COVIDEx for Long-COVID

(PREFACER Trial)

Overseen By Nicole Billias, BPH, CPT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Lawson Health Research Institute

Disqualifiers: Active COVID-19, Major neurocognitive disorder, Schizophrenia, Chronic fatigue syndrome, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 20

Duration: 8 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new rehabilitation program, COVIDEx, designed to reduce fatigue in individuals experiencing Long COVID. It compares this program to the usual care for fatigue after a COVID-19 infection. Participants will either join the COVIDEx group for 8 weeks of therapy sessions or continue with standard care, with progress tracked over 24 weeks. This trial suits individuals who have struggled with fatigue for at least two months after recovering from COVID-19 and can manage light physical activity. As an unphased trial, this study offers a unique opportunity to contribute to pioneering research that could improve care for Long COVID fatigue.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the COVIDEx rehabilitation program is safe for treating fatigue after COVID-19?

Research into the COVIDEx program remains in its early stages, so few studies have examined its safety. This treatment is still being explored, resulting in limited information on patient tolerance. As a rehabilitation program, it is non-invasive and centers on exercises and activities. Generally, rehabilitation programs are considered safe because they do not involve medication or surgery. However, as an experimental treatment, the safety data is not yet fully established. Researchers will closely monitor participants to identify and address any risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

COVIDEx is unique because it offers a structured rehabilitation approach specifically designed for individuals with Long-COVID. Unlike standard care, which typically involves managing symptoms without specific interventions, COVIDEx provides targeted rehabilitation sessions aimed at improving physical function and recovery. Researchers are excited about COVIDEx because it may accelerate recovery and improve the overall quality of life for patients suffering from persistent symptoms after a COVID-19 infection.

What evidence suggests that the COVIDEx program is effective for treating fatigue in Long COVID?

Research has shown that rehabilitation programs can improve symptoms in people with Long COVID. Studies have found that these programs may effectively reduce fatigue, the most common symptom of Long COVID. Participants have also shown improvements in other symptoms, such as memory problems and overall quality of life. This trial will evaluate the effectiveness of COVIDEx, an experimental rehabilitation program, in reducing fatigue and other related issues in Long COVID patients. Early findings suggest that structured rehabilitation, like COVIDEx, can offer real benefits for those experiencing ongoing symptoms after COVID-19. ^{6 7 8 9 10}

Who Is on the Research Team?

Pavlos Bobos, PhD

Principal Investigator

Western University

Are You a Good Fit for This Trial?

This trial is for adults over 18 who've had COVID-19 and are experiencing fatigue that started within 3 months of infection and lasted at least 2 months. Participants must be able to consent and have no other explanation for their fatigue.

Inclusion Criteria

My fatigue is not caused by another known condition.

I have had COVID-19 confirmed by a test or doctor.

I've had fatigue for 2 months since getting COVID-19.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an 8-week multi-modal rehabilitation program with two 50-minute sessions per week

8 weeks

16 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

16 weeks

4 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• COVIDEx

Trial Overview

The PREFACER trial is testing a new rehab program called COVIDEx, designed to reduce post-COVID fatigue. It involves an 8-week course with two sessions per week, compared against standard treatment over a period of 24 weeks.

How Is the Trial Designed?

Group I: COVIDEx Experimental Treatment 1 Intervention

This group will receive two 50-minute rehabilitation sessions per week for 8 weeks.

Group II: Standard of Care Active Control 1 Intervention

This group will receive standard of care (no intervention) for the 8-week intervention period.

Who Is Running the Clinical Trial?

Lawson Health Research Institute

Lead Sponsor

Trials

684

Recruited

432,000+

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

686

Recruited

427,000+

Lawson Research Institute of St. Joseph's

Lead Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

678

Recruited

421,000+

Western University

Collaborator

Trials

31

Recruited

129,000+

Western University, Canada

Collaborator

Trials

270

Recruited

62,500+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Published Research Related to This Trial

Long COVID affects an estimated 10% to 35% of individuals who have had COVID-19, leading to a range of debilitating symptoms and increased risk of psychiatric disorders, including self-harm.

Customized compounded medications may offer effective relief for patients who find standard treatments ineffective or intolerable, highlighting the importance of personalized therapy in managing long COVID.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Compounding for the Treatment of COVID-19 and Long COVID, Part 4: The Legacy of Chronic COVID. Riepl, M., Kaiser, J.[2023]

Citations

1.

sciencedirect.com

sciencedirect.com/science/article/pii/S0003999324007779

Long COVID (Post Acute Sequelae of SARS-CoV-2 ...

Objective(s). To assess and report current effective treatments on clinical outcomes for adults with Long-COVID. Data Sources. We searched PubMed ...

2.

archives-pmr.org

archives-pmr.org/article/S0003-9993(24)00777-9/fulltext

Long COVID (Post Acute Sequelae of SARS-CoV-2 ...

Clinical improvements of various symptomatology including olfactory, cognitive and memory dysfunction, fatigue, visual field, and quality of life were noted in ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11493926/

Post-acute sequelae of SARS-CoV-2 infection (Long COVID ...

Long COVID, also known as PASC (post-acute sequelae of SARS-CoV-2), is a complex infection-associated chronic condition affecting tens of millions of people ...

4.

nature.com

nature.com/articles/s41591-024-02987-8

Three-year outcomes of post-acute sequelae of COVID-19

Our findings show reduction of risks over time, but the burden of mortality and health loss remains in the third year among hospitalized individuals.

5.

thelancet.com

thelancet.com/journals/eclinm/article/PIIS2589-5370(23)00177-3/fulltext

Long-term post-acute sequelae of COVID-19 infection

This study aims to generate coherent evidence on the risk of long-term clinical sequelae of patients recovering from COVID-19 infection using ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11363684/

Postacute Sequelae of COVID (PASC or Long COVID)

PASC is a defined syndrome with ongoing, relapsing, or new conditions after documented or diagnosed infection with SARS-CoV-2.

7.

jamanetwork.com

jamanetwork.com/journals/jama/fullarticle/2805540

Development of a Definition of Postacute Sequelae ...

Postacute sequelae of SARS-CoV-2 infection (PASC), also known as long COVID and defined as ongoing, relapsing, or new symptoms or conditions ...

8.

thelancet.com

thelancet.com/journals/lanam/article/PIIS2667-193X(24)00311-9/fulltext

SARS-COV-2 re-infection and incidence of post-acute ...

This study investigated the association between the number of COVID-19 episodes and the incidence of PASC among essential workers.

9.

nature.com

nature.com/articles/s41591-023-02521-2

Postacute sequelae of COVID-19 at 2 years

SARS-CoV-2 infection can lead to postacute sequelae in multiple organ systems, but evidence is mostly limited to the first year postinfection.

10.

wwwnc.cdc.gov

wwwnc.cdc.gov/eid/article/29/3/22-1522_article

Postacute Sequelae of SARS-CoV-2 in University Setting

It is estimated that 1 in 3 Americans who have SARS-CoV-2 infection will experience symptoms related to postacute sequelae of SARS-CoV-2 (1), also referred to ...