A Multi-centre, Multi-country Retrospective Cohort Study to Evaluate the Clinical Outcomes in Adults With Covid-19 Who Have Been Treated With Remdesivir.
Conditions: Covid19
Sponsor: NEAT ID Foundation

NEAT ID 909REM PROTOCOL V1.0 dated 17 DEC 2020 
 
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A MULTI-CENTRE, MULTI-COUNTRY RETROSPECTIVE COHORT 
STUDY TO EVALUATE THE CLINICAL OUTCOMES IN ADULTS WITH 
COVID-19 WHO HAVE BEEN TREATED WITH REMDESIVIR. 
- 909REM - 
 
Version 1.0 dated 17 December 2020 
Sponsor Protocol ID: NEAT ID 909REM  
IRAS: 293273 
 
 
 
SPONSOR: NEAT ID 
PLEASE DISCARD PREVIOUS COPIES AND RETAIN ONE FOR THE SITE FILE 
 
 
 
 
 
 
Private & Confidential 
 
 
 
Compliance Statement: 
This study will be conducted in accordance with the guidelines of Good Pharmacoepidemiology Practice (GPP) and Heads of Medicines Agencies (HMA) including archiving of essential documents and all applicable regulatory 
requirements. 
 
Confidentiality Statement: 
The information contained in this document, particularly unpublished data, is the property or under control of NEAT ID., and is provided to you in confidence as an investigator, potential investigator, or consultant, for review by 
you, your staff, and an applicable Institutional Review Board or Independent Ethics Committee. The information is only to be used by you. You will not disclose any of the information to others without written authorization from 
NEAT ID 

NEAT ID 909REM PROTOCOL V1.0 dated 17 DEC 2020 
 
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SPONSOR AND CHIEF INVESTIGATOR SIGNATURE PAGE 
 
The undersigned confirm that the following protocol has been agreed and accepted and that the Chief 
Investigator agrees to conduct the trial in compliance with the approved protocol and will adhere to 
the principles outlined in the guidelines of Good Pharmacoepidemiology Practice (GPP) and Heads of 
Medicines Agencies (HMA) GCP guidelines, Data Protection legislation, the Sponsor’s SOPs, and other 
regulatory requirements as applicable. 
 
I agree to ensure that the confidential information contained in this document will not be used for any 
other purpose other than the evaluation or conduct of the clinical investigation without the prior 
written consent of the Sponsor. 
 
I also confirm that I will make the findings of the study publicly available through publication or other 
dissemination tools without any unnecessary delay and that an honest accurate and transparent 
account of the study will be given; and that any discrepancies from the study as planned in this 
protocol will be explained. 
 
For and on behalf of the trial Sponsor: 
 
 
Signature: 
................................................................................................ 
 
 
 
Date: ........../……....../………..... 
 
 
Name: (please print): 
...................................................................................................................................................... 
 
 
 
Chief Investigator: 
 
 
Signature: 
................................................................................................ 
 
 
 
Date: ........../……....../………..... 
 
 
Name: (please print): 
...................................................................................................................................................... 
 
 
 
 

NEAT ID 909REM PROTOCOL V1.0 dated 17 DEC 2020 
 
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STATISTICIAN OR STUDY ANALYST SIGNATURE PAGE 
 
The undersigned confirm that the following protocol has been agreed and accepted and that the 
Statistician or Study Analyst agrees to conduct the trial in compliance with the approved protocol, 
Statistical Principles for Clinical Trials, ICH E10 and will adhere to the principles outlined in the 
guidelines of Good Pharmacoepidemiology Practice (GPP) and Heads of Medicines Agencies (HMA) 
GCP guidelines, the Sponsor’s SOPs and other regulatory requirements as amended. 
 
I agree to ensure that the confidential information contained in this document will not be used for 
any other purpose other than the evaluation or conduct of the clinical investigation without the 
prior written consent of the Sponsor. 
 
I also confirm that I will make the findings of the study publicly available through publication or 
other dissemination tools without any unnecessary delay and that an honest accurate and 
transparent account of the study will be given; and that any discrepancies from the study as planned 
in this protocol will be explained. 
 
 
Statistician or Study Analyst: 
 
 
Signature: 
................................................................................................ 
 
 
 
Date: ........../……....../………..... 
 
 
Name: (please print): 
...................................................................................................................................................... 
 
 
 
 

NEAT ID 909REM PROTOCOL V1.0 dated 17 DEC 2020 
 
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PRINCIPAL INVESTIGATOR SIGNATURE PAGE 
 
I agree to conduct the trial in accordance with principles outlined in the guidelines of Good 
Pharmacoepidemiology Practice (GPP) and Heads of Medicines Agencies (HMA) and ICH-GCP, Data 
Protection legislation, and the applicable regulatory requirements and with the approved protocol. 
 
I agree to comply with the procedures for data recording/reporting 
 
I agree to permit monitoring, auditing and inspection at this site and to retain all trial related essential 
documentation for the duration of the study as required according to the applicable regulatory 
requirements. 
 
 
Principal Investigator: 
 
 
Signature: 
................................................................................................ 
 
 
 
Date: ............./……........./………..... 
 
 
Name: (please print): 
............................................................................................................................................................ 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

NEAT ID 909REM PROTOCOL V1.0 dated 17 DEC 2020 
 
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Table of Contents 
 
 
SPONSOR AND CHIEF INVESTIGATOR SIGNATURE PAGE...............................................................................2 
STATISTICIAN OR STUDY ANALYST SIGNATURE PAGE ...................................................................................3 
PRINCIPAL INVESTIGATOR SIGNATURE PAGE...............................................................................................4 
KEY TRIAL CONTACTS .................................................................................................................................6 
STUDY SYNOPSIS ........................................................................................................................................7 
FUNDING AND SUPPORT ............................................................................................................................8 
2. 
OBJECTIVES AND OUTCOME MEASURES/ENDPOINTS ........................................................................10 
2.1 
PRIMARY OBJECTIVE ......................................................................................................................10 
2.2 
SECONDARY OBJECTIVES .................................................................................................................10 
2.3 
PRIMARY CRITERIA FOR EVALUATION .................................................................................................10 
2.4 
SECONDARY CRITERIA FOR EVALUATION..............................................................................................11 
3 
TRIAL DESIGN...................................................................................................................................11 
4 
ELIGIBILITY CRITERIA ........................................................................................................................11 
4.1 
INCLUSION CRITERIA ......................................................................................................................11 
4.2 
EXCLUSION CRITERIA ......................................................................................................................12 
5 
TRIAL PROCEDURES ..........................................................................................................................12 
6 
STATISTICS AND DATA ANALYSIS ......................................................................................................13 
6.1 
SUBJECT POPULATION ....................................................................................................................13 
6.2 
STUDY SIZE .................................................................................................................................13 
6.3 
STATISTICAL ANALYSIS ....................................................................................................................13 
7 
DATA ...............................................................................................................................................14 
7.1 
AUTHORSHIP ELIGIBILITY GUIDELINES AND ANY INTENDED USE OF PROFESSIONAL WRITERS.................................14 
7.2 
DATA PROTECTION .......................................................................................................................14 
7.3 
DATA RETENTION .........................................................................................................................15 
8 
APPENDICIES ...................................................................................................................................16 
APPENDIX 1 – SCHEDULE OF PROCEDURES ................................................................................................16 
 
 

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KEY TRIAL CONTACTS 
 
 
Chief Investigator 
 
Anton Pozniak 
NEAT ID Foundation  
Registered address: PL 709 Rue Haute 322, 1000 Brussels, 
Belgium  
Administrative office: 27 Old Gloucester Street, London WC1N 
3AX, UK 
anton.pozniak@chelwest.nhs.uk 
 
Sponsor 
 
NEAT ID Foundation (NEAT ID) 
Registered address: PL 709 Rue Haute 322, 1000 Brussels, 
Belgium  
Administrative office: 27 Old Gloucester Street, London WC1N 
3AX, UK 
 
Project Management 
 
909-REM Project Manager 
Research Organisation (KC) Ltd. (ROKC)  
The Stanley Building, 7 Pancras Square, London,UK, N1C 4AG 
909REM@rokcservices.com 
 
Data Management 
 
Clinical Informatics Team  
Research Organisation (KC) Ltd. (ROKC)  
The Stanley Building, 7 Pancras Square, London, UK, N1C 4AG 
 
 
 
 
 

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STUDY SYNOPSIS 
 
 
Full study Title 
A Multi-centre, Multi-country Retrospective Cohort Study to Evaluate the Clinical 
Outcomes in Adults with COVID-19 who have been treated with Remdesivir. 
Short title/Acronym 
NEAT ID 909REM 
Clinical Phase  
IV  
Trial Design 
A multi-centre, multi-country retrospective cohort study 
Name of Non-
Investigational 
Product 
Remdesivir  
Trial Participants 
population 
At least 450 cases 
Planned Sample Size 
At least 450 cases, at least 450 controls (if required, controls will be included in 
Part 2) 
Eligibility Criteria 
Cases 
All Adult participants with COVID-19 confirmed by PCR who meet the following 
criteria: 
1. 
Hospitalised after August 31st 2020 
2. 
Received Remdesivir (RDV) at any time during hospitalisation 
 
 
Indication 
COVID-19 
Number of sites 
up to 20 
Objectives 
Primary 
The primary objectives of this study are 
to assess the clinical course and 
outcome of adults with COVID-19 who 
have been treated with Remdesivir 
assessed by: 
 
1. All-cause mortality at Day 28; 
2. duration of hospitalisation 
 
 
Secondary 
The secondary objectives are to assess 
the clinical course and outcome of 
adults with COVID-19 who have been 
treated with Remdesivir with respect to 
the following: 
 
1. a 7-point ordinal clinical status 
scale on Day 7 and Day 14 
2. timing (from first symptoms and 
from hospitalisation) and duration 
of use of Remdesivir 
3. clinical severity at Day 7, 14, 28 as 
assessed by the NEWS 2 score 
4. clinical status as assessed a 7-point 
ordinal scale on Day 28 (or at last 
observation if discharged or died 

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prior to this time point) in those 
still hospitalised after Day 14. 
5. SpO2 > 94% on room air on day 7, 
14 and 28 
6. duration and type (low versus high 
flow) of oxygen therapy (days) 
7. admitted to ICU (yes versus no) 
8. Number of days spent on ICU/ITU 
9. use of mechanical 
ventilation/ECMO (extracorporeal 
membrane oxygenation); start and 
stop dates 
10. re-admission with COVID-19 
complications or recurrence within 
28 days of discharge and outcome 
(discharged or deceased) 
Criteria for Evaluation 
Primary 
 
1. All-cause mortality at day 28 
 
2. Clinical status assessed by a 7-point 
ordinal scale on Day 14 or at last 
observation if discharged or died prior 
to this time point, where the 7-point 
ordinal scale is defined as: 
 
1. Death 
2. Hospitalised, 
on 
invasive 
mechanical 
ventilation 
or 
ECMO 
3. Hospitalised, on non-invasive 
ventilation or high flow oxygen 
devices 
4. Hospitalised, 
requiring 
low 
flow supplemental oxygen 
5. Hospitalised, 
not 
requiring 
supplemental 
oxygen 
- 
requiring ongoing medical care 
(COVID-19 
related 
or 
otherwise) 
6. Hospitalised, 
not 
requiring 
supplemental oxygen - no 
longer 
requires 
ongoing 
medical care 
7. Not hospitalised 
 
 
Secondary 
 
1. Proportion of clinical improvement 
at Day 14, defined as a ≥ 2-point 
improvement from Day 1 on a 7-
point ordinal scale 
2. Timing and duration (days) of 
Remdesivir 
3. Severity of disease on Day 7, Day 
14 and Day 28 based on NEWS 2 
score 
4. Clinical status assessed by a 7-point 
ordinal scale on Day 28 (or at last 
observation if discharged or died 
prior to this time point) in those 
still Hospitalised after day 14. 
5. Time to SpO2 > 94% on room air 
(number of days when evaluation 
made on day 7, 14 or 28) 
6. Duration of oxygen therapy (total 
days) 
7. Admitted to ICU 
8. Need for and time on mechanical 
ventilation/ECMO of 
hospitalisation 
9. Duration of hospitalisation 
 
 
 
FUNDING AND SUPPORT  
 

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FUNDER(S) 
 
COLLABORATORS/KEY CONTRIBUTORS 
 
Gilead Sciences  
333 Lakeside Drive  
Foster City, CA 94404 
 
 
NEAT ID Foundation  
Registered address: PL 709 Rue Haute 322, 1000 
Brussels, Belgium  
Administrative office: 27 Old Gloucester Street, 
London, UK, WC1N 3AX 
 
 
 
Research Organisation King’s Cross (KC) Ltd.  
The Stanley Building, 7 Pancras Square, London, 
UK, N1C 4AG 
 
 
 
Dr Lambert Assoumou (Director) 
INSERM 
Centre de méthodologie et de gestion (CMG) 
Equipe 3 Epidémiologie clinique de l'infection à 
VIH : stratégies thérapeutiques et comorbidités  
Institut Pierre Louis d’Epidémiologie et de Santé 
Publique 
Sorbonne Université,  
56, Boulevard Vincent Auriol 
CS 81393 - 75646 Paris Cedex 13 
 
 
 
 

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2. OBJECTIVES AND OUTCOME MEASURES/ENDPOINTS 
2.1 Primary objective 
The primary objectives of this study are to assess the clinical course and outcome of adults with 
COVID-19 who have been treated with Remdesivir assessed by: 
1. all-cause mortality at Day 28 
2. duration of hospitalisation 
2.2 Secondary objectives 
The secondary objectives are to assess the clinical course and outcome of adults with COVID-19 who 
have been treated with Remdesivir with respect to the following: 
1. a 7-point ordinal clinical status scale on Day 7 and Day 14 
2. timing (from first symptoms and from hospitalisation) and duration of use of Remdesivir 
3. clinical severity at Day 7, 14, 28 as assessed by the NEWS 2 score 
4. clinical status as assessed a 7-point ordinal scale on Day 28 (or at last observation if 
discharged or died prior to this time point) in those still hospitalised after Day 14. 
5. SpO2 > 94% on room air on day 7, 14 and 28 
6. duration and type (low versus high flow) of oxygen therapy (days) 
7. admitted to ICU (yes versus no) 
8. number of days spent on ICU/ITU 
9. use of mechanical ventilation/ECMO (extracorporeal membrane oxygenation); start and stop 
dates 
10. re-admission with COVID-19 complications or recurrence within 28 days of discharge and 
outcome (discharged or deceased) 
2.3 Primary Criteria for Evaluation  
1. All-cause mortality at day 28 
2. Clinical status assessed by a 7-point ordinal scale on Day 14 or at last observation if 
discharged or died prior to this time point, where the 7-point ordinal scale is defined as: 
1. Death 
2. Hospitalised, on invasive mechanical ventilation or ECMO 
3. Hospitalised, on non-invasive ventilation or high flow oxygen devices 
4. Hospitalised, requiring low flow supplemental oxygen 
5. Hospitalised, not requiring supplemental oxygen - requiring ongoing medical care 
(COVID-19 related or otherwise) 
6. Hospitalised, not requiring supplemental oxygen - no longer requires 
ongoing medical care 
7. Not hospitalised 
 

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2.4 Secondary Criteria for Evaluation 
1. Proportion of clinical improvement at Day 14, defined as a ≥ 2-point improvement from Day 
1 on a 7-point ordinal scale 
2. Timing and duration (days) of Remdesivir 
3. Severity of disease on Day 7, Day 14 and Day 28 based on NEWS 2 score 
4. Clinical status assessed by a 7-point ordinal scale on Day 28 (or at last observation if 
discharged or died prior to this time point) in those still hospitalised after day 14. 
5. Time to SpO2 > 94% on room air (number of days when evaluation made on day 7, 14 or 28) 
6. Duration of oxygen therapy (total days) 
7. Admitted to ICU 
8. Need for and time on mechanical ventilation/ECMO of hospitalisation 
9. Duration of hospitalisation 
 
3 TRIAL DESIGN 
 
This is a multi-centre, multi-country retrospective cohort study. At least 450 COVID-19 cases from up 
to 20 participating study sites who meet all eligibility criteria will be included in the analysis. 
Deidentified data will be extracted from electronic medical record (EMR) databases, clinical registries, 
case series or additional sources from participating sites and countries, and then entered into a 
structured e-CRF system. addition, each site/country will be surveyed to determine the local standard 
of care therapy for COVID-19 infection and to determine if standard protocols were/are in place for the 
use of Remdesivir and if/how the protocols changed over time. 
 
Number of Sites and Subjects Planned 
Up to 20 centres with 450 cases of Covid-19 treated with at least one dose of Remdesivir 
 
Target Population 
Adults with COVID-19 diagnosed and treated with Remdesivir after Aug 31st 2020.   
 
Comparator group-(Part 2) 
Part 2, which is collecting data on non-RDV treated controls, will only be initiated, if required, and 
once data from Part 1, the cases, is collected and analysed. Matching criteria will be detailed in a 
study management document. 
 
  
4 ELIGIBILITY CRITERIA 
4.1 Inclusion criteria 
Diagnosis and Main Eligibility Criteria - Cases(Part 1) 
All Adult participants with COVID-19 confirmed by PCR who meet the following criteria: 

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1. 
Hospitalised after August 31st,2020 
2. 
Received at least one dose of Remdesivir (RDV) at any time during hospitalisation 
 
Diagnosis and Main Eligibility Criteria –Controls (Part 2) 
Adult participants with COVID-19 confirmed by PCR who meet the following criteria: 
1. Hospitalised after August 31st 2020 
4.2 Exclusion criteria 
Exclusion Criteria – Cases (Part 1) 
1. 
Received Remdesivir as part of a clinical trial, compassionate use or expanded access 
program 
2. 
Received Remdesivir prior to this admission at any other health facility than the 
research sites and whose health records are available.  
Exclusion Criteria – Controls (Part 2) 
1. 
Received Remdesivir at any time during hospitalisation 
 
5 TRIAL PROCEDURES  
 
Only real-world retrospective data will be used for this study. Deidentified retrospective data will be 
extracted at each clinical site from source data. No personal identifiable data will be transmitted to 
NEAT ID. Data will be extracted/transcribed in to the eCRF database with standard formatting from 
electronic medical record (EMR) databases, clinical registries, case series or additional sources from 
sites/ countries. The data elements will be extracted/transcribed from source data according to the 
following schedule. Mechanisms to ensure data quality and integrity will be deployed as per applicable 
standard operating procedures. 
 
 
Day1 (Hospital 
Admission) 
Day7 (+/- 1 day) and Day14 
(+/- 2 days) / last observation 
if discharged or died prior to 
these time points. 
Day 28 or last observation 
after Day 14 if discharged or 
died prior to this time point. 
Medical History a 
x 
 
 
Pregnancy test 
x 
 
 
HIV test 
x 
 
 
Vital Signs b 
x 
x 
x 
Laboratory Testing c 
x 
x 
x 
Oxygenation d 
x 
x 
x 
Clinical Status e 
x 
x 
x 
Other Treatments for COVID-19 f 
x 
x 
x 
NEWS SCOREg 
x 
x 
x 
a. 
Focused medical history and also the following information (e.g. demographics including ethnicity, baseline 
characteristics including DM, CV disease and COPD)  
b. 
SpO2, body temperature, body weight and height on admission 
c. 
Includes white blood cell count, creatinine, total bilirubin, ALT, AST at admission Day 7 and day 14 or at discharge 
if before day 14 , radiographic findings at baseline and as available and SARS-CoV-2 pcr, antigen and/or  antibody 
testing. 
d. 
Includes oxygen supplementation: room air, low flow O2 (L/min and %), high flow O2 (L/min and %), non- invasive 

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positive pressure ventilation (FiO2 or %), mechanical ventilation (FiO2 or %), ECMO (extracorporeal membrane 
oxygenation) 
e. 
The ordinal scale is as: 1. Death, 2. Hospitalised, on invasive mechanical ventilation or ECMO, 3. Hospitalised, on 
non-invasive ventilation or high flow oxygen devices, 4. Hospitalised, requiring low flow supplemental oxygen, 5. 
Hospitalised, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or 
otherwise), 6. Hospitalised, not requiring supplemental oxygen - no longer requires ongoing medical care, 7. Not 
hospitalised 
f. 
These include corticosteroids, anticoagulants, azithromycin/other antibiotics, anti-inflammatory agents (e.g. 
Tocilizumab), investigational agents (eg hydroxychloroquine) and immunotherapies such as convalescent plasma 
and monoclonal antibodies. 
g. 
NEWS 2 score is based on Respiration rate (per minute), SpO2 (%) Air or oxygen. Systolic blood pressure (mmHg), 
Pulse (per minute) Consciousness, Temperature (°C) 
 
 
6 STATISTICS AND DATA ANALYSIS 
6.1 Subject population 
 
Target Population 
Adults with COVID-19 diagnosed and treated with Remdesivir after Aug 31st 2020.   
 
Comparator group 
Part 2, which is collecting data on controls, will only be initiated, if required, and once data from Part 
1, the cases, is collected and analysed.  
  
The matching criteria for controls, who were given standard of care but not Remdesivir, and who 
were admitted in a 2 week time window of the cases will be determined once the target population 
of Part 1, the cases, data has been collected and analysed.  
6.2 Study size 
This is a non-interventional, observational study where no formal samples size calculation is to be 
performed. It is anticipated that at least 450 adults with COVID-19 and treated with Remdesivir could be 
recruited across centres from NEAT ID Network. In addition, 450 other adults with COVID-19 treated with 
standard of care (control group) will be recruited if needed.  
6.3 Statistical analysis 
Summary statistics will be generated for the cohort overall and by disease severity at baseline (2 vs 3/4 
vs 5). For categorical variables, numbers and percentages of participants will be reported including the 
95% confidence intervals. For continuous variables, mean, standard deviation (SD), minimum, first and 
third quartile (Q1, Q3), median, maximum and 95% confidence intervals will be calculated, together with 
the total number of observations and the number of missing values. Descriptive statistics will summarize 
demographics and baseline characteristics. Mortality rate (all causes) at day 28 and its associated 95% 
confidence interval will be calculated using Kaplan-Meier estimates. 
The analysis population will be consisted of all enrolled participants with data available at baseline. 
We will assess factors associated with clinical status at day 14 using proportional odds models and factors 
associated with survival at day 28 using Cox proportional hazards models. For continuous variables, the 
decision to treat the variable as a continuous or categorical variable (as tertile) will be based on the lowest 
Akaike information criterion value for the corresponding univariable analysis. Variables achieving P < 0.10 
in univariable analysis will be retained for the multivariable analysis.  
The following variable will be assessed:  

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- 
Participating country 
- 
Age group: < 65 vs ≥ 65 years 
- 
Sex at birth: female vs male 
- 
Geographic origin: European vs Sub-Saharan Africa vs. other 
- 
Baseline clinical status (2 vs 3/4 vs 5) 
- 
Body mass index at baseline (<18.5 vs 18.5-25; 25.01-30 vs >30 kg/m2) 
- 
Diabetes at baseline (yes vs no) 
- 
High blood pressure at baseline (yes vs no) 
- 
Time from symptoms onset and date of treatment start (<7 days vs ≥ 7 days) 
 
Secondary endpoints as well as the effect of remdesivir relative to the control group (if Part 2 is 
performed) will be assessed using appropriate statistical methods for non-randomized cohorts. All details 
of the analyses will be included in the Statistical Analysis Plan (SAP). 
7 
DATA  
7.1 Authorship eligibility guidelines and any intended use of professional writers 
Publication 
Data from the RCS will be published independently by NEAT ID. All contributing PI investigators will 
have the opportunity to participate in publication (abstracts and manuscripts) on the analyses. 
This study will be conducted in accordance with the guidelines of Good Pharmacoepidemiology 
Practice (GPP) and Heads of Medicines Agencies (HMA) including archiving of essential documents. 
7.2 Data Protection 
Personal Data means any information relating to an identified or identifiable natural person (Data 
Participant), including without limitation pseudonymised information, as defined in the Applicable 
Law. The Applicable Law includes the Regulation (EU) 2016/679, its UK counterpart (UK GDPR) and 
other relevant regulations. Personal Data will only be collected in line with the study objectives as 
descried in this protocol, and to safeguard participants’ rights, only relevant, adequate, limited and 
necessary data will be collected and used. It is the Data Controller’s (the sponsor) responsibility to 
ensure compliance with the Applicable Law of a data processor (a CRO or an investigator site).  
Data processor(s) to aid the Controller with the Applicable Law compliance, must ensure that persons 
authorised to process the data, have committed themselves to confidentiality or are under an 
appropriate statutory obligation of confidentiality. Transfer of data must be strictly necessary for the 
implementation of the research or the use of the results. Transfers of data to a third country will be 
carried out in line with the applicable law and/or provisions ensuring adequacy (e.g.  Standard 
Contractual Clauses for the transfer of personal data).  
Data participant rights are upheld according to the applicable law. If a consent has been given, that 
consent may be withdrawn at any time. The withdrawal will not affect the lawfulness of the processing 
carried out prior. The personal data may continue to be processed where there is an appropriate legal 
basis for such processing. Rights to access, change or move of the collected information are limited as 
the information must be managed in specific ways for the research to be reliable and accurate.  

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7.3 Data Retention 
Patient data may be retained for up to two (2) years after the last publication of the results of research 
or, in the absence of publication, until the signing of the final research report.  
The personal data of professionals involved in research cannot be kept beyond a period of fifteen 
years (or in accordance with the current regulatons) after the end of the last research in which they 
participated. 
 
 

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8 APPENDICIES 
 
APPENDIX 1 – Schedule of Procedures 
 
Day1 (Hospital 
Admission) 
Day7 (+/- 1 day) and Day14 
(+/- 2 days) / last observation 
if discharged or died prior to 
these time points. 
Day 28 or last observation 
after Day 14 if discharged or 
died prior to this time point. 
Medical History a 
x 
 
 
Pregnancy test 
x 
 
 
HIV test 
x 
 
 
Vital Signs b 
x 
x 
x 
Laboratory Testing c 
x 
x 
x 
Oxygenation d 
x 
x 
x 
Clinical Status e 
x 
x 
x 
Other Treatments for COVID-19 f 
x 
x 
x 
NEWS SCOREg 
x 
x 
x 
 
a. 
Focused medical history and also the following information (e.g. demographics including ethnicity, baseline 
characteristics including DM, CV disease and COPD)  
b. 
SpO2, body temperature, body weight and height on admission 
c. 
Includes white blood cell count, creatinine, total bilirubin, ALT, AST at admission Day 7 and day 14 or at discharge 
if before day 14 , radiographic findings at baseline and as available and SARS-CoV-2 pcr, antigen and/or  antibody 
testing. 
d. 
Includes oxygen supplementation: room air, low flow O2 (L/min and %), high flow O2 (L/min and %), non- invasive 
positive pressure ventilation (FiO2 or %), mechanical ventilation (FiO2 or %), ECMO (extracorporeal membrane 
oxygenation) 
e. 
The ordinal scale is as: 1. Death, 2. Hospitalised, on invasive mechanical ventilation or ECMO, 3. Hospitalised, on 
non-invasive ventilation or high flow oxygen devices, 4. Hospitalised, requiring low flow supplemental oxygen, 5. 
Hospitalised, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or 
otherwise), 6. Hospitalised, not requiring supplemental oxygen - no longer requires ongoing medical care, 7. Not 
hospitalised 
f. 
These include corticosteroids, anticoagulants, azithromycin/other antibiotics, anti-inflammatory agents (e.g. 
Tocilizumab), investigational agents (eg hydroxychloroquine) and immunotherapies such as convalescent plasma 
and monoclonal antibodies. 
g. 
NEWS 2 score is based on Respiration rate (per minute), SpO2 (%) Air or oxygen. Systolic blood pressure (mmHg), 
Pulse (per minute) Consciousness, Temperature (°C) 
 
 
 

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