Clinical trial NCT04354870
Conditions: COVID-19
Sponsor: NYU Langone Health
Start date: 2020-04-03; Completion date: 2020-10-01
Enrollment: 130 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Off label study to evaluate the efficacy of HCQ for pre-exposure prophylaxis (PrEP) to prevent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. 350 participants will be assigned to the group that takes HCQ or the group that opts to not take the study medication. Participants will be NYULH HCW at high risk for occupational exposure to SARS-CoV-2. Study timepoints will include screening/enrollment, 30 day, 60 day, and 90 day visits. Questionnaires, and DBS will be collected in all timepoints.

Detailed description:
Hydroxychloroquine (HCQ) is licensed for the chemoprophylaxis and treatment of malaria and as a disease modifying antirheumatic drug. It has a long history of being safe and well tolerated at typical doses. HCQ has antiviral activity in vitro against coronaviruses, and specifically Covid-19. This study is designed to evaluate the efficacy of hydroxychloroquine (HCQ) for pre exposure prophylaxis (PrEP) to prevent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection among health care workers at high risk of occupational exposure to SARS-CoV-2 compared to the eligible cohort that declines treatment.

Arms: arm 1: Approximately 300 Health Care Workers (HCW) who choose to be provided HCQ arm 2: approximately 50 HCW who choose not to be provided HCQ
Interventions: intervention 1: Hydroxychloroquine (HCQ)
Intervention descriptions: intervention 1: Loading dose: 600 mg, oral, 1 day Maintenance dose: 200 mg, oral, daily, for 90 days

Protocol documents:
Prot_SAP_000.pdf: 
 
 
Page i 
CONFIDENTIAL 
This material is the property of the NYU School of Medicine and Langone Medical Center. 
Version date:30 Mar 2020 
 
COVID-19 PrEP HCW HCQ Study 
 
 
 
 
 
Study of NYU Langone healthcare workers at high risk for SARS – COV-2 infection 
 
Investigators: 
 
Belmont, H. Michael, M.D. 
Professor, Department of Medicine 
Medical Director, NYU Langone Orthopedic Hospital 
Director, Infusion Services, NYU Langone Orthopedic Center 
Associate Director, Clinical Affairs, Division of Rheumatology 
Email: Michael.Belmont@nyulangone.org 
Tel:646-501-7400 
 
Raabe, Vanessa, MD, MSc  
Clinical Assistant Professor, Division of Infectious Diseases and 
Immunology 
New York University Langone Health 
Email: Vanessa.Raabe@nyulangone.org 
 
NYULMC Study Number: 
S20-00390 
NCT Number: 
NCT04354870 
Study Product: 
Hydroxychloroquine (HCQ) 
 
Initial version: 3.24.2020 
Version 2: 
3.26.2020 
Version 3: 
3.30.2020 
Version 4:  
4.13.2020 
Version 5:  
5.01.2020 
Version 6: 
  8.25.2020 


Study number: S20-00390 
 
Page ii 
Version: 4.0 
 
 
CONFIDENTIAL 
This material is the property of the NYU School of Medicine and Langone Medical Center. 
Version date:30 Mar 2020 
 
COVID-19 PrEP HCW HCQ Study 
 
Statement of Compliance 
 
This study will be conducted in accordance with the Code of Federal Regulations on the Protection of 
Human Subjects (45 CFR Part 46), 21 CFR Parts 50, 56, 312, and 812 as applicable, any other applicable 
US government research regulations, and institutional research policies and procedures. The International 
Conference on Harmonization (“ICH”) Guideline for Good Clinical Practice (“GCP”) (sometimes referred to 
as “ICH-GCP” or “E6”) will be applied only to the extent that it is compatible with FDA and DHHS regulations. 
The Principal Investigator will assure that no deviation from, or changes to the protocol will take place 
without documented approval from the Institutional Review Board (IRB), except where necessary to 
eliminate an immediate hazard(s) to the trial participants. All personnel involved in the conduct of this study 
have completed Human Subjects Protection Training. 
 
 


Study number: S20-00390 
 
Page iii 
Version: 4.0 
 
 
CONFIDENTIAL 
This material is the property of the NYU School of Medicine and Langone Medical Center. 
Version date:30 Mar 2020 
 
COVID-19 PrEP HCW HCQ Study 
 
List of Abbreviations 
 
AE 
Adverse Event/Adverse Experience 
CFR 
Code of Federal Regulations 
COVID-19 
Coronavirus Disease 
CQ 
Chloroquine 
CRF 
Case Report Form 
DBS 
Dried Blood Spot 
DHHS 
Department of Health and Human Services 
DSMB 
Data and Safety Monitoring Board 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
HCQ 
Hydroxychloroquine 
HCW 
Health Care Worker 
HIPAA 
Health Insurance Portability and Accountability Act 
ICF 
Informed Consent Form 
ICH 
International Conference on Harmonization 
ICU 
Intensive Care Unit 
IRB 
Institutional Review Board 
ISM 
Independent Safety Monitor 
MOP 
Manual of Procedures 
N 
Number (typically refers to participants) 
NIH 
National Institutes of Health 
NYULH 
New York University Langone Health 
OHRP 
Office for Human Research Protections 
OHS 
Occupational Health Service 
OHSR 
Office of Human Subjects Research 
PCR 
Polymerase chain reaction 
PEP 
Post exposure prophylaxis 
PI 
Principal Investigator 
PI 
Principal Investigator 
PPE 
Personal Protective Equipment 
PrEP 
Pre Exposure Prophylaxis 
RA 
Rheumatoid Arthritis 
SAE 
Serious Adverse Event/Serious Adverse Experience 
SARS-CoV-2 
Severe acute respiratory syndrome coronavirus 2 


Study number: S20-00390 
 
Page iv 
Version: 4.0 
 
 
CONFIDENTIAL 
This material is the property of the NYU School of Medicine and Langone Medical Center. 
Version date:30 Mar 2020 
 
COVID-19 PrEP HCW HCQ Study 
US 
United States 
WHO 
World Health Organization 
 
 


Study number: S20-00390 
 
Page 1 
Version: 4.0 
 
 
CONFIDENTIAL 
This material is the property of the NYU School of Medicine and Langone Medical Center.  
Version date: 30 Mar 2020 
 
COVID-19 PrEP HCW HCQ Study 
 
Protocol Summary 
Title 
Off label study to evaluate the efficacy of HCQ for pre-exposure prophylaxis 
(PrEP) to prevent severe acute respiratory syndrome coronavirus 2 (SARS-
CoV-2) infection among Health Care Workers (HCWs) who are at high risk of 
occupational exposure to SARS-CoV-2 
Short Study Title: COVID-19 PrEP HCW HCQ Study 
Brief Summary 
The Pre-exposure Prophylaxis (PrEP) Study, single, open and off label 
intervention study. 350 participants will be assigned to group that takes HCQ 
or group that opts to not take study medication. Participants will be NYULH 
HCW at high risk for occupational exposure to SARS-CoV-2. Study 
timepoints will include screening/enrollment, 30 day, 60 day, and 90 day 
visits. Questionnaires, and DBS will be collected in all timepoints. 
Phase 
Off label use of HCQ 
Primary Objectives 
To evaluate the efficacy of hydroxychloroquine (HCQ) for pre exposure 
prophylaxis (PrEP) to prevent severe acute respiratory syndrome coronavirus 
2 (SARS-CoV-2) infection among Health Care Workers High Risk of 
Occupational Exposure to SARS-CoV-2 
Methodology 
The Pre-exposure Prophylaxis (PrEP) Study, single, open and off label 
intervention study 
Primary Endpoint 
Frequency of seroconversion to SARS-CoV-2 
Study Duration 
12 months 
Participant Duration 
Participant Study period: up to 90 days for both groups, inclusive of those 
who convert from Group B to Group A. 
Duration of IP 
administration 
Up to 90 days 
Population 
Total number of participant: 350 NYULH health care workers with high risk of 
occupational exposure to SARS-CoV-2 
Group A: (HCW choose to be provided HCQ) 
Group B: (HCW choose not to be provided HCQ) 
Study Sites 
NYU Langone Health 
Number of participants 
350  
Description of Study 
Agent/Procedure 
Hydroxychloroquine- oral administration 
• 
Duration: up to 90 days or until meeting study termination criteria 
• 
Loading dose: 600 mg once for the first day 
• 
Maintenance dose: 200 mg, daily 
 
Hydroxychloroquine, is licensed for the chemoprophylaxis and treatment of 
malaria and as a disease modifying antirheumatic drug. It has a long history 
of being safe and well tolerated at typical doses. HCQ has antiviral activity in 
vitro against coronaviruses, and specifically Covid-19. 
Key Procedures 
Questionnaires, Dried blood spot (DBS) collection 


Study number: S20-00390 
 
Page 2 
Version: 4.0 
 
 
CONFIDENTIAL 
This material is the property of the NYU School of Medicine and Langone Medical Center. 
Version date:30 Mar 2020 
 
COVID-19 PrEP HCW HCQ Study 
Statistical Analysis 
All data will be summarized using appropriate descriptive statistics, including 
mean, median, standard deviation, and range for continuous variables and 
frequency and proportions for categorical variables. Data will also be 
summarized graphically.  Distributional assumptions will be assess with 
suitable transformation conducted if indicated.  Significance tests will use two-
sided Type I error rate of 0.05. The primary analysis will assess the outcomes 
of seroconversion to SARS-CoV-2 and influenza infections, comparing these 
outcomes across groups defined by treatment with different medications. 
Secondary endpoints include symptoms reported over time via questionnaires, 
as well as other clinical endpoints such as hospital admission, ICU admission, 
and mortality.   
 
 
 


Study number: S20-00390 
 
Page 3 
Version: 4.0 
 
 
CONFIDENTIAL 
This material is the property of the NYU School of Medicine and Langone Medical Center. 
Version date:30 Mar 2020 
 
COVID-19 PrEP HCW HCQ Study 
Schematic of Study Design 
Schedules of Activities for COVID-19 PrEP HCW HCQ Study 
Task 
Screening/ 
Baseline 
30 Day 
(± 7days) 
60 Day 
(± 7days) 
90 Day 
(± 7days) 
Early Termination/ 
5Switch Over Day 
 
Consent 
X 
 
 
 
 
Pre-Screening 
Questionnaire 
X 
 
 
 
 
Demographic and 
Employment 
Questionnaire 
X 
 
 
 
 
Medical History 
Questionnaire 
 
 
 
 
 
1Medication 
Questionnaire 
X 
X 
X 
X 
X 
2Symptom 
Questionnaire 
X 
X 
X 
X 
X 
3Dried blood spot (DBS) 
for serology test 
X 
X 
X 
X 
X 
Data 
collection 
from 
medical chart review 
X 
X 
X 
X 
X 
4Hydroxychloroquine 
dose (HCQ) 
X 
X 
X 
X 
X 
Adverse Events 
 
X 
X 
X 
X 
1Separate Medication Questionnaires will be used for Group A and Group B. See list of attachments. 
2 and 3 Questionnaires and DBS collection need to be done at the same time. 
4Group A only - 600 mg for Day 1 (within 4 days from enrollment), 200 mg everyday thereafter for 90 days  
5 Only if previous questionnaires and DBS sample collection is > 7 days. 
 
 
 


Study number: S20-00390 
 
Page 4 
Version: 4.0 
 
 
CONFIDENTIAL 
This material is the property of the NYU School of Medicine and Langone Medical Center. 
Version date:30 Mar 2020 
 
COVID-19 PrEP HCW HCQ Study 
Key Roles 
Howard Michael Belmont M.D. 
Professor, Department of Medicine 
Medical Director, NYU Langone Orthopedic Hospital 
Director, Infusion Services, NYU Langone Orthopedic Center 
Associate Director, Clinical Affairs, Division of Rheumatology 
Email: Michael.Belmont@nyulangone.org  
 
Vanessa Raabe, MD, MSc  
Clinical Assistant Professor, Division of Infectious Diseases and Immunology 
New York University Langone Health 
Email: Vanessa.Raabe@nyulangone.org 
1 Background Information and Scientific Rationale 
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a coronavirus novel to the human 
population discovered in December 2019; it is currently the cause of a global pandemic [1-3]. The World 
Health Organization (WHO) named the novel coronavirus severe acute respiratory syndrome coronavirus 
2 (SARS-CoV-2) and the disease caused by SARS-CoV-2 coronavirus disease (COVID-19). As of 8 March 
2020, person-to-person transmission has occurred in China, across temperate Asia, Europe, and North 
America,  with sporadic cases in Africa and the southern hemisphere. Accurate reporting is limited by 
availability of diagnostic testing. The WHO declared the COVID-19 pandemic a Public Health Emergency 
of International Concern on 30 January 2020 [4].  Most deaths and severe pneumonitis have occurred in 
the elderly or in persons with underlying pulmonary or cardiac co-morbidities or diabetes. In more healthy 
adults, including pregnant women, it can cause a febrile, self-limited pneumonia. Infection appears less 
severe in children and younger adults [5].  Nevertheless, the burden to health and economic systems 
globally of this pandemic is expected to be substantial. No acquired immunity to this novel viral infection 
appears to exist in the human population globally and no effective treatment or preventative agent is 
licensed at this time.  
 
Over 1700 cases of COVID-19 have been reported among health care workers (HCWs) caring for COVID-
19 patients in China, including 5 deaths, representing 3.8% of all COVID-19 patients in a recently published 
series of over 72,000 cases [6]. The number of HCWs infected with SARS-CoV-2 are increasing every day 
in Italy and other countries.  
 
On 3 March 2020, WHO declared a global shortage of personal protective equipment (PPE) leaving doctors, 
nurses and other frontline workers dangerously ill-equipped to care for COVID-19 patients [7].  By nature 
of their work caring for ill patients and evidence that SARS-CoV-2 can be transmitted from human-to-
human, HCWs are at increased risk for COVID-19 infection. Many aerosol-generating procedures are 
performed without knowing SARS-CoV-2 infection status. The COVID-19 epidemic has put tremendous 
strain on HCW in all aspects.  
 
Scientists at the NYULH are interested in studying this emerging infections, SARS-CoV-2. This includes 
studying the immune response to SARS-CoV-2, developing and validating diagnostic assays, vaccines, 
and therapeutics for SARS-CoV-2, improving our understanding of virus transmission, protecting HCWs, 
and the understanding of HCQ effect on COVID-19. 
 
As of today there is no approved treatment or prophylaxis for COVID-19 by FDA (Food and Drug 
Administration). HCQ is licensed for the chemoprophylaxis and treatment of malaria and as a disease 
modifying antirheumatic drug [8-9]. It has a long history of being safe and well tolerated at typical doses. 
HCQ has antiviral activity in vitro against coronaviruses, and specifically Covid-19. Pharmacologic 
modelling based on observed drug levels and in vitro drug testing suggest that prophylaxis at approved 
doses could prevent Covid-19 infection and/or ameliorate viral shedding. Based on in vitro data that HCQ 
inhibits viral replication and limited observations reported from China HCQ has the potential for PrEP to 
prevent SARS-CoV-2 infection among HCWs who are high risk of occupational exposure to SARS-CoV-2 
[10-12]. 


Study number: S20-00390 
 
Page 5 
Version: 4.0 
 
 
CONFIDENTIAL 
This material is the property of the NYU School of Medicine and Langone Medical Center. 
Version date:30 Mar 2020 
 
COVID-19 PrEP HCW HCQ Study 
 
However, at this time there is no in human data and we are unable to state if the drug will in fact decrease, 
have no effect or increase the chance of COVID-19 infection. This study is designed to answer whether 
pre-exposure prophylaxis (PrEP), HCQ, can mitigate the risk of SARS-CoV-2 infection among HCWs in 
high-risk setting. 
 
IND Exemption:  
• 
HCQ is lawfully marketed in the United States. 
• 
The investigation is not intended to be reported to FDA as a well-controlled study in support of a 
new indication and there is no intent to use it to support any other significant change in the labeling 
of the drug.  
• 
In the case of a prescription drug, the investigation is not intended to support a significant change 
in the advertising for the drug. 
• 
The investigation does not involve a route of administration, dose, patient population, or other factor 
that significantly increases the risk (or decreases the acceptability of the risk) associated with the 
use of the drug product (21 CFR 312.2(b)(1)(iii)).  
• 
The investigation is conducted in compliance with the requirements for review by an IRB (21 CFR 
part 56) and with the requirements for informed consent (21 CFR part 50) 
• 
The investigation is conducted in compliance with the requirements of § 312.7 (i.e., the investigation 
is not intended to promote or commercialize the drug product). 
 
2 Potential Risks & Benefits 
2.1 
Benefits 
It is possible that pre-exposure HCQ will prevent symptomatic or reduce severity of infection.  Additionally, 
medical society and general public may benefit from the information collected from this study.  
 
2.2 
Risks 
2.2.1 
Risk of study agent 
To account for possibilities of drug interactions, we have excluded a small list of anti-arrhythmics because 
of a theoretic concern of the effects on prolonged QTc interval. Additional drug interactions listed in the 
monograph are not expected to be clinically relevant at the doses and duration being prescribed. The PI 
will monitor subjects who develop side effects. The only anticipated side effect we expect to see in 1-2% of 
the subject population is mild, self-limited drug reaction presenting as skin rash.  More rarely, the drug has 
been associated with Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis, therefore subjects who 
experience rash will be asked to discontinue HCQ. Additionally, dyspepsia may be encountered with drug 
administration – not ulcerogenic.  This tends to be mild and self-limiting. The drug can be taken with food.  
Recommendation to subjects is to avoid antacids and cimetidine as they reduce bioavailability. Alternatives 
include proton pump inhibitors and histamine 2 blockers. 
 
Risk of study procedures 
Risks of DBS include temporary discomfort, bleeding, bruising, and rarely infection. The risk of infection will 
be minimized by instructing participants to clean the site with disinfecting agent. 
 
Study Population: The PrEP Study eligibility is high risk HCWs (eg MD/DO, NP, RN, and respiratory 
therapists in ED and on Covid-19 units) at Tisch/Kimmel, Bklyn and Winthrop meeting all inclusion criteria. 
 
 


Study number: S20-00390 
 
Page 6 
Version: 4.0 
 
 
CONFIDENTIAL 
This material is the property of the NYU School of Medicine and Langone Medical Center. 
Version date:30 Mar 2020 
 
COVID-19 PrEP HCW HCQ Study 
3 Objectives 
Primary Objective 
Primary Endpoint 
To evaluate the efficacy of hydroxychloroquine 
(HCQ) for pre exposure prophylaxis (PrEP) to 
prevent severe acute respiratory syndrome 
coronavirus 2 (SARS-CoV-2) infection among 
HCWs at high risk of occupational exposure to 
SARS-CoV-2 compared to eligible cohort that 
declines treatment 
• 
Frequency of seroconversion to SARS-
CoV-2 
Secondary Objectives 
Secondary Endpoints 
To characterize whether high-risk HCW who 
seroconvert to SARS-CoV-2 have asymptomatic 
infection or report symptoms of COVID-19 in the 
4 weeks preceding seroconversion 
• 
Symptom questionnaires 
To assess the severity of SARS-CoV-2 infection 
after treatment with hydroxychloroquine  
• 
Symptom questionnaires 
• 
Hospital admission rate 
• 
ICU admission rate 
• 
Mortality rate 
To assess the tolerability of hydroxychloroquine 
SARS-CoV-2 PrEP in this population 
• 
Incidents of AEs or SAEs related to HCQ 
upon study termination time 
Exploratory Objectives  
Exploratory Endpoints 
To determine whether baseline levels of non-
SARS-CoV-2 coronavirus antibodies correlates 
with COVID-19 disease severity 
• 
Serology test 
• 
Symptom questionnaires 
To characterize whether pre-existing of non-
SARS-CoV-2 coronavirus antibodies are capable 
of causing antibody dependent enhancement of 
a pseudotyped SARS-CoV-2 
• 
Serology test  
• 
Percentage of cells infected in the 
laboratory using a standardized dose 
of pseudotyped SARS-CoV-2 in the 
presence or absence of blood containing 
non-SARS-CoV-2 coronaviruses antibodies 
To determine whether hydroxychloroquine 
reduces time lost from work  
• 
Days away from work 
To assess the compliance of hydroxychloroquine 
PrEP 
• 
Frequency of missing dose 
 
4 Study Design 
4.1 
Description of Study Design 
This is an open and off label use, interventional, single site study 


Study number: S20-00390 
 
Page 7 
Version: 4.0 
 
 
CONFIDENTIAL 
This material is the property of the NYU School of Medicine and Langone Medical Center. 
Version date:30 Mar 2020 
 
COVID-19 PrEP HCW HCQ Study 
4.2 
Study Enrollment and Withdrawal 
4.2.1 
Study Population 
The target population for this study are NYULH health care workers identified as having a high risk of 
occupational exposure to SARS-CoV-2 (ie., locations where aerosol-generating procedures are frequently 
performed such as the intensive care units and emergency departments, health care roles (ICU and ER 
physicians nurses, respiratory therapists, residents, fellows and students,) 
Total number of participant: 350 (Group A and B) 
• 
Group A: (HCW choose to be provided HCQ) 
• 
Group B: (HCW choose not to be provided HCQ) 
4.2.1.1 
Inclusion Criteria for Group A and B 
• 
Men or women ages ≥18 years NYULH health care worker who meets one of the following criteria 
1. Involved in an aerosol generating procedure (nasopharyngeal specimen collection, 
tracheal intubation, nebulizer treatment, open airway suctioning, collection of sputum, 
tracheostomy, bronchoscopy, CPR) on a confirmed COVID-19 patient while wearing 
PPE 
2. Direct bedside care of confirmed COVID-19 patient while wearing PPE for 3 or more 
shifts in a 7 day period    
3. Direct care of PUIs in the ED or other inpatient unit while wearing PPE for 3 or more 
shifts in a 7 day period    
• 
Willing and able to provide informed consent 
4.2.1.2 
Exclusion Criteria 
Exclusion Criteria for Group A only : 
• 
Known hypersensitivity to hydroxychloroquine or chloroquine 
• 
Known diagnosis of COVID-19 
• 
Concomitant use of  
1. amiodarone  
2. digoxin  
3. flecainide  
4. procainamide  
5. propafenone  
• 
History of Torsades de pontes 
• 
History of  retinal disease 
• 
Known chronic kidney disease ≥ stage 4  
• 
Congenital prolonged  QTc interval syndrome (Jervell and Lange-Nielsen syndrome, Romano-
Ward syndrome) 
4.2.1.3 
Vulnerable Subjects 
This study will enroll employees of NYULH. Employees (For example: MD/DO, NP, RN, PA, Respiratory 
Therapists), residents, fellows and students recruited as research subjects are more vulnerable to undue 
influence or coercion because of the possibility that they may perceive employment or other benefits as 
dependent upon their participation in research. In addition, NYULHS employees may experience increased 
risk of invasion of privacy or loss of confidentiality.  To minimize these risks, employees will be allowed to 
self-identify as interested in being contacted for study participation after recruitment materials are sent to 
potentially eligible employees. Employees may then reach out to the research team to learn more about 
the study and if enrolled (if employee elects to participate), informed consent will be performed by a study 
team member with no direct supervisory or evaluation responsibilities. Additionally, at time of enrollment, 
the study team member will emphasize that participation is voluntary and refusal to participate will not affect 


Study number: S20-00390 
 
Page 8 
Version: 4.0 
 
 
CONFIDENTIAL 
This material is the property of the NYU School of Medicine and Langone Medical Center. 
Version date:30 Mar 2020 
 
COVID-19 PrEP HCW HCQ Study 
employment or job performance evaluation. All identifying information for employees will be kept strictly 
confidential following the data security provisions outlined in this protocol.  
 
Residents, Fellows and Students  
Residents, fellows and students recruited as research subjects are more vulnerable to undue influence or 
coercion because they may perceive their employment or grades as dependent upon their participation in 
research. Study team members will emphasize that participation in the study is voluntary and refusal to 
participate will not affect employment, job evaluations or grades. To minimize the risk of invasion of privacy 
or loss of confidentiality residents, fellows and students will self-identify as being interested in study 
participation, as per the strategies for recruitment stated below.  
. 
 
Pregnant women will not be excluded from this study.  HCQ is a standard of care for management of lupus 
and rheumatic diseases in pregnant women. There is an absence of data that the drug increases the rate 
of miscarriages or teratogenicity. Each individual providing consent is fully informed regarding the 
reasonably foreseeable impact of the research on the fetus or neonate. No inducements, monetary or 
otherwise, will be offered to terminate a pregnancy; Individuals engaged in the research will have no part 
in any decisions as to the timing, method, or procedures used to terminate a pregnancy; and Individuals 
engaged in the research will have no part in determining the viability of a neonate. This conclusion: HCQ is 
not associated with any increased risk of congenital defects, spontaneous abortions, fetal death, pre-
maturity and decreased numbers of live births in patients with auto-immune diseases appears as conclusion 
in peer reviewed article entitled Systematic review of hydroxychloroquine use in pregnant patients with 
autoimmune diseases published in Pediatric Rheumatol Online J. 2009; 7: 9.  
Additionally, Arthritis Rheum. 2003 Nov;48(11):3207-11 published. Safety of hydroxychloroquine in 
pregnant patients with connective tissue diseases: a study of one hundred thirty-three cases compared with 
a control group. Hydroxychloroquine in systemic lupus erythematosus and rheumatoid arthritis and its 
safety in pregnancy. Appeared in Expert Opin Drug Saf. 2011 Sep;10(5):705-14.  
 
4.3 
Strategies for Recruitment 
Study participants will be recruited using an IRB approved email blast that will be sent the departments that 
are specific to the desired study population.  We will be using NYU Langone Health listservs which will be 
chosen based on their pertinence to the study population we are looking at, described in Section 4.2.1 of 
this protocol. The email blast will direct interested HCW to send an email to a study team email address 
with their phone number and best times to call. Upon email contact study team will call participant to discuss 
pre-screening criteria. In the phone call, pre-screening questions will be asked and documented on paper. 
 
If potential participant is not eligible, participant cannot enroll in the study, and paper pre-screening form 
will be destroyed. If participant is eligible, paper pre-screening form will be kept in participant’s study records 
and will serve as the screening source document. E-consent will be sent. Participant and study team will 
go over e-consent, and participant will e-sign. Word of mouth will also be used to recruit participants into 
the study.  
4.4 
Duration of Study Participation 
• 
Study period: up to 90 days 
4.5 
Total Number of Participants and Sites  
We expect to enroll 350 participants across NYULH. Subject visits will be conducted remotely.  
4.6 
Participant Withdrawal or Termination 
• 
Reasons for Withdrawal or Termination 
1. 
Participants become PCR-confirmed SARS-CoV-2 status 
2. 
Participant starts disallowed medication (Group A only) 


Study number: S20-00390 
 
Page 9 
Version: 4.0 
 
 
CONFIDENTIAL 
This material is the property of the NYU School of Medicine and Langone Medical Center. 
Version date:30 Mar 2020 
 
COVID-19 PrEP HCW HCQ Study 
3. 
Advent of an adverse event which necessitates discontinuation of HCQ (Group A only) 
4. 
Participant decides to withdraw from the study 
5. 
PI discontinues participation due to safety concerns 
6. 
Participant decides to withdraw consent 
7. 
Participant’s primary care provider determines the study is not under participant’s best 
interest 
8. 
PI decides to withdraw participant due to non-compliance 
4.7 
Study Agent  
Name of the medication-Hydroxychloroquine (Off label use) 
Hydroxychloroquine- The full prescribing information can be accessed at: 
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b82bbda6-64f2-4426-b4ec-254eeea895ae 
Subjects will obtain the study drug in accordance with established SOP from the hospital-based 
pharmacies (Tisch/Kimmel, NYULangone Brooklyn, and NYU Langone Winthrop).  
4.7.1 Disallowed Concomitant Therapy 
• 
amiodarone  
• 
digoxin  
• 
flecainide  
• 
procainamide  
• 
propafenone  
4.7.2 
Dosing and Administration (applies only to Group A) 
4.7.2.1 
Dose Rationale 
Hydroxychloroquine is a long-acting drug (elimination half-life:50 days).  Loading dose of HCQ 600 mg has 
been administered for rheumatoid arthritis or systemic lupus erythematosus, with a usual maintenance 
dose 200 mg. Since the protocol will be used in HCWs with at high risk of exposure to SARS-CoV-2, the 
intent is to rapidly achieve an adequate drug level. For this study, we selected a loading dose of 600 mg on 
day one followed by 200 mg for maintenance dose 
4.7.2.2 
Administration 
• 
Loading dose: 600 mg, oral, 1 day 
• 
Maintenance dose: 200 mg, oral, daily, for 90 days  
The study will follow the study agent’s labeling guidelines except the dosing schedule selected as described 
above. 
 
If participants are already taking HCQ prior to enrolling into the study, patients will continuing their dosing 
schedule as prescribed (200mg per day). We will screen these subjects to document their reason for taking 
HCQ (i.e clinically indicated for lupus, persons who elected to take HCQ off-label). These subjects will be 
included into Group A, but their data will not be incorporated into the analysis for primary endpoint. 
4.7.2.3 
Supplies 
HCQ will be dispensed at outpatient or inpatient pharmacies of NYULH at no cost to the participants.  
Dispense schedules 
• 
33 pills (200 mg oral tablet) at enrollment 
• 
30 pills (200 mg oral tablet) at 30 and 60 day visit 


Study number: S20-00390 
 
Page 10 
Version: 4.0 
 
 
CONFIDENTIAL 
This material is the property of the NYU School of Medicine and Langone Medical Center. 
Version date:30 Mar 2020 
 
COVID-19 PrEP HCW HCQ Study 
5 Study Procedures and Schedule 
5.1 
Study Procedures/Evaluations 
5.1.1 
Study Specific Procedures 
Questionnaires (Attachment A, B,C,D,E, F) 
Participants from both Group A and B will be asked to complete the following questionnaires. 
• 
Attachment A- Pre - Screening questionnaire (paper format) 
• 
Attachment B- Demographic/Employment Questionnaire (paper format) 
• 
Attachment C - Medication Questionnaire for Group A 
• 
Attachment D – Medication Questionnaire for Group B 
• 
Attachment E - Symptoms Questionnaire 
• 
Attachment F - Medical History Questionnaire (paper format) 
 
Confirmation of Pregnancy in Women of Childbearing Potential: We will document in subject’s research 
record whether they are pregnant based on self-report and date of last menses (at Screening and follow-
up visits) 
 
Dried Blood Spots 
Kits will either be mailed to participants or be distributed in specific locations within Tisch/Kimmel, Brooklyn 
and Winthrop locations. Collection kit will include supplies to collect a DBS, instructions to collect, and store 
the sample until ready for drop off. DBS collection and storage supplies will include alcohol pads, lancets, 
gauze, collection cards, desiccant packets, and sealable foil bags for storage. Participants will be instructed 
to use a lancet to prick their fingertip, apply blood spot to the collection card, air dry the card, and store it in 
a foil bag containing desiccant packets. Samples will be returned via designated drop off locations at each 
of the participating NYULH facilities. Participants will be instructed to collect DBS sample on the same time 
of questionnaires. 
 
Chart review 
Chart review will be done after participant sign e-consent form. Data will be collected from participant’s 
EPIC medical chart review, including Occupational Health encounters associated with COVID-19.  Data 
collection will be include information related to the diagnosis of SARS-CoV-2 infection and COVID-19 
disease. This may include data relating to demographics or other medical conditions that are suspected or 
known to be risk factors for SARS-CoV-2 infection and/or modulate COVID-19 disease severity (including 
but not limited to diagnosis of respiratory illness, inclusive of COVID-19, pneumonia, etc). 
5.1.2 
Specimen Preparation, Handling, and Storage 
DBS samples will be initially sent to the CTSI. Upon receipt, the CTSI will check the Symptom Questionnaire 
to label each sample as from a symptomatic or symptomatic participant. All samples will be routed to 
laboratories that are under biosafety level 2 conditions (BSL-2) for initial processing. 
Both samples from participants with and without symptoms will undergoing an initial, brief processing check 
under BSL-2 conditions using a class II biosafety hood. This entails opening the sealed specimen bag, 
check whether the dried blood spot card is appropriately labeled and completed, and re-seal the specimen 
in an individual container labeled with the symptom status of the participant containing desiccant packs. 
The re-sealed specimen container will then be frozen for storage until elution for the intended experiments 
is ready to occur at BSL-2 conditions in a laboratory secured by badge access and/or passcode access 
provided samples from symptomatic and asymptomatic participants are appropriately labeled and stored in 
separate containers. This may occur at either the NYULVC processing lab located on the 4th floor of the 
Medical Science Building, 540 1st Avenue, New York, NY, 10016 or the NYULVC research lab located on 
the 3rd floor of the Alexandria Center for Life Sciences, 430 E 29th Street, New York, NY, 10016. Elution 
of dried blood spots for the intended experiments collected from asymptomatic and symptomatic 


Study number: S20-00390 
 
Page 11 
Version: 4.0 
 
 
CONFIDENTIAL 
This material is the property of the NYU School of Medicine and Langone Medical Center. 
Version date:30 Mar 2020 
 
COVID-19 PrEP HCW HCQ Study 
participants must follow NYU Langone biosafety regulations pertaining to use of samples from COVID 19 
positive research participants in place at the time the elution and/or experiments are performed.  
 
 
Due to the virulent nature of SARS-CoV-2 and other potential pathogens, all personnel handling 
specimens related to this protocol will follow CDC and NIH guidelines. As it is unknown whether 
specimens will contain infectious materials, all dried blood spots will be transported in compliance with 
regulations for Category B Biological substances and CDC shipping guidelines for dried-blood spot 
specimens.  
5.2 
Study Schedule 
5.2.1 Schematic of Study Design 
Schematic of Study Design 
Schedules of Activities for COVID-19 PrEP HCW HCQ Study 
Task 
Screening/ 
Baseline 
30 Day 
(± 7days) 
60 Day 
(± 7days) 
90 Day 
(± 7days) 
Early Termination/ 
5Switch Over Day 
 
Consent 
X 
 
 
 
 
Pre-Screening 
Questionnaire 
X 
 
 
 
 
Demographic and 
Employment 
Questionnaire 
X 
 
 
 
 
Medical History 
Questionnaire 
 
 
 
 
 
1Medication 
Questionnaire 
X 
X 
X 
X 
X 
2Symptom 
Questionnaire 
X 
X 
X 
X 
X 
3Dried blood spot (DBS) 
for serology test 
X 
X 
X 
X 
X 
Data 
collection 
from 
medical chart review 
X 
X 
X 
X 
X 
4Hydroxychloroquine 
dose (HCQ) 
X 
X 
X 
X 
X 
Adverse Events 
 
X 
X 
X 
X 
1Separate Medication Questionnaires will be used for Group A and Group B. See list of attachments. 
2 and 3 Questionnaires and DBS collection need to be done at the same time. 
4Group A only - 600 mg for Day 1 (within 4 days from enrollment), 200 mg everyday thereafter for 90 days  
5 Only if previous questionnaires and DBS sample collection is > 7 days. 
 
5.2.2 
Screening and Enrollment Visit 
Both Screening and Enrollment visits can occur on the same day. Participants will be assessed for study 
eligibility through a pre-screening visit conducted via telephone with a member of the study team and will 
document consent via e-consenting through an email link via REDCap. Demographic and Employment 
questionnaire, Medical History questionnaire will be documented through paper format. Medication 
questionnaire and Symptom questionnaire will be administered via REDCap. Once eligibility is determined, 
participants will be asked if they opt to take study medication. Those who decide to take HCQ will be the 
experimental group (Group A), and participants who do not take HCQ will be part of the control group 
(Group B).   


Study number: S20-00390 
 
Page 12 
Version: 4.0 
 
 
CONFIDENTIAL 
This material is the property of the NYU School of Medicine and Langone Medical Center. 
Version date:30 Mar 2020 
 
COVID-19 PrEP HCW HCQ Study 
 
Specimen collection kit for enrollment visit and all subsequent visits will be either mailed to the participant 
or distributed in specific areas within the Tisch/Kimmel, Bklyn and Winthrop institutions. Kit will include 
instructions for collection.  In addition, the link for study questionnaires will be emailed to the participant 
upon enrollment. 
5.2.3 
30, 60, 90 Day Visits 
Follow-up remote study visits will be conducted in 30 day intervals. Each follow-up visit will entail 
questionnaires, DBS sample collection. Group A will continue study medication as per dosing schedule.  
 
5.2.4 
Visit for Switching from Group B to Group A 
This study will allow participants to switch from Group B to Group A.  If the previous visit is more than 7 
days, questionnaires and DBS collection will be done at the time of switch over. Switched participants will 
follow the study agent administration described in 4.7.2.2. Participants will be rescreened using screening 
form at the time of switch. 
Subjects in Group B can switch to Group A up to Day 65. They will continue the study until day 90. 
5.2.5 
Visit for Switching from Group A to Group B   
In the event where a Group A participant decides to stop HCQ dosing prematurely, but still wishes to 
participate in DBS collection and questionnaire administration, they will be assigned to Group B. These 
patients will continue their original study timeline. 
 
5.2.6 
Early Termination Visit 
Early termination visit will consist of questionnaires, DBS sample collection. 
 
5.3  
Laboratory Procedures/Evaluations 
 
Dried blood spot samples collected in this study will be used for serological testing. If sufficient sample 
remains after the primary and secondary objectives are completed, dried blood spot samples may be used 
to evaluate for the ability of non-SARS-CoV-2 coronavirus antibodies to cause antibody dependent 
enhancement of a pseudotyped virus expressing SARS-CoV-2 spike protein in laboratory cell lines. 
6 Assessment of Safety 
Participants will be asked about any potential side effects experiencing during study period. 
6.1 
Definition of Adverse Events (AE) 
An adverse event (AE) is any symptom, sign, illness or experience that develops or worsens in severity 
during the course of the study.  Intercurrent illnesses or injuries should be regarded as adverse events.  
Abnormal results of diagnostic procedures are considered to be adverse events if the abnormality: 
• results in study withdrawal 
• is associated with a serious adverse event 
• is associated with clinical signs or symptoms 
• leads to additional treatment or to further diagnostic tests 
• is considered by the investigator to be of clinical significance 
All AEs will be recorded on eCRFs. All recorded AE’s will have a severity grade as well as causality 
(related or not related to Hydroxychloroquine) as determined by the investigator. 
6.2 
Definition of Serious Adverse Events (SAE) 
An SAE is defined as any untoward medical occurrence that: 
 
 
• 
Results in death 
• 
Is life-threatening  


Study number: S20-00390 
 
Page 13 
Version: 4.0 
 
 
CONFIDENTIAL 
This material is the property of the NYU School of Medicine and Langone Medical Center. 
Version date:30 Mar 2020 
 
COVID-19 PrEP HCW HCQ Study 
• 
Requires inpatient hospitalization or prolongation of existing hospitalization 
• 
Results in persistent or significant disability/incapacity  
• 
Is an important medical event that may not be immediately life-threatening or result in death or 
hospitalization but may jeopardize the patient or may require intervention to prevent one of the 
other outcomes listed in the definition above) 
6.3 
Classification of an Adverse Event (AE) 
6.3.1 
Severity of Event 
For AEs not included in the protocol defined grading system, the following guidelines will be used to 
describe severity. 
 
• 
Mild – Events require minimal or no treatment and do not interfere with the participant’s daily 
activities. 
• 
Moderate – Events result in a low level of inconvenience or concern with the therapeutic 
measures. Moderate events may cause some interference with functioning. 
• 
Severe – Events interrupt a participant’s usual daily activity and may require systemic drug 
therapy or other treatment. Severe events are usually potentially life-threatening or incapacitating. 
6.3.2 
Relationship to Study Agent 
The clinician’s assessment of an AE's relationship to study agent (drug, biologic, device) is part of the 
documentation process, but it is not a factor in determining what is or is not reported in the study. If there 
is any doubt as to whether a clinical observation is an AE, the event should be reported. All AEs must 
have their relationship to study agent assessed. In a clinical trial, the study product must always be 
suspect. To help assess, the following guidelines are used. 
 
• 
Related – The AE is known to occur with the study agent, there is a reasonable possibility that 
the study agent caused the AE, or there is a temporal relationship between the study agent and 
event. Reasonable possibility means that there is evidence to suggest a causal relationship 
between the study agent and the AE. 
• 
Not Related – There is not a reasonable possibility that the administration of the study agent 
caused the event, there is no temporal relationship between the study agent and event onset, or 
an alternate etiology has been established. 
 
6.4 
Time Period and Frequency for Event Assessment and Follow-Up 
 
All AEs including local and systemic reactions not meeting the criteria for SAEs will be captured on the 
appropriate CRF. Information to be collected includes event description, time of onset, clinician’s 
assessment of severity, relationship to study product (assessed only by those with the training and 
authority to make a diagnosis), and time of resolution/stabilization of the event. All AEs occurring while on 
study must be documented appropriately regardless of relationship.  
 
Any medical condition that is present at the time that the participant is screened will be considered as 
baseline and not reported as an AE. However, if the study participant’s condition deteriorates at any time 
during the study, it will be recorded as an AE and all AEs will be recorded in the data collection system 
throughout the study. 
 
Changes in the severity of an AE will be documented to allow an assessment of the duration of the event 
at each level of severity to be performed. AEs characterized as intermittent require documentation of 
onset and duration of each episode. 
 
The PI will record all reportable events with start dates occurring any time after informed consent is 
obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. At 


Study number: S20-00390 
 
Page 14 
Version: 4.0 
 
 
CONFIDENTIAL 
This material is the property of the NYU School of Medicine and Langone Medical Center. 
Version date:30 Mar 2020 
 
COVID-19 PrEP HCW HCQ Study 
each study visit, designated study personnel will inquire about the occurrence of AE/SAEs since the last 
visit. Events will be followed for outcome information until resolution or stabilization.  
6.4.1 
AEs and SAEs Reporting 
All AEs and SAEs must be reported to the local IRB per their guidelines. 
 
Data Safety Monitoring Plan: The PI’s H. Michael Belmont and Vanessa Raabe will be monitoring the 
subjects in real time for adverse events. Accumulated data and adverse events will be reviewed at 30 day 
intervals. Additionally, data will be reviewed for safety after the first 20 subjects are enrolled, then after 
the next 50 and then in increments of 50 thereafter.  If there is an unanticipated safety signal, stopping 
the study will be considered. A summary of the outcomes of these reviews will be submitted to the IRB. 
7 Statistical Considerations 
7.1 
Statistical and Analytical Plans (SAP) 
All data will be summarized using appropriate descriptive statistics, including mean, median, standard 
deviation, and range for continuous variables and frequency and proportions for categorical variables. Data 
will also be summarized graphically.   
7.2 
Statistical Hypotheses 
We will test the null hypothesis that the seroconversion rate is the same among participants who opt to 
take HCQ as among participants who opt not to take HCQ.  The alternative hypothesis is that the 
seroconversion rate differs between the groups. 
7.3 
Analysis Datasets 
The primary analysis data set will consist of seroconversion outcomes for all enrolled participants.  
Subjects that were initially considered dropouts are permitted to submit DBS samples at a later date and 
will be used as part of the analysis. Sensitivity analyses will be conducted using the subset of HCQ 
participants who complete their entire course of treatment. 
7.4 
Description of Statistical Methods 
7.4.1 
General Approach 
All data will be summarized using appropriate descriptive statistics, including mean, median, standard 
deviation, and range for continuous variables and frequency and proportions for categorical variables. Data 
will also be summarized graphically.  Distributional assumptions will be assess with suitable transformation 
conducted if indicated.  Significance tests will use two-sided Type I error rate of 0.05. 
7.4.2 
Analysis of the Primary Efficacy Endpoint(s) 
The primary analysis will assess the outcomes of seroconversion to SARS-CoV-2 as a marker of SARS-
CoV-2 infection, comparing this outcome across groups defined by treatment with different medications. 
Antibody titers will be measured to determine seroconversion, a binomial endpoint defined by a 
four-fold increase in antibody titers compared to baseline. Seroconversion will be defined as a 
binomial variable (i.e., seroconversion or no seroconversion) and analyzed using Wilcoxon rank 
analysis. Additionally, descriptive analysis will be provided of the antibodies titer results, 
including geometric mean, median, standard deviation, and titer range. Potential confounders of 
the primary endpoint will be addressed by using standard statistical matching techniques, such 
as propensity score matching, and logistical regression to assess for confounding by 
demographic factors and comorbidities that are known or suspected to affect the likelihood of 
developing SARS-CoV-2 infection.  


Study number: S20-00390 
 
Page 15 
Version: 4.0 
 
 
CONFIDENTIAL 
This material is the property of the NYU School of Medicine and Langone Medical Center. 
Version date:30 Mar 2020 
 
COVID-19 PrEP HCW HCQ Study 
7.4.3 
Analysis of the Secondary Endpoint(s) 
Secondary endpoints include symptoms reported over time via questionnaires, as well as other clinical 
endpoints such as hospital admission, ICU admission, and mortality.  These binary clinical outcome will 
be analyzed in a manner similar to that described above for the primary endpoint.  Symptoms will be 
included as predictor variables. 
7.5 
Sample Size 
The total sample size will be approximately 350 participants.  We do not know in advance how many will 
opt to take or not take HCQ.  The table below provides the detectable difference in seroconversion rate 
for different proportions of participants in the treated and control groups.  For example, if two-thirds of the 
sample opt to take HCQ, we will have 80% power to detect a difference in seroconversion rate of 
approximately 15 percentage points (e.g., a 35% serocoversion rate in the control group and a 20% 
sercoversion rate in the HCQ group).  These calculations assume a two-sided Type I error rate of 0.05. 
The exploratory endpoints remain independent of enrollment in Group A vs. Group B.   
 
Treatment Group 
Control Group 
Detectable difference 
175 
175 
0.14 
230 
120 
0.15 
260 
90 
0.17 
 
8 Source Documents 
Source data is all information, original records of clinical findings, observations, or other activities in a 
clinical trial necessary for the reconstruction and evaluation of the trial.  Source data are contained in 
source documents.  Examples of these original documents, and data records include: hospital records, 
clinical and office charts, laboratory notes, memoranda, subjects’ diaries or evaluation checklists, 
pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions 
certified after verification as being accurate and complete, microfiches, photographic negatives, microfilm 
or magnetic media, x-rays, subject files, and records kept at the pharmacy, at the laboratories, and at 
medico-technical departments involved in the clinical trial. It is acceptable to use case report forms 
(CRFs) as source documents. If this is the case, it should be stated in this section what data will be 
collected on CRFs and what data will be collected from other sources. 
 
The study CRF is the primary data collection instrument for the study.  All data requested on the CRF 
must be recorded.  All missing data must be explained.  If a space on the CRF is left blank because the 
procedure was not done or the question was not asked, write “N/D”.  If the item is not applicable to the 
individual case, write “N/A”.  All entries should be printed legibly in black ink.  If any entry error has been 
made, to correct such an error, draw a single straight line through the incorrect entry and enter the correct 
data above it.  All such changes must be initialed and dated.  DO NOT ERASE OR WHITE OUT 
ERRORS.  For clarification of illegible or uncertain entries, print the clarification above the item, then initial 
and date it. 
 
Access to study records will be limited to IRB-approved members of the study team. The investigator will 
permit study-related monitoring, audits, and inspections by the IRB/EC, government regulatory bodies, 
and University compliance and quality assurance groups of all study related documents (e.g. source 
documents, regulatory documents, data collection instruments, study data etc.).  The investigator will 
ensure the capability for inspections of applicable study-related facilities (e.g. pharmacy, diagnostic 
laboratory, etc.). 
 
Participation as an investigator in this study implies acceptance of potential inspection by government 
regulatory authorities and applicable University compliance and quality assurance offices. 


Study number: S20-00390 
 
Page 16 
Version: 4.0 
 
 
CONFIDENTIAL 
This material is the property of the NYU School of Medicine and Langone Medical Center. 
Version date:30 Mar 2020 
 
COVID-19 PrEP HCW HCQ Study 
9 Ethics/Protection of Human Subjects 
9.1 
Ethical Standard 
The investigator will ensure that this study is conducted in full conformity with Regulations for the 
Protection of Human Subjects of Research codified in 45 CFR Part 46, 21 CFR Part 50, 21 CFR Part 56, 
and/or the ICH E6. 
9.2 
Institutional Review Board 
The protocol, informed consent form(s), recruitment materials, and all participant materials will be 
submitted to the IRB for review and approval. Approval of both the protocol and the consent form must be 
obtained before any participant is enrolled. Any amendment to the protocol will require review and 
approval by the IRB before the changes are implemented to the study. All changes to the consent form 
will be IRB approved; a determination will be made regarding whether previously consented participants 
need to be re-consented. 
9.3 
Informed Consent 
 
REDCap will be utilized to capture patient consent to participate in study. This will be an electronic format 
which will reflect language approved by the IRB, referred to as the e-consent. 
 
When patient expresses interest in participating in the study, they are to provide an email address in 
which the study team member will use to email a direct link to the e-consent, as well as phone number. 
The study team member will be on the phone and reviewing the e-consent with the participant. The study 
team member will remain on the phone with the participant to answer any questions and address any 
concerns. 
 
The e-consent will describe in detail the study agent, study procedures, and risks are given to the 
participant and documentation of informed consent is required prior to starting intervention/administering 
study product. The subject will document their consent by approving the e-consent in REDCap. 
 
Language in the e-consent will be submitted to the IRB for review and approval. IRB approval will be 
obtained prior to enrolling any study participants. 
Informed consent is a process that is initiated prior to the individual’s agreeing to participate in the study 
and continues throughout the individual’s study participation. Extensive discussion of risks and possible 
benefits of participation will be provided to the participants and their families. Consent forms will be IRB-
approved and the participant will be asked to read and review the document. Designated study personnel 
will explain the research study to the participant and answer any questions that may arise. All participants 
will receive a verbal explanation in terms suited to their comprehension of the purposes, procedures, and 
potential risks of the study and of their rights as research participants. Participants will have the 
opportunity to carefully review the written consent form via REDCap and ask questions prior to e-signing. 
The participants should have the opportunity to discuss the study with their surrogates or think about it 
prior to agreeing to participate. The participant will e-sign the informed consent document prior to any 
procedures being done specifically for the study. The participants may withdraw consent at any time 
throughout the course of the trial. A copy of the e-signed informed consent document will be given to the 
participants for their records. The rights and welfare of the participants will be protected by emphasizing 
to them that the quality of their medical care will not be adversely affected if they decline to participate in 
this study. 
 
Since this study will enroll NYULH employees, the study personnel will emphasize that participation in this 
research study is voluntary and that the participant’s employment status, job performance evaluation, and 
the quality of any medical care the participant receives will not be adversely effected if he/she declines to 
participate in the study. 
 


Study number: S20-00390 
 
Page 17 
Version: 4.0 
 
 
CONFIDENTIAL 
This material is the property of the NYU School of Medicine and Langone Medical Center. 
Version date:30 Mar 2020 
 
COVID-19 PrEP HCW HCQ Study 
A copy of the e-signed informed consent document will be stored in the subject’s research record. The 
consent process, including the name of the individual obtaining consent, will be thoroughly documented in 
the subject’s research record. Any alteration to the standard consent process and the justification for such 
alteration will likewise be documented.  
9.4 
Participant and Data Confidentiality 
Information about study subjects will be kept confidential and managed according to the requirements of 
the Health Insurance Portability and Accountability Act of 1996 (HIPAA).  Those regulations require a 
signed subject authorization informing the subject of the following:  
• 
What protected health information (PHI) will be collected from subjects in this study 
• 
Who will have access to that information and why 
• 
Who will use or disclose that information  
• 
The rights of a research subject to revoke their authorization for use of their PHI.  
 
In the event that a subject revokes authorization to collect or use PHI, the investigator, by regulation, 
retains the ability to use all information collected prior to the revocation of subject authorization.  For 
subjects that have revoked authorization to collect or use PHI, attempts should be made to obtain 
permission to collect at least vital status (i.e. that the subject is alive) at the end of their scheduled study 
period. 
 
Participant confidentiality is strictly held in trust by the investigators and their staff. This confidentiality is 
extended to cover testing of biological samples and the clinical information relating to participants. 
Therefore, the study protocol, documentation, data, and all other information generated will be held in 
strict confidence. All study data will be stored in REDCap database.  Participant electronic material are 
only labeled with study ID and the link to identifiable info is stored separately. 
 
Representatives of the IRB may inspect all documents and records required to be maintained by the 
investigator, including but not limited to, medical records (office, clinic, or hospital) and pharmacy records 
for the participants in this study. The clinical study site will permit access to such records. 
 
The study participant’s contact information will be securely stored at the site for internal use during the 
study. At the end of the study, all records will continue to be kept in a secure location for as long a period 
as dictated by local IRB and Institutional regulations. 
 
Study participant research data, which is for purposes of statistical analysis and scientific reporting, will 
be stored at NYU Langone Medical Center. This will not include the participant’s contact or identifying 
information. Rather, individual participants and their research data will be identified by a unique study 
identification number. The study data will be secured and password protected. At the end of the study, all 
study databases will be de-identified and archived at the NYU Langone Medical Center. 
10 Data Handling and Record Keeping 
10.1 Data Collection and Management Responsibilities 
Data will be collected on electronic CRFs in REDCap and printed versions of each document will be placed 
in the paper research chart and will be stored at Clinical Research Center. Both electronic (REDCap) and 
paper research charts will be maintained as source documents and for recording data for each participant 
enrolled in the study. Access to REDCap will be restricted to authorized study team members, who must 
log on to the REDCap system through NYU using their Kerberos ID and password to access study 
documents. Any discrepancies between electronic and paper documents will be explained and captured in 
a note and maintained in the participant’s official electronic and paper study records. Data and study charts 
will be maintained for the duration of the study and afterwards per NYULH requirements. 
The study CRFs is the primary data collection instrument for the study. All key elements required to be 
completed during consent, screening, and questionnaires will be listed as required elements in REDCap, 
therefore not allowing submission of the form until all required information has been completed.  


Study number: S20-00390 
 
Page 18 
Version: 4.0 
 
 
CONFIDENTIAL 
This material is the property of the NYU School of Medicine and Langone Medical Center. 
Version date:30 Mar 2020 
 
COVID-19 PrEP HCW HCQ Study 
If a space on the CRF is left blank because the procedure was not done or the question was not asked, 
study team personnel will write/enter “N/D”. If the item is not applicable to the individual case, study team 
personnel will write/enter “N/A”. All paper chart entries will be printed legibly in blue or black ink. If an entry 
error has been made, study team personnel will draw a single straight line through the incorrect entry and 
enter the correct data above it. All such changes will be initialed and dated.  
Documents considered study records include: regulatory documents, protocols, e-consent forms, e-
screening forms, laboratory inventory forms, and electronic case report forms.  
10.2 Protocol Deviations 
A protocol deviation is any noncompliance with the clinical trial protocol, GCP, or Manual of Procedures 
(MOP) requirements. The noncompliance may be either on the part of the participant, the investigator, or 
the study site staff. As a result of deviations, corrective actions are to be developed by the site and 
implemented promptly. 
 
Protocol deviations must be reported to the local IRB per their guidelines. The site PI/study staff is 
responsible for knowing and adhering to their IRB requirements. Further details about the handling of 
protocol deviations will be included in the MOP. 
10.3 Publication 
This study will adhere to the NIH Public Access Policy. NYULH will have the publication right of the papers 
as outcomes of this study. 
 
11 Study Finances 
11.1 Costs to the Participant 
There will be no cost to the participant. 
11.2 Participant Reimbursements or Payments 
There are no participant reimbursements or payment for this study. 
12 Conflict of Interest Policy 
Any investigator who has a conflict of interest with this study (patent ownership, royalties, or financial gain 
greater than the minimum allowable by their institution, etc.) must have the conflict reviewed by the NYU 
Langone Conflict of Interest Management Unit (CIMU) with a Committee-sanctioned conflict management 
plan. All NYULMC investigators will follow the applicable conflict of interest policies. 
 
 
 


Study number: S20-00390 
 
Page 19 
Version: 4.0 
 
 
CONFIDENTIAL 
This material is the property of the NYU School of Medicine and Langone Medical Center. 
Version date:30 Mar 2020 
 
COVID-19 PrEP HCW HCQ Study 
13 References 
 
• 
Huang C, Wang Y, Li X, et al.  2020 Feb 15. Clinical features of patients infected with 2019 novel 
coronavirus in Wuhan, China. Lancet 395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. 
Epub 2020 Jan 24. 
• 
Zhu N, Zhang D, Wang W, et al. 2020 Feb 20. A Novel Coronavirus from Patients with Pneumonia 
in China, 2019. N Engl J Med. 382(8):727-733. doi: 10.1056/NEJMoa2001017. Epub 2020 Jan 24. 
• 
Chen N, Zhou M, Dong X, et al. 2020 Feb 15. Epidemiological and clinical characteristics of 99 
cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet 
395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30. 
• 
WHO News Release. 3O Jan 2020. Statement on the second meeting of the International Health 
Regulations (2005) Emergency Committee regarding the outbreak of novel coronavirus (2019-
nCoV). 
• 
Cai J, Xu J, Lin D, et al. 2020 Feb 28. A Case Series of children with 2019 novel coronavirus 
infection: 
clinical 
and 
epidemiological 
features. 
Clin 
Infect 
Dis. 
pii: 
ciaa198. 
doi: 
10.1093/cid/ciaa198. [Epub ahead of print] 
• 
Wu, Z. and J.M. McGoogan, Characteristics of and Important Lessons From the Coronavirus 
Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72314 Cases From the 
Chinese Center for Disease Control and Prevention. JAMA, 2020. 
• 
WHO News Release. 3 March 2020.  Shortage of personal protective equipment endangering 
health workers worldwide. 
• 
Biot C, Daher W, Chavain N, Fandeur T, Khalife J, Dive D, De Clercq E. 2006 May Design and 
synthesis of hydroxyferroquine derivatives with antimalarial and antiviral activities. 
J Med Chem. 4;49(9):2845-9. 
• 
Schrezenmeier E, Dörner T. 2020 Mar. Mechanisms of action of hydroxychloroquine and 
chloroquine: implications for rheumatology. Nat Rev Rheumatol. 16(3):155-166. doi: 
10.1038/s41584-020-0372-x.  
• 
Devaux CA, Rolain JM, Colson P, Raoult D. New insights on the antiviral effects of chloroquine 
against coronavirus: what to expect for COVID-19? Int J Antimicrob Agents. 2020 Mar 11:105938. 
doi: 10.1016/j.ijantimicag.2020.105938. [Epub ahead of print] 
• 
Yao X, Ye F, Zhang M, Cui C, Huang B, Niu P, Liu X, Zhao L, Dong E, Song C, Zhan S, Lu R, Li 
H, Tan W, Liu D. In Vitro Antiviral Activity and Projection of Optimized Dosing Design of 
Hydroxychloroquine for the Treatment of Severe Acute Respiratory Syndrome Coronavirus 2 
(SARS-CoV-2). Clin Infect Dis. 2020 Mar 9. pii: ciaa237. doi: 10.1093/cid/ciaa237. [Epub ahead of 
print] 
• 
Gao J, Tian Z, Yang X. 2020 Feb 19.  Breakthrough: Chloroquine phosphate has shown apparent 
efficacy in treatment of COVID-19 associated pneumonia in clinical studies. Biosci Trends. doi: 
10.5582/bst.2020.01047. [Epub ahead of print] 
 
 


Study number: S20-00390 
 
Page 20 
Version: 4.0 
 
 
CONFIDENTIAL 
This material is the property of the NYU School of Medicine and Langone Medical Center. 
Version date:30 Mar 2020 
 
COVID-19 PrEP HCW HCQ Study 
14 Attachments 
These documents are relevant to the protocol, but they are not considered part of the protocol.  They are 
stored and modified separately. As such, modifications to these documents do not require protocol 
amendments. 
 
Attachment A – Pre-Screening questionnaire  
Attachment B - Demographic/Employment Questionnaire  
Attachment C - Medication Questionnaire for Group A 
Attachment D – Medication Questionnaire for Group B 
Attachment E - Symptoms Questionnaire 
Attachment F - Medical History Questionnaire 
 


Study number: S20-00390 
 
Page 21 
Version: 4.0 
 
 
CONFIDENTIAL 
This material is the property of the NYU School of Medicine and Langone Medical Center.  
Version date: 30 Mar 2020 
 
COVID-19 PrEP HCW HCQ Study