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.
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. .
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
479
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.
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.
COVID Outcomes Scale Score on Study Day 15 (14 Days After Randomization)
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 symptoms)
Time frame: Assessed on study day 15
COVID Ordinal Outcomes Scale on Study Day 3 (2 Days After Randomization)
We will determine the COVID Ordinal Scale for all patients on study day 3 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 symptoms)
Time frame: assessed on study day 3
COVID Ordinal Outcomes Scale on Study Day 8 (7 Days After Randomization)
We will determine the COVID Ordinal Scale on study day 8 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 symptoms)
Time frame: assessed on study day 8
COVID Ordinal Outcomes Scale on Study Day 29 (28 Days After Randomization)
We will determine the COVID Ordinal Scale on study day 29 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 symptoms)
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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
...and 30 more locations
Time frame: assessed on study day 29
All-location, All-cause Mortality Assessed on Study Day 15 (14 Days After Randomization)
Vital status of the patient on day 15 will be determined using any of the following methods: medical record review, phone calls to patient or proxy. There were two patients for whom we were unable to collect their vital status.
Time frame: assessed on study day 15
All-location, All-cause Mortality Assessed on Study Day 29 (28 Days After Randomization)
Vital status of the patient at day 28 will be determined using any of the following methods: medical record review, phone calls to patient or proxy. There were two patients for whom we were unable to collect their vital status.
Time frame: assessed on study day 29
Number of Patients Dead or With Receipt of ECMO Between Enrollment and Day 28
We will determine the number of patients who are either dead or on ECMO ( extracorporeal membrane oxygenation) between enrollment and day 28
Time frame: Enrollment to Day 28
Oxygen-free Days Through Day 28
The number of calendar days between randomization and 28 days later that the patient is alive and without the use of oxygen therapy. Patients who die prior to day 28 are assigned zero oxygen free days.
Time frame: 28 days after randomization
Ventilator-free Days Through Day 28
Ventilator-free days is defined to be 28 days minus the duration of mechanical ventilation through day 28. Participants who do not survive to day 28 are assigned zero ventilator-free days.
Time frame: 28 days after randomization
Vasopressor-free Days Through Day 28
The number of calendar days between randomization and 28 days later that the patient is alive and without the use of vasopressor therapy. Patients who die prior to day 28 are assigned zero vasopressor free days.
Time frame: 28 days after randomization
ICU-free Days to Day 28
The number of days spent out of the ICU to day 28. Patients who die prior to day 28 are assigned zero ICU free days.
Time frame: 28 days after randomization
Hospital-free Days to Day 28
Defined as 28 days minus the number of days from randomization to discharge home.If a patient has not been discharged home prior to day 28 or dies prior to day 28, hospital free days will be zero.
Time frame: 28 days after randomization