Using Enhanced External Counterpulsation to Treat Long COVID Fatigue
Enhanced External Counterpulsation (EECP/ECPT) to Treat Long-COVID-19 Fatigue - a Randomized Controlled Trial
This study is testing if a special treatment called Enhanced External Counterpulsation can help people with long COVID feel less tired and improve their overall quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sheba Medical Center Government |
| Locations | 1 site (Ramat Gan) |
| Trial ID | NCT05668039 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of Enhanced External Counterpulsation (EECP) in alleviating fatigue in patients suffering from long COVID-19. Participants, who are recovering from acute COVID-19 and experiencing significant fatigue, will be randomly assigned to receive either EECP treatment or a sham procedure over 15 sessions within five weeks. The study will assess improvements in fatigue scores, quality of life, and physical endurance through various tests and questionnaires. The trial is designed to be double-blind to ensure unbiased results.
Who should consider this trial
Good fit: Ideal candidates are individuals recovering from acute COVID-19, 3-12 months post-infection, with a PROMIS-Fatigue score greater than 50.
Not a fit: Patients with severe cardiovascular conditions or other significant health issues that contraindicate EECP will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce fatigue and improve the quality of life for patients suffering from long COVID.
How similar studies have performed: While the use of EECP for long COVID is a novel approach, similar studies have shown promise in treating other conditions related to fatigue and cardiovascular health.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients recovering from PCR or lateral flow testing proven acute COVID-19 * 3-12 months following the acute infection * Suffering from fatigue with a PROMIS-SF-7a T-score of \> 50 Exclusion Criteria: * Acute decompensated heart failure * Recent myocardial infarction within the last 3 months * Unstable angina pectoris * Severe hypertension \> 180/110 mm Hg * Coagulopathy with international normalized ratio of prothrombin time \> 2.0 * Moderate to severe aortic regurgitation * Abdominal aortic aneurysm (\>5 mm) or dissection * Arrhythmias that may interfere with triggering of EECP system (uncontrolled atrial fibrillation, flutter and very frequent premature ventricular contractions) * Heart rate of \<35 or \>125 beats per minute * Any surgical intervention within 6 weeks before EECP * Recent cardiac catheterization (1-2 weeks) or arterial femoral puncture * Severe peripheral arterial disease * Severe venous disease (thrombophlebitis, prior or current deep vein thrombosis or pulmonary embolism) * Severe chronic obstructive pulmonary disease * Pregnancy or women of childbearing age who do not have a negative pregnancy test
Where this trial is running
Ramat Gan
- Sheba medical center — Ramat Gan, Israel (Recruiting)
Study contacts
- Principal investigator: Dana Yelin, MD — Sheba Medical Center
- Study coordinator: Dafna Yahav, MD
- Email: Dafna.Yahav@sheba.health.gov.il
- Phone: 972548866488
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.