Hydroxychloroquine in the Prevention of COVID-19 Infection in Healthcare Workers
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ClinicalTrials.gov Identifier: NCT04333225 |
Recruitment Status :
Completed
First Posted : April 3, 2020
Last Update Posted : January 26, 2021
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Condition or disease | Intervention/treatment | Phase |
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COVID-19 | Drug: Hydroxychloroquine | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 228 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | A Prospective Clinical Study of Hydroxychloroquine in the Prevention of SARS- CoV-2 (COVID-19) Infection in Healthcare Workers After High-risk Exposures |
Actual Study Start Date : | April 3, 2020 |
Actual Primary Completion Date : | June 30, 2020 |
Actual Study Completion Date : | June 30, 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: Treatment
Oral hydroxychloroquine 400 mg twice a day (two 200 mg tabs twice a day) on day 1 followed by two 200 mg tablets once a week for a total of 7 weeks.
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Drug: Hydroxychloroquine
Weekly treatment in individuals at high risk |
No Intervention: Control
Subjects who opt not to receive the study drug will undergo all procedures to form the control group
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- Rate of COVID-19 positive conversion [ Time Frame: 7 weeks ]Rate of COVID-19 positive conversion on weekly nasopharyngeal (NP) sampling
- Time-to-first clinical event [ Time Frame: 7 weeks ]
Time-to-first clinical event consisting of a persistent change for any of the following:
- One positive NP sample
- Common clinical symptoms of COVID-19 infection including fever, cough, and shortness of breath
- Less common signs and symptoms of COVID-19 infection including headache, muscle pain, abdominal pain, sputum production, and sore throat
- Time-to-first clinical worsening event [ Time Frame: 7 weeks ]
Time-to-first clinical worsening event consisting of any of the following:
- Hospitalization for COVID-19 infection
- Intensive care unit admission for COVID-19 infection
- All cause death

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Adult male and female healthcare workers ≥ 18 to ≤ 75 years of age upon study consent
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Healthcare workers with
• One day or more of exposure to suspect and/or positive COVID-19 patients, including but not limited to those working in the Emergency Department or Intensive Care Unit.
OR
• Unprotected exposure to a known positive COVID-19 patient within 72 hours of screening.
- Afebrile with no constitutional symptoms
- Willing and able to comply with scheduled visits, treatment plan, and other study procedures
- Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study prior to initiation of any subject-mandated procedures
Exclusion Criteria:
- Participation in other investigational clinical trials for the treatment or prevention of SARS-COV-2 infection within 30days
- Unwilling to practice acceptable methods of birth control (both males who have partners of childbearing potential and females of childbearing potential) during Screening, while taking study drug, and for at least 30 days after the last dose of study drug is ingested Note: the following criteria follow standard clinical practice for FDA approved indications of this medication
- Having a prior history of blood disorders such as aplastic anemia, agranulocytosis, leukopenia, or thrombocytopenia
- Having a prior history of glucose-6-phosphate dehydrogenase (G-6-PD) deficiency
- Having dermatitis, psoriasis or porphyria
- Taking Digoxin, Mefloquine, methotrexate, cyclosporine, praziquantel, antacids and kaolin, cimetidine, ampicillin, Insulin or antidiabetic drugs, arrhythmogenic drugs, antiepileptic drugs, loop, thiazide, and related diuretics, laxatives and enemas, amphotericin B, high dose corticosteroids, and proton pump inhibitors, neostigmine, praziquantel, Pyridostigmine, tamoxifen citrate
- Allergies: 4-Aminoquinolines
- Pre-existing retinopathy of the eye
- Has a chronic liver disease or cirrhosis, including hepatitis B and/or untreated hepatitis
- Untreated or uncontrolled active bacterial, fungal infection
- Known or suspected active drug or alcohol abuse, per investigator judgment
- Women who are pregnant or breastfeeding
- Known hypersensitivity to any component of the study drug
- A known history of prolonged QT syndrome or history of additional risk factors for torsades de pointe (e.g., heart failure, requires a lab test , family history of Long QT Syndrome), or the use of concomitant medications that prolong the QT/QTc interval

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04333225
United States, Texas | |
Baylor University Medical Center | |
Dallas, Texas, United States, 75226 |
Principal Investigator: | Peter A McCullough, MD, MPH | Baylor Health Care System |
Responsible Party: | Baylor Research Institute |
ClinicalTrials.gov Identifier: | NCT04333225 |
Other Study ID Numbers: |
020-132 |
First Posted: | April 3, 2020 Key Record Dates |
Last Update Posted: | January 26, 2021 |
Last Verified: | May 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
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