Phase 3 N=1,483 Randomized Quadruple-blind Treatment

Pre-exposure Prophylaxis for SARS-Coronavirus-2

COVID-19 · Corona Virus Infection · ARDS · Acute Respiratory Distress Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT04328467 ↗

Enrolled (actual)

1,483

Serious AEs

1.2%

Results posted

Jun 2021

Primary outcome: Primary: COVID-19-free Survival — 464; 468; 454 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Hydroxychloroquine (Drug); Placebo (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Minnesota
Primary completion: Jul 2020

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	—

Summary

Objective: To determine if pre-exposure prophylaxis with hydroxychloroquine is effective for the prevention of COVID-19 disease.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04328467). 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.