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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-30

Study Completion Date

2021-01-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Hydroxychloroquine Monotherapy and in Combination With Azithromycin in Patients With Moderate and Severe COVID-19 Disease

NCT04358081

Covid-19

COMPLETED PHASE3

Evaluating the Efficacy of Hydroxychloroquine and Azithromycin to Prevent Hospitalization or Death in Persons With COVID-19

NCT04358068

COVID-19 SARS-CoV 2

TERMINATED PHASE2

Non-comparative Trial of the Combination of HCQ and AZI in the Treatment of ICU Patients

NCT04458948

COVID-19

TERMINATED PHASE2

Azithromycin in Hospitalized COVID-19 Patients

NCT04359316

COVID-19

UNKNOWN PHASE4

High-dose Hydroxychloroquine for the Treatment of Ambulatory Patients With Mild COVID-19

NCT04351620

COVID-19

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COVID-19

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Hydroxychloroquine

Group Type EXPERIMENTAL

Hydroxychloroquine

Intervention Type DRUG

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.

Azithromycin

Group Type ACTIVE_COMPARATOR

Azithromycin

Intervention Type DRUG

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Adult (age ≥ 18 years)
* Confirmed OR suspected COVID-19,

* Confirmed: Positive assay for COVID-19 within the last 10 days
* Suspected: Pending assay for COVID-19 WITH high clinical suspicion
* Scheduled for admission or already admitted to an inpatient bed

Exclusion Criteria

* Allergy to hydroxychloroquine or azithromycin
* History of bone marrow transplant
* Known G6PD deficiency
* Chronic hemodialysis or Glomerular Filtration Rate \< 20ml/min
* Psoriasis
* Porphyria
* Concomitant use of digitalis, flecainide, amiodarone, procainamide, propafenone, cimetidine, dofetilide, phenobarbital, phenytoin, or sotalol
* Known history of long QT syndrome
* Current known QTc\>500 msec
* Pregnant or nursing
* Prisoner
* Weight \< 35kg
* Seizure disorder
* Severe liver disease
* Outpatient use of hydroxychloroquine for treatment of a disease other than COVID-19 OR has received more than 2 days of hydroxychloroquine or azithromycin for suspected or confirmed COVID-19
* Patient has recovered from COVID-19 and/or is being discharged from the hospital on day of enrollment.
* Treating physician refuses to allow patient participation in the study
* Unable to obtain informed consent
* Prior enrollment in this study

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No