Outcomes Related to COVID-19 Treated With Hydroxychloroquine Among In-patients With Symptomatic Disease
Purpose
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.
Conditions
- Coronavirus
- Acute Respiratory Infection
- SARS-CoV Infection
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- 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.
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Masking Description
- Patients, treating clinicians, trial personnel, and outcome assessors will be blinded to group assignment.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Hydroxychlorquine |
Participants assigned to the hydroxychloroquine arm will receive hydroxychloroquine sulfate 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. |
|
|
Placebo Comparator Placebo |
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. |
|
Recruiting Locations
More Details
- NCT ID
- NCT04332991
- Status
- Completed
- Sponsor
- Massachusetts General Hospital
Detailed Description
Effective therapies for COVID-19 are urgently needed. Hydroxychloroquine is an antimicrobial agent with immunomodulatory and antiviral properties that has demonstrated in vitro activity against SARS-CoV-2, the virus that causes COVID-19. Preliminary reports suggest potential efficacy in small human studies. Clinical trial data are needed to determine whether hydroxychloroquine is effective in treating COVID-19. Study Aim: To compare the effect of hydroxychloroquine versus placebo on clinical outcomes, measured using the COVID Ordinal Outcomes Scale at Day 15, among adults with COVID-19 requiring hospitalization. Study Hypothesis: Among adults hospitalized with COVID-19, administration of hydroxychloroquine will improve clinical outcomes at Day 15. .