What side effects are associated with this type of intervention?

The trial for Long COVID is studying various interventions, though specific treatments are not detailed. Common treatments for Post-COVID Syndrome include medications like metformin, zinc, and peginterferon lambda. Metformin can cause gastrointestinal issues such as nausea, vomiting, and diarrhea. Zinc supplementation may lead to nausea, a metallic taste, and gastrointestinal discomfort. Peginterferon lambda can cause flu-like symptoms, including fever, fatigue, and muscle aches. These treatments aim to alleviate lingering symptoms but come with potential side effects that should be discussed with a healthcare provider.

What prior FDA approvals exist?

As of now, there are no specific FDA-approved treatments exclusively for Post-COVID Syndrome (Long COVID). The RECLAIM trial is exploring various interventions to address lingering symptoms of COVID-19, but it does not specify which treatments are being tested. Current management of Long COVID generally involves symptomatic treatment and supportive care, tailored to the individual's specific symptoms and needs.

What other types of research exist?

Promising novel alternatives for treating Long COVID in 2024 include interventions being tested in the RECLAIM trial, which is an adaptive randomized clinical platform trial assessing various treatments. Additionally, targeting macrophage recruitment, interferon signaling, cytokine storm, pulmonary fibrosis, and hypercoagulability are emerging therapeutic strategies.

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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 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

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

Suicide Attempt

Convulsion

100%

80%

60%

40%

20%

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

0 / 6Eligibility criteria met

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.