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Post-Acute COVID-19 SyndromeEXPECTNCT05668039

Enhanced External Counterpulsation to Treat Long COVID-19 Fatigue

A study testing Enhanced external counterpulsation in people with Post-Acute COVID-19 Syndrome, run by Sheba Medical Center at 1 site in Israel.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Post-Acute COVID-19 Syndrome
What is being tested?
Enhanced external counterpulsation
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
32 participants
Where
1 siteIsrael
Study dates
1 Apr 2023to Jul 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Dafna Yahav, MD contact

972548866488

Dafna.Yahav@sheba.health.gov.il

Dana Yelin, MD contact

972545383536

Dana.Yelin@sheba.health.gov.il

Israel1 site, 1 recruiting

  • Sheba medical center

    Ramat Gan, 52621

    Dana Yelin, MD, Dana.Yelin@sheba.health.gov.il

    Recruiting

Other trials in Israel

About this study

Official title: Enhanced External Counterpulsation (EECP/ECPT) to Treat Long-COVID-19 Fatigue - a Randomized Controlled Trial

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.
Read the detailed description

Participants of this trial will be patients recovering from acute COVID-19, 3-12 months following the acute infection, and suffering from fatigue with a Patient-Reported Outcomes Measurement System (PROMIS)-Fatigue short-form (SF)-7a score of > 50.

Exclusion criteria will include contra-indications for EECP (see protocl). Intervention, comparisn and outcomes are described above. Study plan: participants will be invited using social media, after filling a fatigue score (PROMIS) to test for eligibility. Those with a score of > 50 will be invited for a study visit.

Study visit 1 will include informed consent, followed by physician interview, physical examination, ECG; and will be referred for completion of blood tests including complete blood count (CBC) to rule out significant anemia (Hb< 12 for men or hb <10 for women) and serum beta human chorionic gonadotrophin (bHCG).

Eligible patients will then be randomized into two groups for treatment with EECP vs sham procedure. In study Visit 2 they will answer several questionnaires, perforn EndoPAT test to assess endothelial dysfunction, and six-minute walk test, followed by either:

  1. Treatment group- 1 hour EECP session
  2. Sham group - 1 hour of a sham EECP session (patients will be hooked to the EECP device but it will be set to the lowest setting, and lowest frequency, therefore unable to create a sufficient rise in diastolic return). This visit will be followed by 3 times weekly 1 hour sessions for 5 weeks (15 sessions) of either EECP or sham procdeure, according to randomization group.

Questionnaire that will be used before and after the intervention will include:

  1. Fatigue evaluation using the PROMIS 7a form, attached in appendix (as validated on Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS)patients)
  2. Functional capacity evaluation using the Duke Activity Status Assessment (DASI) (https://www.mdcalc.com/duke-activity-status-index-dasi);
  3. Shortness of Breath using the modified Medical Research Council dyspnea scale
  4. Quality of life using the SF-36 questionnaire. 6mwt and endothelial dysfunction by EndoPAT will be held following the last treatment.

Study Visit 3 (3 months following starting treatment) will be a final Interview to assess improvement by questionnaires, as well as time to return to activity and time to return to work.

Being tested
Enhanced external counterpulsation
Keywords
long COVID, Enhanced eXternal counterpulsation
Medical subject headings
Post-Acute COVID-19 Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Enhanced external counterpulsationProcedure or surgery

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

Study groups in NCT05668039
Study groupRoleWhat they receive
Enhanced external counterpulsationExperimentalEnhanced 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.
Receives: Procedure: Enhanced external counterpulsation
Sham procedureSham comparatorThe procedure will be identical to the experimental procedure, excluding the pressure that will reach only 80 mmHg.
Receives: Procedure: Enhanced external counterpulsation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 15 weeks

Secondary outcomes (3)

  1. Change in quality of life score

    Quality of life improvement per SF-36. Minimum value - 0 and maximum - 100, higher levels indicate worse outcome

    Measured: 15 weeks

  2. Change in six-minute walk test

    Six-minute walk distance improvement in meters

    Measured: 15 weeks

  3. Cahnge in endothelial function

    Endothelial dysfunction improvement by EndoPat test

    Measured: 15 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Dec 2022
  2. Study start1 Apr 2023
  3. Primary completion1 Apr 2024 (estimated)
  4. Study completionJul 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Double blind, outcome assossor blind, randomized controlled trial
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05668039
Sponsor's protocol ID
EECP for long COVID-19
Acronym
EXPECT
Status last verified
Nov 2023
First submitted
24 Dec 2022
Last updated
30 Nov 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data will be shared by approaching the PI, with reasonable request

Publications

  • 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.

    PubMed 34580069

  • 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.

    PubMed 34951953

  • 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.

    PubMed 35182760

  • 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.

    PubMed 34386903

  • 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.

    PubMed 34375505

  • 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.

    PubMed 34425843

  • 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.

    PubMed 14680732

  • 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.

    PubMed 12767662

  • 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.

    PubMed 34729276

  • 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.

    PubMed 33987042

  • 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.

    PubMed 31506915

  • 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.

    PubMed 24504873

  • 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.

    PubMed 29255720

  • 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.

    PubMed 27757230

Questions about this trial

What is this clinical trial studying?

A study testing Enhanced external counterpulsation in people with Post-Acute COVID-19 Syndrome, run by Sheba Medical Center at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Dafna Yahav, MD (972548866488, Dafna.Yahav@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in fatigue score (time frame: 15 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05668039, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2023.

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