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Ibudilast + Pentoxifylline for Long COVID (RECLAIM Trial)

Phase 2 & 3
Recruiting
Led By Angela M Cheung, MD,PhD
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥18 years
Lingering COVID-19 symptoms beyond 3 months from onset of acute COVID and symptoms have lasted at least 2 months. The onset of COVID is considered the earliest of two dates: the date of positive test or the date of first symptoms
Must not have
Contraindications to all of the study interventions
Patients who had mechanical ventilation or extracorporeal membrane oxygen (ECMO) for COVID-19
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to two months

Summary

This trial will test two treatments to find the best way to help people with long-term COVID-19 symptoms. It will adapt based on early results, stopping ineffective treatments and adding new ones as needed.

Who is the study for?
Adults over 18 with Long COVID symptoms persisting for more than 3 months since the earliest of a positive test or symptom onset, and who have been symptomatic for at least 2 months. Participants must have tried standard care therapies for 4 weeks, be able to consent, follow study rules, and if capable of childbearing, agree to use approved contraception methods. Excludes those who had severe COVID requiring mechanical ventilation or ECMO, current severe organ failure or transplant patients.
What is being tested?
The RECLAIM trial is testing Ibudilast and Pentoxifylline against a placebo in Canadian patients with Long COVID. It's an adaptive trial that can modify its arms based on effectiveness results during the process. Treatment lasts two months with four additional months of follow-up to evaluate recovery from lingering symptoms.
What are the potential side effects?
While specific side effects are not listed here, typical reactions may include gastrointestinal discomfort, headaches, dizziness or fatigue. Since this is a trial setting, monitoring will be rigorous and any unexpected side effects will be documented.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have had COVID-19 symptoms for more than 3 months since I first got sick.
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I still have symptoms from COVID-19.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot undergo any of the treatments offered in this study due to health reasons.
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I was on a ventilator or ECMO for COVID-19 treatment.
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I do not have organ failure, haven't had an organ transplant, and am not in the hospital.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline/randomization to 1, 2 months 3 and 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline/randomization to 1, 2 months 3 and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
SF-36 physical component score (PCS)
Secondary study objectives
Blood samples
Brief Fatigue inventory
Dyspnea
+12 more

Side effects data

From 2017 Phase 2 trial • 125 Patients • NCT01860807
50%
Headache
17%
Nausea
16%
Insomnia
13%
Diarrhea
2%
Suicide Attempt
2%
Convulsion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ibudilast
Placebo

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: PENTOXIFYLLINEExperimental Treatment1 Intervention
Participants will receive a 400mg dose (1 pill) 3 times per day taken by mouth.
Group II: IBUDILASTExperimental Treatment1 Intervention
Participants will receive 20 mg dose (2 pills) twice per day taken by mouth.
Group III: PLACEBOPlacebo Group1 Intervention
Participants will receive 2 placebo pills twice per day taken by mouth OR 1 placebo pill 3 times a day taken by mouth.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ibudilast
2016
Completed Phase 2
~410
Pentoxifylline
2021
Completed Phase 4
~1080

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Post-COVID Syndrome include anti-inflammatory medications, which reduce inflammation that may persist after the acute phase of COVID-19; antiviral drugs, which aim to eliminate any lingering viral particles; and supportive therapies like respiratory rehabilitation and corticosteroids, which help improve lung function and reduce symptoms. These treatments are important for Post-COVID Syndrome patients as they address the root causes of their persistent symptoms, potentially leading to better health outcomes and improved quality of life.

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,519 Previous Clinical Trials
502,275 Total Patients Enrolled
Angela M Cheung, MD,PhDPrincipal InvestigatorUniversity Health Network, Toronto
George Tomlinson, PhDPrincipal InvestigatorUniversity Health Network, Toronto
1 Previous Clinical Trials
306 Total Patients Enrolled

Media Library

Ibudilast (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05513560 — Phase 2 & 3
Post-COVID Syndrome Research Study Groups: IBUDILAST, PENTOXIFYLLINE, PLACEBO
Post-COVID Syndrome Clinical Trial 2023: Ibudilast Highlights & Side Effects. Trial Name: NCT05513560 — Phase 2 & 3
Ibudilast (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05513560 — Phase 2 & 3
~261 spots leftby May 2025