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History of Changes for Study: NCT04332991
Outcomes Related to COVID-19 Treated With Hydroxychloroquine Among In-patients With Symptomatic Disease (ORCHID)
Latest version (submitted March 12, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 March 31, 2020 None (earliest Version on record)
2 April 3, 2020 Recruitment Status, Study Status and Contacts/Locations
3 April 22, 2020 Contacts/Locations and Study Status
4 May 20, 2020 Contacts/Locations, Study Status and Eligibility
5 June 2, 2020 Study Status, Contacts/Locations, Eligibility and Outcome Measures
6 June 22, 2020 Recruitment Status, Study Status, Contacts/Locations and Study Design
7 September 1, 2020 Recruitment Status and Study Status
8 February 9, 2021
Quality Control Review has not concluded Returned: February 19, 2021
Outcome Measures, Study Status, Document Section
9 March 1, 2021
Quality Control Review has not concluded Returned: March 8, 2021
Baseline Characteristics, Study Status, Outcome Measures
10 March 12, 2021 Study Status, Adverse Events
Comparison Format:

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Study NCT04332991
Submitted Date:  April 22, 2020 (v3)

Open or close this module Study Identification
Unique Protocol ID: PETAL 05 Orchid
Brief Title: Outcomes Related to COVID-19 Treated With Hydroxychloroquine Among In-patients With Symptomatic Disease (ORCHID)
Official Title: Outcomes Related to COVID-19 Treated With Hydroxychloroquine Among In-patients With Symptomatic Disease
Secondary IDs:
Open or close this module Study Status
Record Verification: April 2020
Overall Status: Recruiting
Study Start: April 2, 2020
Primary Completion: April 2021 [Anticipated]
Study Completion: July 2021 [Anticipated]
First Submitted: March 31, 2020
First Submitted that
Met QC Criteria:
March 31, 2020
First Posted: April 3, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
April 22, 2020
Last Update Posted: April 24, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Massachusetts General Hospital
Responsible Party: Principal Investigator
Investigator: Boyd Taylor Thompson
Official Title: Co-Prinicipal Investigator PETAL CCC
Affiliation: Massachusetts General Hospital
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
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.

.

Open or close this module Conditions
Conditions: Coronavirus
Acute Respiratory Infection
SARS-CoV Infection
Keywords: COVID-19
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Eligible participants will be randomized 1:1 to hydroxychloroquine versus placebo. Randomization will be stratified by site and be in permuted blocks of variable size.
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 510 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Active Comparator: Hydroxychlorquine
Participants assigned to the hydroxychloroquine arm will receive hydroxychloroquine sulfate 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: 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.

Placebo Comparator: 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.
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.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. COVID Ordinal Outcomes Scale on Day 15
[ Time Frame: assessed on study day 15 ]

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)
Secondary Outcome Measures:
1. all-location, all-cause mortality assessed on day 15
[ Time Frame: assessed on study day 15 ]

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
2. all-location, all-cause mortality assessed on day 29
[ Time Frame: assessed on study day 29 ]

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
3. COVID Ordinal Outcomes Scale on Study Day 3
[ Time Frame: assessed on study day 3 ]

We will determine the COVID Ordinal Scale for all patients on study day 3
4. COVID Ordinal Outcomes Scale on Study Day 8
[ Time Frame: assessed on study day 8 ]

We will determine the COVID Ordinal Scale on study day 8
5. COVID Ordinal Outcomes Scale on Study Day 29
[ Time Frame: assessed on study day 29 ]

We will determine the COVID Ordinal Scale on study day 29
6. Number of patients dead or with receipt of ECMO between enrollment and Day 28
[ Time Frame: Enrollment to Day 28 ]

We will determine the number of patients who are either dead or on ECMO ( extracorporeal membrane oxygenation) between enrollment and day 28
7. Oxygen-free days through Day 28
[ Time Frame: 28 days after randomization ]

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.
8. Ventilator-free days through Day 28
[ Time Frame: 28 days after randomization ]

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.
9. Vasopressor-free days through Day 28
[ Time Frame: 28 days after randomization ]

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.
10. ICU-free days to Day 28
[ Time Frame: 28 days after randomization ]

The number of days spent out of the ICU to day 28.
11. Hospital-free days to Day 28
[ Time Frame: 28 days after randomization ]

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.
Other Outcome Measures:
1. Number of patients with seizures to day 28
[ Time Frame: 28 days after randomization ]

We will determine the number of patients that experience seizure between randomization and day 28
2. Number of patients with atrial or ventricular arrhythmia to day 28
[ Time Frame: 28 days after randomization ]

We will determine the number of patients that experience ventricular arrhythmia between randomization and day 28
3. Number of patients with cardiac arrest to day 28
[ Time Frame: 28 days after randomization ]

We will determine the number of patients that experience cardiac arrest between randomization and day 28
4. Number of patients with elevation in aspartate aminotransferase or alanine aminotransferase to twice the local upper limit of normal to day 28
[ Time Frame: 28 days after randomization ]

We will determine the number of patients that experience elevation in aspartate aminotransferase or alanine aminotransferase to twice the local upper limit of normal between randomization and day 28
5. Number of patients with acute pancreatitis arrest to day 28
[ Time Frame: 28 days after randomization ]

We will determine the number of patients that experience acute pancreatitis between randomization and day 28
6. Number of patients with acute kidney injury to day28
[ Time Frame: 28 days after randomization ]

We will determine the number of patients that experience acute kidney injury between randomization and day 28
7. Number of patients with receipt of renal replacement therapy to day 28
[ Time Frame: 28 days after randomization ]

We will determine the number of patients that experience renal replacement therapy between randomization and day 28
8. Number of patients with symptomatic hypoglycemia to day 28
[ Time Frame: 28 days after randomization ]

We will determine the number of patients that experience symptomatic hypoglycemia between randomization and day 28
9. Number of patients with neutropenia, lymphopenia, anemia, or thrombocytopenia to day 28
[ Time Frame: 28 days after randomization ]

We will determine the number of patients that experience neutropenia, lymphopenia, anemia, or thrombocytopenia between randomization and day 28
10. Number of patients with severe dermatologic reaction to day 28
[ Time Frame: 28 days after randomization ]

We will determine the number of patients that experience severe dermatologic reaction between randomization and day 28
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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
    4. sore throat
  4. Laboratory-confirmed SARS-CoV-2 infection within the past 10 days or SARS-CoV-2 laboratory test result pending plus a high clinical suspicion for COVID-19 as indicated by fulfilling all of the following:
    1. Cough with duration ≤10 days
    2. Bilateral pulmonary infiltrates on chest imaging (radiograph, or computed tomography or ultrasound) or new hypoxemia defined as SpO2 ≤94% on room air
    3. No alternative explanation for symptoms of acute respiratory infection

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. Inability to be contacted on Day 15 for clinical outcome assessment
Open or close this module Contacts/Locations
Central Contact Person: Katie Oldmixon, RN
Telephone: 617 726-4777
Email: coldmixon@mgh.harvard.edu
Central Contact Backup: Nancy Ringwood, BSN
Telephone: 617 724-9836
Email: nringwood@mgh.harvard.edu
Study Officials: Boyd Taylor Thompson, MD
Principal Investigator
Massachusetts General Hospital
Locations: United States, Arizona
University of Arizona
[Not yet recruiting]
Tucson, Arizona, United States, 85721
United States, California
UCSF Fresno
[Not yet recruiting]
Fresno, California, United States, 93701
Cedars-Sinai Medical Center
[Not yet recruiting]
Los Angeles, California, United States, 90048
Ronald Reagan UCLA Medical Center
[Not yet recruiting]
Los Angeles, California, United States, 90095
UC Davis Medical Center
[Not yet recruiting]
Sacramento, California, United States, 95817
UCSF Medical Center
[Not yet recruiting]
San Francisco, California, United States, 94143
Stanford University
[Not yet recruiting]
Stanford, California, United States, 94305
United States, Colorado
Medical Center of Aurora
[Not yet recruiting]
Aurora, Colorado, United States, 80045
University of Colorado Hospital
[Not yet recruiting]
Aurora, Colorado, United States, 80045
Denver Health Medical Center
[Not yet recruiting]
Denver, Colorado, United States, 80204
St. Joseph Hospital
[Not yet recruiting]
Denver, Colorado, United States, 80218
United States, Florida
University of Florida
[Not yet recruiting]
Gainesville, Florida, United States, 32608
United States, Kentucky
University of Kentucky
[Recruiting]
Lexington, Kentucky, United States, 40506
United States, Louisiana
University Medical Center
[Not yet recruiting]
New Orleans, Louisiana, United States, 70112
United States, Maine
Maine Medical Center
[Not yet recruiting]
Portland, Maine, United States, 04102
United States, Massachusetts
Massachusetts General Hospital
[Recruiting]
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Medical Center
[Not yet recruiting]
Boston, Massachusetts, United States, 02115
Brigham and Women's Hospital
[Not yet recruiting]
Boston, Massachusetts, United States, 02445
Baystate Medical Center
[Not yet recruiting]
Springfield, Massachusetts, United States, 01199
St. Vincent's Hospital
[Not yet recruiting]
Worcester, Massachusetts, United States, 01608
United States, Michigan
University of Michigan Medical Center
[Not yet recruiting]
Ann Arbor, Michigan, United States, 48109
Henry Ford Medical Center
[Not yet recruiting]
Detroit, Michigan, United States, 48025
United States, Mississippi
University of Mississippi Medical Center
[Not yet recruiting]
Jackson, Mississippi, United States, 39216
United States, New York
Montefiore Medical Center-Weiler
[Not yet recruiting]
Bronx, New York, United States, 10461
Montefiore Medical Center-Moses
[Not yet recruiting]
Bronx, New York, United States, 10467
United States, North Carolina
University of North Carolina at Chapel Hill
[Not yet recruiting]
Chapel Hill, North Carolina, United States, 27514
Wake Forest Baptist Medical Center
[Not yet recruiting]
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
University of Cincinnati Medical Center
[Not yet recruiting]
Cincinnati, Ohio, United States, 45219
Cleveland Clinic Foundation
[Recruiting]
Cleveland, Ohio, United States, 44195
Ohio State University Wexner Medical Center
[Not yet recruiting]
Columbus, Ohio, United States, 43210
United States, Oregon
Oregon Health and Science University
[Not yet recruiting]
Portland, Oregon, United States, 97239
United States, Pennsylvania
Penn State Hershey Medical Center
[Not yet recruiting]
Hershey, Pennsylvania, United States, 17033
Temple University Hospital
[Not yet recruiting]
Philadelphia, Pennsylvania, United States, 19140
UPMC Presbyterian/Mercy/Shadyside
[Not yet recruiting]
Pittsburgh, Pennsylvania, United States, 15261
United States, South Carolina
Medical University of South Carolina
[Not yet recruiting]
Charleston, South Carolina, United States, 29425
United States, Tennessee
Vanderbilt University Medical Center
[Recruiting]
Nashville, Tennessee, United States, 37221
United States, Texas
University of Texas Health Science Center
[Not yet recruiting]
Houston, Texas, United States, 77030
United States, Utah
Intermountain Medical Center
[Not yet recruiting]
Murray, Utah, United States, 84107
University of Utah Hospital
[Not yet recruiting]
Salt Lake City, Utah, United States, 84132
United States, Virginia
University of Virginia Health System
[Not yet recruiting]
Charlottesville, Virginia, United States, 22903
VCU Medical Center
[Not yet recruiting]
Richmond, Virginia, United States, 23298
United States, Washington
Harborview Medical Center
[Recruiting]
Seattle, Washington, United States, 98104
Swedish Hospital First Hill
[Not yet recruiting]
Seattle, Washington, United States, 98122
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links: Description: Website for the PETAL Network
Available IPD/Information:

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