118 Participants Needed

Paxlovid + Remdesivir for Post-COVID Syndrome

(DEFEND Trial)

Recruiting at 3 trial locations
DK
Overseen ByDr. Kieran Quinn
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Mount Sinai Hospital, Canada
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking drugs that interact with Paxlovid or Veklury. It's best to discuss your current medications with the trial team.

What data supports the effectiveness of the drug Paxlovid (nirmatrelvir/ritonavir) for treating Post-COVID Syndrome?

Research shows that Paxlovid (nirmatrelvir/ritonavir) is effective in reducing the risk of severe COVID-19 outcomes, like hospitalization or death, in high-risk patients. Some case series suggest it may also help people with Long COVID, although more research is needed to confirm its benefits for Post-COVID Syndrome.12345

Is Paxlovid safe for humans?

Paxlovid, a combination of nirmatrelvir and ritonavir, has been shown to reduce the risk of hospitalization and death in COVID-19 patients, but it may cause skin reactions and has interactions with other medications. Some patients experience a return of symptoms after treatment, but these are usually mild.56789

How is the drug Paxlovid + Remdesivir unique for treating Post-COVID Syndrome?

Paxlovid, which combines nirmatrelvir and ritonavir, is unique because it is an oral antiviral treatment that targets the main protease of the virus, helping to prevent severe COVID-19 in high-risk patients. This combination is now being explored with Remdesivir, another antiviral, to address Post-COVID Syndrome, a condition with no standard treatment, potentially offering a novel approach by combining two antiviral mechanisms.23458

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for hospitalized adults who have recovered from COVID-19 but are at risk of long-term heart problems. Details on specific inclusion and exclusion criteria were not provided, so participants should inquire about these requirements.

Inclusion Criteria

I tested positive for COVID-19 within 5 days before hospital admission.
I do not need extra oxygen.
I can sign the consent form myself or have someone who can do it for me.

Exclusion Criteria

I cannot take Paxlovid or Veklury due to severe allergies or because I'm on certain medications.
I have not taken Paxlovid or Veklury in the last 14 days.
Known positive SARS-CoV-2 PCR or rapid antigen test 5-90 days prior to admission
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants receive either Paxlovid orally twice daily for 5 days or Veklury intravenously once daily for 5 days, or placebo

1 week
Daily visits (in-person) for 5 days

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of post-acute sequelae of COVID-19

12 months
Periodic visits (in-person and virtual)

Data Validation

Validation of administrative data to collect participant hospital-based outcome measures

12 months

Treatment Details

Interventions

  • Nirmatrelvir/ritonavir
  • Remdesivir
Trial Overview The DEFEND trial is testing whether Paxlovid (Nirmatrelvir/ritonavir) or Veklury (Remdesivir) can prevent heart issues after COVID-19. It's a pilot study to set up for a larger future trial.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: VekluryExperimental Treatment1 Intervention
Veklury vs. placebo
Group II: PaxlovidExperimental Treatment1 Intervention
Paxlovid vs. placebo

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mount Sinai Hospital, Canada

Lead Sponsor

Trials
210
Recruited
70,700+

Kingston Health Sciences Centre

Collaborator

Trials
32
Recruited
34,400+

Kingston Health Sciences Centre (Kingston)

Collaborator

Trials
3
Recruited
12,300+

Niagara Health System

Collaborator

Trials
9
Recruited
2,800+

Unity Health Toronto

Collaborator

Trials
572
Recruited
470,000+

Findings from Research

A case series of 13 individuals with Long COVID who took extended courses of oral nirmatrelvir/ritonavir (7.5-30 days) showed that some experienced a meaningful reduction in symptoms, although the benefits were not consistent for all participants.
While some individuals reported improvements, one participant experienced significant side effects (intense stomach pain), highlighting the need for further research to determine who may benefit from this treatment and the optimal duration for effectiveness.
Impact of extended-course oral nirmatrelvir/ritonavir (Paxlovid) in established Long COVID: Case series and research considerations.Cohen, AK., Jaudon, TW., Schurman, EM., et al.[2023]
In the phase II/III EPIC-HR trial, the combination of nirmatrelvir and ritonavir (Paxlovid™) significantly reduced the risk of severe COVID-19 in symptomatic, unvaccinated adults with mild-to-moderate disease, showing lower rates of hospitalization or death compared to placebo.
Nirmatrelvir plus ritonavir is generally well tolerated, with most side effects being mild or moderate, indicating a favorable safety profile for this treatment option.
Nirmatrelvir plus ritonavir in COVID-19: a profile of its use.Blair, HA.[2023]
Nirmatrelvir/ritonavir (Paxlovid®) is an effective oral antiviral treatment for COVID-19, showing good tolerability and the potential to prevent severe complications when administered early in mild-to-moderate cases.
While it enhances the efficacy of nirmatrelvir, ritonavir can cause drug-drug interactions that may limit its use in patients on certain chronic medications, and there is a risk of infection relapse after treatment.
Preclinical discovery and development of nirmatrelvir/ritonavir combinational therapy for the treatment of COVID-19 and the lessons learned from SARS-COV-2 variants.Pagliano, P., Spera, A., Sellitto, C., et al.[2023]

References

Impact of extended-course oral nirmatrelvir/ritonavir (Paxlovid) in established Long COVID: Case series and research considerations. [2023]
Nirmatrelvir plus ritonavir in COVID-19: a profile of its use. [2023]
Preclinical discovery and development of nirmatrelvir/ritonavir combinational therapy for the treatment of COVID-19 and the lessons learned from SARS-COV-2 variants. [2023]
[Nirmatrelvir/ritonavir (Paxlovid®), a treatment for Covid-19]. [2022]
Efficacy and safety of Paxlovid in severe adult patients with SARS-Cov-2 infection: a multicenter randomized controlled study. [2023]
Nirmatrelvir combined with ritonavir for preventing and treating COVID-19. [2023]
Nirmatrelvir-ritonivir, COVID-19, and possible adverse cutaneous reactions. [2023]
COVID-19 rebound after oral treatment in a nursing home facility: A case series. [2023]
Hospitalization and Emergency Department Encounters for COVID-19 After Paxlovid Treatment - California, December 2021-May 2022. [2022]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security