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Ibudilast + Pentoxifylline for Long COVID (RECLAIM Trial)
Phase 2 & 3
Recruiting
Led By Peter Juni, 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline/randomization to 1, 2 months 3 and 6 months
Awards & highlights
RECLAIM Trial Summary
This trial will help researchers find the best interventions for patients with Long COVID. It is a Canada-wide trial that will last for 6 months and will include 800-1000 patients.
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.Check my eligibility
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.See study design
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.
RECLAIM Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I have had COVID-19 symptoms for more than 3 months since I first got sick.
Select...
I still have symptoms from COVID-19.
RECLAIM Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline/randomization to 1, 2 months 3 and 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline/randomization to 1, 2 months 3 and 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
SF-36 physical component score (PCS)
Secondary outcome measures
Blood samples
Brief Fatigue inventory
Dyspnea
+12 moreSide effects data
From 2017 Phase 2 trial • 125 Patients • NCT0186080750%
Headache
17%
Nausea
16%
Insomnia
13%
Diarrhea
2%
Suicide Attempt
2%
Convulsion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ibudilast
Placebo
RECLAIM 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
2013
Completed Phase 2
~340
Pentoxifylline
2021
Completed Phase 4
~1140
Find a Location
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,482 Previous Clinical Trials
485,422 Total Patients Enrolled
Peter Juni, MD, PhDPrincipal InvestigatorOxford University, UK
Angela M Cheung, MD,PhDPrincipal InvestigatorUniversity Health Network, Toronto
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I have had COVID-19 symptoms for more than 3 months since I first got sick.I cannot undergo any of the treatments offered in this study due to health reasons.I have been on standard cancer treatment for at least 4 weeks.I was on a ventilator or ECMO for COVID-19 treatment.I do not have organ failure, haven't had an organ transplant, and am not in the hospital.I still have symptoms from COVID-19.You have tested positive for COVID-19 in the past three months, or you have symptoms of COVID-19 without a positive test since October 15, 2019.
Research Study Groups:
This trial has the following groups:- Group 1: IBUDILAST
- Group 2: PENTOXIFYLLINE
- Group 3: PLACEBO
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are we still receiving applications for this experiment?
"The clinicaltrials.gov website indicates that this trial is not currently recruiting patients. This particular study was posted on September 1st, 2022 and was last updated on September 12th, 2022. There are 1136 other trials enrolling patients at the moment."
Answered by AI
Who else is applying?
What site did they apply to?
University Health Network, Osteoporosis Department
What portion of applicants met pre-screening criteria?
Met criteria
Why did patients apply to this trial?
I am in desperate need of help with long Covid. I am 25 years old and it has ruined my ability to function as I did prior to being afflicted with Covid in January of 2021.
PatientReceived 1 prior treatment
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