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Hydroxychloroquine vs. Azithromycin for Outpatients in Utah With COVID-19

NCT04334382 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1550

Last updated 2020-04-09

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

Hydroxychloroquine

Patients in the hydroxychloroquine arm will receive hydroxychloroquine 400mg po BID x 1 day, then 200mg po BID x 4 days (dose reductions for weight \< 45kg). The drug dose (2.4 gm over 5 days) chosen falls at the lower end of doses proposed in various international trials, but it has proven in vitro efficacy, with a ratio of lung tissue trough concentrations to the EC50 (effective concentration to suppress 50% of viral activity) of \>20.

DRUG

Azithromycin

Patients in the azithromycin arm will receive azithromycin 500mg PO on day 1 plus 250mg PO daily on days 2-5.

Sponsors & Collaborators

  • University of Utah

    collaborator OTHER

  • Utah Department of Health

    collaborator OTHER

  • Intermountain Health Care, Inc.

    lead OTHER

Principal Investigators

  • Brandon Webb, MD · Intermountain Health Care, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-02
Primary Completion
2020-12-31
Completion
2021-12-31
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 NCT04334382 on ClinicalTrials.gov