Outcomes Related to COVID-19 Treated With Hydroxychloroquine Among In-patients With Symptomatic Disease
Condition: Coronavirus; Acute Respiratory Infection; SARS-CoV Infection
MeSH terms: Infections; Communicable Diseases; COVID-19; Respiratory Tract Infections; Severe Acute Respiratory Syndrome
Intervention: Hydroxychloroquine; Placebo
Intervention description: Hydroxychloroquine is available in 200 mg oral tablets of hydroxychloroquine sulfate.
For this COVID-19 trial, we will use an oral or enteral dose of hydroxychloroquine 400 mg twice daily on the day of enrollment, then 200 mg twice daily for the next 4 days for a 5 day total course.; Participants randomized to the control group will receive a dose of placebo enterally twice daily for 5 days (a total of 10 doses). The placebo pills will be as similar as possible to the hydroxychloroquine pills to ensure blinding.
Intervention MeSH terms: Hydroxychloroquine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Eligible participants will be randomized 1:1 to hydroxychloroquine versus placebo. Randomization will be stratified by site and be in permuted blocks of variable size.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Patients, treating clinicians, trial personnel, and outcome assessors will be blinded to group assignment.
Enrollment: 479.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: COVID-19

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.
    

Eligibility 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