Conditions: COVID-19
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1
Healthy volunteers: yes

Brief summary:
The HCW Prophylaxis (HCWP) Study, single, open and off label intervention study. Up to 350 participants will be assigned to group that takes HCQ or group that opts to not take study medication. Participants will be UNM HEALTH SYSTEM HCW at high risk for occupational exposure to SARSCoV- 2. Study timepoints will include Day 1 screening/enrollment, 30 day, 60 day, and 90 day assessments. Questionnaires will be collected in all timepoints.

Detailed description:
This is an open and off label use, interventional, single site study. The HCWP Study eligibility are HCWs at high risk for SARS-CoV-2 exposure (eg MD/DO, NP, RN, and respiratory therapists in ED, Pediatric ED, Urgent Care, Pediatric Urgent Care and on Covid-19 units) at UNM HEALTH SYSTEM meeting all inclusion criteria. Total number of participants: 350 (Group A and B) Group A: up to 275 (HCW who choose to be provided HCQ). Will receive a 600 mg loading dose followed by 200 mg daily (tablets).

Group B: up to 75 (HCW who choose not to be provided HCQ)

Arms:
arm 1: Group A: up to 275 health care workers who choose to take hydroxychloroquine. Will receive a 600 mg loading dose, followed by 200 mg daily (tablets). arm 2: Group B: Up to 75 health care workers who choose not to take hydroxychloroquine.

Interventions: intervention 1: Hydroxychloroquine
Intervention descriptions: intervention 1: Hydroxychloroquine- oral administration: Duration: up to 90 days or until meeting study termination criteria. Subjects will recieve 600 mg loading dose, followed by 200 mg daily (tablets).

Loading dose: 600 mg once for the first day Maintenance dose: 200 mg, daily

Protocol document:
Prot_SAP_001.pdf: 
Study number: S20-00390
Page 1
Hydroxychloroquine Prophylaxis for UNM HEALTH SYSTEM healthcare workers
at high risk for SARS – COV-2 infection
Investigators:
Walter Dehority, M.D., MSc
Assistant Professor, Department of Pediatrics
Email: WDehority@salud.unm.edu
Tel: 505-272-5535
Renee-Claude Mercier, PharmD
Professor and Regents Lecturer, College of Pharmacy
RMercier@salud.unm.edu
Tel:505-272-0581
Jens Langsjoen, M.D., MSc
Associate Professor, Division of Hospital Medicine
Internal Medicine
JLangsjoen@salud.unm.edu 
Jon Femling, MD, PhD
Assistant Professor, Emergency Medicine
JFemling@salud.unm.edu
UNM HEALTH SYSTEMSC 
HRRC Study Number:
20-206
Study Product:
Hydroxychloroquine (HCQ)
Initial version:
04.16.2020
Protocol Version: 06/19/2020
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 HRRC, 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.


Page 2 of 20
List of Abbreviations
AE
Adverse Event/Adverse Experience
AGP
Aerosol Generating Procedure
CFR
Code of Federal Regulations
COVID-19
Coronavirus Disease
CQ
Chloroquine
CRF
Case Report Form
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
HCWP
Health Care Worker Prophylaxis
HRPO
Human Research Protections Office
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
OHRP
Office for Human Research Protections
OHS
Occupational Health Service
PCR
Polymerase chain reaction
PEP
Post exposure prophylaxis
PI
Principal Investigator
PI
Principal Investigator
PPE
Personal Protective Equipment
RA
Rheumatoid Arthritis
SAE
Serious Adverse Event/Serious Adverse Experience
SARS-CoV-2
Severe acute respiratory syndrome coronavirus 2
UNMH
University of New Mexico Hospital
UNMHS
University of New Mexico Health System


Page 3 of 20
US
United States
WHO
World Health Organization
Protocol Summary
Title
Off label study to evaluate the efficacy of hydroxychloroquine as prophylaxis 
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 HCWP HCQ Study
Brief Summary
The HCW Prophylaxis (HCWP) Study, single, open and off label intervention 
study. Up to 350 participants will be assigned to group that takes HCQ or 
group that opts to not take study medication. Participants will be UNM 
HEALTH SYSTEM HCW at high risk for occupational exposure to SARS-
CoV-2. Study timepoints will include Day 1 screening/enrollment, 30 day, 60 
day, and 90 day assessments. Questionnaires will be collected in all 
timepoints.
Phase
Off label use of HCQ
Primary Objectives
To evaluate the efficacy of hydroxychloroquine (HCQ) for prophylaxis 
(HCWP) 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 Health Care Worker Prophylaxis (HCWP) Study, single, open and off 
label intervention study
Primary Endpoint
Number of HCW who test positive for SARS-CoV-2 while in the trial as 
determined by polymerase chain reaction assays from standard of care swaps.
Study Duration
12 months
Participant Duration
Participant Study period: up to 90 days for both groups, inclusive of those 
who elect to convert from Group B to Group A.
Duration of IP 
administration
Up to 90 days
Population
Total number of participants: Up to 350 UNM HEALTH SYSTEM health care 
workers with high risk of occupational exposure to SARS-CoV-2
Group A: up to 275 (HCW choose to be provided HCQ)
Group B: up to 75 (HCW choose not to be provided HCQ)
Study Sites
UNM HEALTH SYSTEMS
Number of participants
Up to 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


Page 4 of 20
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 assessed 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 number of 
HCW who test positive for SARS-CoV2 while on trial. Secondary endpoints 
include symptoms reported over time via web-based questionnaires, as well as 
other clinical endpoints such as quarantine, hospital admission, ICU 
admission, and mortality. 


Page 5 of 20
Schematic of Study Design
HCWs at risk
SARS-CoV-2
Baseline PCR 
Screen
SARS-CoV-2 PCR
Positive 
Excluded
Consider early 
treatment 
intervention
SARS-CoV-2 PCR
Negative 
HCQ
prophylaxix
Load 600 mg Day 
1 followed by 200 
mg daily
Monthly PCR F/U 
or sooner if SARS-
CoV-2 symptoms
No prophylaxis
(Control Group)
Monthly PCR F/U 
or sooner if SARS-
CoV-2 symptoms
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 7 April 2020, person-
to-person transmission has occurred worldwide, approaching 1.5 million cases and over 75,000 deaths. 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, cardiac, and other co-morbidities. SARS-CoV-2 infection can be asymptomatic, mild with self-limited 
pneumonia and other symptoms, or progress to life threatening respiratory involvement and multi-organ failure. 
The infection often appears less severe in children and younger adults [5].  Nevertheless, the burden to health 
and economic systems globally of this pandemic is already substantial and the pandemic has not peaked on a 
worldwide basis. 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. 
An early report of 1700 cases of COVID-19 among health care workers (HCWs) caring for COVID-19 patients 
in China, included 5 deaths, in a published series of over 72,000 cases [6]. The number of HCWs infected with 
SARS-CoV-2 are increasing every day in USA 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 (AGP) are performed 
without knowing SARS-CoV-2 infection status. The SARS-CoV-2 epidemic has put tremendous strain on HCW 


Page 6 of 20
in all aspects. Scientists at the UNM HEALTH SYSTEMS are interested in studying theSARS-CoV-2 and 
strategies to protect HCWs in high-risk exposure settings.
As of today, there is no approved treatment or prophylaxis for SARS-CoV-2 by FDA (Food and Drug 
Administration). 
The 
FDA 
has 
issued 
an 
“emergency 
use 
authorization” 
for 
HCQ 
use 
https://wwwfda.gov/medical/136537/download. 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 specificallySARS-CoV-2. 
Pharmacologic modeling based on observed drug levels and in vitro drug testing suggest that prophylaxis at 
approved doses could prevent SARS-CoV-2 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 to prevent 
SARS-CoV-2 infection among HCWs at high risk of occupational exposure to SARS-CoV-2 [10-12].
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 SARS-CoV-2 infection. This study is designed to answer whether 
prophylaxis with HCQ can mitigate the risk of SARS-CoV-2 infection among HCWs in high-risk settings.
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 HCQ will prevent positive SARS-CoV-2 conversion in HCW or reduce subsequent severity of 
infection.  Additionally, medical societies and the 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-arrhythmic 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’s 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 


Page 7 of 20
inhibitors and other histamine 2 blockers. As with any experimental treatment for specific diseases, there may 
be unknown or unforeseeable side effects. 
3
Objectives
Primary Objective
Primary Endpoint
To evaluate the efficacy of hydroxychloroquine 
(HCQ) for prophylaxis 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 infection with SARS-CoV-2 as 
determined by positive PCR for the virus on 
standard diagnostic tests.
Secondary Objectives
Secondary Endpoints
1. To characterize whether high-risk HCW who 
test positive for SARS-CoV-2 have an 
asymptomatic infection or report symptoms of 
COVID-19 in the 4 weeks preceding positive 
SARS-CoV-2
1.  Symptom questionnaires performed once daily 
as currently mandated for HCW in high risk settings 
within UNMHS.
2.  Determine role of occupational health 
exposure risk level on subsequent conversion 
frequency (mild-moderate-severe)
2.  Online survey required once daily for all at risk 
HCW (existing document)
3.  To assess the severity of any SARS-CoV-2 
infection after prophylactic treatment with 
hydroxychloroquine.
3. Symptom questionnaires, Hospital admission 
rate, ICU admission rate, Mortality rate, PSI score 
of respiratory compromise
4.  To assess the tolerability of 
hydroxychloroquine prophylaxis of SARS-CoV-2 
in this population
4. Incidence of AEs or SAEs related to HCQ at 
study termination.
Exploratory Objectives 
Exploratory Endpoints
1. To determine whether hydroxychloroquine 
reduces time lost from work 
1. Days away from work
2. 
To 
assess 
the 
compliance 
of 
hydroxychloroquine prophylaxis
2. Frequency of missing dose
3. To assess whether HCQ benefits are different 
for specific AGPs or exposure on certain covid 
units (MICU v. ED v. covid rule out unit) 
3. Frequency of positive test for SARS-CoV-2 
related to AGP’s or specific Covid-19 units.
4.  To compare seroconversion between HCQ-
treated and HCQ-untreated subjects on blood or 
plasma specimens.
4.  Serological analyses at 4 times points (baseline, 
30,60 and 90 days of study enrollment---with a 7-day 
window after each time point to complete analyses)


Page 8 of 20
5.  Metagenomic next generation sequencing of 
SARS-CoV-2 isolates detected in subjects
5.  Sequence of viral isolates compared to published 
genomes and community-circulating SARS-CoV-2
4
Study Design
4.1
Description of Study Design
This is an open and off label use, interventional, single site study
4.2
Study Enrollment and Withdrawal
4.2.1
Study Population
The HCWP Study eligibility are HCWs at high risk for SARS-CoV-2 exposure (eg MD/DO, NP, RN, and 
respiratory therapists in ED, Pediatric ED, Urgent Care, Pediatric Urgent Care and on Covid-19 units) at UNM 
HEALTH SYSTEM meeting all inclusion criteria. 
Total number of participants: 350 (Group A and B)

Group A: up to 275 (HCW who choose to be provided HCQ)

Group B: up to 75 (HCW who choose not to be provided HCQ)
4.2.1.1
Inclusion Criteria
1.
Men or women ≥18 years of age who are UNM HEALTH SYSTEM health care workers and are 
asymptomatic for known presenting symptoms of SARS-CoV-2:
2.
UNMHS HCWs include: MD/DO, NP, RN, and respiratory therapists working in ED, Pediatric ED, 
Urgent Care, Pediatric Urgent Care or on Covid-19 units. Study PI’s will consider study 
enrollment of HCWs from other settings, for example certain outpatient clinics or inpatient units. 
3.
Are not positive for SARS-CoV-2 testing
4.
Willing and able to comply with survey completion, scheduled visits, treatment plan, and other 
study procedures
5.
Willing and able to provide informed consent
4.2.1.2
Exclusion Criteria
Participants are excluded from the study if any of the following criteria apply: 
1. Known hypersensitivity to HCQ or other 4-aminoquinoline compounds 
2. Currently hospitalized 
3. Symptomatic with subjective fever, cough, or sore throat 
4. Current medications exclude concomitant use of HCQ, for example anti-arrhythmic agents, digoxin, 
cyclosporin, cimetidine, or tamoxifen.
5. Concomitant use of other anti-malarial treatment or chemoprophylaxis 
6. History of retinopathy of any etiology 
7. Psoriasis 
8. Porphyria 
9. Known bone marrow disorders with significant neutropenia (polymorphonuclear leukocytes <1500) or 
thrombocytopenia (<100K)
10. Known liver disease 
11. Known long QT syndrome 
12. Use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of 
the study drugs or planned use during the study period. There may be some exceptions to requiring a 
30-day washout that will be evaluated by the Co-Investigators on a case by case basis. 


Page 9 of 20
4.2.1.3
Vulnerable Subjects
This study will enroll employees of UNM HEALTH SYSTEM. Employees (For example: MD/DO, NP, RN, PA, 
Respiratory Therapists) recruited as research subjects may be 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, UNM HEALTH SYSTEMS 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 employment or job performance 
evaluation. All identifying information for employees will be kept strictly confidential following the data security 
provisions outlined in this protocol. 
Pregnant and /or lactating 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. Additionally, the drug is approved to be used in pregnant 
women to treat autoimmune disease and there is consensus in the scientific community that the drug does not 
have adverse effects on the fetus [13-16]. Each participant 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. A systematic review determined that 
HCQ use was not associated with any increased risk of congenital defects, spontaneous abortions, fetal death, 
pre-maturity or decreased numbers of live births in patients with auto-immune diseases. (Systematic review of 
hydroxychloroquine use in pregnant patients with autoimmune diseases, 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 HRRC approved email blast that will be sent to the departments 
that are specific to the desired study population.  We will be using UNM HEALTH SYSTEMSC listservs which 
will be chosen based on their pertinence to the study population. The email blast will direct interested HCW to 
a study team email address for further study information. Upon email contact from potential participant, study 
team will reply asking for a time to speak over the phone 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 up to 350 participants at UNM HEALTH SYSTEM. Subject visits will be conducted remotely 
after the Screen and Enrollment visit.


Page 10 of 20
4.6
Participant Withdrawal or Termination
Reasons for early Withdrawal or Termination

Participants become PCR-confirmed SARS-CoV-2 status

Participant starts disallowed medication (Group A only)

Advent of an adverse event which necessitates discontinuation of HCQ (Group A only, see 
section 6)

Participant decides to withdraw from the study

PI discontinues participation due to safety concerns

Participant decides to withdraw consent

Participant’s primary care provider determines the study is not in participant’s best interest

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 pharmacy. 
4.7.1
Disallowed Concomitant Therapy
See attached appendix of exclusionary and potentially exclusionary medications
4.7.1.1
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 daily maintenance dose.
4.7.1.2
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.
4.7.1.3
Supplies
HCQ will be dispensed at the time of study enrollment or as soon as practical thereafter, after subjects have 
completed all Screening procedures and signed informed consent. The drug will be requested from the UNMH 
Research Pharmacy on the 4th floor or other approved clinical trial pharmacy locations where it may be stored. 
Drug will be dispensed to subjects by qualified study personnel. There will be no cost to the participants. 
Currently there is a sufficient amount of HCQ. This study will not deplete HCQ from stores or pharmacies. HCQ 
supplies for standard of care and patients with preexisting indications will not be compromised by execution of 
this study.
Dispensing schedules

33 pills (200 mg oral tablet) at enrollment

30 pills (200 mg oral tablet) at 30 and 60 day visits


Page 11 of 20
5
Study Procedures and Schedule
5.1
Study Procedures/Evaluations
5.1.1
Study Specific Procedures
Employee Exposure Survey and Aerosol Generating Procedures (Appendix A)
Participants from both Group A and B will be asked to complete the Employee Exposure Survey. This online 
instrument asks health care providers currently working in at risk units to report symptoms or exposures (eg. 
AGPs) related to their encounters with patients who have or are suspected of Covid-19. These HCWs are 
reminded to complete the Survey once per day. The link to this REDCap survey is currently being emailed to 
UNMHSC HCWs and they can access it through widely distributed QR codes. Given its active use, this survey 
will not add additional stress or workload to study participants. Additional study specific questions will be added 
to this survey and the data is linked to REDcap a database.
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). 
Pregnancy is not a contraindication for receiving HCQ.
A list of potential Aerosol Generating Procedures (AGP) is also provided in Appendix A.
Subjects will only be asked to complete SARS-CoV-2 testing at study enrollment and the 30, 60 and 90 day 
follow up points, with a 7-day window after each time point to complete the testing.
5.2
Study Schedule
5.2.1
Schematic of Study Design
Schematic of Study Design
Schedules of Activities for COVID-19 HCWP HCW HCQ Study
Task
Screening/
Baseline
Daily 
(existing 
required 
survey)
30 Day
(± 
7days)
60 Day
(± 
7days)
90 Day
(± 
7days)
Early Termination 
or Clinically 
Suspected SARS-
CoV-2
Consent
X
Health history
X
Exposure Survey (online)
X
X
X
Swab* for SARS-CoV-2 
and plasma/serum sample
X
X
X
X
X
Hydroxychloroquine 
dosing initiation
X
Adverse Events
X
X
X
X
X
*Lab has confirmed ability to test samples from week over next weekend. Estimate up to 50 total per week (25 
Sat, 25 Sun). Lab has also agreed to bank plasma and serum samples for delayed analysis.
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 which may be conducted via telephone and include completion of the 
Employee Exposure Survey. Those who decide to take HCQ will be the experimental group (Group A), and 
participants who choose not to take HCQ will be part of the control group (Group B).  


Page 12 of 20
The Employee Exposure Survey can be accessed online via the following URL: 
https://is.gd/reportexposure. It can also be accessed by this QR code placed strategically in 
relevant patient care areas: 
A hard copy of the survey is also attached as an appendix at the end of this protocol 
document. Questions relevant to this study will be added to the survey if the respondent 
indicates they are a study participant. We will use the REDcap database to track adherence 
to the protocol required surveys and send email or phone reminders if more than 2 days are missed. 
5.2.3
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, 
survey collection will be done at the time of switch over. Switched participants will follow the study agent 
administration described in 4.7.1.2. Participants will be rescreened using screening form at the time of switch.

Group A: approximately up to 275 (HCW choose to be provided HCQ)

Group B: approximately up to 75 (HCW choose not to be provided HCQ)
Subjects who switch from Group B to Group A will not be replaced. 
5.2.4
Early Termination Visit
Early termination visit will consist of questionnaire and nasal swab. 
5.3 
Laboratory Procedures/Evaluations
Standard diagnostic swabs will be collected from the participants at baseline and at 30, 60, and 90 day follow 
up points (with a 7-day window after each time point to complete the testing). A portion of any participant sample 
testing positive for SARS-CoV-2 will also be evaluated with metagenomic next-generation sequencing.  Only 
viral RNA will be sequenced, not human DNA/RNA.
The Executive Director of Research at the UNM Health Sciences Center Office of Research will be working with 
institutional officials to ensure the use of viral transport media and swabs during the study do not interfere with 
adequate supplies available for clinical use. A modification will be submitted to clarify who will supply the swabs 
and the transport media (i.e. TriCore, UNMH).
6
Assessment of Safety
Participants will be asked about any potential side effects experienced during study period at the 30, 60, and 
90 day visits. In addition, subjects will report any potential AE’s as part of the modified, daily Employee Exposure 
Survey to be completed daily. All subjects are HCW’s and a space will be included for them to enter any new 
symptoms they may have experienced. If none they will indicate none. In their busy, at-risk environment, 
enrolled HCW’s will not be presented with a lengthy list of uncommon and rarely serious AE’s reported with 
HCQ. Given concerns of cardiac toxicity (dysrhythmias) with the use of the study drug, particularly when 
combined with azithromycin, the following verbiage will be inserted into the informed consent form:  “In addition, 
taking macrolide antibiotics (azithromycin, clarithromycin, erythromycin, spiramycin, telithromoycin) while 
receiving hydroxychloroquine may increase the risk of serious heart rhythm problems (e.g. torsades de pointes).  
You may wish to consult with your physician before participating in the trial because you may be predisposed 
to these problems.”  The FDA warning about the use of hydroxychloroquine for treatment of COVID-19 (released 
April, 2020) will also be discussed in the consent form.  


Page 13 of 20
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 an 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 

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


Page 14 of 20
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 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 Data Safety Monitoring Board (DSMB) 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.
The DSMB will consist of the following members:

Dr. Greg Mertz, MD, DOIM-Infectious Disease, will chair the DSMB for this study.

CTSC biostatistician as assigned based on demand from other clinical trials.

Medical ethics or legal – Jonathan Bolton or Scott Sauder

Critical care – Dr. Michelle Harkins or designee. Cannot be participating in the clinical trial.
 
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 positive SARS-CoV-2 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 positive 
SARS-CoV-2 rate differs between the groups.
7.3
Analysis Datasets
The primary analysis data set will consist of positive SARS-CoV-2 outcomes for all enrolled participants.  
Sensitivity analyses will be conducted using the subset of HCQ participants who complete their entire course 
of treatment.


Page 15 of 20
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 assessed 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)
Detection of SARS-CoV-2 RNA by PCR will be the primary endpoint and will be compared between treatment 
groups (prophylaxis vs. no prophylaxis).  Positive SARS-CoV-2 will be defined as a binomial variable (i.e., 
positive SARS-CoV-2 or no positive SARS-CoV-2) and analyzed using Wilcoxon rank analysis. 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 exposure risk, 
demographic factors and comorbidities that are known or suspected to affect the likelihood of developing 
SARS-CoV-2 infection. 
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 outcomes will be 
analyzed in a manner similar to that described above for the primary endpoint.  Symptoms will be included as 
predictor variables.  Antibody titers for SARS-CoV-2, measured as an exploratory endpoint in serum or 
plasma samples, will also be analyzed as binomial values. Positive values will be defined as a four-fold or 
greater increase in IgG antibody titers compared to baseline. Other descriptive analyses will be provided of 
the antibody titer results, including geometric mean, median, standard deviation, and titer range.  
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 positive SARS-CoV-2 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 positive SARS-CoV-2 rate of approximately 
15 percentage points (e.g., a 35% PCR positivity rate in the control group and a 20% PCR positivity 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.   Information from clinical parameters will be obtained from the Symptoms Questionnaire. A 
separate electronic dataset (using REDcap) will be constructed to capture the most important clinical 
information on the patients including the following: demographic information (gender, age, DOB, place of 
residence, ethnicity and race), presenting and daily symptoms and signs (including fever, cough, SOB, 
sputum production, anosmia, hyposmia, fatigue, sore throat, nasal congestion, diarrhea, headache, vital 
signs, pulmonary auscultatory findings)
Each person participating in this Study will be assigned a randomly generated study ID that will be linked to 
identifiers (MRN, DOB) in a linking table to be kept separate from the research data. Data and specimens will 


Page 16 of 20
be labelled with the study ID only. Only HRRC-approved members of the study team who have the 
appropriate training will have access to the data and identifiers. All data that we collect in this study will be 
entered into REDCap, a secure data-base, on a password-protected computer using a secure network.  Any 
hard copy records/data will be kept in a locked file cabinet in the locked office of a designated member of the 
Study team.  The specimens will be kept and stored in the Clinical and Translational Science Center at the 
UNM HSC and can only be accessed by the members of the study team.  Investigators will transport the 
specimens to TriCore Reference Laboratories for lab analysis through standard transport hospital procedures.  
Once data collection is complete, data will be de-identified by destruction of the linking table.
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.
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 (UNM HEALTH SYSTEMSC HRRC)
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
An approved member of the study team will conduct the consent process with the participant in a private area 
of the hospital or by phone if needed. . 
It may not be possible to have an in-person discussion of the study with participants. Investigators may need 
to conduct a phone consent via conference phone call because the investigator and participant may not be in 
the same location. Documenting written informed consent in these instances must involve a process as 
follows: the participant receives a copy of the informed consent document in advance of a telephone 
discussion. The investigator obtains consent over the telephone with the participant. A Legal Authorized 
Representative will not be required. Only English-speaking participants will be enrolled. 
The informed consent form may be mailed, emailed or faxed to the participant. The consent discussion may 
then be conducted by phone, conference phone call or in person so that the participant can read the consent 
form during the discussion. 
Investigators will explain the study to the potential participant by reading the informed consent document to 
the participant and provide all pertinent information (purpose, procedures, risks, benefits, alternatives to 
participation), and allowing the potential participant ample opportunity to ask questions. This can be done by 
phone, conference phone call or in person. 


Page 17 of 20
Investigators will ensure a thorough verbal discussion was conducted by phone, conference phone call or in 
person of the consent form. Investigators will allow the potential participant time to read the consent form and 
allow the participant sufficient time to consider whether or not to participate in the research. 
Investigators will ensure the potential participant additional questions have been addressed. 
Participants will be asked to explain the purpose of the study, procedures involved, and/or conditions for 
participation to confirm understanding. 
If the participant agrees to participation, s/he signs the consent form and returns it to the investigator for 
signature and date. If informed consent took place via the phone or via conference phone call, the signed and 
dated consent form can be returned to investigators by mail, fax, or by scanning the consent form and 
returning it through a secure e-mail account by the participant. It is possible that multiple consent forms will be 
obtained for a single participant because the investigator obtaining consent and the participant were not in the 
same location but together via conference phone call. In this instance, each separate consent will be signed 
and dated by each individual appropriately. All dates on the multiple consent forms will be congruent for the 
day the consent took place. In these instances, a note-to-file will explain that separate consent forms exist for 
a single participant because all individuals could not be in the same room and that the consent took place 
over a conference phone call in an effort to decrease the contact and exposure to the novel coronavirus.
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.


Page 18 of 20
10 Data Handling and Record Keeping
10.1 Data Collection and Management Responsibilities

Participants will be assigned a randomly generated study ID that will be linked to identifiers (MRN, 
DOB) in a linking table to be kept separate from the research data. Data and specimens will be labelled 
with the study ID only.

Only HRRC-approved members of the study team who have the appropriate training will have access 
to the data and identifiers.

Data will be entered into REDCap on a password-protected computer using a secure network.

Any hard copy records/data will be kept in a locked file cabinet in the locked office of a designated 
member of the study team

The specimens will be kept and stored in the Clinical and Translational Science Center at the UNM 
HSC and can only be accessed by the members of the study team.  Then specimens will be transported 
to TriCore Laboratory and can only be accessed by laboratory personnel for the purpose specified in 
the protocol. 

Once data collection is complete, data will be de-identified by destruction of the linking table. Study 
records will be kept for 6 years past study closure.

Biological samples collected for the study (e.g. blood) will not be stored in a repository, but will be 
destroyed after analysis and after completion of the study.  
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. UNM HEALTH SYSTEM 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
All investigators and study personnel must have up to date financial declarations reviewed and approved by 
the UNMHSC Conflict of Interest Committee.


Page 19 of 20
13 References
1.
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.
2.
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.
3.
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.
4.
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).
5.
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]
6.
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.
7.
WHO News Release. 3 March 2020.  Shortage of personal protective equipment endangering health 
workers worldwide.
8.
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.
a.
J Med Chem. 4;49(9):2845-9.
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. 
10. 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]
11. 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]
12. 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]
13. Leroux M, Desveaux C, Parcevaux M, et al.  Impact of hydroxychloroquine on preterm delivery and 
intrauterine growth restriction in pregnant women with systemic lupus erythematosus:  a descriptive 
cohort study.  Lupus.  2015;24(13):1382-1391.
14. Abarientos C, Sperber K, Shapiro DL, et al.  Hydroxychloroquine in systemic lupus erythematosus 
and rheumatoid arthritis and its safety in pregnancy.  Expert Opin Drug Saf.  2011;10(5):705-714.
15. Costedoat-Chalumeau N, Amoura Z, Huong DL, et al.  Safety of hydroxychloroquine in pregnant 
patients with connective tissue diseases.  Review of the literature.  Autoimmun Rev.  2005;4(2):111-
115.
16. Clowse ME, Magder L, Whitter F, et al.  Hydroxychloroquine in lupus pregnancy.  2006;54(11):3640-
3647.
17. Sperber K, Hom C, Chao CP, et al.  Systematic review of hydroxychloroquine use in pregnant 
patients with autoimmune diseases.  Pediatr Rheumatol Online J.  2009;7:9.


Page 20 of 20
Appendix A :  Questionnaires or Survey
Employee Exposure Survey
Employee Exposure 
Survey.pdf
List of Potential Aerosol Generating Procedures and Risks:
BiPAP, CPAP, high flow oxygen (>10L/minute)
Bronchoscopy
Cardiopulmonary resuscitation (CPR)
Cardioversion
Clinical (bedside) swallow evaluations
Conscious sedation
Electroconvulsive shock therapy (ECT)
Excessive coughing
Extubation
Fiberoptic endoscopic evaluation of swallowing
GI Endoscopy
Intubation
Laryngoscopy
Manual ventilation before intubation
Nasogastric, orogastric, or nasoenteric feeding tube placement
Nasopharyngeal swabbing
Nebulizer treatments
Oral care
Patient actively coughing in room)
Patient use of Incentive Spirometry
Planned regional anesthetic with high likelihood of requiring conversion GA (mask or intubation)
Prone positioning 
Speech valve trials with tracheostomies
Sputum induction
TEE
Tracheostomy
Videofluoroscopic swallow studies

ICF_000.pdf: 
Page 1 of 12
HRRC #: 20-206
Version Date: 05/14/2020
The University of New Mexico Health Sciences Center
Consent and Authorization to Participate in a Research Study
Key Information for Hydroxychloroquine Prophylaxis for UNM HEALTH SYSTEM 
healthcare workers at high risk for SARS-COV-2 infection 
You are being invited to take part in a research study about using hydroxychloroquine prophylaxis for 
UNM Health System healthcare workers at high risk for SARS-COV-2 infection (also called COVID-19).
WHAT IS THE PURPOSE, PROCEDURES, AND DURATION OF THE STUDY?
By doing this study, we hope to learn if this drug can help prevent respiratory infections caused by SARS-
CoV-2. Your participation in this research will last about 90 days.
The purpose of this research is to evaluate the efficacy of hydroxychloroquine (HCQ) to prevent severe 
acute respiratory syndrome due to SARS-CoV-2 infection among health care workers at high risk of 
occupational exposure to SARS-CoV-2
This drug is approved by the FDA for other conditions, but not for respiratory infections caused by SARS-
CoV-2. There are currently no drugs approved by the FDA for this condition and the FDA has issued an 
“emergency use authorization” for HCQ use https://wwwfda.gov/medical/136537/download.
WHAT ARE THE KEY REASONS YOU MIGHT CHOOSE TO VOLUNTEER FOR THIS STUDY?
You may want to participate in this study because you work in a high risk unit with potential exposure to 
SARS-CoV-2 and this drug may help prevent severe acute respiratory infections.. You may also want to 
participate in order to help find a treatment for this condition. For a complete description of benefits, 
refer to the Detailed Consent section. 
WHAT ARE THE KEY REASONS YOU MIGHT NOT CHOOSE TO VOLUNTEER FOR THIS STUDY?
You might choose not to volunteer for this study because this drug may not help prevent a respiratory 
infection due to SARS-CoV-2, or because you might lose privacy and/or confidentiality. For a complete 
description of the risks, refer to the Detailed Consent and to the Appendix. 
Alternate treatments or procedures would include having access to the study medications without 
taking part in this study. There is currently no standard of care treatment for treating the SARS-CoV-2 
viral infection. 
DO YOU HAVE TO TAKE PART IN THE STUDY?
If you decide to take part in the study, it should be because you really want to volunteer. You will not 
lose any services, benefits or rights you would normally have if you choose not to volunteer
WHAT IF YOU HAVE QUESTIONS, SUGGESTIONS OR CONCERNS?
The person in charge of this study is Dr. Walter Dehority in collaboration with co-investigators Drs. Jens 
Langsjoen, Renee Mercier, and Jon Femling of the University of New Mexico Health Sciences Center. 


Page 2 of 12
HRRC #: 20-206
Version Date: 05/14/2020
Their names, Departments and contact phone numbers are listed at the end of this consent document. If 
you have questions, suggestions, or concerns regarding this study or you want to withdraw from the 
study, you can call any of the co-investigators.
If you have any questions or concerns about your rights as a volunteer in this research, contact staff in 
the University of New Mexico Health Sciences (UNMHSC) Human Research Review Committee (HRRC) 
between the business hours of 8AM and 5PM, Mountain Standard Time (MST), Monday-Friday at 505-
272-1129. 
DETAILED CONSENT
Version April 27, 2020
ARE THERE REASONS WHY YOU WOULD NOT QUALIFY FOR THIS STUDY? 
You would not qualify to be in this study for the following reasons:

You are under the age of 18.

You have an allergy to hydroxychloroquine or have contraindication to treatment with study 
drugs.

Currently hospitalized. 

Symptomatic with subjective fever, cough, or sore throat

Are currently using hydroxychloroquine

Are currently using anti-malarial drugs or chemoprophylaxis

Have retinopathy

Have severe or uncontrolled psoriasis

Have porphyria

Known bone marrow disorders with significant neutropenia (polymorphonuclear leukocytes 
<1500) or thrombocytopenia (<100K)

Are currently using medicines as follows: anti-arrhythmic agents, digoxin, cyclosporin, 
cimetidine, or tamoxifen

Known liver disease

Known long QT syndrome

Use of any investigational or non-registered drug or vaccine within 30 days preceding the first 
dose of the study drugs or planned use during the study period. There may be some exceptions 
that will be evaluated by the Co-Investigators on a case by case basis. 
WHERE IS THE STUDY GOING TO TAKE PLACE AND HOW LONG WILL IT LAST?
The research procedures will be conducted at University of New Mexico Hospital. The total amount of 
time you will be asked to volunteer for this study is over the next 90 days.
WHAT WILL YOU BE ASKED TO DO?


Page 3 of 12
HRRC #: 20-206
Version Date: 05/14/2020
This drug will be given once daily by mouth. We will collect the research specimen using a nose swab at 
screening and on day 30, 60 and 90. 
The study will have two groups of participants, Group A and Group B. 

Group A will be participants who choose to take hydroxychloroquine 

Group B will be participants who choose to opt out of taking hydroxychloroquine.
If you choose to take hydroxychloroquine, the study team will need to assess your medical history to 
determine if you are eligible to be in Group A. This is to minimize the potential risks that may occur with 
taking hydroxychloroquine.
If you are eligible to participate in study and decide to take part, you will be asked to perform tests and 
procedures listed below.
Screening/Enrollment Visit (Group A and Group B)
A study team member will coordinate an initial pre-screening visit or phone call to determine eligibility 
based on the following:

Going over your medical history and medications you are currently taking

If you are a woman of childbearing potential, we will ask you to confirm whether you are 
pregnant and the date of your last menses. Pregnancy is not a contraindication to receiving 
HCQ.

Going over inclusion and exclusion criteria
If you are deemed eligible and have given consent, you will then be asked to:

Complete questionnaires through REDcap, an online data capture system

You will then take your first dose of hydroxychloroquine (Group A subjects only) This visit may 
occur in one day or over the span of a couple of days.
Medication Administration (Group A only)
You will be asked to take 600mg of hydroxychloroquine on the first day (screening/enrollment day) and 
200mg everyday thereafter.
Group A and Group B
You will be asked to complete questionnaires through REDcap daily. A nasal swab for COVID-19 and 
plasma/serum sample will be collected at screening, day 30, day 60 and 90 and at any early 
termination/switch over day.  If SARS-CoV-2 is detected, the virus will undergo whole genome 
sequencing at UNM.  Your DNA/RNA will not be sequenced, only the virus.  You will not be notified of 
these sequencing results.  Serology testing will be done on the blood several months after collection.  If 
desired, you can be notified of these results when they become available.  
Visit for Switching from Group B to Group A
If you were originally in Group B (not taking HCQ) and want to switch to Group A (start taking HCQ), you 
can do so at any time during the study. You will be re-screened to join Group A and begin taking HCQ. 


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Questionnaires (Group A and Group B)
At each study time point, Screen, 30, 60, and 90 days, you will be asked to complete questionnaires 
regarding current medications and symptoms. The survey will include information about any potential 
exposures you many have had participating in aerosol generating procedures (AGP’s).
Early Termination Visit
If you have to stop taking the study medication (Group A), or if you decide to leave the study (Group B) 
you will be asked to complete questionnaires, blood collection and nasal swab collection as part of the 
study termination visit.  However, you may still stop enrollment in the study at any time and will not be 
required to do this.  
WHAT ARE THE POSSIBLE RISKS AND DISCOMFORTS?
NOTE:  The US Food and Drug Administration (FDA) released a safety warning in April 2020 regarding 
reports of serious heart rhythm problems in some patients with COVID-19 treated with 
hydroxychloroquine or chloroquine, often in combination with other medications that can also lead to 
heart rhythm problems.  The FDA cautioned against use of hydroxychloroquine outside the hospital or 
outside clinical trials, and the FDA recommended close supervision.  In light of this new safety warning, 
it is particularly important that you tell one of the investigators about any history of heart rhythm 
problems you may have and about all medications that you are taking, and that you discuss this warning 
with one of the investigators or another physician you see before you begin any new medications.  It is 
currently unclear how long such risks would persist (if at all) after discontinuation of the drug.   
In addition, taking macrolide antibiotics (azithromycin, clarithromycin, erythromycin, spiramycin, 
telithromoycin) while receiving hydroxychloroquine may increase the risk of serious heart rhythm 
problems (e.g. torsades de pointes).  You may wish to consult with your physician before participating in 
the trial because you may be predisposed to these problems.  
HCQ is currently FDA approved for rheumatoid arthritis and malaria. It is generally well tolerated in 
patients for many years with little toxicity. However, we do not know all the side effects that may 
happen when HCQ is taken for this study purpose. All participants of this study will be monitored for any 
side effects you report during participation. Side effects can be mild or very serious. Many side effects 
go away soon after you stop taking the hydroxychloroquine. In some rare cases, side effects can be 
serious, long lasting, or may never go away. As with any experimental treatment for specific diseases, 
there may be unknown or unforeseeable side effects.
Below is a list of possible adverse reactions that may occur while taking hydroxychloroquine. Although 
none of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking 
hydroxychloroquine:
Incidence not known:

Blistering, peeling, loosening of the skin

Blurred vision or other vision changes


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
Chest discomfort, pain, or tightness

Cough or hoarseness

Dark urine

Decreased urination

Defective color vision

Diarrhea

Difficulty breathing

Difficulty seeing at night

Dizziness or fainting

Fast, pounding, uneven heartbeat

Feeling that others are watching you or controlling your behavior

Feeling that others can hear your thoughts

Feeling, seeing, or hearing things that are not there

Fever with or without chills

General feeling of tiredness or weakness

Headache

Inability to move the eyes

Increased blinking or spasms of the eyelid

Joint or muscle pain

Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, and sex 
organs

Loss of hearing

Lower back or side pain

Noisy breathing

Painful or difficult urination

Red irritated eyes

Red skin lesions, often with a purple center

Severe mood or mental changes

Sore throat, sores, ulcers, or white spots on the lips or in the mouth

Sticking out of the tongue

Stomach pain

Swelling of the feet or lower legs

Swollen or painful glands

Trouble with breathing, speaking, or swallowing

Uncontrolled twisting movements of the neck, trunk, arms, or legs

Unusual behavior

Unusual bleeding or bruising

Unusual facial expressions

Unusual tiredness or weakness

Yellow eyes or skin
Some side effects of hydroxychloroquine may occur that usually do not need medical attention. These 
side effects may go away during treatment as your body adjusts to the medicine. Also, your health 
care professional may be able to tell you about ways to prevent or reduce some of these side effects. 
Check with your health care professional if any of the following side effects continue or are 
bothersome or if you have any questions about them:


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Side effects that may go away, incidence not known

Continuing ringing or buzzing or other unexplained noise in the ears

Feeling of constant movement of self or surroundings

Irritability

Nausea

Nervousness

Nightmares

Sensation of spinning

Shakiness and unsteady walk

Uncontrolled eye movements

Unsteadiness, trembling, or other problems with muscle control or coordination

Vomiting
The most common risk we anticipate in this study is allergic reaction to the study drug that will be in 
the form of a skin rash. If you experience a rash, tell the study team right away. You may be asked to 
discontinue the study drug.
Currently, there are no controlled studies to support efficacy and data is limited at this point. It is 
possible that the study drug may increase risk of acquiring COVID-19.
Unknown Risks
Although hydroxychloroquine is well studied and widely used, use of hydroxychloroquine for pre- 
exposure prophylaxis to prevent COVID-19 may have side effects that no one knows about yet. The 
researchers will let you know if they learn anything that might make you change your mind about 
participating in the study.
WHAT ABOUT MY EMPLOYEE STATUS?
Employees 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, UNMHSC employees may experience increased risk of 
invasion of privacy or loss of confidentiality.
To minimize these risks, you will be contacted and consented to enroll in this study by a member of 
the study team who does not have any direct supervisory responsibilities or role in your performance 
evaluation. We will remove identifiers from your data and label it instead with a unique code. The link 
to your identifiable information will be stored separately from your coded data and available to 
members of the study team. However, this link will not be made available to your direct supervisor(s).
Your decision to participate, refuse participation, or to later withdraw from the study will have no 
impact on your employment, salary, or performance evaluation.
CAN I BE IN THE STUDY IF I AM PREGNANT OR BREASTFEEDING?


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You can participate in this study if you are pregnant. Hydroxychloroquine is used as a standard of care 
medication in pregnant lupus patients without increase in miscarriages or birth defects. Additionally, 
there is consensus in the scientific community that the drug does not have adverse effects on the fetus. 
One of the Investigators will answer questions to help you with this decision.
WILL YOU BENEFIT FROM TAKING PART IN THIS STUDY? 
We do not know if you will get any benefit from participating in this study. It is possible that pre-
exposure HCQ will prevent symptoms or reduce severity of infection with SARS-CoV-2. Additionally, the 
medical community and general public may benefit from the information collected from this study.
WHAT WILL IT COST YOU TO PARTICIPATE?
You and/or your insurance company, Medicare, or Medicaid will be responsible for the costs of all care 
and treatment that you would normally receive for any conditions you may already have. These are 
costs that are considered medically necessary and will be part of the care you receive even if you do not 
take part in this study.
The University of New Mexico may not be allowed to bill your insurance company, Medicare, or 
Medicaid for the medical procedures done strictly for research. This means you may have to pay out-of- 
pocket for these costs. 
If a health insurance company insures you, your insurer may pay the costs. You should ask your 
insurer if you have any questions regarding your insurer’s willingness to pay these costs. 
If Medicare or Medicaid covers you, Medicare or Medicaid may cover these costs.  For questions 
regarding Medicare coverage, call 1-800-MEDICARE (1-800-633-4227).  For questions regarding 
Medicaid coverage, call 1-800-2570. Your insurer, Medicare, or Medicaid, may agree to pay for the 
costs. If you are required to expend a co-payment or deductible, the amount of this co-payment or 
deductible may be costly. 
WHO WILL SEE THE INFORMATION THAT YOU GIVE?
Each person participating in this Study will be assigned a randomly generated study ID that will be linked 
to identifiers (MRN, DOB) in a linking table to be kept separate from the research data. Data and 
specimens will be labelled with the study ID only. Only HRRC-approved members of the study team who 
have the appropriate training will have access to the data and identifiers. All data that we collect in this 
study will be entered into REDcap, a secure database, on a password-protected computer using a secure 
network.  Any hard copy records/data will be kept in a locked file cabinet in the locked office of a 
designated member of the Study team.  The specimens will be kept and stored in the Clinical and 
Translational Science Center at the UNM HSC and can only be accessed by the members of the study 
team.  We will transport the specimens to TriCore Reference Laboratories for lab analysis through 
standard transport hospital procedures.  After testing, any left-over samples, including serum or blood 
will be destroyed after the study is completed.  Once data collection is complete, data will be de-
identified by destruction of the linking table. Study records will be kept for 6 years past study closure.


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When we write about or share the results from the study, we will write about the combined 
information. We will keep your name and other identifying information private. 
We will make every effort to prevent anyone who is not on the research team from knowing that you 
gave information, or what the information is. 
You should know there are some circumstances in which we may have to show your information to 
other people. For example, the law may require us to share your information with the following 
agencies and for the following reasons: 

The law requires us to share your information with authorities if you report information about a 
child being abused

If you pose a danger to yourself or someone else. 

A court or agencies, if you have a reportable disease or condition.

Authorities, if you report information about a child being abused, if you pose a danger to 
yourself or someone else. 
CAN YOU CHOOSE TO WITHDRAW FROM THE STUDY EARLY?
You can choose to leave the study at any time. You will not be treated differently if you decide to stop 
taking part in the study. 
If you choose to leave the study early, data collected until that point will remain in the study database 
and may not be removed. 
The investigators conducting the study may need to remove you from the study. The study intervention, 
medication will no longer be provided to you and may not be available for purchase. This may occur for 
a number of reasons. You may be removed from the study if you are not able to follow the direction, 
they find that your participation in the study is more risk than benefit to you, or if the Co-investigators 
choose to stop the study early for a number of scientific reasons. 
You may be removed from the study if:

You are not able to follow the directions.

They find that your participation in the study is more risk than benefit to you.
ARE YOU PARTICIPATING, OR CAN YOU PARTICIPATE, IN ANOTHER RESEACH STUDY AT THE SAME 
TIME AS PARTICIPATING IN THIS ONE? 
You may not take part in this study if you are currently involved in another research study. It is 
important to let the investigator and your doctor know if you are in another research study. It will be up 
to them to determine if you can participate in more than one study. You should discuss this with the 
investigator and your doctor before you agree to participate in another research study while you are in 
this study. 
WHAT HAPPENS IF YOU GET HURT OR SICK DURING THE STUDY? 


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If you believe you are hurt or if you get sick because of something that is due to the study, you should 
call or email one of the Co-investigators immediately. Their contact information is listed at the end of 
this document. If you need to reach someone outside of business hours, please call (505) 272-2121.
A member of the Investigator group will determine what type of treatment, if any, is best for you at that 
time. 
It is important for you to understand that the University of New Mexico does not have funds set aside to 
pay for the cost of any care or treatment that might be necessary because you get hurt or sick while 
taking part in this study. Also, the University of New Mexico will not pay for any wages you may lose if 
you are harmed by this study.
Medical costs related to your care and treatment because of study-related harm will be paid by you 
and/or your insurance
WILL I BE PAID FOR PARTICIPATING IN THIS STUDY?
You will not receive any rewards or payment for taking part in the study. 
WHAT IF NEW INFORMATION IS LEARNED DURING THE STUDY THAT MIGHT AFFECT YOUR DECISION 
TO PARTICIPATE?
You will be informed if the investigators learn new information that could change your mind about 
staying in the study. You may be asked to sign a new informed consent form if the information is 
provided to you after you have joined the study.
WILL YOU BE GIVEN INDIVIDUAL RESULTS FROM THE RESEARCH TESTS?
Except for the results of NP swabs for SARS-CoV-2, you and your doctor will not be given individual results 
from the research tests unless there is a clear potential benefit to your subsequent medical care. 
At your request, a member of the study team will contact you using the information you provided. 
With the help of a member of the study team, they will present possible risks or benefits of receiving 
the information. At that time, you can choose to receive or refuse the result or finding. If you would 
like more information about this, please call one of the study Co-investigators. You may also 
withdraw your consent to be contacted with information about research results by sending a 
written request to a study Co-investigator. 
A description of this clinical trial will be available on ClinicalTrials.gov as required by U.S. Law. This 
website will not include information that can identify you. At most, the website will include a 
summary of the results. You can search this website at any time. 
WHAT ELSE DO YOU NEED TO KNOW?
If you volunteer to take part in this study, you will be one of up to 350 people at UNM to do so. 
FUTURE USE OF YOUR INFORMATION OR PROTECTED HEALTH INFORMATION 


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Identifiable information such as your name, medical record number, or date of birth will be removed 
from the information or samples collected in this study. After removal, the information or samples may 
be used for future research or shared with other researchers without your additional informed consent. 
In addition to the main study, you are being asked to allow us to keep and use your information for 
future research. 
HIPAA AUTHORIZATION FOR USE AND DISCLOSURE OF YOUR PROTECTED HEALTH INFORMATIN (PHI). 
As part of this study, we will be collecting health information about you and sharing it with others.  This 
information is “protected” because it is identifiable or “linked” to you.
Protected Health Information (PHI)
By signing this Consent Document, as described in this consent form, you are allowing the investigators 
and other authorized personnel to use your protected health information for the purposes of this study.  
This information includes results of tests and exams done for your clinical care, your medical history, 
and other information related to the treatment of your condition.  
In addition to researchers and staff at UNMHS and other groups listed in this form, there is a chance that 
your health information may be shared (re-disclosed) outside of the research study and no longer be 
protected by federal privacy laws.  Examples of this include health oversight activities and public health 
measures, safety, monitors, other sites in the study, companies that sponsor this study, government 
agencies such as Food and Drug Administration (FDA). 
Right to Withdraw Your Authorization
Your authorization for the use and disclosure of your health information for this study shall not expire 
unless you cancel this authorization.  This is because the information used and created during the study 
may be analyzed for many years and it is not possible to know when this will be complete. Your health 
information will be used or disclosed as long as it is needed for this study.  However, you may withdraw 
your authorization at any time provided you notify the UNM investigators in writing.  To do this, please 
notify them of your wish to withdraw by email.
Walter Dehority, MD 
WDehority@salud.unm.edu
or
Jens Langsjoen, MD
JLangsjoen@salud.unm.edu
or
Jon Femling, MD
JFemling@salud.unm.edu
or
Renee Mercier, PharmD (Dr. Mercier can answer questions about drug interactions and other issues)
RMercier@salud.unm.edu
Please be aware that the research team will not be required to destroy or retrieve any of your health 
information that has already been used or shared before the date that your withdrawal is received.


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If you become pregnant anytime during the study or within 15 days after stopping the study drug, you 
must inform the study doctor. The study doctor must then report the outcome of your pregnancy to the 
Sponsor (and/or the FDA). 
The researchers agree to only share your health information with the people listed in this document. 
Should your health information be released to anyone that is not regulated by the privacy law, your 
health information may be shared with others without your permission; however, the use of your health 
information would still be regulated by applicable federal and state laws. 
You may not be allowed to participate in the research study if you do not sign this form. If you decide 
not to sign this form it will not affect your: 

Current or future healthcare at the University of New Mexico;

Current or future payments to the University of New Mexico;

Ability to enroll in any health plans (if applicable); or

Eligibility for benefits (if applicable).
After signing the form, you can change your mind and NOT let the researcher(s) collect or release your 
health information (revoke the Authorization). If you revoke the authorization:

You will send a written letter to Dr. Dehority to inform him of your decision. 

Researchers may use and release your health information already collected for his research 
study. 

Your protected health information may still be used and released should you have a bad 
reaction (adverse event).
The use and sharing of your information has no time limit. 
If you have not already received a copy of the Privacy Notice, you may request one. If you have any 
questions about your privacy rights, you should contact the University of New Mexico Health Sciences 
Privacy Officer between the business hours of 8am and 5pm Mountain Pacific Time, Monday-Friday at 
(505) 272-1493.
If I am found to be ineligible to receive the study drug (hydroxychloroquine), I am willing to enroll as a 
control subject (will not take the study drug but will participate in study surveys, nasopharyngeal swabs 
and blood collection):
□  Yes
□  No
Note:  You may sign and fax the consent form to the CTSC at (505) 272-9929 or sign and scan the 
consent form to the email of the investigator above who consented you.


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INFORMED CONSENT SIGNATURE PAGE
You are participating or are authorized to act on behalf of the participant. This consent includes 
the following: 

Key Information Page

Detailed Consent
You will receive a copy of this consent form after it has been signed. 
Signature of research subject
 
Date
Printed name of research subject 
_________________________________________
_______________________
Printed name of [authorized] person obtaining 
Date
informed consent/HIPAA Authorization
Signature of [authorized] person obtaining 
informed consent/HIPAA Authorization
At time of consent, after determining Eligibility 
criteria, patient chooses to be in:
Group A
Group B
Date of Group assignment:
If participant switches Group:
Original Group assignment
Group A
Group B
New Group assignment
Group A
Group B
Date of Group assignment switch: