Phase 2
N=48
Hydroxychloroquine as Chemoprevention for COVID-19 for High Risk Healthcare Workers
Covid19
Bottom Line
View on ClinicalTrials.gov: NCT04345653 ↗Enrolled (actual)
48
Serious AEs
0.0%
Results posted
May 2021
Primary outcome: Primary: Recruitment Feasibility — 46 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Hydroxychloroquine Sulfate (HCQ) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hackensack Meridian Health
- Primary completion
- Jun 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Recruitment Feasibility |
46 | — |
| PRIMARY Resource Utilization |
46 | — |
| PRIMARY Safety as Reflected on the Number and Severity of Adverse Events and Serious Adverse Events |
0; 24 | — |
| PRIMARY Early Feasibility as Reflected on the Number of Participants Contracting COVID-19 (10% or Less) in Comparison to the Expected 30% as Per CDC. |
— | — |
Summary
The study proposes to conduct an open-label Phase II trial to evaluate the feasibility, safety and early efficacy of hydroxychloroquine (HCQ) administration in reduction of transmission of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) and development of Corona Virus Disease 2019 (COVID-19) in high-risk, healthy acute care provider participants exposed, directly or indirectly, to COVID-19 patients. There is a more than 50 years track record of safety of HCQ for treatment and prevention of various disease states. Early data on use of HCQ for COVID treatment suggests anti-viral activity and immunomodulatory properties for reducing inflammation associated with COVID-19.
Eligibility Criteria
Inclusion Criteria
- Volunteers ages 18 to 99 years,
- Able to sign own informed consent form,
- Considered high-risk healthcare care providers in a hospital setting with active exposure to COVID-19 infection.
High-risk healthcare providers are defined as those actively working during the study duration in the Emergency Department and in the Intensive Care Setting, for the purpose of this study.
Exclusion Criteria
- Inability to tolerate an oral medication or known allergy to chloroquine or hydroxychloroquine
- Pregnancy or breast-feeding
- Immunocompromised status, hepatic failure, electrolytic imbalance
- Creatinine clearance (CCL) 450ms for males and QTc > 470 for females)
- Confirmed COVID-19 infection on baseline testing
- Has another known contraindication to treatment with the study drug, including retinopathy.
Data sourced from ClinicalTrials.gov (NCT04345653). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.