COVID-19Phase 2/3NCT04328961
Hydroxychloroquine for COVID-19 Post-exposure Prophylaxis (PEP)
A Phase 2/3 study testing Hydroxychloroquine Sulfate and Ascorbic Acid in people with COVID-19 and Corona Virus Infection, run by University of Washington at 8 sites in United States.
Trial summary
This is a clinical study for the prevention of SARS-CoV-2 infection in adults exposed to the virus. This study will enroll up to 2000 asymptomatic men and women 18 to 80 years of age (inclusive) who are close contacts of persons with laboratory confirmed SARS-CoV-2 or clinically suspected COVID-19. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19, Corona Virus Infection, SARS (Severe Acute Respiratory Syndrome)
- What is being tested?
- Hydroxychloroquine Sulfate and Ascorbic Acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 943 participants
- Where
- 8 sitesUnited States
- Study dates
- 31 Mar 2020to 8 Oct 2020
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men or women 18 to 80 years of age inclusive, at the time of signing the informed consent
- Willing and able to provide informed consent
- Had a close contact of a person (index) with known PCR-confirmed SARS-CoV-2 infection or who is currently being assessed for COVID-19. Close contact defined as:
- Household contact (i.e., residing with the index case in the 14 days prior to index diagnosis)
- Medical staff, first responders, or other care persons who cared for the index case without personal protection (mask and gloves)
- Less than 4 days since last exposure (close contact with a person with SARS-CoV-2 infection) to the index case
- Body weight < 100 kg (self-reported)
- Access to device and internet for Telehealth visits
Who cannot join
- Known hypersensitivity to HCQ or other 4-aminoquinoline compounds
- Currently hospitalized
- Symptomatic with subjective fever, cough, or sore throat
- Current medications exclude concomitant use of HCQ
- Concomitant use of other anti-malarial treatment or chemoprophylaxis
- History of retinopathy of any etiology
Show all 13Show fewer
- Psoriasis
- Porphyria
- Known bone marrow disorders with significant neutropenia (polymorphonuclear leukocytes < 1500) or thrombocytopenia (< 100 K)
- Concomitant use of 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
University of Maryland, Baltimore
Baltimore, Maryland, 21201
Boston University
Boston, Massachusetts, 02215
University of California Los Angeles
Los Angeles, California, 90095
Tulane
New Orleans, Louisiana, 70118
NYU Langone Health
New York, New York, 10016
University of Washington, Coordinating Center
Seattle, Washington, 98104
UW Virology Research Clinic
Seattle, Washington, 98104
SUNY Upstate Medical University
Syracuse, New York, 13210
About this study
Official title: Efficacy of Hydroxychloroquine for Post-exposure Prophylaxis (PEP) to Prevent Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection Among Adults Exposed to Coronavirus Disease (COVID-19): a Blinded, Randomized Study
This is a clinical study for the prevention of SARS-CoV-2 infection in adults exposed to the virus. This study will enroll up to 2000 asymptomatic men and women 18 to 80 years of age (inclusive) who are close contacts of persons with laboratory confirmed SARS-CoV-2 or clinically suspected COVID-19. Eligible participants will be enrolled and randomized to receive the intervention or placebo at the level of the household (all eligible participants in one household will receive the same intervention).
Read the detailed description
This is a randomized, multi-center, placebo-equivalent (ascorbic acid) controlled, blinded study of Hydroxychloroquine (HCQ) post-exposure prophylaxis (PEP) for the prevention of SARS-CoV-2 infection in adults exposed to the virus.The overarching goal of this study is to assess the effectiveness of HCQ PEP on the incidence of SARS-CoV-2 detection by polymerase chain reaction (PCR) to inform public health control strategies.This study will enroll up to 2000 asymptomatic men and women 18 to 80 years of age (inclusive) at baseline who are close contacts of persons with PCR-confirmed SARS-CoV-2 or clinically suspected COVID-19 and a pending SARS-CoV-2 PCR test. Eligible participants will be enrolled and randomized 1:1 to HCQ or ascorbic acid at the level of the household (all eligible participants in one household will receive the same intervention). Participants will be counseled about the preliminary in vitro data on HCQ activity against SARS CoV-2 and equipoise regarding efficacy in humans.The duration of study participation will be approximately 28 days.
- Being tested
- Hydroxychloroquine Sulfate, Ascorbic Acid
- Keywords
- novel coronavirus, post-exposure prophylaxis
- Medical subject headings
- COVID-19, Coronavirus Infections, Severe Acute Respiratory Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydroxychloroquine SulfateDrug
Also called HCQ arm
Eligible participants in a household randomized to this study arm will receive hydrochloroquine therapy
Ascorbic AcidDrug
Also called Placebo arm
Eligible participants in a household randomized to this study arm will receive ascorbic acid therapy.
| Study group | Role | What they receive |
|---|---|---|
| Ascorbic Acid | Placebo comparator | Ascorbic acid 500 mg orally daily for 3 days, then 250 mg orally daily for 11 days Receives: Drug: Ascorbic Acid |
| Hydroxychloroquine | Experimental | Hydrochloroquine 400 mg orally daily for 3 days, then 200 mg orally daily for an additional 11 days Receives: Drug: Hydroxychloroquine Sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Had Polymerase Chain Reaction (PCR) Confirmed SARS-CoV-2 Infection
Polymerase chain reaction (PCR) confirmed severe acute respiratory syndrome coronavirus 2 of the genus Betacoronavirus (SARS-CoV-2) infection from self-collected samples collected daily for 14 days
Measured: Day 1 through Day 14 after enrolment
The Number of Participants Who Had Polymerase Chain Reaction (PCR) Confirmed SARS-CoV-2 Infection
Polymerase chain reaction (PCR) confirmed SARS-CoV-2 infection from self-collected samples collected at study exit
Measured: Day 28 after enrolment
Secondary outcomes (2)
Rate of Participant-reported Adverse Events
Safety and tolerability of Hydroxychloroquine as SARS-CoV-2 PEP in adults
Measured: 28 days from start of Hydroxychloroquine therapy
Number of Participants Who Had COVID-19 Disease
Participants who had a PCR-confirmed SARS-CoV-2 infection and met the Center for Disease Control (CDC) defined criteria for symptomatic COVID-19 disease.
Measured: 28 days from enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2020
- Study start31 Mar 2020
- Primary completion24 Sep 2020
- Study completion8 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 943 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Responsible party
- Principal investigator, Ruanne Barnabas, University of Washington
- Investigators
- Ruanne V. Barnabas, MBChB, DPhil, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04328961
- Sponsor's protocol ID
- STUDY00009750
- Other IDs
- INV-016204
- Status last verified
- Dec 2021
- First submitted
- 23 Mar 2020
- Last updated
- 16 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data from the study will be made available in accordance with the funder's open access policy.
Publications
Barnabas RV, Brown ER, Bershteyn A, Stankiewicz Karita HC, Johnston C, Thorpe LE, Kottkamp A, Neuzil KM, Laufer MK, Deming M, Paasche-Orlow MK, Kissinger PJ, Luk A, Paolino K, Landovitz RJ, Hoffman R, Schaafsma TT, Krows ML, Thomas KK, Morrison S, Haugen HS, Kidoguchi L, Wener M, Greninger AL, Huang ML, Jerome KR, Wald A, Celum C, Chu HY, Baeten JM; Hydroxychloroquine COVID-19 PEP Study Team. Hydroxychloroquine as Postexposure Prophylaxis to Prevent Severe Acute Respiratory Syndrome Coronavirus 2 Infection : A Randomized Trial. Ann Intern Med. 2021 Mar;174(3):344-352. doi: 10.7326/M20-6519. Epub 2020 Dec 8.
PubMed 33284679Barnabas RV, Brown E, Bershteyn A, Miller RS, Wener M, Celum C, Wald A, Chu H, Wesche D, Baeten JM; Hydroxychloroquine COVID-19 PEP Study Team. Efficacy of hydroxychloroquine for post-exposure prophylaxis to prevent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection among adults exposed to coronavirus disease (COVID-19): a structured summary of a study protocol for a randomised controlled trial. Trials. 2020 Jun 3;21(1):475. doi: 10.1186/s13063-020-04446-4.
PubMed 32493478
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Hydroxychloroquine for Post-exposure Prophylaxis (PEP) to Prevent Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection Among Adults Exposed to Coronavirus Disease (COVID-19): a Blinded, Randomized Study
- ClinicalTrials.gov ID
- NCT04328961
- Acronym / sponsor ID
- STUDY00009750
- Keywords
- novel coronavirus, post-exposure prophylaxis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 943 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Study start
- 31 Mar 2020 (actual)
- Primary completion
- 24 Sep 2020 (actual)
- Study completion
- 8 Oct 2020 (actual)
- First posted
- 1 Apr 2020 (actual)
- Results
- Posted 16 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a clinical study for the prevention of SARS-CoV-2 infection in adults exposed to the virus. This study will enroll up to 2000 asymptomatic men and women 18 to 80 years of age (inclusive) who are close contacts of persons with laboratory confirmed SARS-CoV-2 or clinically suspected COVID-19. Eligible participants will be enrolled and randomized to receive the intervention or placebo at the level of the household (all eligible participants in one household will receive the same intervention).
Detailed description
This is a randomized, multi-center, placebo-equivalent (ascorbic acid) controlled, blinded study of Hydroxychloroquine (HCQ) post-exposure prophylaxis (PEP) for the prevention of SARS-CoV-2 infection in adults exposed to the virus.The overarching goal of this study is to assess the effectiveness of HCQ PEP on the incidence of SARS-CoV-2 detection by polymerase chain reaction (PCR) to inform public health control strategies.This study will enroll up to 2000 asymptomatic men and women 18 to 80 years of age (inclusive) at baseline who are close contacts of persons with PCR-confirmed SARS-CoV-2 or clinically suspected COVID-19 and a pending SARS-CoV-2 PCR test. Eligible participants will be enrolled and randomized 1:1 to HCQ or ascorbic acid at the level of the household (all eligible participants in one household will receive the same intervention). Participants will be counseled about the preliminary in vitro data on HCQ activity against SARS CoV-2 and equipoise regarding efficacy in humans.The duration of study participation will be approximately 28 days.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ascorbic Acid | Placebo comparator | Drug: Ascorbic AcidAscorbic acid 500 mg orally daily for 3 days, then 250 mg orally daily for 11 days |
| Hydroxychloroquine | Experimental | Drug: Hydroxychloroquine SulfateHydrochloroquine 400 mg orally daily for 3 days, then 200 mg orally daily for an additional 11 days |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Men or women 18 to 80 years of age inclusive, at the time of signing the informed consent
- Willing and able to provide informed consent
- Had a close contact of a person (index) with known PCR-confirmed SARS-CoV-2 infection or who is currently being assessed for COVID-19. Close contact defined as:
- Less than 4 days since last exposure (close contact with a person with SARS-CoV-2 infection) to the index case
- Body weight < 100 kg (self-reported)
Key exclusion criteria (13 listed)
- Known hypersensitivity to HCQ or other 4-aminoquinoline compounds
- Currently hospitalized
- Symptomatic with subjective fever, cough, or sore throat
- Current medications exclude concomitant use of HCQ
- Concomitant use of other anti-malarial treatment or chemoprophylaxis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydroxychloroquine SulfateAlso: HCQ armEligible participants in a household randomized to this study arm will receive hydrochloroquine therapy | Drug | Hydroxychloroquine |
| Ascorbic AcidAlso: Placebo armEligible participants in a household randomized to this study arm will receive ascorbic acid therapy. | Drug | Ascorbic Acid |
Primary outcome
Number of Participants Who Had Polymerase Chain Reaction (PCR) Confirmed SARS-CoV-2 Infection
Time frame: Day 1 through Day 14 after enrolment
Polymerase chain reaction (PCR) confirmed severe acute respiratory syndrome coronavirus 2 of the genus Betacoronavirus (SARS-CoV-2) infection from self-collected samples collected daily for 14 days
The Number of Participants Who Had Polymerase Chain Reaction (PCR) Confirmed SARS-CoV-2 Infection
Time frame: Day 28 after enrolment
Polymerase chain reaction (PCR) confirmed SARS-CoV-2 infection from self-collected samples collected at study exit
2 secondary outcomes
Rate of Participant-reported Adverse Events
Time frame: 28 days from start of Hydroxychloroquine therapy
Number of Participants Who Had COVID-19 Disease
Time frame: 28 days from enrolment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33284679Barnabas RV, Brown ER, Bershteyn A, Stankiewicz Karita HC, Johnston C, Thorpe LE, Kottkamp A, Neuzil KM, Laufer MK, Deming M, Paasche-Orlow MK, Kissinger PJ, Luk A, Paolino K, Landovitz RJ, Hoffman R, Schaafsma TT, Krows ML, Thomas KK, Morrison S, Haugen HS, Kidoguchi L, Wener M, Greninger AL, Huang ML, Jerome KR, Wald A, Celum C, Chu HY, Baeten JM; Hydroxychloroquine COVID-19 PEP Study Team. Hydroxychloroquine as Postexposure Prophylaxis to Prevent Severe Acute Respiratory Syndrome Coronavirus 2 Infection : A Randomized Trial. Ann Intern Med. 2021 Mar;174(3):344-352. doi: 10.7326/M20-6519. Epub 2020 Dec 8.
- Derived from this study: PubMed 32493478Barnabas RV, Brown E, Bershteyn A, Miller RS, Wener M, Celum C, Wald A, Chu H, Wesche D, Baeten JM; Hydroxychloroquine COVID-19 PEP Study Team. Efficacy of hydroxychloroquine for post-exposure prophylaxis to prevent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection among adults exposed to coronavirus disease (COVID-19): a structured summary of a study protocol for a randomised controlled trial. Trials. 2020 Jun 3;21(1):475. doi: 10.1186/s13063-020-04446-4.
- Individual participant dataSharing planned: Yes. De-identified data from the study will be made available in accordance with the funder's open access policy.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruanne V. Barnabas, MBChB, DPhil principal investigator
University of Washington
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Hydroxychloroquine Sulfate and Ascorbic Acid in people with COVID-19 and Corona Virus Infection, run by University of Washington at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Had Polymerase Chain Reaction (PCR) Confirmed SARS-CoV-2 Infection (time frame: Day 1 through Day 14 after enrolment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04328961, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2021.