NCT04333225
Completed
Phase 2
A Prospective Clinical Study of Hydroxychloroquine in the Prevention of SARS- CoV-2 (COVID-19) Infection in Healthcare Workers After High-risk Exposures
Baylor Research Institute1 site in 1 country221 target enrollmentStarted: April 3, 2020Last updated:
Overview
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Baylor Research Institute
- Enrollment
- 221
- Locations
- 1
- Primary Endpoint
- Number of Participants Infected With COVID-19 or COVID-19 Like Illness During the Trial
Overview
Brief Summary
In order to assess the efficacy of hydroxychloroquine treatment weekly for a total of 7 weeks in the prevention of COVID-19 infection, three hundred sixty (360) Healthcare workers with high risk exposure to patients infected with COVID-19 will be tested for COVID-19 infection via nasopharyngeal (NP) swab once weekly for 7 weeks. Of those, one hundred eighty (180) will receive weekly doses of hydroxychloroquine for the duration of the study. Subjects who opt not to receive the study drug will form the control group.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Adult male and female healthcare workers ≥ 18 to ≤ 75 years of age upon study consent
- •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.
- •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
Arms & Interventions
Hydroxychloroquine
Experimental
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
Intervention: Hydroxychloroquine (Drug)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Time From Study Initiation Until the Occurrence of COVID-19 or COVID-19 Like Illness or Being Censored(Up to 7 weeks after study initiation)
Investigators
Study Sites (1)
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