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

• Status: Completed
• Trial end date: 2020-07-23
• Target enrollment: 0
• Participant gender: All

Summary

ORCHID is a multicenter, blinded, placebo-controlled, randomized clinical trial evaluating hydroxychloroquine for the treatment of adults hospitalized with COVID-19. Patients, treating clinicians, and study personnel will all be blinded to study group assignment.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Hydroxychloroquine

Criteria

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.

Exclusion Criteria:

1. Prisoner

2. Pregnancy

3. Breast feeding

4. Symptoms of acute respiratory infection for >10 days before randomization

5. >48 hours between meeting inclusion criteria and 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