NCT05212688: ACU-COVID

Randomised Study to Investigate the Effectiveness of Acupuncture for the Relief of Long COVID-19 Related Fatigue

Completed Phase 2 Last updated 18 October 2024

What this trial tests

Phase 2 trial testing Acupuncture in COVID-19 in 119 participants. Completed in 25 September 2024.

Timeline

19 July 2022

Primary endpoint
25 September 2024

25 September 2024

Quick facts

Lead sponsor	Royal Marsden NHS Foundation Trust
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	119
Start date	19 July 2022
Primary completion	25 September 2024
Estimated completion	25 September 2024
Sites	1 location across United Kingdom

Drugs / interventions tested

• Acupuncture — full drug profile →
• Active Control — full drug profile →

Conditions studied

• COVID-19 — all drugs for COVID-19 →

Sponsor

Royal Marsden NHS Foundation Trust

Who can join

18 and older, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. The long-term health outcomes, pathophysiological mechanisms and multidisciplinary management of long COVID.
   Li J, Zhou Y, Ma J, Zhang Q, et al · · 2023 · cited 91× · PMID 37907497 · DOI 10.1038/s41392-023-01640-z
2. Acupuncture for cognitive functions in post-COVID-19 condition: study protocol of a three-armed, randomized controlled trial with multimodal MRI.
   Luo T, Luo Y, Liu D, Jin H, et al · · 2026 · PMID 42136829 · DOI 10.3389/fmed.2026.1796351