drugset / Trial / NCT05513560

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

NCT05513560

Phase 2/3 Completed 460 enrolled University Health Network, Toronto
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2023-05-31
Primary completion
2025-03-31
Completion
2025-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Ibudilast Small molecule 20 mg Oral
Subject Pentoxifylline Small molecule 400 mg Oral

Indications