Recruiting

Paxlovid & Remdesivir

Sponsor:

Mount Sinai Hospital, Canada

Code:

NCT06792214

Conditions

SARS CoV-2 Post-Acute Sequelae

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Nirmatrelvir/ritonavir

Remdesivir

Study Details

Brief summary:

The DEFEND trial will be the world's first clinical trial to study the effectiveness of Paxlovid or Veklury in the prevention of cardiovascular post-acute sequelae of SARS-CoV-2 among hospitalized adults. Additionally, this pilot study will inform the design and conduct of a future full-scale multi-centre trial by testing the feasibility and accuracy of this study design.

Conditions

SARS CoV-2 Post-Acute Sequelae

Study ID

NCT06792214

Start date

Jan 3, 2025

Status verified date

Dec, 2024

Completion date

Jan, 2027

Anticipated

Primary completion date

Jan, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

118 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Paxlovid

Paxlovid vs. placebo

experimental: Veklury

Veklury vs. placebo

Interventions

Nirmatrelvir/ritonavir

Paxlovid PO BID for 5 days + standard of care

Remdesivir

Veklury IV daily for 5 days + standard of care

Primary outcome measure

  • Recruitment rate [ Time Frame: From participant screening to enrolment ]
  • Post-acute sequelae of COVID-19 (PASC) [ Time Frame: From enrolment to end of follow up at 1 year ]

Central Contacts and Locations

Central contacts

Dr. Kieran Quinn

416-843-8403kieran.quinn@mail.utoronto.ca

Locations

Mount Sinai Hospital, Sinai Health System

Recruiting

Toronto, Ontario, Canada, M5G 1X5

Contacts

Dr. Kieran Quinn

416-843-8403kieran.quinn@mail.utoronto.ca

Principal Investigator:

Dr. Kieran Quinn

More Information

Sponsor

Mount Sinai Hospital, Canada

Last update posted

Jan 24, 2025

Last verified

Dec, 2024

Keywords

  • SARS CoV-2
  • long covid

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mount Sinai Hospital, Canada on 2025-01-24.