RCT for Yinqiaosan-Maxingganshitang in the Treatment of COVID-19

Assessing the Efficacy and Safety of Yinqiaosan-Maxingganshitang in the Treatment of the Major Symptoms of Mild and Moderate COVID-19 by Telemedicine - a Randomized, Double-blind, Placebo-controlled Trial

This is a randomized, double-blinded, placebo-controlled clinical trial. This study is to evaluate the effectiveness and safety of Yinqiaosan-Maxingganshitang in the treatment of the major symptoms of mild and moderate COVID-19 patients by telemedicine.

Study Overview

• Status: Recruiting
• Conditions: COVID-19
• Intervention / Treatment: Drug: Chinese Herb; Diagnostic test: Placebo

Detailed Description

Subjects who are diagnosed with COVID-19 by RATs or PCR tests and fulfilled the eligibility criteria will receive a maximum of 14 days of treatment with Yinqiaosan-Maxingganshitang (with or without specified additions) or placebo and will be followed up on day 7, 14 and 35 after receiving medication (day 0).

• Study Type: Interventional
• Enrollment (Estimated): 96
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Cho Wing Lo; Phone Number: 35053476; Email: louislo@cuhk.edu.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Hong Kong Institute of Integrative Medicine
    • Contact: Zhixiu LIN; Phone Number: 28733252

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age from 18 to 65 years;
• Tested positive for COVID-19 by RATs, Deep Throat Saliva (DTS) or Throat/Nasal swab RT-PCR tests;
• Patient diagnosed with mild to moderate COVID-19 based on the "Coronavirus disease 2019 (COVID-19) Treatment Guidelines" published by National Institutes of Health;
• Duration of symptoms ≤ 72 hours (Start from the presence of the major symptoms of COVID-19: Fever: oral temperature >37.2°C, or cough score ≥2, or fatigue score ≥2);
• Diagnosed with pattern of wind and heat invading the surface and/or pattern of intense exuberance of lung heat by a registered Chinese medicine practitioner (CMP) (Diagnostic criteria are the corresponding criteria in the "Diagnosis standards for common syndromes in traditional Chinese medicine)" published by "Diagnostic Subcommittee of China Association of Traditional Chinese Medicine in 2008, with ≥20 as the threshold for determination);
• Explicit declaration of willingness to participate in the study at the time of videoconference screening after reading the electronic informed consent form (written consent form have to signed after inclusion).

Exclusion Criteria:

• Diagnosed of Asymptomatic or Presymptomatic Infection, Severe Illness or Critical Illness of COVID-19 based on the "Coronavirus disease 2019 (COVID-19) Treatment Guidelines" published by National Institutes of Health
• Known allergy to the Chinese medicines or other ingredients of the investigational medicinal products (IMP) used in this study;
• Known pregnancy or lactation;
• Known immunocompromised patient (such as malignancy, organ or bone marrow transplant, AIDS or low immune function caused by long-term use of corticosteroids or other immunosuppressants)
• Known obesity (Body Mass Index [BMI] ≥30)
• Heavy smoker (≥400 cigarettes/year)
• Known history of cardiovascular and cerebrovascular diseases (including hypertension), chronic lung disease (chronic obstructive pulmonary disease, moderate and severe asthma or interstitial lung disease), diabetes, chronic liver disease (ALT/AST ≥ 2× the upper limit of normal [ULN], Bilirubin-Total ≥ 1.5ULN), chronic kidney disease (Creatinine ≥1.5ULN), cancer or other chronic diseases.
• Known history of dysphagia or any gastrointestinal disorder that affects drug absorption (such as gastroesophageal reflux disease [GERD], chronic diarrhea, inflammatory bowel disease, intestinal tuberculosis, gastrinoma, short bowel syndrome, gastrectomy);
• Suspected or known history of alcohol or substance abuse or mental illness;
• Subjects having participated in other clinical studies in the past three months;
• Any other condition that in the opinion of the investigators could compromise the study.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active treatment (Yinqiaosan-Maxingganshitang ); Chinese Medicine granules	Drug: Chinese Herb; Yinqiaosan-Maxingganshitang granules; Other Names: CM
Placebo Comparator: Placebo; Placebo granules	Diagnostic test: Placebo; Placebo; Other Names: Plavebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time for the body temperature to change to normal	The time between starting medication and body temperature dropping to normal (oral temperature ≤ 37.2℃ and maintain 24 hours).	From baseline to week 19

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time of negative Rapid Antigen Test	2. The negative rate of Rapid Antigen Tests (RATs) at day 14 and the negative conversion time (two successive negative RATs result with at least 24 hours interval)	From baseline to reaching outcome
Remission rate of cough	The remission of cough will be measured by the score rating from 0 to 4, which representing "None", "Mild", "Moderate", "Severe" and "Very severe" respectively. The score of 1 or below and maintain for 24 hours will be counted as remission.	14 days
Remission rate of fatigue	The remission of fatigue will be measured by the score rating from 0 to 4, which representing "None", "Mild", "Moderate", "Severe" and "Very severe" respectively. The score of 1 or below and maintain for 24 hours will be counted as remission.	14 days
Time of remission of cough	Time from the start of treatment to the symptom remission	From baseline to week 19
Time of remission of fatigue	Time from the start of treatment to the symptom remission	From baseline to week 19
Disappearance rate of COVID symptom	The disappearance rate of the COVID symptom	14 days
Incidence to severe illness	Incidence of the progression to severe ot critical illness during the trial	From baseline to 19 weeks
Mortality	All-cause mortality at the 21th days after stopping the medications	21 days
Utilization rate of rescue drugs	Utilization rate of antipyretic, Paxlovid and molnupiravir within 14 days	14 days
Dosage of rescue drugs	Dosage of antipyretic, Paxlovid and molnupiravir within 14 days	14 days

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Zhixiu Lin, Hong Kong Institute of Integrative Medicine

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2023
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: March 23, 2023
• First Submitted That Met QC Criteria: March 25, 2023
• First Posted (Actual): March 28, 2023

Study Record Updates

• Last Update Posted (Actual): July 7, 2023
• Last Update Submitted That Met QC Criteria: July 6, 2023
• Last Verified: July 1, 2023

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: COVID Acute study

Drug and device information, study documents

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