History of Changes for Study: NCT04308668

Post-exposure Prophylaxis for SARS-Coronavirus-2

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Study Record Versions

Version	Submitted Date	Changes
1	March 11, 2020	None (earliest Version on record)
2	March 17, 2020	Recruitment Status, Study Status, Contacts/Locations, Oversight and Study Identification
3	March 19, 2020	Contacts/Locations, Arms and Interventions and Study Status
4	March 24, 2020	Study Status, Contacts/Locations, Study Identification, Outcome Measures, Study Design, Conditions, Study Description, Eligibility and Arms and Interventions
5	March 25, 2020	Outcome Measures and Study Status
6	April 1, 2020	Contacts/Locations, Study Description, Study Status, Eligibility, Study Design and Sponsor/Collaborators
7	April 6, 2020	Study Description, Study Status and Study Identification
8	April 28, 2020	IPDSharing, Outcome Measures, Study Status, Contacts/Locations, Eligibility and Study Description
9	June 24, 2020	Recruitment Status, Study Status, Contacts/Locations, IPDSharing, Study Design, Document Section, References and Eligibility
10	July 15, 2020	Study Status and Study Identification
11	April 26, 2021	Quality Control Review has not concluded Returned: April 28, 2021 Outcome Measures, Study Status, References, Document Section, IPDSharing and Study Design
12	April 28, 2021	Quality Control Review has not concluded Returned: April 29, 2021 Outcome Measures, Baseline Characteristics, Adverse Events, Document Section, IPDSharing, References and Study Status
13	May 3, 2021	Quality Control Review has not concluded Returned: May 5, 2021 Outcome Measures, Study Status and Baseline Characteristics
14	May 5, 2021	Quality Control Review has not concluded Returned: May 11, 2021 Outcome Measures, Adverse Events and Study Status
15	May 11, 2021	Adverse Events, Study Status, Outcome Measures and More Information

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	PEP-Corona
Brief Title:	Post-exposure Prophylaxis for SARS-Coronavirus-2
Official Title:	Post-exposure Prophylaxis for SARS-Coronavirus-2: A Pragmatic Randomized Clinical Trial
Secondary IDs:

Study Status


Record Verification:	March 2020
Overall Status:	Not yet recruiting
Study Start:	April 2020
Primary Completion:	May 2021 [Anticipated]
Study Completion:	May 2021 [Anticipated]

First Submitted:	March 11, 2020
First Submitted that Met QC Criteria:	March 11, 2020
First Posted:	March 16, 2020 [Actual]

Last Update Submitted that Met QC Criteria:	March 11, 2020
Last Update Posted:	March 16, 2020 [Actual]

Sponsor/Collaborators


Sponsor:	University of Minnesota
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:	Yes
U.S. FDA-regulated Device:	No
Data Monitoring:	Yes

Study Description

Brief Summary:

Study Objective: To test if post-exposure prophylaxis with hydroxychloroquine can prevent progression development of symptomatic COVID19 disease after known exposure to the SARS-CoV2 virus.

Detailed Description:

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a rapidly emerging viral infection causing COVID19. The current strategy uses a public health model of identifying infected cases, isolation, and quarantine to stop transmission. Once exposed, observation is standard-of-care.

No effective therapy currently exists for treatment. The lack of effective therapy diminishes persons presenting post-exposure for self-quarantine. Having an effective post-exposure prophylaxis, even if only partially effective, may additionally create synergy for the public health strategy of case identification and isolation - if a safe prophylaxis is available. People who develop COVID-19 disease generally develop signs and symptoms, including mild respiratory symptoms and fever, after an average of 5-6 days after exposure (i.e. mean incubation period). The range of the incubation period is between 1 to 14 days.

Most people infected with the COVID-19 virus have mild disease and recover. Approximately 80% of laboratory-confirmed patients have had mild to moderate disease, which includes non-pneumonia and pneumonia cases, 14% have severe disease, and 6% are critically ill with respiratory failure, shock, and/or multiple organ dysfunction.

Chloroquine or Hydroxychloroquine may have antiviral effects against SARS-COV2 which may prevent COVID19 disease or early preemptive therapy may ameliorate disease severity. This trial will use a modification of standard malaria dosing of hydroxychloroquine to provide post-exposure prophylaxis / preemptive therapy.

The trial is open to enrollment of healthcare workers or household contacts from across the United States. For information on how to participate in the research trial, please email covid19@umn.edu for instructions.

Conditions


Conditions:	Corona Virus Infection Acute Respiratory Distress Syndrome SARS-CoV Infection
Keywords:	COVID-19 Corona Virus SARS-COV-2

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 2/Phase 3
Interventional Study Model:	Parallel Assignment
Number of Arms:	2
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:	Randomized
Enrollment:	1500 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
Experimental: Treatment Participants in this arm will receive the study drug.	Drug: Hydroxychloroquine 200mg tablet; 800 mg orally once, followed in 6 to 8 hours by 600 mg, then 600mg once a day for 6 consecutive days
Placebo Comparator: Placebo Participants in this arm will receive a placebo treatment.	Placebo 4 placebo tablets once, followed in 6 to 8 hours by 3 tablets, then 3 tablets once-a-day for 6 consecutive days

Outcome Measures


Primary Outcome Measures:
1.	Incidence of COVID19 Disease [ Time Frame: 14 days ] Number of participants at 14 days post enrollment with active COVID19 disease.
2.	Ordinal Scale of COVID19 Disease Severity [ Time Frame: 14 days ] Participants will self-report disease severity status as one of the following 3 options; no COVID19 illness (score of 1), COVID19 illness with no hospitalization (score of 2), or COVID19 illness with hospitalization or death (score of 3). Increased scale score indicates greater disease severity. Outcome is reported as the percent of participants who fall into each category per arm.
Secondary Outcome Measures:
1.	Incidence of Hospitalization [ Time Frame: 14 days ] Outcome reported as the number of participants in each arm who require hospitalization for COVID19-related disease.
2.	Incidence of Death [ Time Frame: 90 days ] Outcome reported as the number of participants in each arm who expire due to COVID-19-related disease.
3.	Incidence of Confirmed SARS-CoV-2 Detection [ Time Frame: 14 days ] Outcome reported as the number of participants in each arm who have confirmed SARS-CoV-2 infection.
4.	Incidence of Symptoms Compatible with COVID19 (possible disease) [ Time Frame: 90 days ] Outcome reported as the number of participants in each arm who self-report symptoms compatible with COVID19 infection.
5.	Incidence of All-Cause Study Medicine Discontinuation or Withdrawal [ Time Frame: 14 days ] Outcome reported as the number of participants in each arm who discontinue or withdraw medication use for any reason.

Eligibility


Minimum Age:	18 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	Yes
Criteria:	Inclusion Criteria: Exposure to a COVID19 case within 3 days as either a healthcare worker or household contact Provision of informed consent Exclusion Criteria: Symptomatic COVID19 disease Current Symptoms of: Fever, Cough, or Shortness of Breath Contraindication or allergy to hydroxychloroquine Retinal eye disease Known glucose-6 phosphate dehydrogenase (G-6-PD) deficiency Known chronic kidney disease, stage 4 or 5 or receiving dialysis Weight < 40 kg Current use of: hydroxychloroquine or cardiac medicines of: flecainide, Tambocor; amiodarone, Cordarone, Pacerone; digoxin or Digox, Digitek, Lanoxin; procainamide or Procan, Procanbid, propafenone, Rythmal)

Contacts/Locations


Central Contact Person:	David Boulware, MD, MPH Telephone: 612-625-4652 Email: covid19@umn.edu
Study Officials:	David Boulware, MD, MPH Principal Investigator University of Minnesota
Locations:	United States, Minnesota
	University of Minnesota Minneapolis, Minnesota, United States, 55455 Contact:Contact: David Boulware, MD, MPH covid19@umn.edu

IPDSharing


Plan to Share IPD:	No

References


Links:
Available IPD/Information: