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Heart drug tested to fight COVID-19 complications

NCT ID NCT04615949

Disease control Sponsor: Cardiol Therapeutics Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a drug called CardiolRx in 90 hospitalized COVID-19 patients who also had heart disease or risk factors like diabetes or high blood pressure. The goal was to see if the drug could lower the chance of death, needing intensive care, or having heart problems. The trial was stopped early, so results are limited.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

90 people

The number who actually took part.

Started

Apr 2021

Finished

Nov 2022

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 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. Exclusion Criteria: 1. Patients who have received vasopressors, extracorporeal membrane oxygenation and mechanical ventilation within last 30 days 2. Background of cardiac transplant surgery 3. Implanted defibrillator (ICD) in the last three months 4. Implanted left-ventricular assist device (LVAD) 5. Acute coronary syndrome (ACS) within 30 days 6. Percutaneous coronary intervention (PCI) within 30 days 7. Receiving any immuno-suppressive agent other than dexamethasone 8. History of QTc interval prolongation 9. QTc interval \> 500 msec 10. Treated with strong inducers of CYP3A4 or CYP2C19 11. Chronic renal failure, determined as eGFR \< 30 ml/min 12. 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 13. Bacterial sepsis, defined as documented bacteremia at the time of presentation or other active bacterial infection 14. 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 15. Inability or unwillingness to give informed consent 16. Ongoing drug, alcohol or cannabis abuse 17. Women who are pregnant or breastfeeding 18. Any factor, which would make it unlikely that the patient can comply with the study procedures 19. Hemoglobin \<8.5 gm/dL 20. Leukocyte count \< 3000/ mm3 21. Platelets \< 100,000 / mm3 22. Current diagnosis of cancer, with the exception of non-melanoma skin cancer 23. Showing suicidal tendency as per the Columbia-Suicide Severity Rating Scale (C-SSRS) administered at screening 24. Any cannabinoid intake in the past month 25. Body weight \> 170 kg

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder COVID-19

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cardiovascular diseases Cardiovascular risk factor COVID-19

Contacts and locations

Locations

  • Baylor Scott & White Health - Temple

    Temple, Texas, 76508, United States

  • Complexo Hospitalar de Niteroi- Centro de Pesquisa Clinica

    Rio de Janeiro, 24020, Brazil

  • Fundação Faculdade Regional de Medicine de Sao Jose do Rio Preto (SJRP)

    São José do Rio Preto, São Paulo, 15090-000, Brazil

  • Fundação Pio XII - Hospital de Amor Barretos

    Barretos, São Paulo, 14784-400, Brazil

  • Hospital São Lucas PUCRS

    Porto Alegre, Rio Grande do Sul, 90619-900, Brazil

  • IPECC-Instituto de Pesquisa Clínica de Campinas

    Campinas, São Paulo, 13060-080, Brazil

  • Instituto do Coração do HCFMUSP

    Cerqueira César, São Paulo, 05403-000, Brazil

  • Irmandade Santa Casa de Misericórdia

    Porto Alegre, Rio Grande do Sul, Brazil

  • JY Research Institute

    Cutler Bay, Florida, 33189, United States

  • Núcleo de Ensino e Pesquisa do Instituto Mário Penna

    Conjunto ACM, Santa Maria, 30380-472, Brazil

  • Prairie Education and Research Cooperative

    Springfield, Illinois, 62769, United States

  • SVRI- Irmandade de Santa Casa de Misercordia de Santos

    Jabaquara, São Paulo, 1409, Brazil

  • Science Valley Research Institute

    Campo Largo, Paraná, 83606, Brazil

  • Science Valley Research Institute

    Santo André, São Paulo, 1409, Brazil

  • TecSalud

    Monterrey, Nuevo León, 64718, Mexico

  • Universidade Estadual de Maringa

    Maringá, Paraná, 87020-900, Brazil

  • University of South Florida

    Tampa, Florida, 33613, United States

  • University of Texas Health Science Center

    San Antonio, Texas, 78229, United States

  • Valleywise Health Medical Center

    Phoenix, Arizona, 85008, United States

  • Westchester General Hospital

    Miami, Florida, 33155, United States

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