The Effects of Acupuncture in Overcoming Inflammatory Response to COVID-19 Mild-moderate Symptoms

The Effects of Combined Treatment of Acupuncture Intervention & Standard of Care on Laboratory and Clinical Outcomes in Hospitalized COVID-19 Patients With Mild-Moderate Symptoms

Coronavirus disease 2019 (COVID-19) is a problem that is being faced in more than 200 countries in the world, including Indonesia. The World Health Organization (WHO) has declared the COVID-19 outbreak as a pandemic. The transmission of the virus occurred rapidly that 2 weeks from the first case diagnosed, 1000 patients tested positive. A week later, the number of positive cases exceeded 4600, reaching more than 30,000 patients and 2,500 deaths on March 18, 2020. The death rate due to COVID-19 in Indonesia is one of the highest in Asia.

To date, no therapy has been shown to be effective for Coronavirus (SARS-CoV-2). A vaccine for SARS-CoV-2 also has not been found at this time and is in the research phase. Current management of COVID-19 patients focuses primarily on providing supportive care. Currently, several countries make treatment guidelines for COVID-19 patients by providing several types of anti-viral drugs and other drugs such as chloroquine or hydroxychloroquine, immunoglobulins, anti-cytokine agents or immunomodulators.

The administration of these drugs does not escape the various side effects experienced by patients. Administration of chloroquine or hydroxychloroquine carries the risk of causing prolonged QT interval which can lead to arrhytmia disturbances such as torsades des pointes in certain people. Administration of chloroquine or hydroxychloroquine in combination with azithromycin increases the risk of developing arrhythmias. Giving anti-viruses such as lopinavir / ritonavir, umifenovir, remdesivir, favipiravir can also cause various side effects including gastrointestinal disturbances (nausea, vomiting, diarrhea), impaired liver function, and hyperuricaemia. Treatment with human immunoglobulins has been associated with a significantly increased risk of thrombotic events.

Currently, no acupuncture research on COVID-19 patients has been published. However, acupuncture can play a role in several conditions that occur in COVID-19 according to the pathophysiology that occurs, this has been proven through several clinical studies conducted on non-COVID-19 cases that have pathophysiology that resemble COVID-19 conditions. In COVID-19 with mild-moderate symptoms, acupuncture can play a role in boosting the immune system, including increasing the number of Natural Killer cells and lymphocytes. Whereas in cases of severe COVID-19 symptoms, it is hoped that acupuncture can provide anti-inflammatory effect and prevent cytokine storm.

Study Overview

• Status: Completed
• Conditions: Covid19; Acupuncture
• Intervention / Treatment: Combination product: acupuncture and standard care; Drug: standard care

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • Jakarta, Indonesia, 10430
    • Medical Acupuncture Department FKUI-RSCM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female patients over 18 years of age, COVID-19 confirmed by RT-PCR with mild-moderate symptoms
• Willing to participate in research.
• Willing to follow the research process to completion.

Exclusion Criteria:

• The patient has contraindications to acupuncture (medical emergencies, pregnancy, malignancy, blood clotting disorders and consumption of anti-coagulant drugs).
• Patients with myeloproliferative disorders.
• There is a tumor or infection in the area where the acupuncture point is inserted.
• Patients with a history of uncontrolled Diabetes Mellitus with random blood sugar levels > 200 mg / dL

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; Manual acupuncture and standard care	Combination product: acupuncture and standard care; manual acupuncture in acupoint LI4, LI11, ST36 every 2 days for 6 times standard care; Other Names: Combined Treatment of Acupuncture Intervention and Standard of Care
Other: Control; Standard care only	Drug: standard care; standard care only; Other Names: standard of care COVID-19

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of percentage of lymphocyte count	Changes of percentage of lymphocyte count (diff count) between before treatment and after 2 weeks of treatment (after sixth acupuncture session given)	before treatment and after 2 weeks of treatment
Changes of Erythrocyte sedimentation rate	Changes of Erythrocyte sedimentation rate between before treatment and after 2 weeks of treatment (after sixth acupuncture session given)	before treatment and after 2 weeks of treatment
Changes of Ferritin level	Changes of Ferritin level between before treatment and after 2 weeks of treatment (after sixth acupuncture session given)	before treatment and after 2 weeks of treatment
Changes of C-Reactive Protein level	Changes of C-reactive protein level between before treatment and after 2 weeks of treatment (after sixth acupuncture session given)	before treatment and after 2 weeks of treatment
Clinical changes	duration of cough and fever during the patients are hospitalized	before treatment and after 2 weeks of treatment

Collaborators and Investigators

• Sponsor: Indonesia University
• Investigators: Principal Investigator: Dwi Rachma Helianthi, MD, Indonesia University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): November 15, 2020
• Study Completion (Actual): November 20, 2020

Study Registration Dates

• First Submitted: April 12, 2021
• First Submitted That Met QC Criteria: April 12, 2021
• First Posted (Actual): April 14, 2021

Study Record Updates

• Last Update Posted (Actual): April 14, 2021
• Last Update Submitted That Met QC Criteria: April 12, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: KET-845/UN2.F1/ ETIK/PPM.2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No