Official Title
Outcomes Related to COVID-19 Treated With Hydroxychloroquine Among In-patients With Symptomatic Disease
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 study personnel will all be blinded to study group assignment.

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.

.

Completed
Coronavirus
Acute Respiratory Infection
SARS-CoV Infection

Drug: Hydroxychloroquine

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.

Drug: 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.

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United States
Locations

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
Bronx, New York, United States

Montefiore Medical Center-Moses
Bronx, New York, United States

Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States

University of Cincinnati Medical Center
Cincinnati, Ohio, United States

Cleveland Clinic Foundation
Cleveland, Ohio, United States

Ohio State University Wexner Medical Center
Columbus, Ohio, United States

Oregon Health and Science University
Portland, Oregon, United States

Penn State Hershey Medical Center
Hershey, Pennsylvania, United States

Temple University Hospital
Philadelphia, Pennsylvania, United States

UPMC Presbyterian/Mercy/Shadyside
Pittsburgh, Pennsylvania, United States

Medical University of South Carolina
Charleston, South Carolina, United States

Vanderbilt University Medical Center
Nashville, Tennessee, United States

University of Texas Health Science Center
Houston, Texas, United States

Intermountain Medical Center
Murray, Utah, United States

University of Utah Hospital
Salt Lake City, Utah, United States

VCU Medical Center
Richmond, Virginia, United States

Harborview Medical Center
Seattle, Washington, United States

Swedish Hospital First Hill
Seattle, Washington, United States

Boyd Taylor Thompson, MD, Principal Investigator
Massachusetts General Hospital

National Heart, Lung, and Blood Institute (NHLBI)
NCT Number
Keywords
Covid-19
MeSH Terms
Infections
Communicable Diseases
COVID-19
Respiratory Tract Infections
Severe Acute Respiratory Syndrome
Hydroxychloroquine