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
Results First Posted : August 20, 2021
Last Update Posted : August 20, 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 : | 221 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: Hydroxychloroquine
Subjects who chose to enter the HCQ arm received a loading dose of 800 mg HCQ 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
Other Names:
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No Intervention: Control
Subjects who declined taking HCQ were considered as controls
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- Number of Participants Infected With COVID-19 or COVID-19 Like Illness During the Trial [ Time Frame: Up to 7 weeks after study initiation ]Number of participants infected with COVID-19 or identified as having COVID-19 like illness during the trial
- Time From Study Initiation Until the Occurrence of COVID-19 or COVID-19 Like Illness or Being Censored [ Time Frame: Up to 7 weeks after study initiation ]
Time-to-first clinical event consisting of a persistent change for any of the following:
- diagnosis of COVID-19
- clinical characteristics of COVID-19 like illness
- being censored

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 |
Documents provided by Baylor Research Institute:
Responsible Party: | Baylor Research Institute |
ClinicalTrials.gov Identifier: | NCT04333225 |
Other Study ID Numbers: |
020-132 |
First Posted: | April 3, 2020 Key Record Dates |
Results First Posted: | August 20, 2021 |
Last Update Posted: | August 20, 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 |
hydroxychloroquine |
COVID-19 Infections Respiratory Tract Infections Pneumonia, Viral Pneumonia Virus Diseases Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections |
Lung Diseases Respiratory Tract Diseases Hydroxychloroquine Antimalarials Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antirheumatic Agents |