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

NCT05513560 | Completed Phase 2 DMC

• 1 other identifier: 21-6203
• Study Type: interventional
• Target: 460
• Locations: 1 country
• Sites: 3

Brief 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

Outcome Measures

Primary Outcomes (1)

• SF-36 physical component score (PCS)

  mean change in the SF-36 (v.1) physical component score (PCS)

  from baseline to two months

Secondary Outcomes (15)

• Symptoms scale

  Baseline/Randomization weekly to 2 months, then once monthly to 6 months.

• Symptom Checklist

  Baseline/Randomization weekly to 2 months, then once monthly to 6 months.

• Six Minute Walking Test (6MWT) with oximetry

  Baseline/Randomization and 2 months

• TestMyBrain cognitive testing

  Baseline/Randomization to 1, 2 months 3 and 6 months

• Post COVID19 functional status scale

  Baseline/Randomization to 1, 2 months 3 and 6 months

Study Arms (3)

IBUDILAST

EXPERIMENTAL

Participants will receive 20 mg dose (2 pills) twice per day taken by mouth.

Drug: Ibudilast

PENTOXIFYLLINE

EXPERIMENTAL

Participants will receive a 400mg dose (1 pill) 3 times per day taken by mouth.

Drug: Pentoxifylline

PLACEBO

PLACEBO COMPARATOR

Participants will receive 2 placebo pills twice per day taken by mouth OR 1 placebo pill 3 times a day taken by mouth.

Other: Placebo

Interventions

Ibudilast DRUG

10mg pills, 2 pills twice per day

Also known as: MN-166

IBUDILAST

Pentoxifylline DRUG

400mg pill 3 times per day

PENTOXIFYLLINE

Placebo OTHER

Placebo matching ibudilast, 2 pills twice per day OR placebo matching pentoxifylline 1 pill 3 time per day.

PLACEBO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years;
• Positive COVID-19 test by nasopharyngeal swab RT-PCR (reverse transcription polymerase chain reaction) test, antibody or antigen tests at least 3 months prior to randomization; OR Presumed COVID-19 assessed by the site investigator (no positive COVID-19 test) with acute illness after October 15, 2019.
• Patients should be treated with standard of care therapies (as discussed in the study manual) for at least 4 weeks prior to entry into trial.
• 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;
• Lingering symptoms from COVID-19 present at the time of randomization.
• Female patients of childbearing potential (as assessed by the overseeing Investigator) who are sexually active must agree to practice true abstinence or use effective methods of contraception while on study treatment. Effective methods of contraception must be discussed and approved by the overseeing Investigator.
• Must be able to provide informed consent and both willing and able to comply with study requirements.

You may not qualify if:

• Patients who had mechanical ventilation or extracorporeal membrane oxygen (ECMO) for COVID-19;
• Current end-organ failure, organ transplantation, or current hospitalization in acute care hospital;
• Contraindications to all of the study interventions;
• Co-enrolment in another interventional trial (co-enrolment in an observational study is permitted);
• Currently pregnant or breastfeeding.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (3)

The Ottawa Hospital

Ottawa, Ontario, Canada

Location

University Health Network, Osteoporosis Department

Toronto, Ontario, M5G 2C4, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Interventions

ibudilast; Pentoxifylline

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Theobromine; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Angela M Cheung, MD,PhD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

• George Tomlinson, PhD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

• Peter Juni, MD, PhD

  Oxford University, UK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants are blinded to intervention in so far as the labelling of the study intervention. However, it is possible that the participant may figure out allocation arm, by the mode of administration, dosing frequency (once a day versus 3 times per day), and treatment form (pill, powder, intervention) etc.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: RECLAIM is a Canada-wide phase ll/lll, prospective, adaptive randomized controlled platform trial that is intended to study various interventions for patients with long COVID. Interventional arms may be discontinued based on interim analysis results and new interventions may be selected and included as part of the platform as the trial progresses. As such, the protocol and consent documents are a modular design including; * Master Protocol and informed consent documents: Contain information applicable to the whole platform. * Interventional Sub-Protocols: Contain additional information, specific to the interventional arm. Interventional Sub-Protocols may be modified, discontinued, or added without revisions to the Master Protocol.

Study Record Dates

• First Submitted: August 22, 2022
• First Posted: August 24, 2022
• Study Start: May 31, 2023
• Primary Completion: March 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 23, 2026

Record last verified: 2025-02

Locations

CA (3)