Status:
TERMINATED
Evaluating the Efficacy of Hydroxychloroquine and Azithromycin to Prevent Hospitalization or Death in Persons With COVID-19
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Teva Pharmaceutical Industries, Ltd.
Conditions:
COVID-19
SARS-CoV 2
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
Detailed Description
This Phase IIB study was designed to evaluate the efficacy of hydroxychloroquine (HCQ) and azithromycin (Azithro) to prevent hospitalization or death in symptomatic adult outpatients with COVID-19 cau...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 8 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04358068
Start Date
May 13 2020
End Date
July 8 2020
Last Update
November 16 2021
Active Locations (11)
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1
Alabama CRS
Birmingham, Alabama, United States, 35294
2
UCSD Antiviral Research Center CRS
San Diego, California, United States, 92103
3
Harbor-UCLA CRS
Torrance, California, United States, 90502
4
Whitman-Walker Health CRS
Washington D.C., District of Columbia, United States, 20009