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Outcomes Related to COVID-19 Treated With Hydroxychloroquine Among In-patients With Symptomatic Disease | Clinical Trials | Clareo Health

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

NCT04332991•Massachusetts General Hospital

View on ClinicalTrials.gov

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. .

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
•6. Seizure disorder
•7. Porphyria cutanea tarda
+9 more criteria

Exclusion Criteria

•1. Prisoner
•2. Pregnancy
•3. Breast feeding
•4. Symptoms of acute respiratory infection for \>10 days before randomization

Locations (40)

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

Key Dates

Start Date

April 2, 2020

Primary Completion Date

June 19, 2020

Completion Date

July 23, 2020

Last Updated

March 17, 2021

Enrollment

479

ACTUAL participants

Conditions

CoronavirusAcute Respiratory InfectionSARS-CoV Infection

Interventions

Hydroxychloroquine

DRUG

Placebo

DRUG

Randomized Double-Blind Placebo-Controlled Trial EValuating Baricitinib on PERSistent NEurologic and Cardiopulmonary Symptoms of Long COVID

NCT06631287

Long COVIDSars-CoV-2 Infection+2 more

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RECRUITINGNA

Effectiveness and Implementation of a National Guideline for Acute Respiratory Tract Infections to Reduce Antibiotic Prescribing in Swiss Primary Care

NCT07396428

Acute Respiratory InfectionInfluenza-like Illness

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 17, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Randomized Double-Blind Placebo-Controlled Trial EValuating Baricitinib on PERSistent NEurologic and Cardiopulmonary Symptoms of Long COVID

Effectiveness and Implementation of a National Guideline for Acute Respiratory Tract Infections to Reduce Antibiotic Prescribing in Swiss Primary Care

The Fever Clinic Acute Respiratory Cohort

FebriDx® Pediatric Validation Study

Post COVID-19 Biorepository

Capturing MultiORgan Effects of COVID-19