NCT05513560

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

REcovering From COVID-19 Lingering Symptoms Adaptive Integrative Medicine (RECLAIM)

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 460 (actual)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Long COVID
• Post COVID Condition
• Post Acute Sequelae of COVID-19

Interventions

Type	Name	Description
DRUG	Ibudilast	10mg pills, 2 pills twice per day
DRUG	Pentoxifylline	400mg pill 3 times per day
OTHER	Placebo	Placebo matching ibudilast, 2 pills twice per day OR placebo matching pentoxifylline 1 pill 3 time per day.

Timeline

• Start date: 2023-05-31
• Primary completion: 2025-03-31
• Completion: 2025-12-31
• First posted: 2022-08-24
• Last updated: 2026-02-23

Locations

3 sites across 1 country: Canada