RECLAIM: Recovering From COVID-19 Lingering Symptoms Adaptive Integrative Medicine

Last updated: February 11, 2025
Sponsor: University Health Network, Toronto
Overall Status: Active - Not Recruiting

Phase

2/3

Condition

Covid-19

Treatment

Ibudilast

Pentoxifylline

Placebo

Clinical Study ID

NCT05513560
21-6203
  • Ages > 18
  • All Genders

Study Summary

The researchers propose to develop a Canada-wide, adaptive randomized clinical platform trial to assess the effectiveness of various interventions in patients with lingering symptoms of COVID-19 ("Long COVID"). Participants will be randomized initially to 1 of 3 arms, including placebo (control) and 2 interventions. Because this is an adaptive trial, arms can be dropped if found to be ineffective and new arms can be added.

Interventions will last for 2 months and participants will be followed for an additional 4 months (6 months total). Approximately 800-1000 patients with Long COVID will be recruited across Canada. Results from this trial will accelerate the availability of high-quality, real-time evidence and solutions to enable Canada to improve the clinical care of patients with Long COVID.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥18 years;

  2. Positive COVID-19 test by nasopharyngeal swab RT-PCR (reverse transcriptionpolymerase chain reaction) test, antibody or antigen tests at least 3 months priorto randomization; OR Presumed COVID-19 assessed by the site investigator (nopositive COVID-19 test) with acute illness after October 15, 2019.

  3. Patients should be treated with standard of care therapies (as discussed in thestudy manual) for at least 4 weeks prior to entry into trial.

  4. Lingering COVID-19 symptoms beyond 3 months from onset of acute COVID and symptomshave lasted at least 2 months. The onset of COVID is considered the earliest of twodates: the date of positive test or the date of first symptoms;

  5. Lingering symptoms from COVID-19 present at the time of randomization.

  6. Female patients of childbearing potential (as assessed by the overseeingInvestigator) who are sexually active must agree to practice true abstinence or useeffective methods of contraception while on study treatment. Effective methods ofcontraception must be discussed and approved by the overseeing Investigator.

  7. Must be able to provide informed consent and both willing and able to comply withstudy requirements.

Exclusion

Exclusion Criteria:

  1. Patients who had mechanical ventilation or extracorporeal membrane oxygen (ECMO) forCOVID-19;

  2. Current end-organ failure, organ transplantation, or current hospitalization inacute care hospital;

  3. Contraindications to all of the study interventions;

  4. Co-enrolment in another interventional trial (co-enrolment in an observational studyis permitted);

  5. Currently pregnant or breastfeeding.

Study Design

Total Participants: 460
Treatment Group(s): 3
Primary Treatment: Ibudilast
Phase: 2/3
Study Start date:
May 31, 2023
Estimated Completion Date:
March 31, 2025

Connect with a study center

  • The Ottawa Hospital

    Ottawa, Ontario
    Canada

    Site Not Available

  • Mount Sinai Hospital

    Toronto, Ontario
    Canada

    Site Not Available

  • University Health Network, Osteoporosis Department

    Toronto, Ontario M5G 2C4
    Canada

    Site Not Available

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