Outcomes Related to COVID-19 Treated With Hydroxychloroquine Among In-patients With Symptomatic Disease

Inclusion Criteria

• •1. Age ≥18 years
• •2. Currently hospitalized or in an emergency department with anticipated hospitalization.
• •3. Symptoms of acute respiratory infection, defined as one or more of the following:
• •1. cough
• •2. fever (\> 37.5° C / 99.5° F)
• •3. shortness of breath (operationalized as any of the following: subjective shortness of breath reported by patient or surrogate; tachypnea with respiratory rate ≥22 /minute; hypoxemia, defined as SpO2 \<92% on room air, new receipt of supplemental oxygen to maintain SpO2 ≥92%, or increased supplemental oxygen to maintain SpO2 ≥92% for a patient on chronic oxygen therapy).
• •4. sore throat
• •4. Laboratory-confirmed SARS-CoV-2 infection within the past 10 days prior to randomization.
• •6. Seizure disorder
• •7. Porphyria cutanea tarda
• •8. Diagnosis of Long QT syndrome
• •9. QTc \>500 ms on electrocardiogram within 72 hours prior to enrollment
• •10. Known allergy to hydroxychloroquine, chloroquine, or amodiaquine
• •11. Receipt in the 12 hours prior to enrollment, or planned administration during the 5-day study period that treating clinicians feel cannot be substituted for another medication, of any of the following: amiodarone; cimetidine; dofetilide; phenobarbital; phenytoin; sotalol
• •12. Receipt of \>1 dose of hydroxychloroquine or chloroquine in the 10 days prior to enrollment
• •13. Inability to receive enteral medications
• •14. Refusal or inability to be contacted on Day 15 for clinical outcome assessment if discharged prior to day 15
• •15. Previous enrollment in this trial
• •16. The treating clinical team does not believe equipoise exists regarding the use of hydroxychloroquine for the treatment of this patient