COVID-19Phase 2/3NCT04615949
Cannabidiol in Patients With COVID-19 and Cardiovascular Disease or Risk Factors
A Phase 2/3 study testing Cannabidiol, pharmaceutically produced with < 5 ppm THC in people with COVID-19 and Cardiovascular Diseases, run by Cardiol Therapeutics Inc. at 20 sites in 3 countries.
Trial summary
Non-critical patients, hospitalized within the previous 24 hours who tested positive for COVID-19 and have a prior history of cardiovascular disease (CVD) and/or significant risk factors for CVD will be treated for 28 days. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Cardiovascular Diseases, Cardiovascular Risk Factor
- What is being tested?
- Cannabidiol, pharmaceutically produced with < 5 ppm THC
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 20 sitesin 3 countries
- Study dates
- 30 Apr 2021to 30 Nov 2022
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Males and females 18 years of age or older 2. Hospitalized for COVID-19 with the most recent test positive; not receiving or likely to receive invasive mechanical ventilation within the next 24 hours 3. Prior history of at least one of: i) CVD [cardiovascular (CV), cerebrovascular or peripheral vascular diagnoses], ii) Age > 64, iii) Diabetes (DM), iv) Hypertension (HTN), v) Abnormal serum lipids, vi) Obesity (BMI > or equal 30 or waist circumference >102 cm [40"] for men and >88 cm [35"] for women), vii) Current smoker
- Must be PCR test.
Who cannot join
- Patients who have received vasopressors, extracorporeal membrane oxygenation and mechanical ventilation within last 30 days
- Background of cardiac transplant surgery
- Implanted defibrillator (ICD) in the last three months
- Implanted left-ventricular assist device (LVAD)
- Acute coronary syndrome (ACS) within 30 days
- Percutaneous coronary intervention (PCI) within 30 days
Show all 25Show fewer
- Receiving any immuno-suppressive agent other than dexamethasone
- History of QTc interval prolongation
- QTc interval > 500 msec
- Treated with strong inducers of CYP3A4 or CYP2C19
- Chronic renal failure, determined as eGFR < 30 ml/min
- Elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 times the upper limit of normal (ULN) or ALT or AST >3x ULN plus bilirubin >2x ULN
- Bacterial sepsis, defined as documented bacteremia at the time of presentation or other active bacterial infection
- Current participation in any research study involving investigational drugs or devices with the exception of dexamethasone, remdesivir, baricitinib plus remdesivir, convalescent plasma or monoclonal antibodies against the SARS-CoV-2 virus or any other therapy approved under emergency use in the region for treatment of COVID-19
- Inability or unwillingness to give informed consent
- Ongoing drug, alcohol or cannabis abuse
- Women who are pregnant or breastfeeding
- Any factor, which would make it unlikely that the patient can comply with the study procedures
- Hemoglobin <8.5 gm/dL
- Leukocyte count < 3000/ mm3
- Platelets < 100,000 / mm3
- Current diagnosis of cancer, with the exception of non-melanoma skin cancer
- Showing suicidal tendency as per the Columbia-Suicide Severity Rating Scale (C-SSRS) administered at screening
- Any cannabinoid intake in the past month
- Body weight > 170 kg
Trial locations and contacts
20 sites in 3 countries.
20 sites in 3 countries
Brazil12 sites
Fundação Pio XII - Hospital de Amor Barretos
Barretos, São Paulo, 14784-400
IPECC-Instituto de Pesquisa Clínica de Campinas
Campinas, São Paulo, 13060-080
Science Valley Research Institute
Campo Largo, Paraná, 83606
Instituto do Coração do HCFMUSP
Cerqueira César, São Paulo, 05403-000
Núcleo de Ensino e Pesquisa do Instituto Mário Penna
Conjunto ACM, Santa Maria, 30380-472
SVRI- Irmandade de Santa Casa de Misercordia de Santos
Jabaquara, São Paulo, 1409
Universidade Estadual de Maringa
Maringá, Paraná, 87020-900
Hospital São Lucas PUCRS
Porto Alegre, Rio Grande do Sul, 90619-900
Irmandade Santa Casa de Misericórdia
Porto Alegre, Rio Grande do Sul
Complexo Hospitalar de Niteroi- Centro de Pesquisa Clinica
Rio de Janeiro, 24020
Science Valley Research Institute
Santo André, São Paulo, 1409
Fundação Faculdade Regional de Medicine de Sao Jose do Rio Preto (SJRP)
São José do Rio Preto, São Paulo, 15090-000
United States7 sites
JY Research Institute
Cutler Bay, Florida, 33189
Westchester General Hospital
Miami, Florida, 33155
Valleywise Health Medical Center
Phoenix, Arizona, 85008
University of Texas Health Science Center
San Antonio, Texas, 78229
Prairie Education and Research Cooperative
Springfield, Illinois, 62769
University of South Florida
Tampa, Florida, 33613
Baylor Scott & White Health - Temple
Temple, Texas, 76508
About this study
Official title: Study to Evaluate the Efficacy and Safety of CardiolRx™ in Patients With COVID-19 and Cardiovascular Disease or Risk Factors A Double-blind, Placebo-controlled Trial
Non-critical patients, hospitalized within the previous 24 hours who tested positive for COVID-19 and have a prior history of cardiovascular disease (CVD) and/or significant risk factors for CVD will be treated for 28 days.
Read the detailed description
Multi-center, double-blind, randomized, placebo-controlled, parallel group design. 1:1 randomization.
Screening (Day 0-1): Patients hospitalized for COVID-19 within the past 24 hours will be screened. If patient consent can be obtained, baseline assessments will be carried out: Physical examination (including vital signs), ECG including QTc interval assessment, echocardiogram to measure left-ventricular ejection fraction (LVEF), chest X-ray, local laboratory (including CBC, AST/ALT, alkaline phosphatase, bilirubin, creatinine/eGFR, INR, pregnancy test (in women with child-bearing potential only), lymphocyte count and LDH. A C-SSRS will also be completed. Frozen plasma will be retained for central analysis of CardiolRx™ levels, hs-troponin, NT-proBNP, D-dimer as well as inflammatory markers (hs-CRP, ferritin, TNF-alpha, IL-1 beta, IL-6, IL-10).
If all eligibility criteria are met, the patient will be randomized to either CardiolRx™ or placebo.
Study treatment will be initiated immediately after all baseline assessments have been completed and the patient is randomized (Day1). Oral administration is as follows:
- Day 1 and Day 2: Initial dose: 2.5 mg/kg of body weight b.i.d. with food: CardiolRx™ or placebo
- Day 3 and Day 4: Increased to 5 mg/kg of body weight b.i.d. with food: CardiolRx™ or placebo
- Day 5 to Day 28: Increased to 7.5 mg/kg of body weight b.i.d. with food: CardiolRx™ or placebo For the first 7 days and on Day 10, an ECG will be recorded 4 hours post morning dose with QTc intervals measured. If the QTc interval is >500 msec or an increase of > 60 msec from baseline is observed, the study medication must be stopped immediately.
If the next higher dose is not tolerated for other reasons, the dose will be reduced to the previous tolerated dose. The highest tolerated dose will be administered until Day 28.
If the patient is discharged before Day 10, the assessments up to Day 10 will be carried out as home visits. After Day 10, all remaining scheduled assessments will be carried out during out-patient visits (or home visits, if out-patient visits are not feasible).
In addition to prolongation of the QTc intervals, careful observation is required to detect other Adverse Drug Reactions (ADRs) and Drug-Drug Interactions (DDIs). Because CardiolRx™, may inhibit the metabolism of other drugs, new symptoms may represent toxicity from a concomitant medication that had previously been well tolerated.
A nasopharyngeal swab will also be done every day until Day 7 and on Day 14 to test for presence of the SARS-CoV-2 virus.
After Day 7, assessments will be carried out on a weekly basis except for as noted above on Day 10.
Frozen plasma will be retained for central analysis of CardiolRx™ levels, hs-troponin, NT-proBNP, D-dimer, inflammatory markers (hs-CRP, ferritin, TNF-alpha, IL-1 beta, IL-6, IL-10) and additional parameters of interest every two days until Day 7 as well as on day 28.
The assessments on Day 28 include the following: Physical examination (including vital signs), ECG (recorded 4 hours post morning dose for measurement of QTc interval), echocardiogram to measure LVEF, chest X-ray, local laboratory assessments, including CBC, AST/ALT, alkaline phosphatase, bilirubin, creatinine/eGFR, INR, lymphocyte count and LDH. In addition, a C-SSRS will be completed and the patient will be asked to answer a PICQ.
Further follow-up visits are scheduled for Day 45 and Day 60 post randomization. These include a clinical assessment (including vital signs) as well as the completion of the PICQ (PICQ on Day 60 only). Any changes in concomitant medications and (S)AEs will also be recorded.
- Being tested
- Cannabidiol, pharmaceutically produced with < 5 ppm THC, Placebo
- Medical subject headings
- COVID-19, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cannabidiol, pharmaceutically produced with < 5 ppm THCDrug
Also called CardiolRx
CardiolRx 2.5 mg/kg to 7.5 mg/kg of body weight b.i.d taken orally with food
PlaceboDrug
Placebo 2.5 mg/kg to 7.5 mg/kg of body weight b.i.d taken orally with food
| Study group | Role | What they receive |
|---|---|---|
| Cannabidiol, pharmaceutically produced with < 5 ppm THC | Experimental | CardiolRx Receives: Drug: Cannabidiol, pharmaceutically produced with < 5 ppm THC |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of All-cause Mortality, Requirement for ICU Admission and/or Ventillatory Support and Cardiovascular Complications
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)
Measured: 28 days post randomization
Secondary outcomes (1)
Ordinal Outcome Scale
Ordinal Outcome Scale:
- Not hospitalized and no limitations of activities.
- Not hospitalized, with limitation of activities, home oxygen requirement, or both.
- Hospitalized, not requiring supplemental oxygen and no longer requiring ongoing medical care.
- Hospitalized, not requiring supplemental oxygen but requiring ongoing medical care.
- Hospitalized, requiring any supplemental oxygen.
- Hospitalized, requiring noninvasive ventilation or use of high-flow oxygen devices.
- Hospitalized, receiving invasive mechanical ventilation or ECMO.
- MI or stroke diagnosed since randomization.
- Death.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study start30 Apr 2021
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Why it stopped: The changing nature of COVID-19 including a more vaccinated population, increasing natural population immunity, milder variants and other related factors has meant that it is no longer realistic to recruit the patients in a reasonable time frame.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind, placebo-controlled, parallel study, randomization 1:1
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiol Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dennis McNamara, MD, Study chair, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04615949
- Sponsor's protocol ID
- CARDIOL 100-03
- Status last verified
- Feb 2026
- First submitted
- 2 Nov 2020
- Last updated
- 21 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will become available once the study has been published
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Evaluate the Efficacy and Safety of CardiolRx™ in Patients With COVID-19 and Cardiovascular Disease or Risk Factors A Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT04615949
- Acronym / sponsor ID
- CARDIOL 100-03
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The changing nature of COVID-19 including a more vaccinated population, increasing natural population immunity, milder variants and other related factors has meant that it is no longer realistic to recruit the patients in a reasonable time frame.
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Cardiol Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Apr 2021 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 4 Nov 2020 (actual)
- Results
- Posted 25 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Non-critical patients, hospitalized within the previous 24 hours who tested positive for COVID-19 and have a prior history of cardiovascular disease (CVD) and/or significant risk factors for CVD will be treated for 28 days.
Detailed description
Multi-center, double-blind, randomized, placebo-controlled, parallel group design. 1:1 randomization.
Screening (Day 0-1): Patients hospitalized for COVID-19 within the past 24 hours will be screened. If patient consent can be obtained, baseline assessments will be carried out: Physical examination (including vital signs), ECG including QTc interval assessment, echocardiogram to measure left-ventricular ejection fraction (LVEF), chest X-ray, local laboratory (including CBC, AST/ALT, alkaline phosphatase, bilirubin, creatinine/eGFR, INR, pregnancy test (in women with child-bearing potential only), lymphocyte count and LDH. A C-SSRS will also be completed. Frozen plasma will be retained for central analysis of CardiolRx™ levels, hs-troponin, NT-proBNP, D-dimer as well as inflammatory markers (hs-CRP, ferritin, TNF-alpha, IL-1 beta, IL-6, IL-10).
If all eligibility criteria are met, the patient will be randomized to either CardiolRx™ or placebo.
Study treatment will be initiated immediately after all baseline assessments have been completed and the patient is randomized (Day1). Oral administration is as follows:
- Day 1 and Day 2: Initial dose: 2.5 mg/kg of body weight b.i.d. with food: CardiolRx™ or placebo
- Day 3 and Day 4: Increased to 5 mg/kg of body weight b.i.d. with food: CardiolRx™ or placebo
- Day 5 to Day 28: Increased to 7.5 mg/kg of body weight b.i.d. with food: CardiolRx™ or placebo For the first 7 days and on Day 10, an ECG will be recorded 4 hours post morning dose with QTc intervals measured. If the QTc interval is >500 msec or an increase of > 60 msec from baseline is observed, the study medication must be stopped immediately.
If the next higher dose is not tolerated for other reasons, the dose will be reduced to the previous tolerated dose. The highest tolerated dose will be administered until Day 28.
If the patient is discharged before Day 10, the assessments up to Day 10 will be carried out as home visits. After Day 10, all remaining scheduled assessments will be carried out during out-patient visits (or home visits, if out-patient visits are not feasible).
In addition to prolongation of the QTc intervals, careful observation is required to detect other Adverse Drug Reactions (ADRs) and Drug-Drug Interactions (DDIs). Because CardiolRx™, may inhibit the metabolism of other drugs, new symptoms may represent toxicity from a concomitant medication that had previously been well tolerated.
A nasopharyngeal swab will also be done every day until Day 7 and on Day 14 to test for presence of the SARS-CoV-2 virus.
After Day 7, assessments will be carried out on a weekly basis except for as noted above on Day 10.
Frozen plasma will be retained for central analysis of CardiolRx™ levels, hs-troponin, NT-proBNP, D-dimer, inflammatory markers (hs-CRP, ferritin, TNF-alpha, IL-1 beta, IL-6, IL-10) and additional parameters of interest every two days until Day 7 as well as on day 28.
The assessments on Day 28 include the following: Physical examination (including vital signs), ECG (recorded 4 hours post morning dose for measurement of QTc interval), echocardiogram to measure LVEF, chest X-ray, local laboratory assessments, including CBC, AST/ALT, alkaline phosphatase, bilirubin, creatinine/eGFR, INR, lymphocyte count and LDH. In addition, a C-SSRS will be completed and the patient will be asked to answer a PICQ.
Further follow-up visits are scheduled for Day 45 and Day 60 post randomization. These include a clinical assessment (including vital signs) as well as the completion of the PICQ (PICQ on Day 60 only). Any changes in concomitant medications and (S)AEs will also be recorded.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind, placebo-controlled, parallel study, randomization 1:1
| Arm | Type | Receives |
|---|---|---|
| Cannabidiol, pharmaceutically produced with < 5 ppm THC | Experimental | Drug: Cannabidiol, pharmaceutically produced with < 5 ppm THCCardiolRx |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1. Males and females 18 years of age or older 2. Hospitalized for COVID-19 with the most recent test positive; not receiving or likely to receive invasive mechanical ventilation within the next 24 hours 3. Prior history of at least one of: i) CVD [cardiovascular (CV), cerebrovascular or peripheral vascular diagnoses], ii) Age > 64, iii) Diabetes (DM), iv) Hypertension (HTN), v) Abnormal serum lipids, vi) Obesity (BMI > or equal 30 or waist circumference >102 cm [40"] for men and >88 cm [35"] for women), vii) Current smoker
- Must be PCR test.
Key exclusion criteria (25 listed)
- Patients who have received vasopressors, extracorporeal membrane oxygenation and mechanical ventilation within last 30 days
- Background of cardiac transplant surgery
- Implanted defibrillator (ICD) in the last three months
- Implanted left-ventricular assist device (LVAD)
- Acute coronary syndrome (ACS) within 30 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cannabidiol, pharmaceutically produced with < 5 ppm THCAlso: CardiolRxCardiolRx 2.5 mg/kg to 7.5 mg/kg of body weight b.i.d taken orally with food | Drug | Cannabidiol, pharmaceutically produced with < 5 ppm THC |
| PlaceboPlacebo 2.5 mg/kg to 7.5 mg/kg of body weight b.i.d taken orally with food | Drug | Placebo |
Primary outcome
Composite of All-cause Mortality, Requirement for ICU Admission and/or Ventillatory Support and Cardiovascular Complications
Time frame: 28 days post randomization
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)
1 secondary outcome
Ordinal Outcome Scale
Time frame: 28 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. The data will become available once the study has been published
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dennis McNamara, MD study chair
University of Pittsburgh
20 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Cannabidiol, pharmaceutically produced with < 5 ppm THC in people with COVID-19 and Cardiovascular Diseases, run by Cardiol Therapeutics Inc. at 20 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Brazil, United States, Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of All-cause Mortality, Requirement for ICU Admission and/or Ventillatory Support and Cardiovascular Complications (time frame: 28 days post randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.