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

Completed · Phase 3 · Has a placebo group

Conditions studied: Coronavirus, Acute Respiratory Infection, SARS-CoV Infection

In brief

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.

Key facts

Study ID

NCT04332991

Run by

Massachusetts General Hospital

People needed

479

Starts

2020-04-02

Expected to finish

2020-07-23

Last updated by the study team

2021-03-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• University of Arizona — Tucson, Arizona, United States
• UCSF Fresno — Fresno, California, United States
• Ronald Reagan UCLA Medical Center — Los Angeles, California, United States
• UC Davis Medical Center — Sacramento, California, United States
• UCSF Medical Center — San Francisco, California, United States
• Stanford University — Stanford, California, United States
• Medical Center of Aurora — Aurora, Colorado, United States
• University of Colorado Hospital — Aurora, Colorado, United States
• Denver Health Medical Center — Denver, Colorado, United States
• St. Joseph Hospital — Denver, Colorado, United States
• University of Florida — Gainesville, Florida, United States
• University of Kentucky — Lexington, Kentucky, United States
• University Medical Center — New Orleans, Louisiana, United States
• Maine Medical Center — Portland, Maine, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Baystate Medical Center — Springfield, Massachusetts, United States
• St. Vincent's Hospital — Worcester, Massachusetts, United States
• University of Michigan Medical Center — Ann Arbor, Michigan, United States
• Henry Ford Medical Center — Detroit, Michigan, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• Montefiore Medical Center-Weiler — The Bronx, New York, United States
• Montefiore Medical Center-Moses — The Bronx, New York, United States
• Wake Forest Baptist Medical Center — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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