Registry to Study Factors That May Impact COVID-19 Occurrence and Severity
Conditions: COVID-19
Sponsor: IQVIA Pty Ltd

COVID-19 Registry 
                                            Version 4.0 dated 9Mar2020 
Protocol/Study No.: IQVIA_COVIDREGISTRY_2020 
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and its subsidiaries. Unauthorized use, disclosure or reproduction is strictly prohibited. 
 
 
 
COVID-19 REGISTRY STUDY PROTOCOL 
 
 
TITLE 
Registry to study factors that may impact COVID-19 occurrence and severity 
PROTOCOL/STUDY NO. 
IQVIA_COVIDREGISTRY_2020 
VERSION  
4.0; 9 Mar 2021 
CONDUCTED BY 
 
IQVIA  
201 Broadway 
Cambridge, MA 02139 USA 
This protocol contains confidential information that should only be disclosed to those persons responsible for 
execution and organization of the study and on condition that all such persons agree not to further disseminate it.  
 
 
 
 

COVID-19 Registry 
                                            Version 4.0 dated 9Mar2020 
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and its subsidiaries. Unauthorized use, disclosure or reproduction is strictly prohibited. 
TABLE OF CONTENTS 
INFORMATIONAL CONTACTS ......................................................................................... 4 
DOCUMENTATION OF PROTOCOL AMENDMENTS ................................................. 5 
STUDY SYNOPSIS ................................................................................................................. 7 
1. 
BACKGROUND AND RATIONALE .......................................................................... 9 
2. 
OBJECTIVES ................................................................................................................. 9 
3. 
STUDY DESIGN .......................................................................................................... 10 
3.1 
Study Description ............................................................................................... 10 
3.2 
Study Population ................................................................................................ 10 
 
Inclusion Criteria .............................................................................. 10 
 
Exclusion Criteria ............................................................................. 11 
 
Study Enrollment .............................................................................. 11 
 
Participant Withdrawal ..................................................................... 11 
3.3 
Data Sources and Collection .............................................................................. 11 
 
Baseline/Enrollment ......................................................................... 12 
 
Follow-up ......................................................................................... 14 
4. 
STATISTICAL METHODS ........................................................................................ 16 
4.1 
Sample Size ........................................................................................................ 16 
4.2 
Data Analyses ..................................................................................................... 16 
 
General Considerations .................................................................... 16 
 
Limitations of Research Methods ..................................................... 16 
4.3 
Data Reporting ................................................................................................... 17 
5. 
STUDY MANAGEMENT ........................................................................................... 17 
5.1 
Source Documents .............................................................................................. 17 
5.2 
File Retention and Archiving ............................................................................. 17 
5.3 
Quality Assurance and Monitoring .................................................................... 17 
5.4 
Data Management ............................................................................................... 17 
5.5 
Changes to the Protocol ...................................................................................... 18 
5.6 
Study Governance .............................................................................................. 18 

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6. 
SAFETY REPORTING ............................................................................................... 18 
7. 
ETHICAL AND REGULATORY CONSIDERATIONS ......................................... 18 
7.1 
Guiding Principles .............................................................................................. 18 
7.2 
Participant Confidentiality ................................................................................. 19 
7.3 
Participant Information and Informed Consent .................................................. 19 
7.4 
Independent Ethics Committee (IEC)/Institutional Review Board 
(IRB) ................................................................................................................... 19 
8. 
REFERENCES ............................................................................................................. 20 
 
 
 

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Informational Contacts 
 
IQVIA is the clinical research organization responsible for this study. 
 
Name and Title 
Role 
Contact Information 
Nancy Dreyer, PhD, MPH, FISPE 
Chief Scientific Officer and Senior 
Vice President, Head Center for 
Advanced Evidence Generation 
Principal Investigator 
Email: Nancy.Dreyer@IQVIA.com 
Phone: +1 617 715 6810 
Matthew Reynolds, PhD 
Vice President, Real-World 
Evidence 
Co-Principal 
Investigator 
Email: 
Matthew.Reynolds@IQVIA.com 
Phone: +1 410 739 2453 
Heather Valine, MS 
Director, Patient Initiated Data 
Generation 
Product Manager 
Email: Heather.Valine@iqvia.com  
Phone: +44 7795 265627 
Christina Mack, PhD, MSPH 
Vice President, Epidemiology and 
Clinical Evidence, Head Injury 
Surveillance and Analytics 
Senior Scientific 
Advisor 
Email: Christina.Mack@IQVIA.com  
Phone: +1 574 276 7958 
 
 
Mail correspondence can be sent to Emma Brinkley, 4820 Emperor Blvd, Durham, NC, 27703 and 
should be accompanied by a notification by email (Emma.Brinkley@IQVIA.com).  
 
 
 
 
 
 

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Documentation of Protocol Amendments 
 
Version 
Date 
Summary of Revisions 
Original 
March 27, 2020 
N/A 
V2.0 
April 13, 2020 
Revised study title and added 3 months of 
longitudinal follow-up 
V3.0 
December 7, 2020 
Revised duration of follow-up from 3 months 
to 12 months, removed questions on social 
distancing, and added questions on mental 
health conditions, healthcare encounters, and 
vaccines. 
V4.0 
March 9, 2021 
Revised inclusion criteria to include 
vaccinated adults as well as participants from 
the UK; added questions about post-
vaccination symptoms and health care 
encounters.  
 
 

COVID-19 Registry 
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List of Abbreviations 
COVID-19 
coronavirus disease 2019 
FDA 
U.S. Food and Drug Administration 
GDPR 
General Data Protection Regulation 
GPP 
good pharmacoepidemiology practices 
HIPAA 
Health Insurance Portability and Accountability Act of 1996 
ICF 
informed consent form 
ICH 
International Council for Harmonisation of Technical Requirements for 
Pharmaceuticals for Human Use 
IEC 
independent ethics committee 
IRB 
institutional review board 
ISPE 
International Society for Pharmacoepidemiology 
NSAID 
nonsteroidal anti-inflammatory drugs 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Study Synopsis 
 
Full Study Title: Registry to study factors that may impact COVID-19 occurrence and severity 
Background & Rationale:  The 2019 coronavirus disease (COVID-19) has presented major challenges to 
countries around the world. Currently there is little information about (1) symptom presentation, severity, and 
duration especially for cases that do not require hospitalization, (2) understanding which prescription 
medications, if any, influence risk, including various hypertension and anti-diabetic medications, (3) whether 
vitamin and mineral supplements, alone or in combination with established medications offer any degree of 
protection, and (4) what medical management is most effective at reducing the high toll of this infection. 
Initial research suggests a wide range of potential symptoms including those that would be expected with a 
respiratory virus (e.g., fever, cough) as well as gastrointestinal issues, dizziness, inability to concentrate, and 
effects on the sense of smell and taste. Additionally, there are a wide range of treatments, both prescribed and 
over-the-counter, that are being used to manage symptoms. Systematic data collection and analytics will 
contribute empirical information about benefits and risks that could have immediate public health impact. This 
registry will enroll participants in an observational, direct-to-participant longitudinal study to assess disease risk, 
progression, treatments, and vaccines.   
Objectives: The objectives of this study are to: 
1. Identify factors that may impact the occurrence, severity, or duration of COVID-19 infections including 
examining the role of underlying health conditions, prescription and over-the-counter medications, 
vitamins and supplements.  
2. Assess post-vaccine symptoms and COVID-19 infection among participants reporting a COVID-19 
vaccination 

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Study Design: This is an observational, direct-to-participant, web-based, longitudinal study of adults with 
COVID-19 or COVID-19 like illness to better understand risk factors, symptoms, and treatments for COVID-19 
illness and vaccine safety and effectiveness. This study will be launched and conducted in the US and UK. 
Participants will be recruited through postings from partner organizations such as governments and professional 
associations as well as support from advertising, social media, and public relations. People with COVID-19, 
COVID-19 like symptoms, exposure to COVID-19, and/or COVID-19 vaccination will be asked to visit the 
online study portal. All study data will be reported by participants within the web-based study portal. 
Participants will complete an initial baseline survey reporting their demographics, relevant medical history, 
testing, vaccination, symptoms, use of prescription and non-prescription medications (prophylactic and curative) 
as well as use of supplements (e.g., vitamins, minerals, and herbals) and other factors. The study follow-up 
period is 12 months. During the first month of follow-up participants will be invited to complete a symptom 
diary weekly to gauge symptom progression and severity and to provide updates on pharmaceutical and non-
pharmaceutical interventions as well as healthcare encounters. Reporting will then reduce to monthly for Month 
2 through 12.  Participants reporting COVID-19 vaccination (first or second dose) will be moved into weekly 
follow-up, if not already in weekly follow-up, for 4 weeks after vaccination to capture subsequent symptoms and 
healthcare encounters as well as a second vaccine dose if applicable. This survey schedule represents reminders 
for survey completion, noting the technology will allow for participants to enter data at any time during the 
follow-up window. 
Study Population: The study population will include adults aged 18 and older who have COVID-19, have 
COVID-19 like symptoms, were exposed to COVID-19, or received a COVID-19 vaccine.  Participants must 
have access to an internet-connected computer, smartphone or tablet to answer registry questions. 
Data Management and Quality Assurance: Data will be collected using a web-based, mobile-friendly portal. 
Data will be collected and stored in a HIPAA-compliant manner consistent with high levels of privacy and 
security for storing sensitive information about participant health. Data will be encrypted during transit and at 
rest. Access privileges will be granular and tightly controlled with strong passwords required from administrative 
users. Personally identifiable information collected for registration, including personal contact information will 
be stored separately from other collected information and will only be accessible to staff with administrative 
privileges and with a specific and legitimate purpose to use that information. 
Ethical and Regulatory Considerations: This observational study will be conducted in accordance with the 
protocol and all applicable laws and regulations including, but not limited to good pharmacoepidemiology 
practices (GPP), and the ethical principles that have their origins in the Declaration of Helsinki and applicable 
privacy laws. Data protection and privacy regulations will be strictly observed in capturing, forwarding, 
processing, and storing participant data. Every effort will be made to protect participant confidentiality according 
to the General Data Protection Regulation (GDPR) on the protection of individuals, and in compliance with EU-
US Privacy Shield, and other relevant data privacy and protection regulations. An IRB/IEC must review and 
approve the protocol and informed consent form before any participants are enrolled. Before any protocol-
directed data collection is performed, the participant must sign and date the IRB/IEC-approved informed consent 
form.  This protocol will be posted on clinicaltrials.gov and the EU PAS Register 
(http://www.encepp.eu/encepp/studiesDatabase.jsp). 

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1. 
BACKGROUND AND RATIONALE 
The ongoing coronavirus disease (COVID-19) pandemic has caused a worldwide crisis in 
terms of social, medical and financial systems. The number of cases globally has increased 
significantly since the first reported case in December 2019. Initially, the disease was thought 
to severely affect primarily older patients (60 years and above)1 but as the virus continues to 
spread, it has become evident that several other patient populations are at high risk for 
hospitalization, complications, and even death2. 
The United States has been severely burdened by COVID-19, with over 28 million cases and 
500,000 deaths reported as of 25 February 20213. Additionally, there have been evolving 
reports of COVID-19 symptoms and progression4,5,6,7, making it difficult for people to 
determine when they should seek medical attention and/or quarantine for suspected COVID-
19 illness. Therefore, there is a need for systematic data collection from people who may be 
infected with COVID-19 but may not have access to a test to confirm their diagnosis.  
Currently, there is a paucity of data describing disease risk, symptoms, and non-prescription 
medication use including supplements among the broader non-hospitalized community. Most 
publicly available data is limited to surveillance of the number of tested cases and the number 
of deaths, with little to no longitudinal follow-up of symptom progression, outcomes, 
treatments, and other related information.  In addition, there is a need for long-term follow-up 
for people receiving COVID-19 vaccinations to continue to monitor safety and effectiveness 
outside of well controlled clinical trials and as COVID-19 strains evolve over time. 
With recent Emergency Use Authorization of several COVID-19 vaccines, there is also a 
need to understand broad and long-term safety and effectiveness of the COVID-19 vaccines 
over time and as new strains emerge.  
Systematic data collection and analytics would contribute empirical information about 
benefits and risks that could have immediate public health impact. This Registry will enroll 
participants in an observational, direct-to-participant longitudinal study to assess disease risk, 
progression, treatments, and vaccines.   
2. 
OBJECTIVES 
The objectives of this study are to: 
1. Identify factors that may impact the occurrence or severity of COVID-19 
infections including examining the role of underlying health conditions, 
prescription and over-the-counter medications, vitamins and supplements. 
2. Assess post-vaccine symptoms and COVID-19 infection among participants 
reporting a COVID-19 vaccination 
 

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3. 
STUDY DESIGN 
3.1 
Study Description 
This is an observational, direct-to-participant, web-based, longitudinal study of adults with 
potential exposure to COVID-19 to better understand risk factors, symptoms, and treatments 
for COVID-19 illness as well as vaccine safety and effectiveness. This study will be 
conducted in the US and UK. Participants will be recruited through postings from partner 
organizations such as governments and professional associations as well as support from 
advertising, social media, and public relations. People who have been vaccinated against 
COVID, who have COVID-like symptoms, or were exposed to COVID-19 will be asked to 
visit a portal landing page. All study data will be reported by participants within the web-
based study portal. Upon consent and enrollment, participants will complete an initial baseline 
survey reporting their demographics, relevant medical history, symptoms, use of prescription 
and non-prescription medications (prophylactic and curative) as well as use of supplements 
(e.g., vitamins, minerals, herbals) and other factors. Participants are then followed for 12 
months. During Month 1, participants will complete a symptom diary to record symptom 
progression and severity and provide updates on pharmaceutical and non-pharmaceutical 
interventions as well as healthcare encounters once a week. During Months 2 through 12, 
follow-up is reduced to twice a month to reduce patient burden and capture longer-term 
disease progression (now often referred to as “long COVID”) and treatment. Longer follow-
up is required to assess symptoms that may linger or worsen.  
No medical advice will be provided; links to credible medical resources about COVID-19 will 
be made available. 
3.2 
Study Population 
There is no sample size restriction for this study. This study is designed for open enrollment 
of all eligible participants and can accommodate millions of respondents.     
 
Inclusion Criteria 
The following criteria must be met in order to be enrolled in the study:  
• Adult (18 years or older) 
• Currently living in the US or UK 
• Have COVID-19 or COVID-19 like symptoms 
• Received a COVID-19 vaccine  
• Potential exposure to COVID-19 

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• Have regular access to a computer, smartphone or tablet and sufficient internet to 
support registry demands (note: this registry is designed to operate well even in 
regions with low bandwidth) 
• Willing and able to provide informed consent 
• Willing and able to follow the procedures of the study 
 
Exclusion Criteria 
Participants meeting ANY of the following criteria are not eligible for participation: 
• Unable to provide informed consent 
• Unable to perform the requested study tasks  
 
Study Enrollment 
The registry will engage participants through postings from partner organizations such as 
governments and professional associations as well as support from advertising, social media, 
and public relations to visit a portal landing page. Once on the landing page, the participant 
will answer questions to confirm eligibility, consent into the study, and then register by 
providing an email address and, optionally, a mobile phone number. As part of consenting 
into this registry, participants also agree to be contacted for future research opportunities. 
Participants are not required to participate in any future studies, and there is no consequence 
for ignoring the request or declining to participate. Participation in any future research 
opportunities will require a separate, study-specific consent. 
At enrollment, participants will also be asked to provide an alternative contact (next of kin or 
close friend) who may be contacted if we are unable to reach the participant. The intent here 
is to minimize loss to follow-up and to allow for proxy data collection in the event of serious 
illness or death. 
 
Participant Withdrawal 
Participants may withdraw consent and discontinue participation in the study at any time. All 
survey data would be deleted from the central system and would not be included in any future 
data distributions. However, the data will not be withdrawn from past data distributions to 
partners or deleted from archival backup files. 
3.3 
Data Sources and Collection  
This is a direct-to-participant registry. All data will be reported by participants through a web-
enabled application. No visits or examinations, laboratory tests or procedures are mandated or 
required for this study. Table 1 outlines reminders for participants to complete surveys, noting 
the technology will allow for participants to enter data at any time during the follow-up 
window. 

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Table 1. Data Collection Schedule 
 
Enrollment 
/Baseline 
Month 1 
(once a 
week) 
Month 2 
through 12 
(twice a 
month) 
 
Informed Consent 
X 
 
 
Demography 
X 
 
 
Static Medical History and Risk Factors (e.g., height, weight, 
occupation) 
X 
 
 
Medical History (e.g., diagnoses, concomitant medications, 
vitamins/supplements, pregnancy, seasonal flu vaccine)* 
X 
X* 
X* 
COVID-19 test, if conducted 
X 
X 
X 
COVID-19 vaccination including manufacturer, date, lot number 
and first shot or booster, post-vaccine symptoms, and healthcare 
encounters for possible reactions, if available 
X 
X** 
X** 
COVID-19 symptoms  
X 
X 
X 
COVID-19 medications, both prescription and OTC, that may be 
intended as prophylactic or curative treatments  
X 
X 
X 
*Participants will be asked during follow-up if they had any changes in their underlying medical 
history (e.g., new diagnoses, new medications). If yes, they will report changes in key medical history 
that may influence COVID-19 risk factors and/or recovery (e.g., new comorbidities, pregnancy, etc). 
**Participants reporting COVID-19 vaccination (first or second dose) will be moved into weekly 
follow-up, if not already in weekly follow-up, for 4 weeks after vaccination to capture subsequent 
symptoms and healthcare encounters as well as a second vaccine dose if applicable. 
 
Baseline/Enrollment 
The following data are planned to be collected at baseline for all enrolled participants: 
• Demographics 

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o geography (zip code/ postcode) 
o age (date of birth) 
o gender 
o race/racial designation 
o ethnicity  
o education 
• Medical History and Other Risk Factors 
o weight  
o height 
o baseline medical history including: 
▪ comorbidities that are thought to be potential risk factors including 
cardiovascular disease, lung disease, diabetes, kidney, blood disorders, 
and auto-immune conditions 
▪ history of depression, anxiety, and insomnia 
▪ prescription medications 
o frequency of use of certain medications of interest, including daily aspirin, 
Pepcid (famotidine), Tagamet HB (cimetidine), and antihistamine (cetirizine, 
loratadine) 
o use of supplements (vitamin D, zinc, other vitamins/minerals, herbals) 
o current smoking status 
o history of organ transplant 
o current treatment for cancer 
o pregnant  
o vaccinations, including childhood vaccinations (e.g. MMR) and seasonal flu 
o occupation, including healthcare worker or other job with heightened risk of 
exposure (e.g., grocery, daycare, mail/delivery) 
• COVID-19  
o type of test, test results and date of test, if any 
o presence and severity (4-point scale) of symptoms including fever, cough, 
fatigue, dizziness, eye pain, blurry vision, shortness of breath, persistent pain 
or pressure in the chest, heart palpitations, new onset of confusion, inability to 
arouse, aches and pains, muscle twitching, rash, nasal congestion, runny nose, 

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sore throat, decreased sense of taste, decreased appetite, decreased sense of 
smell, diarrhea, vomiting, nausea, depression, anxiety, insomnia, other 
o healthcare encounters, including type (telemedicine, office visit, emergency 
department, hospitalization), date, and whether the encounter was related to 
COVID-19 
▪ if hospitalized, duration of hospitalization 
o household member has COVID-19 or flu-like symptoms  
o receipt of COVID-19 vaccination, either as part of a clinical trial or standard of 
care once authorized by FDA or Medicines and Healthcare products 
Regulatory Agency (MHRA), along with date, manufacturer, and lot number if 
known, and whether it was the first shot or a booster shot. 
▪ among vaccinated:  
• symptoms following the vaccination including pain at injection 
site, swollen lymph nodes, fever, fatigue, headache, joint or 
muscle pain, nausea or vomiting, severe allergic reaction 
• impact symptoms had on ability to take care of yourself and 
ability to work 
• healthcare encounters, including hospitalization, following the 
vaccination 
o medications including prescriptions (antimalarials, antivirals, antibiotics, 
biologics, corticosteroids, monoclonal antibody), over-the-counter 
(acetaminophen, nonsteroidal anti-inflammatory drugs [NSAIDs]),  
▪ for treatments the participant reports taking, timing of treatment 
relative to symptom onset  
o participation in clinical trials or receipt of experimental treatments  
 
Follow-up 
The following data are planned to be collected for all enrolled participants once a week during 
Month 1, twice a month during Months 2 through 12. Participants reporting a COVID-19 
vaccine (first or second dose/booster) will be followed weekly for 4 weeks after their COVID-
19 vaccine to capture symptoms, medical encounters and a booster, if applicable.  Participants 
will be asked during follow-up to report any changes in their medical history (e.g., new 
comorbidities, prescription medications, pregnant) to reduce participant burden and allow for 
capture of updated medical history that may influence risk factors and disease progression. 
• COVID-19  
o type of test, test results and date of test, if any 

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o presence and severity (4-point scale) of symptoms including fever, cough, 
fatigue, dizziness, eye pain, blurry vision, shortness of breath, persistent pain 
or pressure in the chest, heart palpitations, new onset of confusion, inability to 
arouse, aches and pains, muscle twitching, rash, nasal congestion, runny nose, 
sore throat, decreased sense of taste, decreased appetite, decreased sense of 
smell, diarrhea, vomiting, nausea, depression, anxiety, insomnia, other 
o healthcare encounters, including type (telemedicine, office visit, emergency 
department, hospitalization), date, and whether the encounter was related to 
COVID-19 
▪ if hospitalized, duration of hospitalization 
o household member has COVID-19 or flu-like symptoms 
o receipt of COVID-19 vaccination, either as part of a clinical trial or standard of 
care once authorized by FDA or Medicines and Healthcare products 
Regulatory Agency (MHRA), along with date, manufacturer, and lot number if 
known 
▪ among vaccinated: 
• symptoms following the vaccination including pain at injection 
site, swollen lymph nodes, fever, fatigue, headache, joint or 
muscle pain, nausea or vomiting, severe allergic reaction 
• impact symptoms had on ability to take care of yourself and 
ability to work 
• healthcare encounters, including hospitalization, following the 
vaccination 
o medications including prescriptions (antimalarials, antivirals, antibiotics, 
biologics, corticosteroids), over-the-counter (acetaminophen, NSAIDs),  
▪ for treatments the participant reports taking, timing of treatment 
relative to symptom onset  
o participation in clinical trials or receipt of experimental treatments 
• Medical History and Other Risk Factors (if participant reports a change in medical 
history since last survey) 
o comorbidities that are thought to be potential risk factors including 
cardiovascular disease, lung disease, diabetes, kidney, blood disorders, and 
auto-immune conditions 
o history of depression, anxiety, and insomnia 
o prescription medications 

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o frequency of use of certain medications of interest, including daily aspirin, 
Pepcid (famotidine), Tagamet HB (cimetidine), and antihistamine (cetirizine, 
loratadine) 
o use of supplements (vitamin D, zinc, other vitamins/minerals, herbals) 
o history of organ transplant 
o current treatment for cancer 
o pregnant  
o flu vaccine 
 
4. 
 STATISTICAL METHODS 
4.1 
Sample Size 
No formal sample size calculations were performed for this study. All interested, qualifying 
participants will be able to enroll without restriction.  
4.2 
Data Analyses 
 
General Considerations 
Data analysis will be designed to respond to high priority medical and public health issues, 
with feasibility counts and analytic plans designed in advance of conducting the analyses, as 
has been established in previous pandemic research on H5N1 avian influenza8.  Computations 
and generation of tables, listings and data for figures will be performed using SAS® version 
9.2 or higher (SAS Institute, Cary, NC, USA) and/or data visualization tools.  
Descriptive analyses will be performed to gain an understanding of the qualitative and 
quantitative nature of the data collected and the characteristics of the respondents. Additional, 
in-depth analyses will be outlined in supplementary objective-specific analytic plans.   
 
Limitations of Research Methods 
This is a voluntary direct-to-participant study. While there are many advantages to this 
approach in the context of studying a pandemic, there are inherent limitations.  
Participants voluntarily enroll in the study. Participants who enroll may be different from the 
broader population in meaningful ways. For example, they could be more aware of COVID-
19 and therefore more likely to take precautions such as social distancing or be more 
proactive regarding their health. Participants may also include people who are more reluctant 
to seek medical care, despite serious symptoms. Further, the requirement of access to the 
internet and the ability to participate in an online study is likely to be a barrier to participation 

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for populations without reliable internet access, who are not literate or who are not 
comfortable with online or mobile technology.  
Participants may misreport data or may not complete follow-up. This could result in some 
systematic error that will need to be addressed analytically, including various sensitivity 
analyses. The recruitment strategy and web-based application will be designed to minimize 
these risks as well as maximize high quality and complete data.  
Loss-to-follow up is a limitation, particularly for participants who have become extremely 
sick or passed away. Efforts to engage an alternative contact (next of kin, family member or 
close friend) will be taken to minimize loss to follow-up.   
4.3 
Data Reporting 
Periodic descriptive analyses will be produced at key timepoints during this study. A final 
study report will be generated after all data collection is complete. The final report will 
summarize all analyses, including a description of the complete study population, as described 
above and in a study-specific analysis plan. The results of this study will be made public, 
mostly likely in the peer-reviewed medical literature.  
5. 
STUDY MANAGEMENT 
This study will be performed by IQVIA, including development of materials, recruitment, 
data management and analysis.   
5.1 
Source Documents 
There are no source documents for this registry. All data are reported by enrolled participants. 
5.2 
File Retention and Archiving 
Key study documents will be stored in a centralized online location for the duration of the 
study and two years following study completion.  
5.3 
Quality Assurance and Monitoring 
The data collection instruments will be developed to maximize data quality. This includes 
providing clear and appropriate response options, minimizing free text entries, and adding 
validation checks. Data will be reviewed on an ongoing basis to determine if alternative 
response options are needed to reduce missingness or ‘other’ responses, and the data 
collection instrument will be refined accordingly.  
5.4 
Data Management 
Data will be collected using a secure web-based application using a computer, smartphone, or 
tablet. Data will be collected and stored in a manner consistent with high levels of privacy and 
security for storing sensitive information about participant health, and with the expectations 

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and its subsidiaries. Unauthorized use, disclosure or reproduction is strictly prohibited. 
that the system will need to be HIPAA-compliant and subject to all relevant privacy 
regulations. Any personally identifiable data will be encrypted before being sent to the central 
database and will also be encrypted during storage. Only authorized persons will be able to 
access the data. Personally identifiable information (such as name and birthdate) will be 
stored separately from other information and will only be made available to staff with a 
specific need to use that information for a legitimate purpose, like re-contacting the 
participant for future research.  
5.5 
Changes to the Protocol 
Changes to the protocol will be documented in written protocol amendments. Major (i.e., 
substantial, significant) amendments will usually require submission to the relevant IRB/IEC.  
In such cases, the amendment will be implemented only after approval has been obtained. 
Minor (nonsubstantial) protocol amendments, including administrative changes, will be filed 
and submitted to the relevant IRB/IEC where required by pertinent regulations. Any 
amendment that could have an impact on the participant’s agreement to participate in the 
study requires the participant’s informed consent prior to continued participation in the study. 
5.6 
Study Governance 
This study will be governed by a qualified study team consisting of epidemiologists, medical 
doctors, biostatisticians, technical experts and other personnel. As new analyses are proposed, 
appropriate governance will continue to be put in place specific to research needs.  
6. 
SAFETY REPORTING 
No product-related adverse events are being collected from participants.  
7. 
ETHICAL AND REGULATORY CONSIDERATIONS 
7.1 
Guiding Principles 
To ensure the quality and integrity of research, this study will be conducted under the 
guidelines good pharmacoepidemiology practices (GPPs) issued by the International Society 
for Pharmacoepidemiology (ISPE), the Declaration of Helsinki and its amendments, and any 
applicable national guidelines. 
The study will be conducted in compliance with the US FDA Title 21 CFR Part 50 – 
Protection of Human Patients and/or Part 56 – Institutional Review Boards; the International 
Conference on Harmonisation (ICH) GCP E6(R2) guidelines (15 December 2016) as they 
apply to observational studies; the Declaration of Helsinki and its amendments; and the 
Health Insurance Portability and Accountability Act of 1996 (HIPAA). 

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and its subsidiaries. Unauthorized use, disclosure or reproduction is strictly prohibited. 
7.2 
Participant Confidentiality 
In accordance with local regulations in each of the registry countries, participants will be 
informed about data handling procedures and asked for their consent. Data protection and 
privacy regulations will be strictly observed in capturing, forwarding, processing, and storing 
participant data. Every effort will be made to protect participant confidentiality according to 
applicable data privacy laws, including the Regulation (EU) 2016/679 (General Data 
Protection Regulation - GDPR) on the protection of individuals. All parties will ensure 
protection of patient personal data and will not include patient names on any reports, 
publications, or in any other disclosures, except where required by law. 
7.3 
Participant Information and Informed Consent 
An informed consent form (ICF) will be obtained from each participant through the online 
portal prior to participation in the study. An electronic copy of the ICF will be available for 
participants to download for their own records. 
The ICF will be revised whenever there are changes to procedures outlined in the informed 
consent or when new information becomes available that may affect the willingness of the 
participant to participate.   Separate ICFs will be used in the US and UK, according to local 
ethics requirements. 
7.4 
Independent Ethics Committee (IEC)/Institutional Review Board (IRB) 
Consistent with local regulations and prior to enrollment of participants, the study protocol 
will be submitted together with associated documents (e.g., ICF) to the IRB/IEC for its 
review. Participant enrollment will not start before IQVIA has obtained written confirmation 
of a favorable opinion/approval from the relevant central or local IRB/IEC. The IRB/IEC will 
be asked to provide documentation of the date of the meeting at which the favorable 
opinion/approval was given that clearly identifies the study, the protocol version, and the ICF 
version reviewed. 
Before implementation of any substantial changes to the protocol, protocol amendments will 
also be submitted to the relevant IRB/IEC in a manner consistent with local regulations.   
Should the study be terminated early for any unanticipated reason, IQVIA will inform the 
IRB/IEC of the early termination. 
 
 

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and its subsidiaries. Unauthorized use, disclosure or reproduction is strictly prohibited. 
8. 
REFERENCES 
1. The Novel Coronavirus Pneumonia Emergency Response Epidemiology Team. The 
Epidemiological Characteristics of an Outbreak of 2019 Novel Coronavirus Diseases 
(COVID-19) — China, 2020[J]. China CDC Weekly, 2020, 2(8): 113-122.  
2. CDC. People Who Are Higher Risk for Severe Illness. Last updated 2 Apr 2020. 
Accessed 5 Apr 2020. Available at https://www.cdc.gov/coronavirus/2019-
ncov/need-extra-precautions/people-at-higher-
risk.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2
019-ncov%2Fspecific-groups%2Fpeople-at-higher-risk.html 
3. CDC. CDC COVID Data Tracker. Accessed 25 Feb 2021. Available at: 
https://covid.cdc.gov/covid-data-tracker/#cases_casesinlast7days 
4. Guan WJ, Ni ZY, Hu Y, et al. Clinical Characteristics of Coronavirus Disease 2019 
in China. The New England journal of medicine. 2020. 
5. Xu XW, Wu XX, Jiang XG, et al. Clinical findings in a group of patients infected 
with the 2019 novel coronavirus (SARS-Cov-2) outside of Wuhan, China: 
retrospective case series. BMJ (Clinical research ed). 2020;368:m606. 
6. Huang C, Wang Y, Li X, et al. Clinical features of patients infected with 2019 novel 
coronavirus in Wuhan, China. Lancet (London, England). 2020;395(10223):497-506. 
7. Pan L, Mu M, Ren HG, et al. Clinical characteristics of COVID-19 patients with 
digestive symptoms in Hubei, China: a descriptive, cross-sectional, multicenter 
study. Am J Gastroenterol. 2020;[Epub ahead of print]. 
8. Dreyer NA, Toovey S, Oner AF, et al. Investigating outbreaks of novel infectious 
disease: an international case study.  Journal of Clinical Studies 2013; 5(2):52-53.