Phase 3
Completed N=1,483
Pre-exposure Prophylaxis for SARS-Coronavirus-2
COVID · Corona Virus Infection · Acute Respiratory Distress Syndrome
Source: ClinicalTrials.gov NCT04328467 ↗
Enrolled (actual)
1,483
Serious AEs
1.2%
Results posted
Jun 2021
Primary outcomePrimary: COVID-19-free Survival — 464; 468; 454 Participants
◆ Published Evidence
Highly cited
128citations · ~26 / year
Hydroxychloroquine as Pre-exposure Prophylaxis for Coronavirus Disease 2019 (COVID-19) in Healthcare Workers: A Randomized Trial.
Summary
Objective: To determine if pre-exposure prophylaxis with hydroxychloroquine is effective for the prevention of COVID-19 disease.
Linked Publications (2)
-
Hydroxychloroquine as Pre-exposure Prophylaxis for Coronavirus Disease 2019 (COVID-19) in Healthcare Workers: A Randomized Trial.
-
Safety of Hydroxychloroquine Among Outpatient Clinical Trial Participants for COVID-19.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY COVID-19-free Survival |
464; 468; 454 | — |
| SECONDARY Number of Confirmed SARS-CoV-2 Detection |
29; 29; 39 | — |
| SECONDARY Incidence of Possible COVID-19 Symptoms |
29; 28; 38 | — |
| SECONDARY Incidence of All-cause Study Medicine Discontinuation |
119; 158; 133 | — |
| SECONDARY Ordinal Scale of COVID-19 Disease Maximum Severity if COVID-19 Diagnosed at Study End |
1; 1 | — |
| SECONDARY Incidence of Hospitalization for COVID-19 or Death |
3; 8; 9 | — |
| SECONDARY Incidence of Possible Study Medication-related Side Effects |
148; 168; 100 | — |
Eligibility Criteria
Inclusion Criteria
- A healthcare worker at high risk for COVID-19 exposure (defined below):
- Persons primarily working in emergency departments (physicians, nurses, ancillary staff, triage personnel)
- Persons primarily working in intensive care units (physicians, nurses, ancillary staff, respiratory therapists)
- Persons performing aerosol generating procedures (i.e. anesthesiologists, nurse anesthetists (CRNAs)
- First responders (i.e. EMTs, paramedics)
Exclusion Criteria
- Active COVID-19 disease
- Prior COVID-19 disease
- Current fever, cough, shortness of breath
- Allergy to chloroquine or hydroxychloroquine
- Prior retinal eye disease
- Known Chronic Kidney disease, Stage 4 or 5 or dialysis
- Known glucose-6 phosphate dehydrogenase (G-6-PD) deficiency
- Weight <40 kg
- Prolonged QT syndrome
- Current use of hydroxychloroquine, chloroquine, or cardiac medicines of flecainide, amiodarone, digoxin, procainamide, or propafenone
- Current use of medications with known significant drug-drug interactions: artemether, lumefantrine, mefloquine, tamoxifen, or methotrexate.
Data sourced from ClinicalTrials.gov (NCT04328467) and the linked publication. 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. Informational only — not medical advice.