Evaluating the Efficacy of Hydroxychloroquine and Azithromycin to Prevent Hospitalization or Death in Persons With COVID-19
Stopped early · Phase 2 · Has a placebo group
Conditions studied: COVID-19, SARS-CoV 2
In brief
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.
Key facts
- Study ID
- NCT04358068
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 20
- Starts
- 2020-05-13
- Expected to finish
- 2020-07-08
- Last updated by the study team
- 2021-11-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Alabama CRS — Birmingham, Alabama, United States
- UCSD Antiviral Research Center CRS — San Diego, California, United States
- Harbor-UCLA CRS — Torrance, California, United States
- Whitman-Walker Health CRS — Washington D.C., District of Columbia, United States
- Northwestern University CRS — Chicago, Illinois, United States
- Rush University CRS — Chicago, Illinois, United States
- Greensboro CRS — Greensboro, North Carolina, United States
- Cincinnati Clinical Research Site — Cincinnati, Ohio, United States
- University of Pittsburgh CRS — Pittsburgh, Pennsylvania, United States
- Trinity Health and Wellness Center CRS — Dallas, Texas, United States
- University of Washington AIDS CRS — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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