONS  
 
10.1 Declaration of Helsinki  
The Investigators will ensure that this study is conducted in accordance with the principles of 
the Declaration of Helsinki.  
 
10.2 Guidelines for Good Clinical Practice  
The Investigators will ensure that this trial is conducted in accordance with relevant 
regulations and with Good Clinical Practice.  
 
10.3 Approvals  
Following Sponsor approval, the protocol, informed consent form, participant information 
sheets and any proposed informing material will be submitted to an appropriate Research 
Ethics Committee (REC) and regulatory authorities for written approval. The PI will ensure and 
confirm correct regulatory approvals are gained prior to recruitment.  
The Investigator will submit and, where necessary, obtain approval from the above parties for 
all substantial amendments to the original approved documents.  
 
10.4 Reporting  
The CI shall submit once a year throughout the clinical trial, to NoMA. In addition, an End of 
Trial notification and final report will be submitted to NoMA.  
 
10.5 Participant Confidentiality  
The study will comply with the Norwegian General Data Protection Regulation (GDPR) and 
Data Protection Act 2018, which require data to be anonymised as soon as it is practical to do 
so. The processing of the personal data of participants will be minimised by making use of a 
unique participant study number only on all study documents and any electronic database(s). 

 
37 
 
 
A separate electronic file will be securely stored providing linkage between the unique 
participant identification numbers and the contact details. All documents will be stored 
securely and only accessible by study staff and authorised personnel. The study staff will 
safeguard the privacy of participants’ personal data.  
 
10.6 Expenses and Benefits  
There will be no prescription charges for trial antiviral agents incurred by trial participants. 
11. FINANCE AND INSURANCE  
 
11.1 Funding  
The study is funded by the Norwegian Ministry of Health (MoH) through the KlinBeForsk 
programme, funds from the Regional Health Authority of Western Norway, the Municipality 
of Bergen and the University of Bergen.  
The MoH will provide the antiviral agents to be evaluated in the trial without cost to the trial 
budget for trial use.  
 
11.2 Insurance  
Patients are insured in accordance with the Product Liability Act in the Drug Insurance and the 
Patient Injuries Act.  
 
11.3 Contractual arrangements  
Appropriate contractual arrangements will be put in place with all third parties. 
  
12. PUBLICATION POLICY  
The Investigators (those listed on the protocol and others to be decided at publication) will be 
involved in reviewing drafts of the manuscripts, abstracts, press releases and any other 
publications arising from the study. Authors will acknowledge the study funders. Authorship 
will be determined in accordance with the ICMJE guidelines and other contributors will be 
acknowledged.  
 
13. DEVELOPMENT OF A NEW PRODUCT/ PROCESS OR THE GENERATION OF 
INTELLECTUAL PROPERTY  
Ownership of IP generated by employees of Helse Bergen and the University vests in the 
institutions. Helse Bergen and the University will ensure appropriate arrangements are in 
place as regards any new IP arising from the trial.  
 
14. ARCHIVING  
Archiving will be done according to the NorCRIN SOP and study specific working instructions. 
Research documents with personal information, such as consent forms, will be held securely 
at the University of Bergen’s archiving facility according to the NorCRIN Archiving SOP.  
 
15. REFERENCES  
 

 
38 
 
 
1. Blomberg B, Cox RJ, Langeland N. Long COVID: A growing problem in need of intervention. 
Cell Rep Med. 2022 Feb 14;3(3):100552.  
2. Blomberg B, Mohn KG, Brokstad KA, Zhou F, Linchausen DW, Hansen BA, Lartey S, Onyango 
TB, Kuwelker K, Sævik M, Bartsch H, Tøndel C, Kittang BR; Bergen COVID-19 Research Group; 
Cox RJ, Langeland N. Long COVID in a prospective cohort of home-isolated patients. Nat Med. 
2021 Sep;27(9):1607-1613. 
3. Fjelltveit EB, Blomberg B, Kuwelker K, Zhou F, Onyango TB, Brokstad KA, Elyanow R, Kaplan 
IM, Tøndel C, Mohn KGI, Özgümüş T, Cox RJ, Langeland N; Bergen COVID-19 Research Group. 
Symptom burden and immune dynamics 6 to 18 months following mild SARS-CoV-2 infection 
-a case-control study. Clin Infect Dis. 2022 Aug 12:ciac655 
4. Hippisley-Cox J, Coupland CA, Mehta N, Keogh RH, Diaz-Ordaz K, Khunti K, et al. Risk 
prediction of covid-19 related death and hospital admission in adults after covid-19 
vaccination: national prospective cohort study. BMJ. 2021;374:n2244.  
5. Stokel-Walker C. The search for antivirals for covid-19. BMJ. 2021;374:n2165.  
6. Kim PS, Read SW, Fauci AS. Therapy for Early COVID-19: A Critical Need. JAMA. 
2020;324(21):2149-50.  
7. Cevik M, Tate M, Lloyd O, Maraolo AE, Schafers J, Ho A. SARS-CoV-2, SARS-CoV, and MERS-
CoV viral load dynamics, duration of viral shedding, and infectiousness: a systematic review 
and meta-analysis. Lancet Microbe. 2021;2(1):e13-e22.  
8. Hammond J, Leister-Tebbe H, Gardner A, Abreu P, Bao W, et al. EPIC-HR Investigators. Oral 
Nirmatrelvir for High-Risk, Nonhospitalized Adults with Covid-19. N Engl J Med. 2022 Apr 
14;386(15):1397-1408.  
9. Butler CC, Hobbs FDR, Gbinigie OA, Rahman NM, Hayward G, Richards DB, et al. 
PANORAMIC Trial Collaborative Group. Molnupiravir plus usual care versus usual care alone 
as early treatment for adults with COVID-19 at increased risk of adverse outcomes 
(PANORAMIC): an open-label, platform-adaptive randomised controlled trial. Lancet. 2022 
Dec 22:S0140-6736(22)02597-1. 10. National Institute for Health and Care Excellence (NICE). 
NICE Guide to the methods of technology appraisal London, UK: NICE; 2013 [Available from: 
http://www.nice.org.uk/article/pmg9/resources/non-guidance-guide-to-the-methods-
oftechnology-appraisal-2013-pdf. 11. HM Treasury. The Green Book. Appraisal and Evaluation 
in 
Central 
Government. 
2020 
[Available 
from: 
https://www.gov.uk/government/publications/the-green-book-appraisal-and-evaluationin-
central-governent.  
12. Gastine S, Pang J, Boshier FAT, Carter SJ, Lonsdale DO, Cortina-Borja M, et al. Systematic 
Review and Patient-Level Meta-Analysis of SARS-CoV-2 Viral Dynamics to Model Response to 
Antiviral Therapies. Clin Pharmacol Ther. 2021;110(2):321-33.  
13. Laouenan C, Guedj J, Mentre F. Clinical trial simulation to evaluate power to compare the 
antiviral effectiveness of two hepatitis C protease inhibitors using nonlinear mixed effect 
models: a viral kinetic approach. BMC Med Res Methodol. 2013;13:60.  
 
 

 
39 
 
 
16. APPENDIX A: SCHEDULE OF PROCEDURES 
  

40 
 
Procedures 
Day 0  
Day 1  
Day 2  
Diary day 0-7, 14, 21 and 
28, and 3 and 6 months  
Day 0 – Up to 
1 year  
3 months 
6 months 
12 months 
 
Eligibility, consent and 
baseline completed by 
participant and trial team# 
Telephone call: 
confirm 
pregnancy test  
Telephone call 
to all 
participants  
Symptom Diaries completed 
by participant online/ phone  
Retrospective 
data collection 
by study team $ 
Exploratory 
substudies  
Exploratory 
substudies  
Exploratory 
substudies  
Informed consent  
X 
 
 
 
 
 
 
 
Questionnaire 
 
 
 
X 
 
 
 
 
Pregnancy test 
confirmation 
 
X£ 
 
  
 
 
 
 
Demographics 
X 
 
 
 
 
 
 
 
Medical history 
X 
 
 
 
X 
 
 
 
Concomitant medications 
X 
 
 
 
X 
 
 
 
Eligibility assessment 
X 
 
 
 
 
 
 
 
Randomisation 
X 
 
 
 
 
 
 
 
Dispensing of trial drugs 
X 
 
 
 
 
 
 
 
Compliance 
 
 
X 
X 
 
 
 
 
Primary endpoint and 
secondary outcomes 
 
 
 
X 
X 
 
 
 
Adverse event 
assessments 
 
 
X 
X 
 
 
 
 
Evidence of sequalae and 
health care utilization 
 
 
 
X 
X 
 
 
 
Blood samples 
exploratory substudy 
X 
 
 
 
 
X 
X 
X 
Sputum sample 
exploratory substudy 
X 
 
 
 
 
 
 
 
MRI 
 
 
 
 
 
X 
X 
 
EEG 
 
 
 
 
 
X 
X 
 
 The trial team will retrospectively retrieve relevant information from Norwegian health registries, including emergency hospitalization events (Norwegian Patient Registry (NPR)), details concerning 
COVID-related hospital admittance (Norwegian Pandemic Registry), mortality and cause of death (Norwegian Cause of Death Registry), contacts with primary care (Norwegian Registry for Primary 
Health Care (KPR)), COVID vaccine history (Norwegian Immunisation Registry (Sysvak)), drug prescription (Norwegian Prescription Database (NorPD), Norwegian Surveillance System for Communicable 
Diseases (MSIS) and sick leave (The Sickness Absence Registry). 
 All patient-related procedures at Day 0 will occur after the informed consent form is signed.    

41 
 
 Further pregnancy testing (home test) may be done during the course of the study should pregnancy be suspected

 
42 
 
Følsomhet Intern (gul) 
17. APPENDIX B: AMENDMENT HISTORY  
Amendment 
No.  
Protocol 
Version No.  
Date issued  
Author(s) of 
changes  
Details of Changes made  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Lists details of all protocol amendments whenever a new version of the protocol is produced.  
 
Protocol amendments must be submitted to the Sponsor for approval prior to submission to the 
REC committee, HRA (where required) and/or MHRA. 

 
43 
 
Følsomhet Intern (gul) 
18. APPENDIX C: SUPPLEMENTARY MATERIAL 
A. Abbreviations 
3CLpro 
3C-like protease 
ADR 
Adaptive Design Report 
AE  
Adverse event  
AR  
Adverse reaction  
AUC24 
Area under the curve at 24 hours 
BMI 
Body Mass Index 
CACE 
CACE - Complier Average Causal Effect 
CD4 
Cluster of differentiation 4 
CI  
Chief Investigator  
CRF  
Case Report Form  
CT  
Clinical Trials  
CTA  
Clinical Trials Authorisation  
CTU 
Clinical Trials Unit 
CYP3A 
Cytochrome P450 3A4 
DHSC  
Department of Health and Social Care  
DSMC  
Data Monitoring Committee / Data and 
Safety Monitoring Committee  
DSUR  
Development Safety Update Report  
eCFR 
electronic Case Report Form 
EDTA 
Ethylenediaminetetraacetic acid 
EEG 
Electroencephalogram 
ELISpot 
Enzyme-linked immune absorbent spot 
EMA 
Emergency Medical Assistance 
EPIC-HR 
Evaluation of Protease Inhibition for 
Covid-19 in High-Risk Patients 
fMRI 
functional Magnetic Resonance Imaging 
GCP  
Good Clinical Practice  
GDF-15 
Growth differentiation factor 15 
GDPR 
General Data Protection Regulation 
GP  
General Practitioner  
GPDPR  
General Practice Data for planning and 
research  
HCP  
Healthcare professional  
HMG Co-A 
3-hydroxy-3-methylglutaryl coenzyme A 
HRA  
Health Research Authority  
HUS 
Haukeland University Hospital 
IB  
Investigators Brochure  
ICF  
Informed Consent Form  
ICH  
International Conference on 
Harmonization  
ICMJE 
International Committee of Medical 
Journal Editors 
IGS 
Department of Global Public Health and 
Primary Care, UiB 
IMP  
Investigational Medicinal Product  
K2 
Department of Clinical Science, UiB 

 
44 
 
Følsomhet Intern (gul) 
KPR 
Norwegian Registry for Primary Health 
Care 
LAG-3 
Lymphocyte-activation gene 3 
LARC 
Long-acting reversible contraceptive 
mAb 
monoclonal antibody treatment 
MAdCAM 
Mucosal addressin cell adhesion 
molecule 
MHRA  
Medicines and Healthcare products 
Regulatory Agency  
mITT 
modified intent-to-treat 
MoH 
Norwegian Ministry of Health 
Mpro 
SARS-CoV-2 main protease 
MRI 
Magnetic resonance imaging 
M-SAP 
Master Statistical Analysis Plan 
MSIS 
Norwegian Surveillance System for 
Communicable Diseases 
NCAD 
Neuronal cadherin 
NHS  
National Health Service  
NNT 
Numbers to treat 
NoMA 
Norwegian Medicines Agency 
NorCRIN 
Norwegian Clinical Research 
Infrastructures Network 
NorPD 
Norwegian Prescription Database 
NPR 
Norwegian Patient Registry 
NTNU 
Norwegian University of Science and 
Technology 
PANORAMIC Norway 
PAxlovid loNg cOvid-19 pRevention 
triAl with recruitMent In the 
Community in Norway 
PCR 
Polymerase chain reaction 
PDE5 
Phosphodiesterase type 5 
PI  
Principal Investigator  
PIS  
Participant/ Patient Information Sheet  
PraksisNett 
General Practice Data 
PT 
Core project team 
QALY 
Quality-adjusted life year 
RCGP 
Royal College of General Practitioners 
RCT 
Randomized controlled trial 
REC  
Research Ethics Committee  
RSI  
Reference Safety Information  
SAC 
Statistical Analysis Committee 
SAE  
Serious Adverse Event  
SAR  
Serious Adverse Reaction  
SDV  
Source Data Verification  
SmPC  
Summary of Medicinal Product 
Characteristics  
SOP  
Standard Operating Procedure  

 
45 
 
Følsomhet Intern (gul) 
SUSAR  
Suspected Unexpected Serious Adverse 
Reactions  
Sysvak 
Norwegian Immunisation Registry 
TIM-3 
T-cell immunoglobulin mucin-3 
TSC  
Trial Steering Committee  
TMF  
Trial Master File  
TMG 
Trial Management Group 
UiB 
University of Bergen 
 
 
 
 
 
B. Key Trial Contacts 
 
 
 
Chief Investigator  
Professor Nina Langeland 
E mail: Nina.langeland@uib.no 
+47 416 16 450
Mobile: 
 
 
Sponsor  
Department of Medicine 
Helse Bergen HF 
Jonas Lies Vei 87 
N5021 Bergen, 
Norway  
 
Funder(s)  
KlinBeForsk programme, 
Regional Health Authority of Western Norway  
Municipality of Bergen  
University of Bergen 
 
Statistician  
Professor Rolv Terje Lie 
E mail: rolv.lie@uib.no 
Mobile: +47 930 87 160 
Committees  
DSMC Chair:  
Bjørn Tore Gjertsen, Haukeland University Hospital 
DSMC Members:  
Knut Engedal, University of Oslo 
 
TSC Chair  
Pål Aukrust, Oslo University Hospital 
TSC Members 
Axel Sandvig, NTNU 
Maja Wilhelmsen, UNN  
Rolv Terje Lie, UiB 
Tuva Børresdatter Dahl, OUD 
Nina Langeland, HUS/UiB 
PPI representatives  
TBC 

 
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C. Adverse Events 
Definitions 
Adverse Event (AE)  
Any untoward medical occurrence in a participant to whom a 
medicinal product has been administered, including occurrences 
which are not necessarily caused by or related to that product.  
Adverse Reaction (AR)  
An untoward and unintended response in a participant to an 
investigational medicinal product which is related to any dose 
administered to that participant.  
The phrase "response to an investigational medicinal product" 
means that a causal relationship between a trial medication and an 
AE is at least a reasonable possibility, i.e. the relationship cannot be 
ruled out.  
All cases judged by either the reporting medically qualified 
professional or the Sponsor as having a reasonable suspected causal 
relationship to the trial medication qualify as adverse reactions.  
Serious Adverse Event 
(SAE)  
A serious adverse event is any untoward medical occurrence that:  
• 
results in death  
• 
is life-threatening  
• 
requires inpatient hospitalisation or prolongation of existing 
hospitalisation  
• 
results in persistent or significant disability/incapacity  
• 
consists of a congenital anomaly or birth defect*.  
 
Other ‘important medical events’ may also be considered a serious 
adverse event when, based upon appropriate medical judgement, 
the event may jeopardise the participant and may require medical or 
surgical intervention to prevent one of the outcomes listed above.  
NOTE: The term "life-threatening" in the definition of "serious" 
refers to an event in which the participant was at risk of death at the 
time of the event; it does not refer to an event which hypothetically 
might have caused death if it were more severe.  
*NOTE: Pregnancy is not, in itself an SAE. In the event that a 
participant or their partner becomes pregnant whilst taking part in a 
clinical trial or during a stage where the foetus could have been 
exposed to the medicinal product (in the case of the active 
substance or one of its metabolites having a long half-life) the 
pregnancy should be followed up by the investigator until delivery 
for congenital abnormality or birth defect, at which point it would 
fall within the definition of “serious”.  
Serious Adverse 
Reaction (SAR)  
An adverse event that is both serious and, in the opinion of the 
reporting Investigator, believed with reasonable probability to be 
due to one of the trial antiviral agents, based on the information 
provided.  

 
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Suspected Unexpected 
Serious Adverse 
Reaction (SUSAR)  
A serious adverse reaction, the nature and severity of which is not 
consistent with the Reference Safety Information for the medicinal 
product in question set out:  
• 
in the case of a product with a marketing authorisation, in 
the approved summary of product characteristics (SmPC) for 
that product  
• 
in the case of any other investigational medicinal product, in 
the approved investigator’s  
 
 
NB: To avoid confusion or misunderstanding the difference between the terms “serious” and 
“severe”, the following note of clarification is provided: “Severe” is often used to describe 
intensity of a specific event, which may be of relatively minor medical significance.  
 
 

 
48 
 
Følsomhet Intern (gul) 
19. APPENDIX D: CASE REPORT FORMS 
 
 

 
49 
 
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Covid-19 infeksjon: Panoramic Norway dag 0 
 
Dato i dag:            /             /              . 
 
Pasient ID______________________ 
 
1. Etter du testet positiv, har du nå plager som du ikke hadde før Covid-19? 
 
□ Feber  
 
 
 
 
 
 
□ Magesmerter 
□ Tung pust 
 
 
 
 
 
 
□ Redusert lukte/smakssans 
□ Prikking/nummenhet i armer/ben/kropp  
 
 
□ Sliten 
□ Hodepine 
 
 
 
 
 
 
□ Søvnproblemer 
□ Svimmelhet 
 
 
 
 
 
 
□ Redusert hukommelse 
□ Hjertebank 
 
 
 
 
 
 
□ Konsentrasjonsproblemer 
□ Kvalme 
 
 
 
 
 
 
□ Brystsmerter 
□ Oppkast 
 
 
 
 
 
 
□ Muskel eller leddsmerter 
□ Diare  
 
 
 
 
 
 
□ Deprimert/nedfor 
□ Andre symptomer, nevn hvilke: ___________________ 
□ Nei, ingen symptomer 
 
2. Har du noen kroniske sykdommer? 
      □ Nei                    □ Ja  
 
 
à   Hvis ja, hvilke sykdommer: 
 
□ Diabetes 
□ Astma eller KOLS 
□ Medfødte sykdommer slik som Down’s sykdom 
□ Hjertesykdom eller høyt blodtrykk 
□ Hjernesykdom (slag, demens, epilepsi) 
□ Revmatisk sykdom 
□ Annen kronisk sykdom. Vennligst spesifiser:                                                                            .  
 
3. Bruker du noen faste medisiner? 
  □ Nei  
  □ Ja   
 
 
à   Navn på medisin (nevn alle): _____________________________________ 
 
4. Høyde:            cm 
 
Vekt:           kg 
5. Har du tidligere testet positiv for Covid-19? 
    ☐ Nei  
      ☐ Ja     
 
à   Hvis ja, hvor mange ganger? ___________________  
à   Dato eller måned og år siste gang du testet positiv ___________________  

 
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6. Har du tatt Covid-19 vaksine?  
☐ Nei 
 
☐ Ja     
à   Hvis ja, hvor mange doser? ___________________  
à   Når var siste dose? ___________________  
7. Hva var din yrkessituasjon før du fikk covid denne gangen? 
□ I jobb 
 
□ Student 
□ Sykmeldt 
□ Arbeidsledig           □ Ufør 
                               
□ Pensjonist 
8. Hvor mange bor i husstanden inkludert deg:   
Antall barn under 18: ________ 
Antall voksne: ________ 
9. Har du tidligere gjennomført MR av hodet? 
 
☐ Nei 
 
☐ Ja     
 
 
 

 
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Covid-19 infeksjon: Panoramic Norway dag 1 
 
Pasient ID                                   Dato i dag:       /____        
 
1. Tok du alle studiemedisinene i går?  
 
□ Nei  
□ Ja 
à    Hvis nei, hvor mange tabletter tok du? _____________________________ 
 
2. Har du symptomer i dag? 
        
 
□ Feber  
 
 
 
 
 
□ Redusert lukte/smakssans 
□ Tung pust 
 
 
 
 
 
□ Mer sliten 
□ Prikking/nummenhet i armer/ben/kropp  
 
□ Søvnproblemer 
□ Hodepine 
 
 
 
 
 
□ Redusert hukommelse 
□ Svimmelhet 
 
 
 
 
 
□ Konsentrasjonsproblemer 
□ Hjertebank 
 
 
 
 
 
□ Brystsmerter 
□ Kvalme 
 
 
 
 
 
□ Hoste 
□ Oppkast 
 
 
 
 
 
□ Utslett  
□ Diare  
 
 
 
 
 
□ Muskel eller leddsmerterel 
□ Magesmerter  
 
 
 
 
□ Deprimert/nedfor 
□ Andre symptomer, nevn hvilke: ___________________________________________  
 
    
□ Nei, ingen symptomer  
 
 
3. Har du vært innlagt sykehus?                    □ Nei                  □ Ja 
4.  Har du vært i kontakt med fastlege eller legevakt på grunn av covid? 
            □ Nei                  □ Ja 
5. (Spm. til kvinner) Hvis du fikk graviditetstest hos oss i går, var den positiv?           □ Nei                   □ Ja 
 
 
 
 

 
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Covid-19 infeksjon: Panoramic Norway dag 2 
 
Pasient ID:                                   Dato i dag:       /       /___   
        
1. Tok du alle studiemedisinene i går?  
 
□ Nei 
 
□ Ja 
à Hvis nei, hvor mange tabletter tok du? _____________________________ 
 
2. Har du symptomer i dag? 
        
 
□ Feber  
 
 
 
 
 
□ Redusert lukte/smakssans 
□ Tung pust 
 
 
 
 
 
□ Mer sliten 
□ Prikking/nummenhet i armer/ben/kropp  
 
□ Søvnproblemer 
□ Hodepine 
 
 
 
 
 
□ Redusert hukommelse 
□ Svimmelhet 
 
 
 
 
 
□ Konsentrasjonsproblemer 
□ Hjertebank 
 
 
 
 
 
□ Brystsmerter 
□ Kvalme 
 
 
 
 
 
□ Hoste 
□ Oppkast 
 
 
 
 
 
□ Utslett  
□ Diare  
 
 
 
 
 
□ Muskel eller leddsmerterel 
□ Magesmerter  
 
 
 
 
□ Deprimert/nedfor 
□ Andre symptomer, nevn hvilke: ___________________________________________  
 
     
□ Nei, ingen symptomer  
 
 
3. Har du vært innlagt sykehus?                    □ Nei                  □ Ja 
4. Har du vært i kontakt med fastlege eller legevakt på grunn av covid? 
            □ Nei                  □ Ja 
 
 
 
 
 

 
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Covid-19 infeksjon: Panoramic Norway dag 3 
 
Pasient ID:                                   Dato i dag:       /       /___          
 
1. Tok du alle studiemedisinene i går?  
 
□ Nei 
 
□ Ja 
à Hvis nei, hvor mange tabletter tok du? _____________________________ 
 
2. Har du symptomer i dag? 
        
 
□ Feber  
 
 
 
 
 
□ Redusert lukte/smakssans 
□ Tung pust 
 
 
 
 
 
□ Mer sliten 
□ Prikking/nummenhet i armer/ben/kropp  
 
□ Søvnproblemer 
□ Hodepine 
 
 
 
 
 
□ Redusert hukommelse 
□ Svimmelhet 
 
 
 
 
 
□ Konsentrasjonsproblemer 
□ Hjertebank 
 
 
 
 
 
□ Brystsmerter 
□ Kvalme 
 
 
 
 
 
□ Hoste 
□ Oppkast 
 
 
 
 
 
□ Utslett  
□ Diare  
 
 
 
 
 
□ Muskel eller leddsmerterel 
□ Magesmerter  
 
 
 
 
□ Deprimert/nedfor 
□ Andre symptomer, nevn hvilke: ___________________________________________  
 
      
□ Nei, ingen symptomer  
 
 
3. Har du vært innlagt sykehus?                    □ Nei                  □ Ja 
4.  Har du vært i kontakt med fastlege eller legevakt på grunn av covid? 
            □ Nei                  □ Ja 
 
 
 
 

 
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Covid-19 infeksjon: Panoramic Norway dag 4 
 
Pasient ID:                                   Dato i dag:       /       /_____         
  
1. Tok du alle studiemedisinene i går?  
 
□ Nei 
 
□ Ja 
à Hvis nei, hvor mange tabletter tok du? _____________________________ 
 
2. Har du symptomer i dag? 
        
 
□ Feber  
 
 
 
 
 
□ Redusert lukte/smakssans 
□ Tung pust 
 
 
 
 
 
□ Mer sliten 
□ Prikking/nummenhet i armer/ben/kropp  
 
□ Søvnproblemer 
□ Hodepine 
 
 
 
 
 
□ Redusert hukommelse 
□ Svimmelhet 
 
 
 
 
 
□ Konsentrasjonsproblemer 
□ Hjertebank 
 
 
 
 
 
□ Brystsmerter 
□ Kvalme 
 
 
 
 
 
□ Hoste 
□ Oppkast 
 
 
 
 
 
□ Utslett  
□ Diare  
 
 
 
 
 
□ Muskel eller leddsmerterel 
□ Magesmerter  
 
 
 
 
□ Deprimert/nedfor 
□ Andre symptomer, nevn hvilke: ___________________________________________  
                
□ Nei, ingen symptomer  
 
 
3. Har du vært innlagt sykehus?                    □ Nei                  □ Ja 
4.  Har du vært i kontakt med fastlege eller legevakt på grunn av covid? 
            □ Nei                  □ Ja 
 
 
 
 
 

 
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Covid-19 infeksjon: Panoramic Norway dag 5 
 
Pasient ID:                                   Dato i dag:       /       /____ 
          
1. Tok du alle studiemedisinene i går?  
 
□ Nei 
 
□ Ja 
à Hvis nei, hvor mange tabletter tok du? _____________________________ 
 
2. Har du symptomer i dag? 
        
 
□ Feber  
 
 
 
 
 
□ Redusert lukte/smakssans 
□ Tung pust 
 
 
 
 
 
□ Mer sliten 
□ Prikking/nummenhet i armer/ben/kropp  
 
□ Søvnproblemer 
□ Hodepine 
 
 
 
 
 
□ Redusert hukommelse 
□ Svimmelhet 
 
 
 
 
 
□ Konsentrasjonsproblemer 
□ Hjertebank 
 
 
 
 
 
□ Brystsmerter 
□ Kvalme 
 
 
 
 
 
□ Hoste 
□ Oppkast 
 
 
 
 
 
□ Utslett  
□ Diare  
 
 
 
 
 
□ Muskel eller leddsmerterel 
□ Magesmerter  
 
 
 
 
□ Deprimert/nedfor 
□ Andre symptomer, nevn hvilke: ___________________________________________  
 
          
□ Nei, ingen symptomer  
 
 
3. Har du vært innlagt sykehus?                    □ Nei                  □ Ja 
4.  Har du vært i kontakt med fastlege eller legevakt på grunn av covid? 
            □ Nei                  □ Ja 
 
 
 
 
 

 
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Covid-19 infeksjon: Panoramic Norway dag 6 
 
Pasient ID:                                   Dato i dag:       /       /____        
   
1. Tok du alle studiemedisinene i går?  
 
□ Nei 
 
□ Ja 
à Hvis nei, hvor mange tabletter tok du? _____________________________ 
 
2. Har du symptomer i dag? 
        
 
□ Feber  
 
 
 
 
 
□ Redusert lukte/smakssans 
□ Tung pust 
 
 
 
 
 
□ Mer sliten 
□ Prikking/nummenhet i armer/ben/kropp  
 
□ Søvnproblemer 
□ Hodepine 
 
 
 
 
 
□ Redusert hukommelse 
□ Svimmelhet 
 
 
 
 
 
□ Konsentrasjonsproblemer 
□ Hjertebank 
 
 
 
 
 
□ Brystsmerter 
□ Kvalme 
 
 
 
 
 
□ Hoste 
□ Oppkast 
 
 
 
 
 
□ Utslett  
□ Diare  
 
 
 
 
 
□ Muskel eller leddsmerterel 
□ Magesmerter  
 
 
 
 
□ Deprimert/nedfor 
□ Andre symptomer, nevn hvilke: ___________________________________________  
 
 
□ Nei, ingen symptomer  
 
 
3. Har du vært innlagt sykehus?                    □ Nei                  □ Ja 
4.  Har du vært i kontakt med fastlege eller legevakt på grunn av covid? 
            □ Nei                  □ Ja 
 
 
 
 
 
 

 
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Covid-19 infeksjon: Panoramic Norway dag 7 
 
Pasient ID:                                   Dato i dag:       /       /____       
 
1. Har du symptomer i dag? 
        
 
□ Feber  
 
 
 
 
 
□ Redusert lukte/smakssans 
□ Tung pust 
 
 
 
 
 
□ Mer sliten 
□ Prikking/nummenhet i armer/ben/kropp  
 
□ Søvnproblemer 
□ Hodepine 
 
 
 
 
 
□ Redusert hukommelse 
□ Svimmelhet 
 
 
 
 
 
□ Konsentrasjonsproblemer 
□ Hjertebank 
 
 
 
 
 
□ Brystsmerter 
□ Kvalme 
 
 
 
 
 
□ Hoste 
□ Oppkast 
 
 
 
 
 
□ Utslett  
□ Diare  
 
 
 
 
 
□ Muskel eller leddsmerterel 
□ Magesmerter  
 
 
 
 
□ Deprimert/nedfor 
□ Andre symptomer, nevn hvilke: ___________________________________________  
 
 
□ Nei, ingen symptomer  
 
 
2. Har du vært innlagt sykehus?                    □ Nei                  □ Ja 
3.  Har du vært i kontakt med fastlege eller legevakt på grunn av covid? 
            □ Nei                  □ Ja 
 
 
 
 
 
 

 
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Covid-19 infeksjon: Panoramic Norway Uke 2 
 
Pasient ID:                                   Dato i dag:       /       /____       
 
 
1. Etter du testet positiv, har du nå plager som du ikke hadde før Covid-19? 
 
□ Feber  
 
 
 
 
 
 
□ Magesmerter 
□ Tung pust 
 
 
 
 
 
 
□ Oppkast 
□ Prikking/nummenhet i armer/ben/kropp  
 
 
□ Diarre 
□ Hodepine 
 
 
 
 
 
 
□ Redusert lukte/smakssans 
□ Svimmelhet 
 
 
 
 
 
 
□ Søvnproblemer 
□ Hjertebank 
 
 
 
 
 
 
□ Brystsmerter 
□ Kvalme 
 
 
 
 
 
 
□ Muskel eller leddsmerter 
□ Hoste 
 
 
 
 
 
 
 
□ Andre plager, nevn hvilke: ___________ 
□ Nei, ingen plager 
 
 
 
Spørsmålene nedenfor gjelder symptomer nå: 
 
2. Har du problemer med at du føler deg sliten? 
□ Mindre enn vanlig  
□ Ikke mer enn vanlig 
 
□ Mer enn vanlig 
 
            
□ Mye mer enn vanlig 
 
3. Har du vansker med å konsentrere deg? 
□ Mindre enn vanlig  
□ Som vanlig  
 
 
□ Mer enn vanlig 
 
               
□ Mye mer enn vanlig 
 
4. Hvordan er hukommelsen din? 
□ Bedre enn vanlig 
 
□ Ikke verre enn vanlig 
 
□ Verre enn vanlig 
 
                
□ Mye verre enn vanlig 
 
5. Hvis du har dårlig hukommelse, konsentrasjonsvansker eller er sliten for tiden, omtrent hvor mye av 
tiden? 
□ 25 % av tiden  
 
 
□ 50 % av tiden  
 
□ 75 % av tiden  
       
□ Hele tiden 
 
 
6. Hvis du for tiden har dårlig hukommelse, konsentrasjonsvansker eller er sliten, omtrent hvor lenge har 
det vart?  
□ < 1 uke 
 
 
□ < 3 måneder  
 
□ 3-6 måneder  
 
                    
□ 6 måneder eller mer  

 
59 
 
Følsomhet Intern (gul) 
 
7. Har du følt deg nedfor og deprimert?  
□ Mindre enn vanlig 
 
□ Ikke mer enn vanlig 
 
□ Mer enn vanlig 
 
                
□ Mye mer enn vanlig  
 
8. Er du tungpustet?  
□ Mindre enn vanlig 
 
□ Ikke mer enn vanlig 
 
□ Mer enn vanlig 
 
                 
□ Mye mer enn vanlig 
 
 
9. Har du vært innlagt sykehus?   
□ Nei             
□ Ja 
10. Har du vært i kontakt med fastlege eller legevakt på grunn av covid?                   □ Nei 
         □ Ja
 
 
à  Hvis ja, hvor mange ganger: ______ 
 
11. Hvor mange andre i familien har blitt smittet? 
 
Antall barn under 18: ______ 
Antall voksne: ______ 
 
12. Har du vært borte fra jobb eller studie/skole på grunn av covid?  
 □ Nei  
□ Ja 
 
 
à Hvis ja, hvor mange dager: ______ 
 
13. Var andre voksne i familien borte fra jobb på grunn av covid?  
 
□ Nei 
                □ Ja 
 
à Hvis ja, hvor mange dager: ______ 
 
14. Har du eller partneren din blitt gravid siden du ble med i studien?  
□ Nei 
                □ Ja 
 
 
 
EQ-5D-5L validert skjema 
Under hver overskrift ber vi deg krysse av den ENE boksen som best beskriver helsen din I DAG. 
GANGE 
□ Jeg har ingen problemer med å gå omkring 
 
 
 
 
 
 
 
□ Jeg har litt problemer med å gå omkring  
 
 
 
 
 
 
□ Jeg har middels store problemer med å gå omkring 
 
 
 
□ Jeg har store problemer med å gå omkring 
 
 
 
 
 
 
                
□ Jeg er ute av stand til å gå omkring 
 
PERSONLIG STELL 
 
 
□ Jeg har ingen problemer med å vaske meg eller kle meg 
 
 
 
 
 
          
□ Jeg har litt problemer med vaske meg eller kle meg                          
 
 
 
 
                   
□ Jeg har middels store problemer med å vaske meg eller kle meg 
 
 
 
□ Jeg har store problemer med å vaske meg eller kle meg 
 
 
 
 
                      
□ Jeg er ute av stand til å vaske meg eller kle meg 
 

 
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VANLIGE GJØREMÅL (f. eks. arbeid, studier, husarbeid, familie- eller fritidsaktiviteter) 
□ Jeg har ingen problemer med å utføre mine vanlige gjøremål 
 
 
 
 
     
□ Jeg har litt problemer med å utføre mine vanlige gjøremål  
 
 
 
 
 
□ Jeg har middels store problemer med å utføre mine vanlige gjøremål 
 
 
 
□ Jeg har store problemer med å utføre mine vanlige gjøremål 
 
 
 
 
 
□ Jeg er ute av stand til å utføre mine vanlige gjøremål 
 
SMERTER/UBEHAG 
□ Jeg har verken smerter eller ubehag 
 
 
 
 
 
 
 
□ Jeg har litt smerter eller ubehag  
 
 
 
 
 
□ Jeg har middels sterke smerter eller ubehag 
 
 
□ Jeg har sterke smerter eller ubehag 
 
 
 
 
 
 
□ Jeg har svært sterke smerter eller ubehag 
 
ANGST/DEPRESJON 
□ Jeg er verken engstelig eller deprimert 
 
 
 
 
 
 
 
□ Jeg er litt engstelig eller deprimert 
 
 
 
 
 
 
 
□ Jeg er middels engstelig eller deprimert  
□ Jeg er svært engstelig eller deprimert 
 
 
 
 
 
 
 
□ Jeg er ekstremt engstelig eller deprimert  
 
 
 
 
 
 
 
· Vi vil gjerne vite hvor god eller dårlig helsen din er I DAG. 
 
· Denne skalaen er nummerert fra 0 til 100. 
 
· 100 betyr den beste helsen du kan tenke deg. 0 betyr den dårligste helsen du kan tenke deg. 
 
· Sett en X på skalaen for å angi hvordan helsen din er I DAG. 
 
· Skriv deretter tallet du merket av på skalaen 
inn i boksen nedenfor. 
 
 
Helsen din i dag: _______ 
 
 
 
 
 

 
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Covid-19 infeksjon: Panoramic Norway Uke 3 
 
Pasient ID:                                   Dato i dag:       /       /____       
 
 
 
1. Etter du testet positiv, har du nå plager som du ikke hadde før Covid-19? 
 
□ Feber  
 
 
 
 
 
 
□ Magesmerter 
□ Tung pust 
 
 
 
 
 
 
□ Oppkast 
□ Prikking/nummenhet i armer/ben/kropp  
 
 
□ Diarre 
□ Hodepine 
 
 
 
 
 
 
□ Redusert lukte/smakssans 
□ Svimmelhet 
 
 
 
 
 
 
□ Søvnproblemer 
□ Hjertebank 
 
 
 
 
 
 
□ Brystsmerter 
□ Kvalme 
 
 
 
 
 
 
□ Muskel eller leddsmerter 
□ Hoste 
 
 
 
 
 
 
 
□ Andre plager, nevn hvilke: ___________ 
□ Nei, ingen plager 
 
2. Har du vært innlagt sykehus?  □ Nei □ Ja 
3. Har du vært i kontakt med fastlege eller legevakt på grunn av covid?                   □ Nei 
         □ Ja
 
 
à Hvis ja, hvor mange ganger: ______ 
 
4. Hvor mange andre i familien enn deg har blitt smittet? 
 
Antall barn under 18: ______ 
Antall voksne: ______ 
 
5. Har du vært borte fra jobb eller studie/skole på grunn av covid?  
 □ Nei  
□ Ja 
 
 
à  Hvis ja, hvor mange dager: ______ 
 
6. Var andre voksne i familien borte fra jobb?  
 
□ Nei 
                □ Ja 
 
à  Hvis ja, hvor mange dager: ______ 
 
 
 
 

 
62 
 
Følsomhet Intern (gul) 
 
 
Covid-19 infeksjon: Panoramic Norway Uke 4 
 
Pasient ID:                                   Dato i dag:       /       /____       
 
 
1. Etter du testet positiv, har du nå plager som du ikke hadde før Covid-19? 
 
□ Feber  
 
 
 
 
 
 
□ Magesmerter 
□ Tung pust 
 
 
 
 
 
 
□ Oppkast 
□ Prikking/nummenhet i armer/ben/kropp  
 
 
□ Diarre 
□ Hodepine 
 
 
 
 
 
 
□ Redusert lukte/smakssans 
□ Svimmelhet 
 
 
 
 
 
 
□ Søvnproblemer 
□ Hjertebank 
 
 
 
 
 
 
□ Brystsmerter 
□ Kvalme 
 
 
 
 
 
 
□ Muskel eller leddsmerter 
□ Hoste 
 
 
 
 
 
 
 
□ Andre plager, nevn hvilke: ___________ 
□ Nei, ingen plager 
 
 
Spørsmålene nedenfor gjelder symptomer nå: 
 
2. Har du problemer med at du føler deg sliten? 
□ Mindre enn vanlig  
□ Ikke mer enn vanlig 
 
□ Mer enn vanlig 
 
            
□ Mye mer enn vanlig 
 
3. Har du vansker med å konsentrere deg? 
□ Mindre enn vanlig  
□ Som vanlig  
 
 
□ Mer enn vanlig 
 
               
□ Mye mer enn vanlig 
 
4. Hvordan er hukommelsen din? 
□ Bedre enn vanlig 
 
□ Ikke verre enn vanlig 
 
□ Verre enn vanlig 
 
                
□ Mye verre enn vanlig 
 
5. Hvis du har dårlig hukommelse, konsentrasjonsvansker eller er sliten for tiden, omtrent hvor mye av 
tiden? 
□ 25 % av tiden  
 
 
□ 50 % av tiden  
 
□ 75 % av tiden  
       
□ Hele tiden 
 
 
6. Hvis du for tiden har dårlig hukommelse, konsentrasjonsvansker eller er sliten, omtrent hvor lenge har 
det vart?  

 
63 
 
Følsomhet Intern (gul) 
□ < 1 uke 
 
 
□ < 3 måneder  
 
□ 3-6 måneder  
 
                    
□ 6 måneder eller mer  
 
7. Har du følt deg nedfor og deprimert?  
□ Mindre enn vanlig  
□ Ikke mer enn vanlig 
 
□ Mer enn vanlig 
 
                
□ Mye mer enn vanlig  
 
8. Er du tungpustet?  
□ Mindre enn vanlig  
□ Ikke mer enn vanlig 
 
□ Mer enn vanlig 
 
                 
□ Mye mer enn vanlig 
 
 
 
9. Har du vært innlagt sykehus?  □ Nei □ Ja 
10. Har du vært i kontakt med fastlege eller legevakt på grunn av covid?                   □ Nei 
         □ Ja
 
 
à  Hvis ja, hvor mange ganger: ______ 
 
11. Hvor mange andre i familien enn deg har blitt smittet? 
 
Antall barn under 18: ______ 
Antall voksne: ______ 
 
12. Har du eller partneren din blitt gravid siden du ble med i studien? 
 
□ Nei 
                □ Ja 
13. Var du borte fra jobb på grunn av covid?  
 
□ Nei 
                □ Ja 
 
à   Hvis ja, hvor mange dager:  
 
100% fravær - antall dager ______ 
75-95% fravær - antall dager ______ 
50-70% fravær - antall dager ______ 
30-45% fravær - antall dager ______ 
20% fravær - antall dager ______ 
 
14. Var andre voksne i familien din borte fra jobb?  
□ Nei 
                □ Ja 
 
à   Hvis ja, hvor mange dager: ______ 
 
 
EQ-5D-5L validert skjema 
Under hver overskrift ber vi deg krysse av den ENE boksen som best beskriver helsen din I DAG. 
GANGE 
□ Jeg har ingen problemer med å gå omkring 
 
 
 
 
 
 
 
□ Jeg har litt problemer med å gå omkring  
 
 
 
 
 
 
□ Jeg har middels store problemer med å gå omkring 
 
 
 
□ Jeg har store problemer med å gå omkring 
 
 
 
 
 
 
               
□ Jeg er ute av stand til å gå omkring 
 
 

 
64 
 
Følsomhet Intern (gul) 
PERSONLIG STELL 
 
 
□ Jeg har ingen problemer med å vaske meg eller kle meg 
 
 
 
 
 
         
□ Jeg har litt problemer med vaske meg eller kle meg 
 
 
 
 
 
         
□ Jeg har middels store problemer med å vaske meg eller kle meg 
 
 
 
□ Jeg har store problemer med å vaske meg eller kle meg 
                                                                                      
□ Jeg er ute av stand til å vaske meg eller kle meg 
 
VANLIGE GJØREMÅL (f. eks. arbeid, studier, husarbeid, familie- eller fritidsaktiviteter) 
□ Jeg har ingen problemer med å utføre mine vanlige gjøremål 
 
 
 
 
 
□ Jeg har litt problemer med å utføre mine vanlige gjøremål  
 
 
 
 
 
□ Jeg har middels store problemer med å utføre mine vanlige gjøremål 
 
 
 
□ Jeg har store problemer med å utføre mine vanlige gjøremål 
 
 
 
 
 
□ Jeg er ute av stand til å utføre mine vanlige gjøremål 
 
SMERTER/UBEHAG 
□ Jeg har verken smerter eller ubehag 
 
 
 
 
 
 
 
□ Jeg har litt smerter eller ubehag  
 
 
 
 
 
□ Jeg har middels sterke smerter eller ubehag 
 
 
□ Jeg har sterke smerter eller ubehag 
 
 
 
 
 
 
□ Jeg har svært sterke smerter eller ubehag 
 
ANGST/DEPRESJON 
□ Jeg er verken engstelig eller deprimert 
 
 
 
 
 
 
 
□ Jeg er litt engstelig eller deprimert 
 
 
 
 
 
 
 
□ Jeg er middels engstelig eller deprimert  
□ Jeg er svært engstelig eller deprimert 
 
 
 
 
 
 
 
□ Jeg er ekstremt engstelig eller deprimert  
 
 
· Vi vil gjerne vite hvor god eller dårlig helsen din er I DAG. 
 
· Denne skalaen er nummerert fra 0 til 100. 
 
· 100 betyr den beste helsen du kan tenke deg. 0 betyr den dårligste helsen du kan tenke deg. 
 
· Sett en X på skalaen for å angi hvordan helsen din er I DAG. 
 
· Skriv deretter tallet du merket av på skalaen 
inn i boksen nedenfor. 
 
 
Helsen din i dag: _______ 
 
 

 
65 
 
Følsomhet Intern (gul) 
 
Covid-19 infeksjon: Panoramic Norway 3 mnd oppfølging 
 
Pasient ID:                                   Dato i dag:       /       /____       
 
 
 
1. Etter du testet positiv, har du nå plager som du ikke hadde før Covid-19?             □ Nei 
 
□ Ja 
 
à Hvis ja, hvilke symptomer (vennligst kryss av):  
 
  
 
□ Feber  
 
 
 
 
 
 
□ Redusert lukte/smakssans 
□ Tung pust 
 
 
 
 
 
 
□ Søvnproblemer 
□ Prikking/nummenhet i armer/ben/kropp  
 
 
□ Brystsmerter 
□ Hodepine 
 
 
 
 
 
 
□ Muskel eller leddsmerter 
□ Svimmelhet 
 
 
 
 
 
 
□ Kvalme 
□ Hjertebank 
 
 
 
 
 
 
□ Oppkast 
□ Hoste 
 
 
 
 
 
 
□ Diarre 
 
Andre symptomer: _________               __ 
 
 
2. Har du blitt covid-smittet på nytt? 
□ Nei 
 
□ Ja  
 
à    Hvis ja, når: _________               __  
 
 
Spørsmålene nedenfor gjelder symptomer nå: 
 
3. Har du problemer med at du føler deg sliten? 
□ Mindre enn vanlig  
□ Ikke mer enn vanlig 
 
□ Mer enn vanlig 
 
      
□ Mye mer enn vanlig 
 
4. Har du vansker med å konsentrere deg? 
□ Mindre enn vanlig  
□ Som vanlig  
 
 
□ Mer enn vanlig 
                       
□ Mye mer enn vanlig 
 
5. Hvordan er hukommelsen din? 
□ Bedre enn vanlig 
 
□ Ikke verre enn vanlig 
 
□ Verre enn vanlig 
 
      
□ Mye verre enn vanlig 
 
6. Hvis du har dårlig hukommelse, konsentrasjonsvansker eller er sliten for tiden, omtrent hvor mye av 
tiden? 
□ 25 % av tiden  
 
 
□ 50 % av tiden  
 
□ 75 % av tiden  
      
□ Hele tiden 
 
 
 
 

 
66 
 
Følsomhet Intern (gul) 
7. Hvis du for tiden har dårlig hukommelse, konsentrasjonsvansker eller er sliten, omtrent hvor lenge har 
det vart?  
□ < 1 uke 
 
 
□ < 3 måneder  
 
□ 3-6 måneder  
 
      
□ 6 måneder eller mer  
 
8. Har du følt deg nedfor og deprimert?  
□ Mindre enn vanlig  
□ Ikke mer enn vanlig 
 
□ Mer enn vanlig 
 
           
□ Mye mer enn vanlig  
 
9. Er du tungpustet?  
□ Mindre enn vanlig  
□ Ikke mer enn vanlig 
 
□ Mer enn vanlig 
 
       
□ Mye mer enn vanlig 
 
 
 
10. Har du vært innlagt sykehus?           □ Nei 
            □ Ja 
 
à Hva var grunnen?: ____________   
 
11. Har du vært i kontakt med fastlege eller legevakt på grunn av covid? 
□ Nei 
 
□ Ja 
à  Hvis ja, hvor mange ganger: _______ 
 
12. Har du eller partneren din blitt gravid siden du ble med i studien? 
□ Nei 
                □ Ja 
13. Var du borte fra jobb på grunn av covid?  
□ Nei 
                □ Ja 
 
à  Hvis ja, hvor mange dager: 
100% fravær - antall dager ______ 
75-95% fravær - antall dager ______ 
50-70% fravær - antall dager ______ 
30-45% fravær - antall dager ______ 
20% fravær - antall dager ______ 
 
14. Var andre voksne i familien din borte fra jobb?  
□ Nei 
                □ Ja 
 
à  Hvis ja, hvor mange dager: ______  
 
 
EQ-5D-5L validert skjema 
Under hver overskrift ber vi deg krysse av den ENE boksen som best beskriver helsen din I DAG. 
GANGE 
□ Jeg har ingen problemer med å gå omkring 
 
 
 
 
 
 
 
□ Jeg har litt problemer med å gå omkring  
 
 
 
 
 
 
□ Jeg har middels store problemer med å gå omkring 
 
 
 
□ Jeg har store problemer med å gå omkring 
 
 
 
 
 
                       
□ Jeg er ute av stand til å gå omkring 
 
 
 
 

 
67 
 
Følsomhet Intern (gul) 
PERSONLIG STELL 
 
 
□ Jeg har ingen problemer med å vaske meg eller kle meg 
 
 
 
 
 
         
□ Jeg har litt problemer med vaske meg eller kle meg 
 
 
 
 
 
             
□ Jeg har middels store problemer med å vaske meg eller kle meg 
 
 
 
□ Jeg har store problemer med å vaske meg eller kle meg 
 
 
 
 
                       
□ Jeg er ute av stand til å vaske meg eller kle meg 
 
VANLIGE GJØREMÅL (f. eks. arbeid, studier, husarbeid, familie- eller fritidsaktiviteter) 
□ Jeg har ingen problemer med å utføre mine vanlige gjøremål 
 
 
 
 
 
□ Jeg har litt problemer med å utføre mine vanlige gjøremål  
 
 
 
 
 
□ Jeg har middels store problemer med å utføre mine vanlige gjøremål 
 
 
 
□ Jeg har store problemer med å utføre mine vanlige gjøremål 
 
 
 
 
 
□ Jeg er ute av stand til å utføre mine vanlige gjøremål 
 
SMERTER/UBEHAG 
□ Jeg har verken smerter eller ubehag 
 
 
 
 
 
 
 
□ Jeg har litt smerter eller ubehag  
 
 
 
 
 
□ Jeg har middels sterke smerter eller ubehag 
 
 
□ Jeg har sterke smerter eller ubehag 
 
 
 
 
 
 
□ Jeg har svært sterke smerter eller ubehag 
 
ANGST/DEPRESJON 
 
□ Jeg er verken engstelig eller deprimert 
 
 
 
 
 
 
 
□ Jeg er litt engstelig eller deprimert 
 
 
 
 
 
 
 
□ Jeg er middels engstelig eller deprimert  
□ Jeg er svært engstelig eller deprimert 
 
 
 
 
 
 
 
□ Jeg er ekstremt engstelig eller deprimert  
 
 
 
· Vi vil gjerne vite hvor god eller dårlig helsen din er I DAG. 
 
· Denne skalaen er nummerert fra 0 til 100. 
 
· 100 betyr den beste helsen du kan tenke deg. 0 betyr den dårligste helsen du kan tenke deg. 
 
· Sett en X på skalaen for å angi hvordan helsen din er I DAG. 
 
· Skriv deretter tallet du merket av på skalaen 
inn i boksen nedenfor. 
 
 
Helsen din i dag: _______ 
 
 

 
68 
 
Følsomhet Intern (gul) 
 
Covid-19 infeksjon: Panoramic Norway 6 mnd oppfølgning 
 
Pasient ID:                                   Dato i dag:       /       /____       
 
 
 
1. Etter du testet positiv, har du nå plager som du ikke hadde før Covid-19? □ Nei 
 
□ Ja 
 
à  Hvis ja, hvilke symptomer (vennligst kryss av):  
 
  
 
□ Feber  
 
 
 
 
 
 
□ Redusert lukte/smakssans 
□ Tung pust 
 
 
 
 
 
 
□ Søvnproblemer 
□ Prikking/nummenhet i armer/ben/kropp  
 
 
□ Brystsmerter 
□ Hodepine 
 
 
 
 
 
 
□ Muskel eller leddsmerter 
□ Svimmelhet 
 
 
 
 
 
 
□ Kvalme 
□ Hjertebank 
 
 
 
 
 
 
□ Oppkast 
□ Hoste 
 
 
 
 
 
 
□ Diarre 
 
 
 
 
 
 
 
 
 
 
Andre symptomer: _________               __ 
 
 
 
 
 
 
 
2. Har du blitt covid-smittet på nytt? 
□ Nei 
 
□ Ja  
 
à  Hvis ja, når: _________               __  
 
 
Spørsmålene nedenfor gjelder symptomer nå: 
 
3. Har du problemer med at du føler deg sliten? 
□ Mindre enn vanlig  
□ Ikke mer enn vanlig 
 
□ Mer enn vanlig 
 
       
□ Mye mer enn vanlig 
 
4. Har du vansker med å konsentrere deg? 
□ Mindre enn vanlig  
□ Som vanlig  
 
 
□ Mer enn vanlig 
 
       
□ Mye mer enn vanlig 
 
5. Hvordan er hukommelsen din? 
□ Bedre enn vanlig 
 
□ Ikke verre enn vanlig 
 
□ Verre enn vanlig 
 
        
□ Mye verre enn vanlig 
 
6. Hvis du har dårlig hukommelse, konsentrasjonsvansker eller er sliten for tiden, omtrent hvor mye av 
tiden? 
□ 25 % av tiden  
 
 
□ 50 % av tiden  
 
□ 75 % av tiden  
         
□ Hele tiden 
 
 
 
 
 
 
 

 
69 
 
Følsomhet Intern (gul) 
7. Hvis du for tiden har dårlig hukommelse, konsentrasjonsvansker eller er sliten, omtrent hvor lenge har 
det vart?  
□ < 1 uke 
 
 
□ < 3 måneder  
 
□ 3-6 måneder  
 
        
□ 6 måneder eller mer  
 
8. Har du følt deg nedfor og deprimert?  
□ Mindre enn vanlig  
□ Ikke mer enn vanlig 
 
□ Mer enn vanlig 
 
         
□ Mye mer enn vanlig  
 
9. Er du tungpustet?  
□ Mindre enn vanlig  
□ Ikke mer enn vanlig 
 
□ Mer enn vanlig 
                          
□ Mye mer enn vanlig                        
 
 
 
10. Har du vært innlagt sykehus?           □ Nei 
            □ Ja 
 
Hva var grunnen?: ____________   
 
11. Har du vært i kontakt med fastlege eller legevakt på grunn av covid? 
□ Nei 
 
□ Ja 
à  Hvis ja, hvor mange ganger: _______ 
 
12. Har du eller partneren din blitt gravid siden du ble med i studien?             □ Nei 
           □ Ja 
13. Var du borte fra jobb på grunn av covid?  
□ Nei 
                □ Ja 
à Hvis ja, hvor mange dager: 
100% fravær - antall dager ______ 
75-95% fravær - antall dager ______ 
50-70% fravær - antall dager ______ 
30-45% fravær - antall dager ______ 
20% fravær - antall dager ______ 
 
14. Var andre voksne i familien din borte fra jobb?   
□ Nei 
                □ Ja 
 
à  Hvis ja, hvor mange dager: ______  
 
EQ-5D-5L validert skjema 
Under hver overskrift ber vi deg krysse av den ENE boksen som best beskriver helsen din I DAG. 
GANGE 
□ Jeg har ingen problemer med å gå omkring 
 
 
 
 
 
 
 
□ Jeg har litt problemer med å gå omkring  
 
 
 
 
 
 
□ Jeg har middels store problemer med å gå omkring 
 
 
 
□ Jeg har store problemer med å gå omkring 
 
 
 
 
 
 
           
□ Jeg er ute av stand til å gå omkring 
 
 
 
 

 
70 
 
Følsomhet Intern (gul) 
PERSONLIG STELL 
 
 
□ Jeg har ingen problemer med å vaske meg eller kle meg 
 
 
 
 
 
 
□ Jeg har litt problemer med vaske meg eller kle meg 
 
 
 
 
 
 
□ Jeg har middels store problemer med å vaske meg eller kle meg 
 
 
 
□ Jeg har store problemer med å vaske meg eller kle meg 
 
 
 
 
                      
□ Jeg er ute av stand til å vaske meg eller kle meg 
 
 
VANLIGE GJØREMÅL (f. eks. arbeid, studier, husarbeid, familie- eller fritidsaktiviteter) 
□ Jeg har ingen problemer med å utføre mine vanlige gjøremål 
 
 
 
 
 
□ Jeg har litt problemer med å utføre mine vanlige gjøremål  
 
 
 
 
 
□ Jeg har middels store problemer med å utføre mine vanlige gjøremål 
 
 
 
□ Jeg har store problemer med å utføre mine vanlige gjøremål 
 
 
 
 
 
□ Jeg er ute av stand til å utføre mine vanlige gjøremål 
 
SMERTER/UBEHAG 
□ Jeg har verken smerter eller ubehag 
 
 
 
 
 
 
 
□ Jeg har litt smerter eller ubehag  
 
 
 
 
 
□ Jeg har middels sterke smerter eller ubehag 
 
 
□ Jeg har sterke smerter eller ubehag 
 
 
 
 
 
 
□ Jeg har svært sterke smerter eller ubehag 
 
ANGST/DEPRESJON 
□ Jeg er verken engstelig eller deprimert 
 
 
 
 
 
 
 
□ Jeg er litt engstelig eller deprimert 
 
 
 
 
 
 
 
□ Jeg er middels engstelig eller deprimert  
□ Jeg er svært engstelig eller deprimert 
 
 
 
 
 
 
 
□ Jeg er ekstremt engstelig eller deprimert  
 
 
 
 
· Vi vil gjerne vite hvor god eller dårlig helsen din er I DAG. 
 
· Denne skalaen er nummerert fra 0 til 100. 
 
· 100 betyr den beste helsen du kan tenke deg. 0 betyr den dårligste helsen du kan tenke deg. 
 
· Sett en X på skalaen for å angi hvordan helsen din er I DAG. 
 
· Skriv deretter tallet du merket av på skalaen 
inn i boksen nedenfor. 
 
 
Helsen din i dag: _______ 
 

 
71 
 
Følsomhet Intern (gul) 
 
 
Covid-19 infeksjon: Panoramic Norway 12 mnd oppfølgning 
 
Pasient ID:                                   Dato i dag:       /       /____       
 
 
 
 
1. Etter du testet positiv, har du nå plager som du ikke hadde før Covid-19?           □ Nei 
 
□ Ja 
 
à Hvis ja, hvilke symptomer (vennligst kryss av):  
 
  
 
□ Feber  
 
 
 
 
 
 
□ Redusert lukte/smakssans 
□ Tung pust 
 
 
 
 
 
 
□ Søvnproblemer 
□ Prikking/nummenhet i armer/ben/kropp  
 
 
□ Brystsmerter 
□ Hodepine 
 
 
 
 
 
 
□ Muskel eller leddsmerter 
□ Svimmelhet 
 
 
 
 
 
 
□ Kvalme 
□ Hjertebank 
 
 
 
 
 
 
□ Oppkast 
□ Hoste 
 
 
 
 
 
 
□ Diarre 
 
 
 
 
 
 
 
 
 
 
Andre symptomer: ______ 
 
 
 
 
 
 
 
2. Har du blitt covid-smittet på nytt? 
□ Nei 
 
□ Ja  
 
à  Hvis ja, når: _________               __  
 
 
Spørsmålene nedenfor gjelder symptomer nå: 
 
3. Har du problemer med at du føler deg sliten? 
□ Mindre enn vanlig  
□ Ikke mer enn vanlig 
 
□ Mer enn vanlig 
 
           
□ Mye mer enn vanlig 
 
4. Har du vansker med å konsentrere deg? 
□ Mindre enn vanlig  
□ Som vanlig  
 
 
□ Mer enn vanlig 
 
             
□ Mye mer enn vanlig 
 
5. Hvordan er hukommelsen din? 
□ Bedre enn vanlig 
 
□ Ikke verre enn vanlig 
 
□ Verre enn vanlig 
 
            
□ Mye verre enn vanlig 
 
6. Hvis du har dårlig hukommelse, konsentrasjonsvansker eller er sliten for tiden, omtrent hvor mye av 
tiden? 
□ 25 % av tiden  
 
 
□ 50 % av tiden  
 
□ 75 % av tiden  
               
□ Hele tiden 
 
 

 
72 
 
Følsomhet Intern (gul) 
7. Hvis du for tiden har dårlig hukommelse, konsentrasjonsvansker eller er sliten, omtrent hvor lenge har 
det vart?  
□ < 1 uke 
 
 
□ < 3 måneder  
 
□ 3-6 måneder  
 
           
□ 6 måneder eller mer  
 
8. Har du følt deg nedfor og deprimert?  
□ Mindre enn vanlig  
□ Ikke mer enn vanlig 
 
□ Mer enn vanlig 
 
          
□ Mye mer enn vanlig  
 
9. Er du tungpustet?  
□ Mindre enn vanlig  
□ Ikke mer enn vanlig 
 
□ Mer enn vanlig 
 
        
□ Mye mer enn vanlig 
 
 
 
10. Har du vært innlagt sykehus?           □ Nei 
            □ Ja 
 
à Hva var grunnen?: ____________   
 
11. Har du vært i kontakt med fastlege eller legevakt på grunn av covid? 
□ Nei 
 
□ Ja 
à  Hvis ja, hvor mange ganger: _______ 
12. Var du borte fra jobb på grunn av covid?  
□ Nei 
                □ Ja 
à  Hvis ja, hvor mange dager: 
 
100% fravær - antall dager ______ 
75-95% fravær - antall dager ______ 
50-70% fravær - antall dager ______ 
30-45% fravær - antall dager ______ 
20% fravær - antall dager ______ 
 
13. Var andre voksne i familien din borte fra jobb?   
□ Nei 
                □ Ja 
 
à  Hvis ja, hvor mange dager: ______  
 
 
EQ-5D-5L validert skjema 
Under hver overskrift ber vi deg krysse av den ENE boksen som best beskriver helsen din I DAG. 
GANGE 
□ Jeg har ingen problemer med å gå omkring 
 
 
 
 
 
 
 
□ Jeg har litt problemer med å gå omkring  
 
 
 
 
 
 
□ Jeg har middels store problemer med å gå omkring 
 
 
 
□ Jeg har store problemer med å gå omkring 
 
 
 
                                                                    
□ Jeg er ute av stand til å gå omkring 
 
 
 

 
73 
 
Følsomhet Intern (gul) 
PERSONLIG STELL 
 
 
□ Jeg har ingen problemer med å vaske meg eller kle meg 
 
 
 
 
 
 
□ Jeg har litt problemer med vaske meg eller kle meg 
 
 
 
 
 
 
□ Jeg har middels store problemer med å vaske meg eller kle meg 
 
 
 
□ Jeg har store problemer med å vaske meg eller kle meg 
 
                                                                            
□ Jeg er ute av stand til å vaske meg eller kle meg 
 
 
VANLIGE GJØREMÅL (f. eks. arbeid, studier, husarbeid, familie- eller fritidsaktiviteter) 
□ Jeg har ingen problemer med å utføre mine vanlige gjøremål 
 
 
 
 
             
□ Jeg har litt problemer med å utføre mine vanlige gjøremål  
 
 
 
 
 
□ Jeg har middels store problemer med å utføre mine vanlige gjøremål 
 
 
 
□ Jeg har store problemer med å utføre mine vanlige gjøremål 
 
 
 
 
 
□ Jeg er ute av stand til å utføre mine vanlige gjøremål 
 
SMERTER/UBEHAG 
□ Jeg har verken smerter eller ubehag 
 
 
 
 
 
 
 
□ Jeg har litt smerter eller ubehag  
 
 
 
 
 
□ Jeg har middels sterke smerter eller ubehag 
 
 
□ Jeg har sterke smerter eller ubehag 
 
 
 
 
 
 
□ Jeg har svært sterke smerter eller ubehag 
 
ANGST/DEPRESJON 
 
□ Jeg er verken engstelig eller deprimert 
 
 
 
 
 
 
 
□ Jeg er litt engstelig eller deprimert 
 
 
 
 
 
 
 
□ Jeg er middels engstelig eller deprimert  
□ Jeg er svært engstelig eller deprimert 
 
 
 
 
 
 
 
□ Jeg er ekstremt engstelig eller deprimert  
 
 
 
· Vi vil gjerne vite hvor god eller dårlig helsen din er I DAG. 
 
· Denne skalaen er nummerert fra 0 til 100. 
 
· 100 betyr den beste helsen du kan tenke deg. 0 betyr den dårligste helsen du kan tenke deg. 
 
· Sett en X på skalaen for å angi hvordan helsen din er I DAG. 
 
· Skriv deretter tallet du merket av på skalaen 
inn i boksen nedenfor. 
 
 
Helsen din i dag: _______