Status:
COMPLETED
Outcomes Related to COVID-19 Treated With Hydroxychloroquine Among In-patients With Symptomatic Disease
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Coronavirus
Acute Respiratory Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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...
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-C...
Eligibility Criteria
Inclusion
- Age ≥18 years
- Currently hospitalized or in an emergency department with anticipated hospitalization.
- Symptoms of acute respiratory infection, defined as one or more of the following:
- cough
- fever (\> 37.5° C / 99.5° F)
- 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).
- sore throat
- Laboratory-confirmed SARS-CoV-2 infection within the past 10 days prior to randomization.
Exclusion
- Prisoner
- Pregnancy
- Breast feeding
- Symptoms of acute respiratory infection for \>10 days before randomization
- \>48 hours between meeting inclusion criteria and randomization
- Seizure disorder
- Porphyria cutanea tarda
- Diagnosis of Long QT syndrome
- QTc \>500 ms on electrocardiogram within 72 hours prior to enrollment
- Known allergy to hydroxychloroquine, chloroquine, or amodiaquine
- 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
- Receipt of \>1 dose of hydroxychloroquine or chloroquine in the 10 days prior to enrollment
- Inability to receive enteral medications
- Refusal or inability to be contacted on Day 15 for clinical outcome assessment if discharged prior to day 15
- Previous enrollment in this trial
- The treating clinical team does not believe equipoise exists regarding the use of hydroxychloroquine for the treatment of this patient
Key Trial Info
Start Date :
April 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 23 2020
Estimated Enrollment :
479 Patients enrolled
Trial Details
Trial ID
NCT04332991
Start Date
April 2 2020
End Date
July 23 2020
Last Update
March 17 2021
Active Locations (40)
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1
University of Arizona
Tucson, Arizona, United States, 85721
2
UCSF Fresno
Fresno, California, United States, 93701
3
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States, 90095
4
UC Davis Medical Center
Sacramento, California, United States, 95817