Table 1.
Eligibility criteria
| Inclusion criteria | 1. Age ≥18 yr |
| 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: | |
| a. Cough | |
| b. Fever (>37.5°C/99.5°F) | |
| c. Shortness of breath (operationalized as any of the following: subjective shortness of breath reported by patient/surrogate; hypoxemia, defined as SpO2 < 92% on room air or increased oxygen requirement for a patient on chronic oxygen to maintain SpO2 ≥ 92%; tachypnea with respiratory rate ≥22/min). | |
| d. Sore throat | |
| 4. Laboratory-confirmed SARS-CoV-2 infection within the past 10 d before randomization | |
| Exclusion criteria | 1. Prisoner |
| 2. Pregnancy | |
| 3. Breast feeding | |
| 4. Unable to randomize within 10 d after onset of acute respiratory infection symptoms | |
| 5. Unable to randomize within 48 h after hospital arrival | |
| 6. Seizure disorder | |
| 7. Porphyria cutanea tarda | |
| 8. QTc > 500 ms on electrocardiogram within 72 h before enrollment | |
| 9. Diagnosis of long QT syndrome | |
| 10. Known allergy to hydroxychloroquine, chloroquine, or amodiaquine | |
| 11. Receipt in the 12 h before enrollment or planned administration during the 5-d 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 d before enrollment | |
| 13. Inability to receive enteral medications | |
| 14. Refusal or inability to be contacted on Day 15 for clinical outcome assessment if discharged before 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 |
Definition of abbreviations: QTc = corrected QT; SARS-CoV-2 = severe acute respiratory syndrome coronavirus 2; SpO2 = oxygen saturation as measured by pulse oximetry.