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A Randomised Phase II Study to Investigate the Effectiveness of ACUpuncture for the Relief of Long COVID Related Fatigue (ACU-COVID)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05212688
Recruitment Status : Not yet recruiting
First Posted : January 28, 2022
Last Update Posted : January 28, 2022
Sponsor:
Information provided by (Responsible Party):
Royal Marsden NHS Foundation Trust

Brief Summary:

The Covid pandemic has left us with a significant number of people suffering from Long COVID, which is a clinical diagnosis of significant and varying ongoing symptoms at least 12 weeks following COVID-19 infection and characterised frequently by fatigue and breathlessness. Randomised studies have shown that both these symptoms can be helped by acupuncture in both cancer patients and non cancer situations. Fatigue in the largest study, was assessed by the multiple functional inventory (MFI) score, assessing 5 domains of health, to give a single score.

Full Set of Project Data IRAS Version 6.1 5 DRAFT Patients have been taught to self administer acupuncture in one study. Dyspnoea in the UK acupuncture study was assessed by a visual analogue scale (VAS) and a modified Borg score. This is a randomised study in 160 people with and without cancer, who fit the definition of Long COVID and have a fatigue score of >5, on the UK developed, COVID-19 Yorkshire Rehabilitation Screen. After baseline workup as per national Long COVID guidelines, participants who consent will be randomised to either acupuncture given weekly for 6 weeks or telephone consultation and advice weekly for 6 weeks. A number of other questionnaires will be completed by both groups at baseline, 2, 6 and 12 weeks, including the MFI, modified Borg and VASs.

The primary endpoint is General Fatigue scores, as self-reported by patients using the MFI, at 6 weeks. A 2-unit difference between groups (Acupuncture vs Active Control) in General Fatigue score is considered clinically important.

The secondary endpoints will include differences in scores of various questionnaires and tests.


Condition or disease Intervention/treatment Phase
COVID-19 Other: Acupuncture Other: Phone Call Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomised Phase II Study to Investigate the Effectiveness of ACUpuncture for the Relief of Long COVID Related Fatigue
Estimated Study Start Date : March 1, 2022
Estimated Primary Completion Date : March 1, 2024
Estimated Study Completion Date : March 1, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Acupuncture Other: Acupuncture
This is an intervention of weekly acupuncture over 6 weeks, delivered by a highly trained practitioner.

Active Comparator: Active Control Other: Phone Call
Telephone call to patients home with 15 minutes rest after interview.




Primary Outcome Measures :
  1. General Fatigue Score [ Time Frame: 2 years. ]

    The primary endpoint is General Fatigue scores, as self-reported by patients using the MFI, at 6 weeks. A 2-unit difference between groups (Acupuncture vs Active Control) in General Fatigue score is considered clinically important.

    The secondary endpoints will include differences in scores of various questionnaires and tests.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Able to give informed consent
  2. Male or female, age > 18 years
  3. Female patients of childbearing age must confirm their intention not to fall pregnant during the study period of 6 weeks
  4. For the clinical diagnosis of Long COVID a fatigue score of ≥ 5 on the C19-YRS First Assessment and
  5. A self-reported fatigue score on the C19-YRS ≥ 2 points more severe than their pre-COVID baseline
  6. More than 12 weeks following a positive COVID-19 swab test (lateral flow or PCR) or an illness in keeping with COVID-19 infection in the opinion of the Chief Investigator, despite the absence of swab confirmation (not tested or test negative)
  7. If applicable, have completed any other therapeutic rehabilitation intervention for Long COVID-related fatigue.
  8. Willing and able to attend for a course of 6 once per week acupuncture treatments
  9. Co-existing reversible causes of fatigue and/or breathlessness medically optimized
  10. If a patient has ongoing breathlessness a chest X-ray should have been performed
  11. If on steroids should be on stable dose for at least two weeks at time of study entry
  12. If taking other dietary/vitamin interventions should be on a stable regimen for at least two weeks at the time of study entry
  13. If vaccinated should be a least two weeks post second dose
  14. Participants may have a diagnosis of cancer if on a stable dose of treatments such as oral TKIs, or antiestrogen therapies
  15. Participants may have had a diagnosis of cancer if more than 2 years from diagnosis and completion of radical treatment

Exclusion Criteria:

  1. Recent acupuncture in the last 4 weeks
  2. Relative contraindications to acupuncture e.g., cancer related thoracic bone mets, sites of metastatic disease can be discussed with Dr Jacqueline Filshie
  3. Aspirin, clopidogrel and stable dose of oral anticoagulants are permitted but should be discussed with the acupuncturist prior to study entry
  4. Patients currently receiving chemotherapy or immunotherapy at regular intervals likely to induce cyclical fatigue or within the last 12 months
  5. Patients currently receiving radiotherapy or within the last 12 months
  6. Pregnancy
  7. Patients with heart valve pathology/dysfunction are contra-indicated from using semi-permanent acupuncture studs for maintenance

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05212688


Contacts
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Contact: Imogen Locke 0208664011 ext 3169 imogen.locke@rmh.nhs.uk

Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
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Responsible Party: Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT05212688    
Other Study ID Numbers: 5576
First Posted: January 28, 2022    Key Record Dates
Last Update Posted: January 28, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fatigue