Evaluating the Efficacy of Hydroxychloroquine and Azithromycin to Prevent Hospitalization or Death in Persons With COVID-19
Condition: COVID-19; SARS-CoV 2
MeSH terms: COVID-19
Intervention: Hydroxychloroquine (HCQ); Azithromycin (Azithro); Placebo for Hydroxychloroquine; Placebo for Azithromycin
Intervention description: Administered orally; Administered orally; Administered orally; Administered orally
Intervention MeSH terms: Azithromycin; Hydroxychloroquine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility 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