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| ID | Type | Description | Link |
|---|---|---|---|
| INV-016204 | Other Grant/Funding Number | Bill and Melinda Gates Foundation |
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| Name | Class |
|---|---|
| Bill and Melinda Gates Foundation | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ascorbic Acid | Placebo Comparator | Ascorbic acid 500 mg orally daily for 3 days, then 250 mg orally daily for 11 days |
|
| Hydroxychloroquine | Experimental | Hydrochloroquine 400 mg orally daily for 3 days, then 200 mg orally daily for an additional 11 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydroxychloroquine Sulfate | Drug | Eligible participants in a household randomized to this study arm will receive hydrochloroquine therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | Day 28 after enrolment |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Participant-reported Adverse Events | Safety and tolerability of Hydroxychloroquine as SARS-CoV-2 PEP in adults | 28 days from start of Hydroxychloroquine therapy |
| Number of Participants Who Had COVID-19 Disease |
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Inclusion Criteria:
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)
Access to device and internet for Telehealth visits
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ruanne V. Barnabas, MBChB, DPhil | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Los Angeles | Los Angeles | California | 90095 | United States | ||
| Tulane |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33284679 | Derived | 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. | |
| 32493478 |
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De-identified data from the study will be made available in accordance with the funder's open access policy.
Within 3 months of publication of primary results.
De-identified data from the study will be made available in accordance with the funder's open access policy.
949 participants were assessed for eligibility, 114 were excluded and 829 were randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ascorbic Acid | Ascorbic acid 500 mg orally daily for 3 days, then 250 mg orally daily for 11 days Ascorbic Acid: Eligible participants in a household randomized to this study arm will receive ascorbic acid therapy. |
| FG001 | Hydroxychloroquine |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 9, 2020 | Oct 8, 2021 |
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| Ascorbic Acid | Drug | Eligible participants in a household randomized to this study arm will receive ascorbic acid therapy. |
|
|
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.
| 28 days from enrolment |
| New Orleans |
| Louisiana |
| 70118 |
| United States |
| University of Maryland, Baltimore | Baltimore | Maryland | 21201 | United States |
| Boston University | Boston | Massachusetts | 02215 | United States |
| NYU Langone Health | New York | New York | 10016 | United States |
| SUNY Upstate Medical University | Syracuse | New York | 13210 | United States |
| University of Washington, Coordinating Center | Seattle | Washington | 98104 | United States |
| UW Virology Research Clinic | Seattle | Washington | 98104 | United States |
| Derived |
| Barnabas 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. |
Hydrochloroquine 400 mg orally daily for 3 days, then 200 mg orally daily for an additional 11 days Hydroxychloroquine Sulfate: Eligible participants in a household randomized to this study arm will receive hydrochloroquine therapy |
| COMPLETED |
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| NOT COMPLETED |
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The above participants contributed to the Modified Intention-to-Treat Cohort.
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| ID | Title | Description |
|---|---|---|
| BG000 | Ascorbic Acid | Ascorbic acid 500 mg orally daily for 3 days, then 250 mg orally daily for 11 days Ascorbic Acid: Eligible participants in a household randomized to this study arm will receive ascorbic acid therapy. |
| BG001 | Hydroxychloroquine | Hydrochloroquine 400 mg orally daily for 3 days, then 200 mg orally daily for an additional 11 days Hydroxychloroquine Sulfate: Eligible participants in a household randomized to this study arm will receive hydrochloroquine therapy |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Median | Inter-Quartile Range | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | The above participants qualified for the Modified Intention-to-Treat Cohort | Posted | Count of Participants | Participants | Day 1 through Day 14 after enrolment |
|
|
| |||||||||||||||||||||||||||||
| Primary | 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 | Posted | Count of Participants | Participants | Day 28 after enrolment |
|
| |||||||||||||||||||||||||||||||
| Secondary | Rate of Participant-reported Adverse Events | Safety and tolerability of Hydroxychloroquine as SARS-CoV-2 PEP in adults | Posted | Count of Participants | Participants | 28 days from start of Hydroxychloroquine therapy |
|
| |||||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Count of Participants | Participants | 28 days from enrolment |
|
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Adverse event data was collected during the period of follow up, which was 28 days.
Adverse event collection was obtained through daily surveys completed by participants. If participants were experiencing symptoms they were contacted by study staff for more information.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ascorbic Acid | Ascorbic acid 500 mg orally daily for 3 days, then 250 mg orally daily for 11 days Ascorbic Acid: Eligible participants in a household randomized to this study arm will receive ascorbic acid therapy. | 0 | 422 | 2 | 422 | 46 | 422 |
| EG001 | Hydroxychloroquine | Hydrochloroquine 400 mg orally daily for 3 days, then 200 mg orally daily for an additional 11 days Hydroxychloroquine Sulfate: Eligible participants in a household randomized to this study arm will receive hydrochloroquine therapy | 0 | 407 | 2 | 407 | 66 | 407 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalizations | Infections and infestations | Non-systematic Assessment |
| ||
| Allergic Reaction | Immune system disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea, abdominal discomfort, or vomiting | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Nausea or upset stomach | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Skin reaction/rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Neurologic reaction: irritability, dizziness, or vertifgo | General disorders | Non-systematic Assessment |
| ||
| Headache | General disorders | Non-systematic Assessment |
| ||
| Hot flashes, night sweats, or palpitations | General disorders | Non-systematic Assessment |
| ||
| Taste change or dry mouth | General disorders | Non-systematic Assessment |
| ||
| Fatigue | General disorders | Non-systematic Assessment |
| ||
| Visual Changes | Eye disorders | Non-systematic Assessment |
| ||
| Allergic reaction | Immune system disorders | Non-systematic Assessment |
| ||
| Tinnitus | Ear and labyrinth disorders | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ruanne Barnabas | University of Washington | 206 520 3800 | rbarnaba@uw.edu |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 22, 2020 | Oct 8, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D018352 | Coronavirus Infections |
| D045169 | Severe Acute Respiratory Syndrome |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D006886 | Hydroxychloroquine |
| D001205 | Ascorbic Acid |
| ID | Term |
|---|---|
| D002738 | Chloroquine |
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D006880 | Hydroxy Acids |
| D002241 | Carbohydrates |
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| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|