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

NCT05513560 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 460

Last updated 2026-02-23

No results posted yet for this 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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • Angela M Cheung, MD,PhD · University Health Network, Toronto

  • George Tomlinson, PhD · University Health Network, Toronto

  • Peter Juni, MD, PhD · Oxford University, UK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05513560 on ClinicalTrials.gov