Colheart-19: Colchicine for the Treatment of Cardiac Injury in Hospitalized Patients With COVID-19 (COLHEART-19)

Sponsor
Baptist Health South Florida (Other)
Overall Status
Terminated
CT.gov ID
NCT04762771
Collaborator
University of California, Los Angeles (Other)
2
1
2
8.9
0.2

Study Details

Study Description

Brief Summary

This is an open-label unblinded, randomized study to treat hospitalized covid-19 patients with colchicine plus current care (per institution treating physicians) vs. current care per institution treating physicians alone (the control arm)

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Detailed Description

We aim to determine if Colchicine improves short-term outcomes in hospitalized coronavirus disease-19 (COVID-19) patients with cardiac manifestations of disease.

Myocardial injury has been described in up to 30% of COVID-19 infected patients, and portends a poor prognosis with currently no known treatment. Colchicine is a widely available, well-established, inexpensive, oral anti-inflammatory agent that has been FDA approved for the treatment of inflammatory disorders including gout and familial Mediterranean Fever. Trials have also shown its benefit to prevent post-cardiotomy syndrome, to treat acute and recurrent pericarditis, and reduce cardiovascular events after myocardial infarction. We extrapolate based on these indications and studies that colchicine may also help improve outcomes in hospitalized COVID-19 patients with evidence of cardiac injury.

This is an unblinded randomized study to treat hospitalized covid-19 patients with colchicine plus current care per institution treating physicians vs. current care per institution treating physicians alone (the control arm)

Study Design

Study Type:
Interventional
Actual Enrollment :
2 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
This is an unblinded randomized study to treat hospitalized covid-19 patients with colchicine plus current care per institution treating physicians vs. current care per institution treating physicians alone (the control arm)This is an unblinded randomized study to treat hospitalized covid-19 patients with colchicine plus current care per institution treating physicians vs. current care per institution treating physicians alone (the control arm)
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Open-label (Unblinded) Randomization to Treatment of Colchicine Plus Current Care Per Institution Treating Physicians vs. Current Care Per Institution Treating Physicians (Control Arm)
Actual Study Start Date :
Dec 23, 2020
Actual Primary Completion Date :
May 12, 2021
Actual Study Completion Date :
Sep 20, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Active

Hospitalized covid-19 patients treated with colchicine plus current care per institution treating physicians.

Drug: Colchicine
Colchicine dosing = 0.6 mg bid x 30 days Decrease dose to 0.3-0.6 mg daily or every other day in setting of gastrointestinal intolerance (nausea, diarrhea, emesis, abdominal discomfort) Decrease dose to 0.6 mg daily in the setting of weak or moderate CYP3A4 inhibitor Decrease dose to 0.3 mg daily in the setting of strong CYP3A4, P-glycoprotein inhibitors, or protease inhibitors Decrease dose to 0.3 mg daily in the setting of chronic kidney disease (CKD) stage ≥ 4 (CrCl ≤ 30 ml/min) or liver failure (aspartate aminotransferase /alanine aminotransferase > 3x normal). Decrease dose to 0.6 mg every 14 days in patients with end stage renal disease (ESRD) or requiring dialysis Route of Administration: oral
Other Names:
  • Treatment with Colchicine plus standard of care in hospitalized patients with Covid-19
  • No Intervention: Control

    Hospitalized covid-19 patients treated with current standard of care (per institution treating physicians) alone.

    Outcome Measures

    Primary Outcome Measures

    1. Mortality [90 days]

      Composite of all-cause mortality

    2. Mechanical Ventilation [90 days]

      Need for mechanical ventilation

    3. Mechanical Circulatory Support [90 days]

      Need for mechanical circulatory support

    Secondary Outcome Measures

    1. Time (Days) to the Primary End Point [90 days]

      Number of days from start of therapy to either mortality or need for Mechanical Ventilation or Mechanical Circulatory Support

    2. Peak and Delta (Change From Baseline) Troponin Level [baseline and 90 days]

      Change from baseline to the time when Troponin levels peak during the hospitalization

    3. Baseline Brain Natriuretic Peptide (BNP) Level [baseline]

      Documenting baseline Brain Natriuretic Peptide (BNP) at the time of hospitalization

    4. Inflammatory Biomarkers [baseline and 90 days]

      Baseline and delta (change from baseline) of C-Reactive Protein

    5. Hospital Length of Stay [90 days]

      Duration of Hospitalization on each arm

    6. Need for Re-hospitalization [90 days]

      90-day re-hospitalization rate

    7. Change in Inflammatory Biomarkers [baseline and 90 days]

      Baseline and delta (change from baseline) of D-Dimer

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Men and Women ≥ 18 years of age

    • Covid-19 Positive

    • Hospitalized patients able to provide informed consent

    • Cardiac injury (as evidenced by any of the following)

    1. Elevated troponin level

    2. Elevated BNP level

    3. New ischemic or arrhythmogenic ECG/telemetry changes

    4. New decrease in Left Ventricular Ejection Fraction (LVEF) or new pericardial effusion on echocardiogram

    Exclusion Criteria:
    • Pregnancy, breastfeeding mothers, and women of childbearing age who are unable to use adequate contraception, which includes:
    1. Intrauterine devices (IUD), contraceptive implants, or tubal sterilization

    2. Hormone method with a barrier method

    3. Two barrier methods

    4. If a partner's vasectomy is the chosen method of contraception, a hormone or barrier method must also be used in conjunction

    • History of severe hematologic or neuromuscular disorder

    • Co-administration of Cytochrome P450 3A4 (CYPA3A4) and P-glycoprotein transport inhibitor

    • Severe renal impairment with concomitant hepatic impairment

    • Concurrent use of colchicine and strong or P-glycoprotein inhibitor with renal or hepatic impairment

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Baptist Hospital of Miami Miami Florida United States 33176

    Sponsors and Collaborators

    • Baptist Health South Florida
    • University of California, Los Angeles

    Investigators

    • Principal Investigator: Sandra Chaparro, MD, Baptist Health South Florida
    • Study Director: Raul E Herrera, MD, Baptist Health South Florida

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Baptist Health South Florida
    ClinicalTrials.gov Identifier:
    NCT04762771
    Other Study ID Numbers:
    • 152247
    • NCT04510038
    First Posted:
    Feb 21, 2021
    Last Update Posted:
    Jul 25, 2022
    Last Verified:
    Jul 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details The rapid decline in COVID patients and other competing trials did not allowed enrollment of additional subjects. Given the small sample size, the study was terminated.
    Pre-assignment Detail Patients who test positive for COVID-19, sign informed consent and have any of the study specific manifestations of cardiac injury were randomized 1:1 .
    Arm/Group Title Control - Standard of Care Alone Active - Colchicine Plus Standard of Care
    Arm/Group Description Hospitalized covid-19 patients treated with current standard of care (per institution treating physicians) alone. Hospitalized covid-19 patients treated with colchicine plus current care per institution treating physicians. Colchicine: Colchicine dosing = 0.6 mg bid x 30 days Decrease dose to 0.3-0.6 mg daily or every other day in setting of gastrointestinal intolerance (nausea, diarrhea, emesis, abdominal discomfort) Decrease dose to 0.6 mg daily in the setting of weak or moderate CYP3A4 inhibitor Decrease dose to 0.3 mg daily in the setting of strong CYP3A4, P-glycoprotein inhibitors, or protease inhibitors Decrease dose to 0.3 mg daily in the setting of chronic kidney disease (CKD) stage ≥ 4 (CrCl ≤ 30 ml/min) or liver failure (aspartate aminotransferase /alanine aminotransferase > 3x normal). Decrease dose to 0.6 mg every 14 days in patients with end stage renal disease (ESRD) or requiring dialysis Route of Administration: oral
    Period Title: Overall Study
    STARTED 1 1
    COMPLETED 1 1
    NOT COMPLETED 0 0

    Baseline Characteristics

    Arm/Group Title Active Control Total
    Arm/Group Description Hospitalized covid-19 patients treated with colchicine plus current care per institution treating physicians. Colchicine: Colchicine dosing = 0.6 mg bid x 30 days Decrease dose to 0.3-0.6 mg daily or every other day in setting of gastrointestinal intolerance (nausea, diarrhea, emesis, abdominal discomfort) Decrease dose to 0.6 mg daily in the setting of weak or moderate CYP3A4 inhibitor Decrease dose to 0.3 mg daily in the setting of strong CYP3A4, P-glycoprotein inhibitors, or protease inhibitors Decrease dose to 0.3 mg daily in the setting of chronic kidney disease (CKD) stage ≥ 4 (CrCl ≤ 30 ml/min) or liver failure (aspartate aminotransferase /alanine aminotransferase > 3x normal). Decrease dose to 0.6 mg every 14 days in patients with end stage renal disease (ESRD) or requiring dialysis Route of Administration: oral Hospitalized covid-19 patients treated with current standard of care (per institution treating physicians) alone. Total of all reporting groups
    Overall Participants 1 1 2
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    0
    0%
    0
    0%
    0
    0%
    >=65 years
    1
    100%
    1
    100%
    2
    100%
    Sex: Female, Male (Count of Participants)
    Female
    0
    0%
    1
    100%
    1
    50%
    Male
    1
    100%
    0
    0%
    1
    50%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    Asian
    0
    0%
    0
    0%
    0
    0%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    0
    0%
    0
    0%
    0
    0%
    White
    1
    100%
    1
    100%
    2
    100%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    Race/Ethnicity, Customized (Count of Participants)
    Hispanic
    0
    0%
    1
    100%
    1
    50%
    Non-Hispanic
    1
    100%
    0
    0%
    1
    50%
    Region of Enrollment (participants) [Number]
    United States
    1
    100%
    1
    100%
    2
    100%

    Outcome Measures

    1. Primary Outcome
    Title Mortality
    Description Composite of all-cause mortality
    Time Frame 90 days

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Active Control
    Arm/Group Description Hospitalized covid-19 patients treated with colchicine plus current care per institution treating physicians. Colchicine: Colchicine dosing = 0.6 mg bid x 30 days Decrease dose to 0.3-0.6 mg daily or every other day in setting of gastrointestinal intolerance (nausea, diarrhea, emesis, abdominal discomfort) Decrease dose to 0.6 mg daily in the setting of weak or moderate CYP3A4 inhibitor Decrease dose to 0.3 mg daily in the setting of strong CYP3A4, P-glycoprotein inhibitors, or protease inhibitors Decrease dose to 0.3 mg daily in the setting of chronic kidney disease (CKD) stage ≥ 4 (CrCl ≤ 30 ml/min) or liver failure (aspartate aminotransferase /alanine aminotransferase > 3x normal). Decrease dose to 0.6 mg every 14 days in patients with end stage renal disease (ESRD) or requiring dialysis Route of Administration: oral Hospitalized covid-19 patients treated with current standard of care (per institution treating physicians) alone.
    Measure Participants 1 1
    Count of Participants [Participants]
    0
    0%
    0
    0%
    2. Primary Outcome
    Title Mechanical Ventilation
    Description Need for mechanical ventilation
    Time Frame 90 days

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Active Control
    Arm/Group Description Hospitalized covid-19 patients treated with colchicine plus current care per institution treating physicians. Colchicine: Colchicine dosing = 0.6 mg bid x 30 days Decrease dose to 0.3-0.6 mg daily or every other day in setting of gastrointestinal intolerance (nausea, diarrhea, emesis, abdominal discomfort) Decrease dose to 0.6 mg daily in the setting of weak or moderate CYP3A4 inhibitor Decrease dose to 0.3 mg daily in the setting of strong CYP3A4, P-glycoprotein inhibitors, or protease inhibitors Decrease dose to 0.3 mg daily in the setting of chronic kidney disease (CKD) stage ≥ 4 (CrCl ≤ 30 ml/min) or liver failure (aspartate aminotransferase /alanine aminotransferase > 3x normal). Decrease dose to 0.6 mg every 14 days in patients with end stage renal disease (ESRD) or requiring dialysis Route of Administration: oral Hospitalized covid-19 patients treated with current standard of care (per institution treating physicians) alone.
    Measure Participants 1 1
    Count of Participants [Participants]
    0
    0%
    0
    0%
    3. Primary Outcome
    Title Mechanical Circulatory Support
    Description Need for mechanical circulatory support
    Time Frame 90 days

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Active Control
    Arm/Group Description Hospitalized covid-19 patients treated with colchicine plus current care per institution treating physicians. Colchicine: Colchicine dosing = 0.6 mg bid x 30 days Decrease dose to 0.3-0.6 mg daily or every other day in setting of gastrointestinal intolerance (nausea, diarrhea, emesis, abdominal discomfort) Decrease dose to 0.6 mg daily in the setting of weak or moderate CYP3A4 inhibitor Decrease dose to 0.3 mg daily in the setting of strong CYP3A4, P-glycoprotein inhibitors, or protease inhibitors Decrease dose to 0.3 mg daily in the setting of chronic kidney disease (CKD) stage ≥ 4 (CrCl ≤ 30 ml/min) or liver failure (aspartate aminotransferase /alanine aminotransferase > 3x normal). Decrease dose to 0.6 mg every 14 days in patients with end stage renal disease (ESRD) or requiring dialysis Route of Administration: oral Hospitalized covid-19 patients treated with current standard of care (per institution treating physicians) alone.
    Measure Participants 1 1
    Count of Participants [Participants]
    0
    0%
    0
    0%
    4. Secondary Outcome
    Title Time (Days) to the Primary End Point
    Description Number of days from start of therapy to either mortality or need for Mechanical Ventilation or Mechanical Circulatory Support
    Time Frame 90 days

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Active Control
    Arm/Group Description Hospitalized covid-19 patients treated with colchicine plus current care per institution treating physicians. Colchicine: Colchicine dosing = 0.6 mg bid x 30 days Decrease dose to 0.3-0.6 mg daily or every other day in setting of gastrointestinal intolerance (nausea, diarrhea, emesis, abdominal discomfort) Decrease dose to 0.6 mg daily in the setting of weak or moderate CYP3A4 inhibitor Decrease dose to 0.3 mg daily in the setting of strong CYP3A4, P-glycoprotein inhibitors, or protease inhibitors Decrease dose to 0.3 mg daily in the setting of chronic kidney disease (CKD) stage ≥ 4 (CrCl ≤ 30 ml/min) or liver failure (aspartate aminotransferase /alanine aminotransferase > 3x normal). Decrease dose to 0.6 mg every 14 days in patients with end stage renal disease (ESRD) or requiring dialysis Route of Administration: oral Hospitalized covid-19 patients treated with current standard of care (per institution treating physicians) alone.
    Measure Participants 1 1
    Number [days]
    0
    0
    5. Secondary Outcome
    Title Peak and Delta (Change From Baseline) Troponin Level
    Description Change from baseline to the time when Troponin levels peak during the hospitalization
    Time Frame baseline and 90 days

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Active Control
    Arm/Group Description Hospitalized covid-19 patients treated with colchicine plus current care per institution treating physicians. Colchicine: Colchicine dosing = 0.6 mg bid x 30 days Decrease dose to 0.3-0.6 mg daily or every other day in setting of gastrointestinal intolerance (nausea, diarrhea, emesis, abdominal discomfort) Decrease dose to 0.6 mg daily in the setting of weak or moderate CYP3A4 inhibitor Decrease dose to 0.3 mg daily in the setting of strong CYP3A4, P-glycoprotein inhibitors, or protease inhibitors Decrease dose to 0.3 mg daily in the setting of chronic kidney disease (CKD) stage ≥ 4 (CrCl ≤ 30 ml/min) or liver failure (aspartate aminotransferase /alanine aminotransferase > 3x normal). Decrease dose to 0.6 mg every 14 days in patients with end stage renal disease (ESRD) or requiring dialysis Route of Administration: oral Hospitalized covid-19 patients treated with current standard of care (per institution treating physicians) alone.
    Measure Participants 1 1
    Baseline (Peak)
    0.16
    0.02
    Delta
    -0.07
    0
    6. Secondary Outcome
    Title Baseline Brain Natriuretic Peptide (BNP) Level
    Description Documenting baseline Brain Natriuretic Peptide (BNP) at the time of hospitalization
    Time Frame baseline

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Active Control
    Arm/Group Description Hospitalized covid-19 patients treated with colchicine plus current care per institution treating physicians. Colchicine: Colchicine dosing = 0.6 mg bid x 30 days Decrease dose to 0.3-0.6 mg daily or every other day in setting of gastrointestinal intolerance (nausea, diarrhea, emesis, abdominal discomfort) Decrease dose to 0.6 mg daily in the setting of weak or moderate CYP3A4 inhibitor Decrease dose to 0.3 mg daily in the setting of strong CYP3A4, P-glycoprotein inhibitors, or protease inhibitors Decrease dose to 0.3 mg daily in the setting of chronic kidney disease (CKD) stage ≥ 4 (CrCl ≤ 30 ml/min) or liver failure (aspartate aminotransferase /alanine aminotransferase > 3x normal). Decrease dose to 0.6 mg every 14 days in patients with end stage renal disease (ESRD) or requiring dialysis Route of Administration: oral Hospitalized covid-19 patients treated with current standard of care (per institution treating physicians) alone.
    Measure Participants 1 1
    Number [pg/ml]
    27
    205
    7. Secondary Outcome
    Title Inflammatory Biomarkers
    Description Baseline and delta (change from baseline) of C-Reactive Protein
    Time Frame baseline and 90 days

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Active Control
    Arm/Group Description Hospitalized covid-19 patients treated with colchicine plus current care per institution treating physicians. Colchicine: Colchicine dosing = 0.6 mg bid x 30 days Decrease dose to 0.3-0.6 mg daily or every other day in setting of gastrointestinal intolerance (nausea, diarrhea, emesis, abdominal discomfort) Decrease dose to 0.6 mg daily in the setting of weak or moderate CYP3A4 inhibitor Decrease dose to 0.3 mg daily in the setting of strong CYP3A4, P-glycoprotein inhibitors, or protease inhibitors Decrease dose to 0.3 mg daily in the setting of chronic kidney disease (CKD) stage ≥ 4 (CrCl ≤ 30 ml/min) or liver failure (aspartate aminotransferase /alanine aminotransferase > 3x normal). Decrease dose to 0.6 mg every 14 days in patients with end stage renal disease (ESRD) or requiring dialysis Route of Administration: oral Hospitalized covid-19 patients treated with current standard of care (per institution treating physicians) alone.
    Measure Participants 1 1
    Baseline
    34.2
    3.0
    Delta
    19.1
    -0.1
    8. Secondary Outcome
    Title Hospital Length of Stay
    Description Duration of Hospitalization on each arm
    Time Frame 90 days

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Active Control
    Arm/Group Description Hospitalized covid-19 patients treated with colchicine plus current care per institution treating physicians. Colchicine: Colchicine dosing = 0.6 mg bid x 30 days Decrease dose to 0.3-0.6 mg daily or every other day in setting of gastrointestinal intolerance (nausea, diarrhea, emesis, abdominal discomfort) Decrease dose to 0.6 mg daily in the setting of weak or moderate CYP3A4 inhibitor Decrease dose to 0.3 mg daily in the setting of strong CYP3A4, P-glycoprotein inhibitors, or protease inhibitors Decrease dose to 0.3 mg daily in the setting of chronic kidney disease (CKD) stage ≥ 4 (CrCl ≤ 30 ml/min) or liver failure (aspartate aminotransferase /alanine aminotransferase > 3x normal). Decrease dose to 0.6 mg every 14 days in patients with end stage renal disease (ESRD) or requiring dialysis Route of Administration: oral Hospitalized covid-19 patients treated with current standard of care (per institution treating physicians) alone.
    Measure Participants 1 1
    Number [days]
    5
    14
    9. Secondary Outcome
    Title Need for Re-hospitalization
    Description 90-day re-hospitalization rate
    Time Frame 90 days

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Active Control
    Arm/Group Description Hospitalized covid-19 patients treated with colchicine plus current care per institution treating physicians. Colchicine: Colchicine dosing = 0.6 mg bid x 30 days Decrease dose to 0.3-0.6 mg daily or every other day in setting of gastrointestinal intolerance (nausea, diarrhea, emesis, abdominal discomfort) Decrease dose to 0.6 mg daily in the setting of weak or moderate CYP3A4 inhibitor Decrease dose to 0.3 mg daily in the setting of strong CYP3A4, P-glycoprotein inhibitors, or protease inhibitors Decrease dose to 0.3 mg daily in the setting of chronic kidney disease (CKD) stage ≥ 4 (CrCl ≤ 30 ml/min) or liver failure (aspartate aminotransferase /alanine aminotransferase > 3x normal). Decrease dose to 0.6 mg every 14 days in patients with end stage renal disease (ESRD) or requiring dialysis Route of Administration: oral Hospitalized covid-19 patients treated with current standard of care (per institution treating physicians) alone.
    Measure Participants 1 1
    Number [times hospitalized]
    1
    2
    10. Secondary Outcome
    Title Change in Inflammatory Biomarkers
    Description Baseline and delta (change from baseline) of D-Dimer
    Time Frame baseline and 90 days

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Active Control
    Arm/Group Description Hospitalized covid-19 patients treated with colchicine plus current care per institution treating physicians. Colchicine: Colchicine dosing = 0.6 mg bid x 30 days Decrease dose to 0.3-0.6 mg daily or every other day in setting of gastrointestinal intolerance (nausea, diarrhea, emesis, abdominal discomfort) Decrease dose to 0.6 mg daily in the setting of weak or moderate CYP3A4 inhibitor Decrease dose to 0.3 mg daily in the setting of strong CYP3A4, P-glycoprotein inhibitors, or protease inhibitors Decrease dose to 0.3 mg daily in the setting of chronic kidney disease (CKD) stage ≥ 4 (CrCl ≤ 30 ml/min) or liver failure (aspartate aminotransferase /alanine aminotransferase > 3x normal). Decrease dose to 0.6 mg every 14 days in patients with end stage renal disease (ESRD) or requiring dialysis Route of Administration: oral Hospitalized covid-19 patients treated with current standard of care (per institution treating physicians) alone.
    Measure Participants 1 1
    Baseline
    0.46
    0.27
    Delta
    19
    0

    Adverse Events

    Time Frame Adverse event data was collected from baseline through the 90 day follow-up period.
    Adverse Event Reporting Description
    Arm/Group Title Active Control
    Arm/Group Description Hospitalized covid-19 patients treated with colchicine plus current care per institution treating physicians. Colchicine: Colchicine dosing = 0.6 mg bid x 30 days Decrease dose to 0.3-0.6 mg daily or every other day in setting of gastrointestinal intolerance (nausea, diarrhea, emesis, abdominal discomfort) Decrease dose to 0.6 mg daily in the setting of weak or moderate CYP3A4 inhibitor Decrease dose to 0.3 mg daily in the setting of strong CYP3A4, P-glycoprotein inhibitors, or protease inhibitors Decrease dose to 0.3 mg daily in the setting of chronic kidney disease (CKD) stage ≥ 4 (CrCl ≤ 30 ml/min) or liver failure (aspartate aminotransferase /alanine aminotransferase > 3x normal). Decrease dose to 0.6 mg every 14 days in patients with end stage renal disease (ESRD) or requiring dialysis Route of Administration: oral Hospitalized covid-19 patients treated with current standard of care (per institution treating physicians) alone.
    All Cause Mortality
    Active Control
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/1 (0%) 0/1 (0%)
    Serious Adverse Events
    Active Control
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1/1 (100%) 1/1 (100%)
    Respiratory, thoracic and mediastinal disorders
    Pneumonia 1/1 (100%) 1 1/1 (100%) 1
    COVID-19 0/1 (0%) 0 1/1 (100%) 1
    Other (Not Including Serious) Adverse Events
    Active Control
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/1 (0%) 0/1 (0%)

    Limitations/Caveats

    The rapid decline in COVID patients and other competing trials did not allowed enrollment of additional subjects. Given the small sample size, the study was terminated.

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Raul Herrera, MD (Director Miami Cardiac & Vascular Institute)
    Organization baptist health south florida
    Phone 786-596-7609
    Email RaulH@BaptistHealth.net
    Responsible Party:
    Baptist Health South Florida
    ClinicalTrials.gov Identifier:
    NCT04762771
    Other Study ID Numbers:
    • 152247
    • NCT04510038
    First Posted:
    Feb 21, 2021
    Last Update Posted:
    Jul 25, 2022
    Last Verified:
    Jul 1, 2022