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

Официальное название

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

Обзор

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.

Подробное описание

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).

Вмешательства

• Препарат Chinese Herb
  Yinqiaosan-Maxingganshitang granules
• Диагностический тест Placebo
  Placebo

Первичные конечные точки

• Time for the body temperature to change to normal [Срок оценки: From baseline to week 19]

Вторичные конечные точки (10)

• Time of negative Rapid Antigen Test [Срок оценки: From baseline to reaching outcome]
• Remission rate of cough [Срок оценки: 14 days]
• Remission rate of fatigue [Срок оценки: 14 days]
• Time of remission of cough [Срок оценки: From baseline to week 19]
• Time of remission of fatigue [Срок оценки: From baseline to week 19]
• Disappearance rate of COVID symptom [Срок оценки: 14 days]
• Incidence to severe illness [Срок оценки: From baseline to 19 weeks]
• Mortality [Срок оценки: 21 days]
• Utilization rate of rescue drugs [Срок оценки: 14 days]
• Dosage of rescue drugs [Срок оценки: 14 days]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Гонконг · 1 центр

• Hong Kong Institute of Integrative Medicine — Гонконг

Публикации

• Sum CH, Li TW, Zhang H, Hung HY, Fong BYF, Lin WL, Chow TY, Leung KC, Lo CW, Chia CP, Chan KL, Lin ZX. Assessing the efficacy and safety of Yinqiao powder-maxing Ganshi decoction in the treatment of the major symptoms of mild and moderate COVID-19 by telemedicine-study protocol for a randomized, double-blind, placebo-controlled trial. Front Pharmacol. 2024 Jan 8;14:1261338. doi: 10.3389/fphar.2023 PMID 38259270

Идентификаторы

NCT: NCT05787327 · COVID Acute study

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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