RECLAIM: Recovering From COVID-19 Lingering Symptoms Adap... | NCT05513560

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

NCT05513560

Sponsor

University Health Network, Toronto

Status

Completed

Last Update Posted

Feb 23, 2026Actual

Enrollment

460Actual

Phase

Phase 2Phase 3

Conditions

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

Interventions

Ibudilast
Pentoxifylline
Placebo

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 31, 2023Actual

Primary Completion Date

Mar 31, 2025Actual

Completion Date

Dec 31, 2025Actual

First Submitted Date

Aug 22, 2022

First Submission Date that Met QC Criteria

Aug 22, 2022

First Posted Date

Aug 24, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 19, 2026

Last Update Posted Date

Feb 23, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

460Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Ibudilast	Drug	10mg pills, 2 pills twice per day	IBUDILAST	MN-166

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Symptoms scale	Three point Likert scale assessing how bothersome symptoms are on a weekly basis for two months then monthly until end of study, as reported by the participant: to provide a granular, detailed picture of the symptom trajectory.	Baseline/Randomization weekly to 2 months, then once monthly to 6 months.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Ottawa Hospital		Ottawa	Ontario		Canada
University Health Network, Osteoporosis Department

ID	Term
D000094024	Post-Acute COVID-19 Syndrome

ID	Term
D000086382	COVID-19
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections

ID	Term
C038366	ibudilast
D010431	Pentoxifylline

ID	Term
D013805	Theobromine
D014970	Xanthines
D011688	Purinones
D011687	Purines
D006574

Intervention Model Description

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.

Masking Info

Masking

Triple

Masking Description

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.

Who Masked

ParticipantInvestigatorOutcomes Assessor