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NCT04332991 · ClinicalTrials.gov registry record · Phase 3
Outcomes Related to COVID-19 Treated With Hydroxychloroquine Among In-patients With Symptomatic Disease
A Phase 3 study of Coronavirus and SARS-CoV Infection, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 3
- Development phase
- 479
- Enrollment target
- 20
- Study locations
NCT04332991: Completed Phase 3 study of Coronavirus and SARS-CoV Infection, sponsored by Massachusetts General Hospital.
NCT04332991 is a Phase 3 study of Coronavirus and SARS-CoV Infection that has completed, run by Massachusetts General Hospital. The registered enrollment target is 479 participants, below the 1,381-participant average among 20 other Coronavirus trials with a reported enrollment target (65% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04332991, a Phase 3 study of Coronavirus and SARS-CoV Infection, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 479 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
We will determine the COVID Ordinal Scale for all patients on study day 15 COVID Ordinal Scale defined as: 1. Death 2. Hospitalized on invasive mechanical ventilation or ECMO ( extracorporeal membrane oxygenation) 3. Hospitalized on non-invasive ventilation or high flow nasal cannula 4. Hospitalized on supplemental oxygen 5. Hospitalized not on supplemental oxygen 6. Not hospitalized with limitation in activity (continued symptoms) 7. Not hospitalized without limitation in activity (no symptom
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Hydroxychloroquine
Study Locations (20)
California
- UCSF Fresno - Fresno
- Ronald Reagan UCLA Medical Center - Los Angeles
- UC Davis Medical Center - Sacramento
- UCSF Medical Center - San Francisco
- Stanford University - Stanford
Massachusetts
- Massachusetts General Hospital - Boston
- Beth Israel Deaconess Medical Center - Boston
- Brigham and Women's Hospital - Boston
- Baystate Medical Center - Springfield
- St. Vincent's Hospital - Worcester
Colorado
- Medical Center of Aurora - Aurora
- University of Colorado Hospital - Aurora
- Denver Health Medical Center - Denver
- St. Joseph Hospital - Denver
Arizona
- University of Arizona - Tucson
Florida
- University of Florida - Gainesville
Kentucky
- University of Kentucky - Lexington
Louisiana
- University Medical Center - New Orleans
Maine
- Maine Medical Center - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 479 participants |
| Start Date | 2020-04-02 |
| Est. Completion | 2020-07-23 |
| Phase | Phase 3 |
What the finished NCT04332991 record still lists
NCT04332991 is an interventional study that assigns participants to a tested intervention. The registered 479 participants enrollment target is mid-sized for trials with a published cap, below the 1,381-participant average among 20 other Coronavirus trials with a reported enrollment target (65% lower).
The record links to 3 conditions, with Coronavirus appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04332991 names 20 study sites across 9 states, led by California, Massachusetts, Colorado.
Frequently Asked Questions
What is clinical trial NCT04332991 about?
NCT04332991 is a clinical study titled "Outcomes Related to COVID-19 Treated With Hydroxychloroquine Among In-patients With Symptomatic Disease". 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.
What is the current status of trial NCT04332991?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 479 participants. The study started on 2020-04-02. Estimated completion is 2020-07-23.
What conditions does trial NCT04332991 study?
This clinical trial studies the following conditions: Coronavirus, SARS-CoV Infection, Acute Respiratory Infection.
What interventions are being tested in trial NCT04332991?
The interventions under investigation include: Placebo (DRUG), Hydroxychloroquine (DRUG).
Who is sponsoring clinical trial NCT04332991?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04332991 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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479 6th of 20 higher than 15 of 20 other Coronavirus trials
participants (enrollment target), bucketed by value
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