Trial Outcomes & Findings for Cannabidiol in Patients With COVID-19 and Cardiovascular Disease or Risk Factors (NCT NCT04615949)
NCT ID: NCT04615949
Last Updated: 2025-07-25
Results Overview
Proportions of patients not surviving
Recruitment status
TERMINATED
Study phase
PHASE2/PHASE3
Target enrollment
90 participants
Primary outcome timeframe
28 days post randomization
Results posted on
2025-07-25
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=5 Participants
|
62.0 years
STANDARD_DEVIATION 12.95 • n=7 Participants
|
61.2 years
STANDARD_DEVIATION 13.89 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
42 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
26 participants
n=7 Participants
|
51 participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
6 participants
n=5 Participants
|
4 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
14 participants
n=5 Participants
|
15 participants
n=7 Participants
|
29 participants
n=5 Participants
|
|
Obesity
|
19 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Diabetes
|
17 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Hyperlipidemia
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Hypertension
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 28 days post randomizationPopulation: ITT
Proportions of patients not surviving
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
|
|---|---|---|
|
All-cause Mortality
|
0 Participants
|
2 Participants
|
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
|
|---|---|---|
|
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
|
|
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
|
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