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

Trial Summary

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 data supports the effectiveness of the treatment COVIDEx for Long-COVID?

The effectiveness of COVIDEx for Long-COVID may be indirectly supported by research showing that early antiviral therapy reduces the risk of long COVID symptoms and related hospitalizations or deaths by about 27.5% and 29.7%, respectively. This suggests that treatments targeting the virus early could be beneficial for long COVID. ^{1 2 3 4 5}

How is the treatment COVIDEx different from other treatments for Long COVID?

COVIDEx is unique because there are currently no standard treatments for Long COVID, making it a novel option for addressing the persistent symptoms associated with this condition. ^{6 7 8 9 10}

What is the purpose of this trial?

Long COVID is a complex condition that affects approximately 1.4 million Canadians following SARS-CoV-2 infection. Fatigue is the most common symptom of Long COVID. This feasibility trial will evaluate a new rehabilitation program called COVIDEx for treating fatigue after COVID-19, and compare its effectiveness to the standard treatment currently used. The experimental treatment group will receive an 8-week multi-modal rehabilitation program with two 50-minute sessions per week. 60 participants will be recruited, randomly assigned to the COVIDEx program or standard of care (SoC) and followed for 24 weeks.

Research Team

Pavlos Bobos, PhD

Principal Investigator

Western University

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Long-Term Patient-Centred Follow-up in a Prospective Cohort of Patients with COVID-19. [2021]

2. India pubmed.ncbi.nlm.nih.gov

Supervised hospital based pulmonary rehabilitation outcome in long COVID-experience from a tertiary care hospital. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

The Greifswald Post COVID Rehabilitation Study and Research (PoCoRe)-Study Design, Characteristics and Evaluation Tools. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Effectiveness of Antiviral Therapy on Long COVID: A Systematic Review and Meta-Analysis. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Use of latent class analysis and patient reported outcome measures to identify distinct long COVID phenotypes: A longitudinal cohort study. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Persistent Symptoms in Adult Patients 1 Year After Coronavirus Disease 2019 (COVID-19): A Prospective Cohort Study. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Long-term high-dose immunoglobulin successfully treats Long COVID patients with pulmonary, neurologic, and cardiologic symptoms. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Role of Tau protein in long COVID and potential therapeutic targets. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

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

10. England pubmed.ncbi.nlm.nih.gov

Long COVID: An inevitable sequela of SARS-CoV-2 infection. [2023]