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

Inclusion Criteria:

• Documentation of confirmed active severe acute respiratory syndrome coronavirus (SARS-CoV-2) infection from any respiratory specimen collected ≤7 days from when thefirst dose of study treatment was expected to be taken.
• Experienced at least one of the following SARS-CoV-2 infection symptoms within 24hours of screening (symptom(s) must be new or worse compared to pre-COVID-19 healthstatus):
• 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 orSARS-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 thestudy investigator.
• History of or current hospitalization for COVID-19.
• History of ventricular arrhythmia or use of antiarrhythmics within 30 days prior toentry.
• 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 ormagnesium supplementation
• Personal medical history of porphyria, retinopathy, severe hepatic impairment, orglucose-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 involvingany of these drugs whether for treatment or prophylaxis.
• Requirement or expected requirement for a medication that significantly prolongs QTintervals or increases risk for QT prolongation.
• Loop diuretics are exceptions to above exclusion criterion but these cannot be usedwithin 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-2infection 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