Trial Outcomes & Findings for Cannabidiol in Patients With COVID-19 and Cardiovascular Disease or Risk Factors (NCT NCT04615949)
NCT ID: NCT04615949
Last Updated: 2026-04-21
Results Overview
Proportions of patients in each group not having one of the outcome measures as described above (All-cause mortality, requirement for ICU admission and/or ventillatory support and cardiovascular complications)
Recruitment status
TERMINATED
Study phase
PHASE2/PHASE3
Target enrollment
90 participants
Primary outcome timeframe
28 days post randomization
Results posted on
2026-04-21
Participant Flow
Participant milestones
| Measure |
Cannabidiol, Pharmaceutically Produced With < 5 Ppm THC
CardiolRx
Cannabidiol, pharmaceutically produced with \< 5 ppm THC: CardiolRx 2.5 mg/kg to 7.5 mg/kg of body weight b.i.d taken orally with food
|
Placebo
Placebo
Placebo: Placebo 2.5 mg/kg to 7.5 mg/kg of body weight b.i.d taken orally with food
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
45
|
|
Overall Study
COMPLETED
|
41
|
37
|
|
Overall Study
NOT COMPLETED
|
4
|
8
|
Reasons for withdrawal
| Measure |
Cannabidiol, Pharmaceutically Produced With < 5 Ppm THC
CardiolRx
Cannabidiol, pharmaceutically produced with \< 5 ppm THC: CardiolRx 2.5 mg/kg to 7.5 mg/kg of body weight b.i.d taken orally with food
|
Placebo
Placebo
Placebo: Placebo 2.5 mg/kg to 7.5 mg/kg of body weight b.i.d taken orally with food
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
4
|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
|
Overall Study
Death
|
0
|
2
|
Baseline Characteristics
Cannabidiol in Patients With COVID-19 and Cardiovascular Disease or Risk Factors
Baseline characteristics by cohort
| Measure |
Cannabidiol, Pharmaceutically Produced With < 5 Ppm THC
n=45 Participants
CardiolRx
Cannabidiol, pharmaceutically produced with \< 5 ppm THC: CardiolRx 2.5 mg/kg to 7.5 mg/kg of body weight b.i.d taken orally with food
|
Placebo
n=45 Participants
Placebo
Placebo: Placebo 2.5 mg/kg to 7.5 mg/kg of body weight b.i.d taken orally with food
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.4 years
STANDARD_DEVIATION 14.86 • n=13 Participants
|
62.0 years
STANDARD_DEVIATION 12.95 • n=13 Participants
|
61.2 years
STANDARD_DEVIATION 13.89 • n=26 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=13 Participants
|
20 Participants
n=13 Participants
|
39 Participants
n=26 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=13 Participants
|
25 Participants
n=13 Participants
|
51 Participants
n=26 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
42 Participants
n=13 Participants
|
42 Participants
n=13 Participants
|
84 Participants
n=26 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=13 Participants
|
3 Participants
n=13 Participants
|
6 Participants
n=26 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=26 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=26 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=26 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=26 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=13 Participants
|
3 Participants
n=13 Participants
|
5 Participants
n=26 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=13 Participants
|
27 Participants
n=13 Participants
|
55 Participants
n=26 Participants
|
|
Race (NIH/OMB)
More than one race
|
15 Participants
n=13 Participants
|
15 Participants
n=13 Participants
|
30 Participants
n=26 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=26 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=13 Participants
|
26 participants
n=13 Participants
|
51 participants
n=26 Participants
|
|
Region of Enrollment
Brazil
|
6 participants
n=13 Participants
|
4 participants
n=13 Participants
|
10 participants
n=26 Participants
|
|
Region of Enrollment
Mexico
|
14 participants
n=13 Participants
|
15 participants
n=13 Participants
|
29 participants
n=26 Participants
|
|
Obesity
|
19 Participants
n=13 Participants
|
23 Participants
n=13 Participants
|
42 Participants
n=26 Participants
|
|
Diabetes
|
17 Participants
n=13 Participants
|
19 Participants
n=13 Participants
|
36 Participants
n=26 Participants
|
|
Hyperlipidemia
|
7 Participants
n=13 Participants
|
9 Participants
n=13 Participants
|
16 Participants
n=26 Participants
|
|
Hypertension
|
30 Participants
n=13 Participants
|
30 Participants
n=13 Participants
|
60 Participants
n=26 Participants
|
PRIMARY outcome
Timeframe: 28 days post randomizationPopulation: Intention-to-treat population
Proportions of patients in each group not having one of the outcome measures as described above (All-cause mortality, requirement for ICU admission and/or ventillatory support and cardiovascular complications)
Outcome measures
| Measure |
Cannabidiol, Pharmaceutically Produced With < 5 Ppm THC
n=45 Participants
CardiolRx
Cannabidiol, pharmaceutically produced with \< 5 ppm THC: CardiolRx 2.5 mg/kg to 7.5 mg/kg of body weight b.i.d taken orally with food
|
Placebo
n=45 Participants
Placebo
Placebo: Placebo 2.5 mg/kg to 7.5 mg/kg of body weight b.i.d taken orally with food
|
|---|---|---|
|
Composite of All-cause Mortality, Requirement for ICU Admission and/or Ventillatory Support and Cardiovascular Complications
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 28 daysPopulation: Patients for whom the Ordinal Outcome Scale was available (only implemented after protocol amendment; not recorded for patients randomized prior to amendment)
Ordinal Outcome Scale: 1. Not hospitalized and no limitations of activities. 2. Not hospitalized, with limitation of activities, home oxygen requirement, or both. 3. Hospitalized, not requiring supplemental oxygen and no longer requiring ongoing medical care. 4. Hospitalized, not requiring supplemental oxygen but requiring ongoing medical care. 5. Hospitalized, requiring any supplemental oxygen. 6. Hospitalized, requiring noninvasive ventilation or use of high-flow oxygen devices. 7. Hospitalized, receiving invasive mechanical ventilation or ECMO. 8. MI or stroke diagnosed since randomization. 9. Death.
Outcome measures
| Measure |
Cannabidiol, Pharmaceutically Produced With < 5 Ppm THC
n=35 Participants
CardiolRx
Cannabidiol, pharmaceutically produced with \< 5 ppm THC: CardiolRx 2.5 mg/kg to 7.5 mg/kg of body weight b.i.d taken orally with food
|
Placebo
n=35 Participants
Placebo
Placebo: Placebo 2.5 mg/kg to 7.5 mg/kg of body weight b.i.d taken orally with food
|
|---|---|---|
|
Ordinal Outcome Scale
|
1.40 score on a scale
Standard Deviation 1.39
|
1.51 score on a scale
Standard Deviation 1.85
|
Adverse Events
Cannabidiol, Pharmaceutically Produced With < 5 Ppm THC
Serious events: 5 serious events
Other events: 24 other events
Deaths: 0 deaths
Placebo
Serious events: 4 serious events
Other events: 23 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Cannabidiol, Pharmaceutically Produced With < 5 Ppm THC
n=45 participants at risk
CardiolRx
Cannabidiol, pharmaceutically produced with \< 5 ppm THC: CardiolRx 2.5 mg/kg to 7.5 mg/kg of body weight b.i.d taken orally with food
|
Placebo
n=44 participants at risk
Placebo
Placebo: Placebo 2.5 mg/kg to 7.5 mg/kg of body weight b.i.d taken orally with food
|
|---|---|---|
|
Cardiac disorders
Cardiac failure
|
2.2%
1/45 • Number of events 1 • 60 days
|
0.00%
0/44 • 60 days
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/45 • 60 days
|
2.3%
1/44 • Number of events 1 • 60 days
|
|
Infections and infestations
Pneumonia
|
2.2%
1/45 • Number of events 2 • 60 days
|
0.00%
0/44 • 60 days
|
|
Infections and infestations
Septic Shock
|
0.00%
0/45 • 60 days
|
2.3%
1/44 • Number of events 1 • 60 days
|
|
Investigations
ALT increase
|
0.00%
0/45 • 60 days
|
2.3%
1/44 • Number of events 1 • 60 days
|
|
Investigations
QTC segment prolongation
|
2.2%
1/45 • Number of events 1 • 60 days
|
0.00%
0/44 • 60 days
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/45 • 60 days
|
2.3%
1/44 • Number of events 1 • 60 days
|
|
Renal and urinary disorders
Renal impairment
|
2.2%
1/45 • Number of events 1 • 60 days
|
0.00%
0/44 • 60 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.2%
1/45 • Number of events 1 • 60 days
|
2.3%
1/44 • Number of events 1 • 60 days
|
Other adverse events
| Measure |
Cannabidiol, Pharmaceutically Produced With < 5 Ppm THC
n=45 participants at risk
CardiolRx
Cannabidiol, pharmaceutically produced with \< 5 ppm THC: CardiolRx 2.5 mg/kg to 7.5 mg/kg of body weight b.i.d taken orally with food
|
Placebo
n=44 participants at risk
Placebo
Placebo: Placebo 2.5 mg/kg to 7.5 mg/kg of body weight b.i.d taken orally with food
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress Syndrome
|
2.2%
1/45 • 60 days
|
0.00%
0/44 • 60 days
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.2%
1/45 • 60 days
|
0.00%
0/44 • 60 days
|
|
Respiratory, thoracic and mediastinal disorders
Laryngospasm
|
2.2%
1/45 • 60 days
|
0.00%
0/44 • 60 days
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.2%
1/45 • 60 days
|
0.00%
0/44 • 60 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
2.2%
1/45 • 60 days
|
0.00%
0/44 • 60 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Fibrosis
|
0.00%
0/45 • 60 days
|
2.3%
1/44 • 60 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
2.2%
1/45 • 60 days
|
0.00%
0/44 • 60 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/45 • 60 days
|
2.3%
1/44 • 60 days
|
|
Cardiac disorders
Atrial fibrillation
|
2.2%
1/45 • 60 days
|
0.00%
0/44 • 60 days
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/45 • 60 days
|
2.3%
1/44 • 60 days
|
|
Cardiac disorders
Cardiac failure
|
2.2%
1/45 • 60 days
|
0.00%
0/44 • 60 days
|
|
Cardiac disorders
Left ventricular hypertrophy
|
2.2%
1/45 • 60 days
|
0.00%
0/44 • 60 days
|
|
Cardiac disorders
Pericardial effusion
|
2.2%
1/45 • 60 days
|
0.00%
0/44 • 60 days
|
|
Infections and infestations
Pneumonia
|
4.4%
2/45 • 60 days
|
2.3%
1/44 • 60 days
|
|
Infections and infestations
Fungal infection
|
2.2%
1/45 • 60 days
|
0.00%
0/44 • 60 days
|
|
Infections and infestations
Septic Shock
|
0.00%
0/45 • 60 days
|
2.3%
1/44 • 60 days
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/45 • 60 days
|
2.3%
1/44 • 60 days
|
|
Infections and infestations
Blood glucose increased
|
2.2%
1/45 • 60 days
|
2.3%
1/44 • 60 days
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/45 • 60 days
|
2.3%
1/44 • 60 days
|
|
Investigations
Blood creatinine increased
|
2.2%
1/45 • 60 days
|
0.00%
0/44 • 60 days
|
|
Investigations
Blood pressure increased
|
2.2%
1/45 • 60 days
|
0.00%
0/44 • 60 days
|
|
Investigations
Electrocardiogram QT increased
|
2.2%
1/45 • 60 days
|
0.00%
0/44 • 60 days
|
|
General disorders
Oedema peripheral
|
4.4%
2/45 • 60 days
|
2.3%
1/44 • 60 days
|
|
General disorders
Chest discomfort
|
2.2%
1/45 • 60 days
|
0.00%
0/44 • 60 days
|
|
General disorders
Oedema
|
2.2%
1/45 • 60 days
|
0.00%
0/44 • 60 days
|
|
General disorders
Pyrexia
|
2.2%
1/45 • 60 days
|
0.00%
0/44 • 60 days
|
|
General disorders
Secretion discharge
|
2.2%
1/45 • 60 days
|
0.00%
0/44 • 60 days
|
|
Investigations
Insomnia
|
4.4%
2/45 • 60 days
|
4.5%
2/44 • 60 days
|
|
General disorders
Nightmare
|
0.00%
0/45 • 60 days
|
2.3%
1/44 • 60 days
|
|
Vascular disorders
Hypotension
|
4.4%
2/45 • 60 days
|
0.00%
0/44 • 60 days
|
|
Renal and urinary disorders
Renal impairement
|
4.4%
2/45 • 60 days
|
0.00%
0/44 • 60 days
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/45 • 60 days
|
2.3%
1/44 • 60 days
|
|
Renal and urinary disorders
Renal artery stenosis
|
2.2%
1/45 • 60 days
|
0.00%
0/44 • 60 days
|
|
Blood and lymphatic system disorders
Anemia
|
4.4%
2/45 • 60 days
|
0.00%
0/44 • 60 days
|
|
Blood and lymphatic system disorders
Lymphopenia
|
2.2%
1/45 • 60 days
|
0.00%
0/44 • 60 days
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.2%
1/45 • 60 days
|
0.00%
0/44 • 60 days
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
2.2%
1/45 • 60 days
|
0.00%
0/44 • 60 days
|
|
Metabolism and nutrition disorders
Hypokalemia
|
2.2%
1/45 • 60 days
|
0.00%
0/44 • 60 days
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
2.2%
1/45 • 60 days
|
0.00%
0/44 • 60 days
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.4%
2/45 • 60 days
|
0.00%
0/44 • 60 days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.2%
1/45 • 60 days
|
0.00%
0/44 • 60 days
|
|
Endocrine disorders
Adrenal insufficiency
|
2.2%
1/45 • 60 days
|
0.00%
0/44 • 60 days
|
|
Immune system disorders
Seasonal allergy
|
2.2%
1/45 • 60 days
|
0.00%
0/44 • 60 days
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
2.2%
1/45 • 60 days
|
0.00%
0/44 • 60 days
|
|
Gastrointestinal disorders
Nausea
|
11.1%
5/45 • 60 days
|
4.5%
2/44 • 60 days
|
|
Gastrointestinal disorders
Constipation
|
4.4%
2/45 • 60 days
|
6.8%
3/44 • 60 days
|
|
Gastrointestinal disorders
Dyspepsia
|
4.4%
2/45 • 60 days
|
6.8%
3/44 • 60 days
|
|
Nervous system disorders
Headache
|
8.9%
4/45 • 60 days
|
6.8%
3/44 • 60 days
|
|
Nervous system disorders
Dysgeusia
|
6.7%
3/45 • 60 days
|
4.5%
2/44 • 60 days
|
|
Nervous system disorders
Dizziness
|
0.00%
0/45 • 60 days
|
6.8%
3/44 • 60 days
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/45 • 60 days
|
6.8%
3/44 • 60 days
|
|
Vascular disorders
Hypertension
|
6.7%
3/45 • 60 days
|
2.3%
1/44 • 60 days
|
|
Gastrointestinal disorders
Diarrhea
|
4.4%
2/45 • 60 days
|
2.3%
1/44 • 60 days
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/45 • 60 days
|
2.3%
1/44 • 60 days
|
|
Gastrointestinal disorders
Abdominal pain
|
2.2%
1/45 • 60 days
|
0.00%
0/44 • 60 days
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
2.2%
1/45 • 60 days
|
0.00%
0/44 • 60 days
|
|
Gastrointestinal disorders
Vomiting
|
2.2%
1/45 • 60 days
|
0.00%
0/44 • 60 days
|
|
Nervous system disorders
Somnolence
|
2.2%
1/45 • 60 days
|
4.5%
2/44 • 60 days
|
|
Nervous system disorders
Taste disorder
|
0.00%
0/45 • 60 days
|
2.3%
1/44 • 60 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
4.4%
2/45 • 60 days
|
2.3%
1/44 • 60 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/45 • 60 days
|
4.5%
2/44 • 60 days
|
Additional Information
Andrea B. Parker, MSc. PhD, Senior Director Clinical Operations
CardiolRx
Phone: +1 289 9100862
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place