Colheart-19: Colchicine for the Treatment of Cardiac Injury in Hospitalized Patients With COVID-19 (COLHEART-19)
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
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:
|
No Intervention: Control Hospitalized covid-19 patients treated with current standard of care (per institution treating physicians) alone. |
Outcome Measures
Primary Outcome Measures
- Mortality [90 days]
Composite of all-cause mortality
- Mechanical Ventilation [90 days]
Need for mechanical ventilation
- Mechanical Circulatory Support [90 days]
Need for mechanical circulatory support
Secondary Outcome Measures
- 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
- 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
- Baseline Brain Natriuretic Peptide (BNP) Level [baseline]
Documenting baseline Brain Natriuretic Peptide (BNP) at the time of hospitalization
- Inflammatory Biomarkers [baseline and 90 days]
Baseline and delta (change from baseline) of C-Reactive Protein
- Hospital Length of Stay [90 days]
Duration of Hospitalization on each arm
- Need for Re-hospitalization [90 days]
90-day re-hospitalization rate
- Change in Inflammatory Biomarkers [baseline and 90 days]
Baseline and delta (change from baseline) of D-Dimer
Eligibility Criteria
Criteria
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)
-
Elevated troponin level
-
Elevated BNP level
-
New ischemic or arrhythmogenic ECG/telemetry changes
-
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:
-
Intrauterine devices (IUD), contraceptive implants, or tubal sterilization
-
Hormone method with a barrier method
-
Two barrier methods
-
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.- 152247
- NCT04510038
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
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%
|
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%
|
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%
|
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
|
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
|
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
|
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
|
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
|
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
|
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
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 |
RaulH@BaptistHealth.net |
- 152247
- NCT04510038