Clinical trial NCT05787327: RCT for Yinqiaosan-Maxingganshitang in the Treatment of COVID-19
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: COVID-19
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2023-03-28
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Time for the body temperature to change to normal
timeFrame: From baseline to week 19
Secondary outcomes:
measure: Time of negative Rapid Antigen Test
timeFrame: From baseline to reaching outcome
measure: Remission rate of cough
timeFrame: 14 days
measure: Remission rate of fatigue
timeFrame: 14 days
measure: Time of remission of cough
timeFrame: From baseline to week 19
measure: Time of remission of fatigue
timeFrame: From baseline to week 19
measure: Disappearance rate of COVID symptom
timeFrame: 14 days
measure: Incidence to severe illness
timeFrame: From baseline to 19 weeks
measure: Mortality
timeFrame: 21 days
measure: Utilization rate of rescue drugs
timeFrame: 14 days
measure: Dosage of rescue drugs
timeFrame: 14 days
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Hong Kong Institute of Integrative Medicine
Study officials:
affiliation: Hong Kong Institute of Integrative Medicine
name: Zhixiu Lin
role: PRINCIPAL_INVESTIGATOR
References: