Acupuncture as an Adjunctive Therapy for Covid-19 Omicron Randomised Controlled Trial in Patients With Moderate/Severe Pneumonia (ZCFZZLXGBDFYHZ)

• ClinicalTrials.gov Identifier: NCT05692258
• Recruitment Status: Recruiting
• First Posted: January 20, 2023
• Last Update Posted: January 20, 2023
• Sponsor: The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
• Information provided by (Responsible Party): ZhangWei, The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Acupuncture; Covid-19 Omicron; Pulmonary Function	Other: Acupuncture	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 146 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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.
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Masking Description: On account of the particularity of acupuncture research, it is impossible to blind acupuncture operators. 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.
• Primary Purpose: Treatment
• Official Title: Acupuncture as an Adjunctive Therapy for Covid-19 Omicron Randomised Controlled Trial in Patients With Moderate/Severe Pneumonia
• Actual Study Start Date: January 6, 2023
• Estimated Primary Completion Date: April 6, 2023
• Estimated Study Completion Date: April 6, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Acupuncture therapy + basic therapy; Acupuncture treatment-Selected acupoints: Dazhui (GV14) , Feishu(BL13), Dingchuan(EX-B1), Tiantu(CV22), Danzhong(RN17), Quchi(LI11), Kongzui(LU6), Neiguan(PC6), Yinlingquan(SP9), Fenglong(ST40), Qihai(cv6). Once a day for 10 consecutive times. Western medicine treatment (basic treatment) : According to the Diagnosis and Treatment Plan for Novel Coronavirus Infection (Trial 10th Edition) issued by the General Office of the National Health Commission and the General Department of the National Administration of Traditional Chinese Medicine, patients are arranged to be quarantined in hospitals for treatment. Conventional Western medicine treatment includes supportive treatment, antiviral therapy, immunotherapy, anticoagulant therapy, antibiotic therapy, etc.	Other: Acupuncture; Acupuncture is a kind of therapy used to treat diseases, in which a needle (usually a millimeter needle) is inserted into a patient's skin or tissue at a certain Angle to stimulate a specific part of the body (acupoint). Disposable sterile acupuncture filiform needle (0.30mm×25mm、0.30mm×40mm), Guizhou Andi Medical Equipment Co, LTD, Guizhou Food and Drug Supervision and Equipment Production Xu 20170011.; Other Name: basic therapy
Sham Comparator: sham acupuncture + basic therapy; sham acupuncture. Acupoint selection, body position, intervention time and course of treatment are the same as those in acupuncture treatment group. After acupoint disinfection, fixed pad is pasted on the acupoint, and 1.5 blunt needle will be used to Pierce directly through the sham instrument to fix pad to the skin surface without piercing the skin, and do not require Deqi. Western medicine treatment (basic treatment) is the same as the acupuncture group.	Other: Acupuncture; Acupuncture is a kind of therapy used to treat diseases, in which a needle (usually a millimeter needle) is inserted into a patient's skin or tissue at a certain Angle to stimulate a specific part of the body (acupoint). Disposable sterile acupuncture filiform needle (0.30mm×25mm、0.30mm×40mm), Guizhou Andi Medical Equipment Co, LTD, Guizhou Food and Drug Supervision and Equipment Production Xu 20170011.; Other Name: basic therapy

Outcome Measures

Primary Outcome Measures :

1. Modified Medical Research Council Dyspnea Scale [ Time Frame: Once a day ]
   On a scale of 0-4, the higher the score, the more severe the symptoms
2. Symptom Assessment Scale for novel coronavirus pneumonia [ Time Frame: Evaluate once a day ]
   15 items: 7 main symptoms (0-3 points), 8 secondary symptoms (0-1 points), the higher the score, the more severe the symptoms
3. Leicester cough questionnaire [ Time Frame: During the screening period and on the 10th day of treatment ]
   19 items, divided into physiological, pathological and social dimensions, each item scored 1-7 points. Dimension score = Total score of item questions in each dimension ➗ Number of questions (1-7).Total score = Sum of three dimensions scores (3-21)
4. Visual Analogue Scale/Scor [ Time Frame: Evaluate once a day ]
   3 items: pharyngeal pain, muscle soreness, headache. Pain is divided into 10 points, 0 points means no pain, 10 points means severe pain, the middle part of the different degrees of pain. Have the patient draw a mark on the horizontal line according to how they feel, which indicates the level of pain. The higher the score, the worse the pain.

Secondary Outcome Measures :

1. Vital signs and oxygen saturation [ Time Frame: Record twice daily ]
   Body temperature, pulse, respiration, blood pressure, oxygen saturation
2. Chest CT score [ Time Frame: Screening period, the 10th day of treatment ]
   In 6 areas of the right lung upper field, right lung middle field, right lung lower field, left lung upper field, left lung middle field, left lung lower field, reticular change 1 point, ground glass 2 points, patchy blur 3 points, small patchy blur 4 points, cystic lung honeycomb 5 points, the total score is 30 points, the higher the score is, the more severe the lung lesions.
3. Related blood biochemical indicators [ Time Frame: Screening period, treatment days 3, 7, and 10. ]
   Routine blood test, coagulation test, 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 laboratory indicators, and blood gas analysis were also recorded in severe patients.
4. Negative conversion rate of nucleic acid [ Time Frame: Screening period, treatment days 3, 7, and 10. ]
   The nucleic acid of 2019-ncov will be detected by fluorescence quantitative polymerase chain reaction, and the negative conversion rate of nucleic acid will be calculated
5. Conversion rate of severe disease [ Time Frame: Tenth day of treatment ]
   According to the clinical classification of "Diagnosis and Treatment Protocol for Novel Coronavirus Infection (Trial 10th Edition)", the number of patients who turned from medium to severe or critical will be recorded. Calculate the conversion rate of severe disease (number of severe disease cases/total cases × 100%)
6. The total score of the self-rating anxiety Scale [ Time Frame: Screening period, treatment days 3, 7, and 10 ]
   20 items, each item 1-4 points, total score and standard score (total score ×1.25), the higher the score, the more severe symptoms.

Eligibility Criteria

• Ages Eligible for Study: 30 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Contacts

Contact: Wei Zhang, Doctor; +8613548639198 ext 0731; 507395550@qq.com

Contact: Wenying Shi, Master; +8613875866937 ext 0731; 273727875@qq.com

Locations

China, Hunan

The First Affiliated Hospital of Hunan University of Chinese Medicine; Recruiting

Changsha, Hunan, China, 410001

Contact: Wei Zhang, Doctor +86 135 4863 9198 ext 0731 507395550@qq.com

Sponsors and Collaborators

The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine

Investigators

• Study Chair: Wei Zhang, Doctor; +86 135 4863 9198

More Information

Additional Information:

Chen Wen-tao, Fu Huai-li, ZHANG Chao-yuan, et al. Feasibility Analysis of Acupuncture and Moxibustion in the Prevention and Treatment of COVID-19 from an International Perspective. Clinical Journal of Acupuncture and Moxibustion, 2020, 36(9): 82-87. 

Gong Yabin, Shi Xin-jie, Zhang Yan, et al. Clinical application and practice ofacupuncture therapy in treatment of coronavirus disease 2019. Chinese Acupuncture and Moxibustion, 2021, 41(2): 142-144. 

Yin Xin, CAI Shubin, Chen Luming, et al. Seventeen cases with coronavirus disease 2019(COVID-19)treated with the combination of acupuncture and herbal medicine. Chinese Acupuncture and Moxibustion, 2021, 41(5): 498-500. 

Diagnosis and Treatment Protocol for Novel Coronavirus infection (Trial version 10) 

Publications of Results:

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.

• Responsible Party: ZhangWei, The First Affiliated Hospital of Hunan University of Chinese Medicine, The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
• ClinicalTrials.gov Identifier: NCT05692258
• Other Study ID Numbers: 2019SK4004-06
• First Posted: January 20, 2023
• Last Update Posted: January 20, 2023
• Last Verified: January 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: Our subject database is called Zintuikang Integrated Big Data Application Platform, and other researchers can access it through the website. The administrator set up the account, and other researchers can log in by changing the password after registration. Their account has the authority to access the data and enter the CRF form.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

COVID-19; Pneumonia; Respiratory Tract Infections; Infections; Pneumonia, Viral; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases