Purpose

The purpose of this study is to evaluate the efficacy of hydroxychloroquine (HCQ) and azithromycin (Azithro) to prevent hospitalization or death in symptomatic adult outpatients with COVID-19 caused by SARS-CoV-2 infection.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Documentation of confirmed active severe acute respiratory syndrome coronavirus (SARS-CoV-2) infection.
  • Experiencing at least one of the following SARS-CoV-2 infection symptoms within 24 hours of screening: fever (can be subjective) OR cough OR shortness of breath.
  • Agrees to not participate in another clinical trial for the treatment of COVID-19 or SARS-CoV-2 during the study period up until reaching hospitalization or 21 days, whichever is earliest.
  • Agrees to not obtain study medications outside of the A5395 study.

Exclusion Criteria

  • Need for hospitalization or immediate medical attention in the clinical opinion of the study investigator.
  • History of or current hospitalization for COVID-19.
  • History of ventricular arrhythmia or using antiarrhythmics within the past 30 days.
  • Personal or family history of Long QT syndrome.
  • History of kidney disease.
  • History of ischemic or structural heart disease.
  • History of hypokalemia or hypomagnesemia or taking potassium supplementation or magnesium supplementation
  • Personal medical history of porphyria, retinopathy, severe hepatic impairment, or glucose-6-phosphate dehydrogenase (G6PD) deficiency.
  • Use of drugs with possible anti-SARS-CoV-2 activity within 30 days prior to study entry, e.g., remdesivir, lopinavir/ritonavir fixed dose combination, ribavirin, chloroquine, hydroxychloroquine, and azithromycin, or participation in a clinical trial involving any of these drugs whether for treatment or prophylaxis.
  • Requirement or expected requirement for a medication that significantly prolongs QT intervals or increases risk for QT prolongation.
  • Loop diuretics are exceptions to above exclusion criterion but these cannot be used within 30 days prior to study entry.
  • Participating in a study where co-enrollment is not allowed.
  • Receipt of a SARS-CoV-2 vaccination prior to study entry.
  • Known allergy/sensitivity or any hypersensitivity to components of HCQ, azithromycin, or their formulation.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A: Hydroxychloroquine (HCQ) and Azithromycin (Azithro)
Hydroxychloroquine 400 mg (administered as two 200 mg capsules) orally twice daily for 2 doses starting on Day 0, followed by 200 mg (administered as one 200 mg capsule) orally twice daily for 12 doses (6 days), PLUS: Azithromycin 500 mg (administered as two 250 mg capsules) orally as a single dose on Day 0, followed by 250 mg (administered as one 250 mg capsule) orally once daily for 4 doses (4 days).
  • Drug: Hydroxychloroquine (HCQ)
    Administered orally
  • Drug: Azithromycin (Azithro)
    Administered orally
Placebo Comparator
Arm B: Placebo for Hydroxychloroquine and Azithromycin
Placebo for Hydroxychloroquine (administered as two matching placebo capsules) orally twice daily for 2 doses starting on Day 0, followed by Placebo for HCQ (administered as one 200 mg capsule) orally twice daily for 12 doses (6 days), PLUS: Placebo for Azithromycin (administered as two matching placebo capsules) orally as a single dose on Day 0, followed by Placebo for Azithromycin (administered as one matching placebo capsule) orally once daily for 4 doses (4 days).
  • Drug: Placebo for Hydroxychloroquine
    Administered orally
  • Drug: Placebo for Azithromycin
    Administered orally

Recruiting Locations

Alabama CRS
Birmingham, Alabama 35294
Contact:
Faye Heard, M.P.H.
205-996-4405
fhoward@uabmc.edu

More Details

Status
Recruiting
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

Study Contact

Detailed Description

This Phase IIB study will evaluate the efficacy of hydroxychloroquine (HCQ) and azithromycin (Azithro) to prevent hospitalization or death in symptomatic adult outpatients with COVID-19 caused by SARS-CoV-2 infection.

Participants will be randomized 1:1 to receive active/placebo study treatment as follows: HCQ/Placebo 400 mg orally twice a day on Day 0 followed by 200 mg orally twice a day for 6 days, and Azithro/Placebo 500 mg once on Day 0, followed by 250 mg daily for 4 days.

Stratification will be by "high" versus "low" risk of progression to severe COVID-19, where "high risk" is defined as a person age ≥60 years or having at least one of several specified comorbidities.

Participants will receive study treatment for 7 days and will be followed for an additional 23 weeks. Assessments on a subset of 200 participants will include blood collection, self-collected nasal swabs, and nasopharyngeal swabs.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.