COVID-19Phase 2ACU-COVIDNCT05212688
Randomised Study to Investigate the Effectiveness of Acupuncture for the Relief of Long COVID-19 Related Fatigue
A Phase 2 study testing Acupuncture in people with COVID-19, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Acupuncture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Jul 2022to 25 Sep 2024
- Phase
- Phase 2
- 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
- Able to give informed consent.
- Male or female, age > 18 years.
- Female patients of childbearing age must confirm their intention not to fall pregnant during the study period of 6 weeks.
- A clinical diagnosis of Long COVID a fatigue score of ≥ 5 on the C19-YRS First Assessment
- A self-reported fatigue score on the C19-YRS ≥ 2 points more severe than their pre-COVID baseline
- 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).
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- Where applicable, have completed any other therapeutic rehabilitation intervention for Long COVID-related fatigue.
- Willing and able to attend for a course of 6 once per week acupuncture treatments
- Co-existing reversible causes of fatigue and/or breathlessness medically optimized
- If a patient has ongoing breathlessness a chest X-ray should have been performed
- If on steroids should be on stable dose for at least two weeks at time of study entry
- If taking other dietary/vitamin interventions should be on a stable regimen for at least two weeks at the time of study entry
- If vaccinated should be a least two weeks post last vaccine dose or booster
- Participants with a history of cancer must be on a stable dose of treatments such as oral TKIs, or antiestrogen therapies or be more than 2 years from diagnosis and completion of radical treatment
- Where applicable, participants on aspirin, clopidogrel or oral anticoagulants are on a stable dose and discussed with the acupuncture clinician (Dr Jacqueline Filshie or a suitably qualified member of her team) before study entry.
Who cannot join
- Recent acupuncture in the last 4 weeks
- Contraindication to acupuncture in the opinion of the acupuncture clinician (Dr Jacqueline Filshie or a suitably qualified member of her team).
- Patients currently receiving chemotherapy or immunotherapy at regular intervals likely to induce cyclical fatigue or within the last 12 months.
- Patients currently receiving radiotherapy or within the last 12 months
- Pregnancy
- Patients with heart valve pathology/dysfunction are contra-indicated from using semi-permanent acupuncture studs for maintenance
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Royal Marsden NHS Foundation Trust
Sutton, Surrey, SM2 5PT
About this study
Official title: A Randomised Phase II Study to Investigate the Effectiveness of ACUpuncture for the Relief of Long COVID Related Fatigue.
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. Acupuncture has been shown to help breathlessness and fatigue in other conditions including in patients with cancer. Cancer related fatigue in the largest study, was assessed by the multiple functional inventory (MFI) score, assessing 5 domains of health, to give a single score.
We aim to randomise 160 patients, 80 in each arm. Randomisation and recruitment should take 24 months.
Read more
Each patient will be offered 6 weeks of weekly acupuncture treatment with a structured questionnaire on wellbeing or no acupuncture with a structure questionnaire on well-being. Both groups of patients will be given continued general advice on management of their symptoms. The next point of involvement will be at 12 weeks which will also be the final visit unless patients in Arm B (Active Control) chose crossover to receive acupuncture. Data at this point will correspond to the end of the participants participation. Over the next 3 months data will be cleaned and analysed.
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.
- Conditions
- COVID-19
- Being tested
- Acupuncture, Active Control
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
Weekly treatment of 15 minutes for 6 weeks using Seirin 36 g 30 mm needles applied to two upper midline sternal points, thoracic paravertebral points, 5 pairs, 2 bilateral Trapezius trigger points, LI4, TE5, ST36, GB34, SP6, LR3 bilaterally, GV20 \& GV24 midline.
Active ControlOther
Weekly contact once per week for 6 weeks for a semi-structured telephone consultation.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Active comparator | * Weekly treatment of 15 minutes for 6 weeks using Seirin 36 g 30 mm needles applied to two upper midline sternal points, thoracic paravertebral points, 5 pairs, 2 bilateral Trapezius trigger points, LI4, TE5, ST36, GB34, SP6, LR3 bilaterally, GV20 \& GV24 midline
* A maximum of two upper sternal indwelling studs [Seirin Pyonex semi-permanent studs] may be used after the second treatment if dyspnoea is present
* Instructions will be given to massage the studs for 1 minute prior to exercise, if dyspnoeic or if very anxious, as often as necessary up to 12 times/day
* Patients will be asked to rest for 15 minutes after each acupuncture treatment.
* Clear instructions about self-needling for ongoing maintenance will be given to each patient
The acupuncture will be given in 6 sessions at weekly intervals. Delays of up to 2 weeks in delivery of acupuncture are allowed within the protocol. The timing of the study questionnaires at weeks 2, 6 and 12 will remain unchanged. Receives: Other: Acupuncture |
| Active Control | Active comparator | Patients randomised to the Active Control will be contacted once per week for 6 weeks for a semi-structured telephone consultation. Delays of up to 2 weeks in delivery of the Active Control session are allowed within the protocol. Patients will be asked during the telephone call to complete the study questionnaires at week 0, 2, 6. Participants will also be asked after the telephone call to rest for 15 minutes if they are able. The patients will also be telephoned on week 12 to complete the study assessments. Patients in Arm B will be required to attend RM in person for the baseline visit and at week 6 to perform the 1 Minute Sit to Stand Test (1-MSTS). The 1-MSTS can be performed virtually rather than in person. Other visits will be telephone calls and completion of questionnaires (paper or via patient portal) Once patients in the Active Control group have completed the 12 week study assessments, they will be offered crossover to receive acupuncture. Receives: Other: Active Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
General Fatigue Score
The primary outcome will be the difference in General Fatigue scores, as self-reported by patients using the MFI ( Multidimensional Fatigue Inventory)
, at 6 weeks. The MFI is a brief 20 item validated scale measuring general fatigue and other dimensions of physical and mental fatigue, activity and motivation.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start19 Jul 2022
- Primary completion25 Sep 2024
- Study completion25 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Royal Marsden NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Acupuncture vs Control
- Masking
- None (open label)
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05212688
- Sponsor's protocol ID
- CCR5576
- Acronym
- ACU-COVID
- Status last verified
- Oct 2024
- First submitted
- 26 Jan 2022
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Phase II Study to Investigate the Effectiveness of ACUpuncture for the Relief of Long COVID Related Fatigue.
- ClinicalTrials.gov ID
- NCT05212688
- Acronym / sponsor ID
- ACU-COVID / CCR5576
- Conditions
- COVID-19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Study start
- 19 Jul 2022 (actual)
- Primary completion
- 25 Sep 2024 (actual)
- Study completion
- 25 Sep 2024 (actual)
- First posted
- 28 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. Acupuncture has been shown to help breathlessness and fatigue in other conditions including in patients with cancer. Cancer related fatigue in the largest study, was assessed by the multiple functional inventory (MFI) score, assessing 5 domains of health, to give a single score.
We aim to randomise 160 patients, 80 in each arm. Randomisation and recruitment should take 24 months.
Each patient will be offered 6 weeks of weekly acupuncture treatment with a structured questionnaire on wellbeing or no acupuncture with a structure questionnaire on well-being. Both groups of patients will be given continued general advice on management of their symptoms. The next point of involvement will be at 12 weeks which will also be the final visit unless patients in Arm B (Active Control) chose crossover to receive acupuncture. Data at this point will correspond to the end of the participants participation. Over the next 3 months data will be cleaned and analysed.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Acupuncture vs Control
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Active comparator | Other: Acupuncture* Weekly treatment of 15 minutes for 6 weeks using Seirin 36 g 30 mm needles applied to two upper midline sternal points, thoracic paravertebral points, 5 pairs, 2 bilateral Trapezius trigger points, LI4, TE5, ST36, GB34, SP6, LR3 bilaterally, GV20 \& GV24 midline * A maximum of two upper sternal indwelling studs [Seirin Pyonex semi-permanent studs] may be used after the second treatment if dyspnoea is present * Instructions will be given to massage the studs for 1 minute prior to exercise, if dyspnoeic or if very anxious, as often as necessary up to 12 times/day * Patients will be asked to rest for 15 minutes after each acupuncture treatment. * Clear instructions about self-needling for ongoing maintenance will be given to each patient The acupuncture will be given in 6 sessions at weekly intervals. Delays of up to 2 weeks in delivery of acupuncture are allowed within the protocol. The timing of the study questionnaires at weeks 2, 6 and 12 will remain unchanged. |
| Active Control | Active comparator | Other: Active ControlPatients randomised to the Active Control will be contacted once per week for 6 weeks for a semi-structured telephone consultation. Delays of up to 2 weeks in delivery of the Active Control session are allowed within the protocol. Patients will be asked during the telephone call to complete the study questionnaires at week 0, 2, 6. Participants will also be asked after the telephone call to rest for 15 minutes if they are able. The patients will also be telephoned on week 12 to complete the study assessments. Patients in Arm B will be required to attend RM in person for the baseline visit and at week 6 to perform the 1 Minute Sit to Stand Test (1-MSTS). The 1-MSTS can be performed virtually rather than in person. Other visits will be telephone calls and completion of questionnaires (paper or via patient portal) Once patients in the Active Control group have completed the 12 week study assessments, they will be offered crossover to receive acupuncture. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Able to give informed consent.
- Male or female, age > 18 years.
- Female patients of childbearing age must confirm their intention not to fall pregnant during the study period of 6 weeks.
- A clinical diagnosis of Long COVID a fatigue score of ≥ 5 on the C19-YRS First Assessment
- A self-reported fatigue score on the C19-YRS ≥ 2 points more severe than their pre-COVID baseline
Key exclusion criteria (6 listed)
- Recent acupuncture in the last 4 weeks
- Contraindication to acupuncture in the opinion of the acupuncture clinician (Dr Jacqueline Filshie or a suitably qualified member of her team).
- Patients currently receiving chemotherapy or immunotherapy at regular intervals likely to induce cyclical fatigue or within the last 12 months.
- Patients currently receiving radiotherapy or within the last 12 months
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureWeekly treatment of 15 minutes for 6 weeks using Seirin 36 g 30 mm needles applied to two upper midline sternal points, thoracic paravertebral points, 5 pairs, 2 bilateral Trapezius trigger points, LI4, TE5, ST36, GB34, SP6, LR3 bilaterally, GV20 \& GV24 midline. | Other | Acupuncture |
| Active ControlWeekly contact once per week for 6 weeks for a semi-structured telephone consultation. | Other | Active Control |
Primary outcome
General Fatigue Score
Time frame: 6 weeks
The primary outcome will be the difference in General Fatigue scores, as self-reported by patients using the MFI ( Multidimensional Fatigue Inventory) , at 6 weeks. The MFI is a brief 20 item validated scale measuring general fatigue and other dimensions of physical and mental fatigue, activity and motivation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Acupuncture in people with COVID-19, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
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 15 inclusion and 6 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: finished, as of the sponsor's last update on 18 Oct 2024. 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 United Kingdom. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General Fatigue Score (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Oct 2024; AzTrials last refreshed its copy on 7 Nov 2026.