Enhanced External Counterpulsation to Treat Long COVID-19 Fatigue

NCT05668039 | Unknown

• 1 other identifier: EECP for long COVID-19
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this double blind, outcome-assessor blind, randomized controlled trial, is to compare the effectiveness of external encounter counterpulsation (EECP) versus sham procedure in participants with long COVID-19 fatigue. The main question\[s\] it aims to answer are:

• Whether EECP improves fatigue score
• Whether EECP improves quality of life, six-minute walk test, and endothelial function Participants will attend 15 sessions (1-hour each) of EECP during 5 weeks Researchers will compare EECP versus sham procedure for the above outcomes.

Conditions

Post-Acute COVID-19 Syndrome

Keywords

long COVID; Enhanced eXternal counterpulsation

Outcome Measures

Primary Outcomes (1)

• Change in fatigue score

  Change in PROMIS Fatigue 7a T score from baseline. Minimum score is 29, maximum 83, higher levels indicate worse outcome

  15 weeks

Secondary Outcomes (3)

• Change in quality of life score

  15 weeks

• Change in six-minute walk test

  15 weeks

• Cahnge in endothelial function

  15 weeks

Study Arms (2)

Enhanced external counterpulsation

EXPERIMENTAL

Enhanced external counterpulsation (EECP/ECPT) is a non-invasive technique used to improve cardiac and cerebral perfusion. It aims to achieve 'diastolic augmentation' by increasing arterial blood pressure and retrograde aortic blood flow during diastole. This technique is currently used to treat refractory angina and heart failure, and was demonstrated to be well tolerated without limiting side effect. Practially, blood pressure cuffs are put along the lower limbs and are inflated to 300 mmHg pressure intermittently during one hour session. 15 sessions will be performed over 15 weeks.

Procedure: Enhanced external counterpulsation

Sham procedure

SHAM COMPARATOR

The procedure will be identical to the experimental procedure, excluding the pressure that will reach only 80 mmHg.

Procedure: Enhanced external counterpulsation

Interventions

Enhanced external counterpulsation PROCEDURE

15 one-hour sessions during 15 weeks of enhanced external counterpulsation.

Enhanced external counterpulsation; Sham procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients recovering from PCR or lateral flow testing proven acute COVID-19
• months following the acute infection
• Suffering from fatigue with a PROMIS-SF-7a T-score of \> 50

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba medical center

Ramat Gan, 52621, Israel

RECRUITING

Related Publications (14)

• Michelen M, Manoharan L, Elkheir N, Cheng V, Dagens A, Hastie C, O'Hara M, Suett J, Dahmash D, Bugaeva P, Rigby I, Munblit D, Harriss E, Burls A, Foote C, Scott J, Carson G, Olliaro P, Sigfrid L, Stavropoulou C. Characterising long COVID: a living systematic review. BMJ Glob Health. 2021 Sep;6(9):e005427. doi: 10.1136/bmjgh-2021-005427.

  PMID: 34580069 BACKGROUND

• Soriano JB, Murthy S, Marshall JC, Relan P, Diaz JV; WHO Clinical Case Definition Working Group on Post-COVID-19 Condition. A clinical case definition of post-COVID-19 condition by a Delphi consensus. Lancet Infect Dis. 2022 Apr;22(4):e102-e107. doi: 10.1016/S1473-3099(21)00703-9. Epub 2021 Dec 21.

  PMID: 34951953 BACKGROUND

• Yelin D, Moschopoulos CD, Margalit I, Gkrania-Klotsas E, Landi F, Stahl JP, Yahav D. ESCMID rapid guidelines for assessment and management of long COVID. Clin Microbiol Infect. 2022 Jul;28(7):955-972. doi: 10.1016/j.cmi.2022.02.018. Epub 2022 Feb 17.

  PMID: 35182760 BACKGROUND

• Buoite Stella A, Furlanis G, Frezza NA, Valentinotti R, Ajcevic M, Manganotti P. Autonomic dysfunction in post-COVID patients with and witfhout neurological symptoms: a prospective multidomain observational study. J Neurol. 2022 Feb;269(2):587-596. doi: 10.1007/s00415-021-10735-y. Epub 2021 Aug 12.

  PMID: 34386903 BACKGROUND

• Fogarty H, Townsend L, Morrin H, Ahmad A, Comerford C, Karampini E, Englert H, Byrne M, Bergin C, O'Sullivan JM, Martin-Loeches I, Nadarajan P, Bannan C, Mallon PW, Curley GF, Preston RJS, Rehill AM, McGonagle D, Ni Cheallaigh C, Baker RI, Renne T, Ward SE, O'Donnell JS; Irish COVID-19 Vasculopathy Study (iCVS) investigators. Persistent endotheliopathy in the pathogenesis of long COVID syndrome. J Thromb Haemost. 2021 Oct;19(10):2546-2553. doi: 10.1111/jth.15490. Epub 2021 Sep 12.

  PMID: 34375505 BACKGROUND

• Pretorius E, Vlok M, Venter C, Bezuidenhout JA, Laubscher GJ, Steenkamp J, Kell DB. Persistent clotting protein pathology in Long COVID/Post-Acute Sequelae of COVID-19 (PASC) is accompanied by increased levels of antiplasmin. Cardiovasc Diabetol. 2021 Aug 23;20(1):172. doi: 10.1186/s12933-021-01359-7.

  PMID: 34425843 BACKGROUND

• Shechter M, Matetzky S, Feinberg MS, Chouraqui P, Rotstein Z, Hod H. External counterpulsation therapy improves endothelial function in patients with refractory angina pectoris. J Am Coll Cardiol. 2003 Dec 17;42(12):2090-5. doi: 10.1016/j.jacc.2003.05.013.

  PMID: 14680732 BACKGROUND

• Bonetti PO, Barsness GW, Keelan PC, Schnell TI, Pumper GM, Kuvin JT, Schnall RP, Holmes DR, Higano ST, Lerman A. Enhanced external counterpulsation improves endothelial function in patients with symptomatic coronary artery disease. J Am Coll Cardiol. 2003 May 21;41(10):1761-8. doi: 10.1016/s0735-1097(03)00329-2.

  PMID: 12767662 BACKGROUND

• Varanasi S, Sathyamoorthy M, Chamakura S, Shah SA. Management of Long-COVID Postural Orthostatic Tachycardia Syndrome With Enhanced External Counterpulsation. Cureus. 2021 Sep 30;13(9):e18398. doi: 10.7759/cureus.18398. eCollection 2021 Sep.

  PMID: 34729276 BACKGROUND

• Dayrit JK, Verduzco-Gutierrez M, Teal A, Shah SA. Enhanced External Counterpulsation as a Novel Treatment for Post-acute COVID-19 Sequelae. Cureus. 2021 Apr 7;13(4):e14358. doi: 10.7759/cureus.14358.

  PMID: 33987042 BACKGROUND

• Yang M, Keller S, Lin JS. Psychometric properties of the PROMIS(R) Fatigue Short Form 7a among adults with myalgic encephalomyelitis/chronic fatigue syndrome. Qual Life Res. 2019 Dec;28(12):3375-3384. doi: 10.1007/s11136-019-02289-4. Epub 2019 Sep 10.

  PMID: 31506915 BACKGROUND

• Fan X, Lee KS, Frazier SK, Lennie TA, Moser DK. Psychometric testing of the Duke Activity Status Index in patients with heart failure. Eur J Cardiovasc Nurs. 2015 Jun;14(3):214-21. doi: 10.1177/1474515114523354. Epub 2014 Feb 5.

  PMID: 24504873 BACKGROUND

• Rajala K, Lehto JT, Sutinen E, Kautiainen H, Myllarniemi M, Saarto T. mMRC dyspnoea scale indicates impaired quality of life and increased pain in patients with idiopathic pulmonary fibrosis. ERJ Open Res. 2017 Dec 14;3(4):00084-2017. doi: 10.1183/23120541.00084-2017. eCollection 2017 Oct.

  PMID: 29255720 BACKGROUND

• Lins L, Carvalho FM. SF-36 total score as a single measure of health-related quality of life: Scoping review. SAGE Open Med. 2016 Oct 4;4:2050312116671725. doi: 10.1177/2050312116671725. eCollection 2016.

  PMID: 27757230 BACKGROUND

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dana Yelin, MD

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dafna Yahav, MD

CONTACT

972548866488; Dafna.Yahav@sheba.health.gov.il

Dana Yelin, MD

CONTACT

972545383536; Dana.Yelin@sheba.health.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Masking of participants - the sham procedure includes the same location of pneumatic blood-pressure cuffs used for the intervention; and will be perfoemd in the same frequency and duration as the intervention. Participants will be invited for the procedures at separate times to avoid connection between them. Masking of investigator and outcome assessor - unblinded nurses and one unblinded physician will be responsible for performing the procedures (either intervention or sham), without involving other team members (other investigators or outcome assessors), who would remain blinded to the treatment arm.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Infectious Diseases Unit

Model Details: Double blind, outcome assossor blind, randomized controlled trial

Study Record Dates

• First Submitted: December 24, 2022
• First Posted: December 29, 2022
• Study Start: April 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: July 1, 2024
• Last Updated: November 30, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share

Locations

IL (1)