Clinical trial NCT05513560: RECLAIM: Recovering From COVID-19 Lingering Symptoms Adaptive Integrative Medicine
Official title: REcovering From COVID-19 Lingering Symptoms Adaptive Integrative Medicine (RECLAIM)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Long COVID
Post COVID Condition
Post Acute Sequelae of COVID-19
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2022-08-24
Enrollment: 460
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years;
2. 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.
3. 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.
4. 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;
5. Lingering symptoms from COVID-19 present at the time of randomization.
6. 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.
7. Must be able to provide informed consent and both willing and able to comply with study requirements.

Exclusion Criteria:

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

Primary outcomes:
measure: SF-36 physical component score (PCS)
timeFrame: from baseline to two months
Secondary outcomes:
measure: Symptoms scale
timeFrame: Baseline/Randomization weekly to 2 months, then once monthly to 6 months.
measure: Symptom Checklist
timeFrame: Baseline/Randomization weekly to 2 months, then once monthly to 6 months.
measure: Six Minute Walking Test (6MWT) with oximetry
timeFrame: Baseline/Randomization and 2 months
measure: TestMyBrain cognitive testing
timeFrame: Baseline/Randomization to 1, 2 months 3 and 6 months
measure: Post COVID19 functional status scale
timeFrame: Baseline/Randomization to 1, 2 months 3 and 6 months
measure: Reintegration to Normal Living Index (RNLI)
timeFrame: Baseline/Randomization to 1, 2 months 3 and 6 months
measure: Fatigue Scale
timeFrame: Baseline/Randomization to 1, 2 months 3 and 6 months
measure: Brief Fatigue inventory
timeFrame: Baseline/Randomization to 1, 2 months 3 and 6 months
measure: Post-Exertional Malaise
timeFrame: Baseline/Randomization to 1, 2 months 3 and 6 months
measure: Mental Health - Post-traumatic Stress Disorder Checklist (PCL-5)
timeFrame: Baseline/Randomization to 1, 2 months 3 and 6 months
measure: Mental Health - General Anxiety Assessment Form (GAD-7)
timeFrame: Baseline/Randomization to 1, 2 months 3 and 6 months
measure: Mental Health - Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline/Randomization to 1, 2 months 3 and 6 months
measure: Mental Health Composite score (MCS) of the SF-36
timeFrame: Baseline/Randomization to 1, 2 months 3 and 6 months
measure: Dyspnea
timeFrame: Baseline/Randomization to 1, 2 months 3 and 6 months
measure: Blood samples
timeFrame: Baseline/Randomization and 2 months
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Toronto
country: Canada
facility: University Health Network, Osteoporosis Department
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Angela M Cheung, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Health Network, Toronto
name: George Tomlinson, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oxford University, UK
name: Peter Juni, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: