Evaluating antiviral treatments to prevent long-term heart issues after COVID-19

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The DEFEND trial aims to assess the effectiveness of Paxlovid and Remdesivir in preventing cardiovascular complications in hospitalized adults who test positive for SARS-CoV-2. This pilot study will help determine the feasibility of a larger multicenter trial by estimating recruitment rates and validating hospital-based outcome measures. Participants aged 18 and older will be enrolled from four hospitals in Ontario, and the study will follow a double-blind, randomized, placebo-controlled design. The trial will also track the occurrence of serious cardiovascular events within one year following treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* ≥18 years old
* Positive PCR test for SARS-CoV-2 within 5 days of admission to hospital
* Normoxic (not receiving supplemental oxygen)
* Able to provide informed written consent (or, if patient is unable, have substitute decision maker available)

Exclusion Criteria:

* Absolute contraindications to Paxlovid or Veklury (any of the following): Severe allergy to Paxlovid or Veklury (e.g. anaphylaxis), co-administration with drugs highly dependent on CYP3A for clearance, co-administration with potent CYP3A inducers
* Exposure to Paxlovid or Veklury within previous 14 days;
* Receiving supplemental oxygen;
* Known positive SARS-CoV-2 PCR or rapid antigen test 5-90 days prior to admission;
* Limited life expectancy estimated to be ≤3 months;
* Pregnant and breastfeeding women

Where it's running

• Mount Sinai Hospital, Sinai Health System
  Toronto, Ontario, Canada Recruiting
• Kingston Health Sciences Centre
  Kingston, Ontario, Canada Not yet recruiting
• Niagara Health System
  St. Catharines, Ontario, Canada Not yet recruiting
• St. Joseph's Health Centre, Unity Health Toronto
  Toronto, Ontario, Canada Not yet recruiting

Study contacts

• Study coordinator: Dr. Kieran Quinn
• Email: kieran.quinn@mail.utoronto.ca
• Phone: 416-843-8403

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.