Clinical trial NCT05692258: Acupuncture as an Adjunctive Therapy for Covid-19 Omicron Randomised Controlled Trial in Patients With Moderate/Severe Pneumonia
Official title: Acupuncture as an Adjunctive Therapy for Covid-19 Omicron Randomised Controlled Trial in Patients With Moderate/Severe Pneumonia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acupuncture
Covid-19 Omicron
Pulmonary Function
Lead sponsor: The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2023-01-20
Enrollment: 146
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a randomized controlled study. According to the design of stratified random grouping, the subjects is stratified according to the degree of disease (moderate, severe) and age stage (30-59 years, \> 60 years), and then randomly assigned to the observation group and the control group within each stratum.
Primary purpose: TREATMENT

Brief summary: At present, China is facing the first wave of COVID-19 epidemic after the liberalization. The infection rate has exceeded 50% in most areas, and even exceeded 80% in some cities. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) belongs to the beta genus of coronavirus and enters cells mainly by binding angiotensin converting enzyme 2 (ACE-2) to the spike protein on the envelope. The Omicron strain is the main epidemic strain at present. The transmission ability of Omicron strain is stronger than Delta strain, but the pathogenicity is weakened. At present, the published articles on the adjuvant treatment of COVID-19 with acupuncture are mostly theoretical discussions or case reports, and randomized controlled trials on the observation of curative effect are rare. The purpose of this study is to clarify the effectiveness of the adjuvant treatment of COVID-19 with acupuncture. Providing high-level research evidence for them.

Detailed description: This is a stratified randomized trial. Firstly, the subjects were stratified according to disease severity (moderate, severe) and age stage (30-59 years, \> 60 years), and then the subjects were randomly assigned to the observation group and the control group within each stratum. The study center will screen cases strictly according to the diagnostic criteria, inclusion criteria and exclusion criteria. After confirmation of enrollment, random numbers will be obtained according to the application for random coding process until the total number of observation is completed. Blinded evaluation will be adopted in the trial, and the third party who does not know the grouping will evaluate the efficacy. Blind statistical analysis was used in the data summary stage, and the researchers, operators and statisticians were separated. In the observation group (acupuncture treatment + basic treatment), acupuncture will be applied at Dazhui (GV 14), Feishu (BL 13), Dingchuan (GV 14), Tiantu (GV 14), Danzhong (CV 17), Quchi (GV 20), Gongzhi (CV 4), Neiguan (PC 6), Yinlingquan (SP 9), Fenglong (ST 40), Qihai (CV 6). In the control group (sham acupuncture + basic treatment), sham acupuncture will be used. The acupoint selection is the same as the acupuncture treatment group, Before acupuncture, the fixed pad was pasted on the acupoints, 1.5-inch blunt needle will be used to Pierce the skin surface through the fixed pad of the sham appliance without puncturing the skin.

The mMRC and COVID-19 symptom assessment scale were used as the main evaluation indicators, and the Leicester cough questionnaire LCQ was used to record cough. VAS pain score visual analogue scale was used to evaluate the daily situation of sore throat, muscle soreness, and headache. Secondary outcomes included vital signs and oxygen saturation, chest CT score, and related blood biochemical indicators, including: Blood routine, coagulation routine, D-dimer, C-reactive protein, erythrocyte sedimentation rate, procalcitonin, cytokines (interleukin-6, interleukin-1, ferritin), myocardial enzymes, T lymphocyte subsets (CD4+, CD8+), liver function, renal function, blood gas analysis (severe patients), nucleic acid negative conversion rate, severe conversion rate, self-rating anxiety scale (SAS). Uniform training was provided to all study personnel. The training focused on the use of randomization system and case entry system, project implementation and standard operating procedures, so that each researcher could be familiar with the research process and specific implementation rules, so as to improve the intra-observer consistency and inter-observer consistency of researchers and ensure the reliability of clinical research conclusions. An independent efficacy evaluator was required. Efficacy raters and statistical analysts were blinded. Statistical analyses were performed by a third party, and statistical analysts were blinded during the trial. Statistical analysis will be calculated using SPSS22.0 statistical analysis software. P\<0.05 (i.e., =0.05) was considered to indicate statistical significance.

Eligibility criteria: Inclusion Criteria:

* (1) in accordance with the diagnostic criteria of western medicine. (2) moderate and severe clinical types; (3) patients over 30 years old. (4) Patients voluntarily participated in the study and signed the informed consent.

Exclusion Criteria:

- (1) critical COVID-19 patients; (2) Allergic constitution, allergic to traditional Chinese medicine components; (3) pregnant or lactating women; (4) complicated with severe cognitive and mental disorders that cannot be clearly expressed; (5) those participating in other clinical trials; (6) According to the investigator's judgment, there will be patients with complicated enrollment or poor compliance, which will affect the efficacy and safety evaluation.

(7) complicated with active pulmonary tuberculosis, malignant arrhythmia, acute myocardial infarction, acute stroke, etc.

Primary outcomes:
measure: Modified Medical Research Council Dyspnea Scale
timeFrame: Once a day
measure: Symptom Assessment Scale for novel coronavirus pneumonia
timeFrame: Evaluate once a day
measure: Leicester cough questionnaire
timeFrame: During the screening period and on the 10th day of treatment
measure: Visual Analogue Scale/Scor
timeFrame: Evaluate once a day
Secondary outcomes:
measure: Vital signs and oxygen saturation
timeFrame: Record twice daily
measure: Chest CT score
timeFrame: Screening period, the 10th day of treatment
measure: Related blood biochemical indicators
timeFrame: Screening period, treatment days 3, 7, and 10.
measure: Negative conversion rate of nucleic acid
timeFrame: Screening period, treatment days 3, 7, and 10.
measure: Conversion rate of severe disease
timeFrame: Tenth day of treatment
measure: The total score of the self-rating anxiety Scale
timeFrame: Screening period, treatment days 3, 7, and 10
Other outcomes:
Locations:
city: Changsha
country: China
facility: The First Affiliated Hospital of Hunan University of Chinese Medicine
state: Hunan
Study officials:
affiliation: +86 135 4863 9198
name: Wei Zhang, Doctor
role: STUDY_CHAIR
References:
citation: Liu ST, Zhan C, Ma YJ, Guo CY, Chen W, Fang XM, Fang L. Effect of qigong exercise and acupressure rehabilitation program on pulmonary function and respiratory symptoms in patients hospitalized with severe COVID-19: a randomized controlled trial. Integr Med Res. 2021;10(Suppl):100796. doi: 10.1016/j.imr.2021.100796. Epub 2021 Oct 29.