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

• Status: Terminated
• Trial end date: 2020-07-08
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study was 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: Teva Pharmaceuticals Industries LTD
• Treatments: Azithromycin; Hydroxychloroquine

Criteria

Inclusion Criteria:

• Documentation of confirmed active severe acute respiratory syndrome coronavirus (SARS-CoV-2) infection from any respiratory specimen collected ≤7 days from when the first dose of study treatment was expected to be taken.

• Experienced at least one of the following SARS-CoV-2 infection symptoms within 24 hours of screening (symptom(s) must be new or worse compared to pre-COVID-19 health status):

• Fever (can be subjective) or feeling feverish

• Cough

• Shortness of breath or difficulty breathing at rest or with exertion

• Sore throat

• Body pain or muscle pain

• Fatigue

• Headache

• Agreed 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 20 days, whichever is earliest.

• Agreed 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 use of antiarrhythmics within 30 days prior to entry.

• 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.

• Used 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.

• Participated in a study where co-enrollment was 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.

• More than 10 days of any of the following symptoms attributed to the SARS-CoV-2 infection at study entry:

• Fever (can be subjective) or feeling feverish

• Cough

• Shortness of breath or difficulty breathing at rest or with exertion

• Sore throat

• Body pain or muscle pain

• Fatigue

• Headache

• Chills

• Nasal obstruction or congestion

• Loss of taste or smell

• Nausea or vomiting

• Diarrhea