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Hydroxychloroquine vs. Azithromycin for Hospitalized Patients With Suspected or Confirmed COVID-19

NCT04329832 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2022-04-20

Study results available
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Summary

This study will compare two drugs (hydroxychloroquine and azithromycin) to see if hydroxychloroquine is better than azithromycin in treating hospitalized patients with suspected or confirmed COVID-19.

Conditions

Interventions

DRUG

Hydroxychloroquine

Patients in the hydroxychloroquine arm will receive hydroxychloroquine 400 mg by mouth twice daily for 1 day, then 200 mg by mouth twice daily for 4 days (dose reductions for weight \< 45 kg or GFR (glomerular filtration rate)\<50ml/min). For patients \< 45kg, doses will be halved. For patients with GFR\<50ml/min, the final dose of hydroxychloroquine will not be administered. If the patient has already received hydroxychloroquine prior to randomization (no more than 2 days), the prior doses will count toward the 5-day total.

DRUG

Azithromycin

Patients in the azithromycin arm will receive azithromycin 500 mg on day 1 plus 250 mg daily on days 2-5 (may be administered intravenously per clinician preference). If the patient has already received azithromycin prior to randomization (no more than 2 days), the prior doses will count toward the 5-day total.

Sponsors & Collaborators

Principal Investigators

  • Samuel M Brown, MD MS · Intermountain Health Care, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-30
Primary Completion
2020-07-01
Completion
2021-01-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04329832 on ClinicalTrials.gov