COVID-19 Huashi Baidu Formula Clinical Study

Study Overview
=================
Brief Summary
-----------------
Combined with the regional and population characteristics of Asia and Africa, Huashi Baidu Granule was used to intervene in mild and moderate patients with COVID-19, evaluate its efficacy and safety, and clarify its characteristics of action.

Detailed Description
-----------------
In this study, a double-blind, double dummy, randomized control method was used to include 300 cases of mild and moderate COVID-19 patients in three centers at home and abroad. The clinical efficacy of Huashi Baidu Granule and Monapiravir in intervening COVID-19 patients was compared, It is proved that Huashi Baidu Granule has the same clinical efficacy and safety against COVID-19 as Monapiravir, and its characteristics of action are clarified to obtain high-level clinical evidence-based medical evidence of Huashi Baidu Granule in treating COVID-19 mild and moderate.

Official Title
-----------------
A Multicenter, Double-blind, Double-dummy, Randomized, Parallel-controlled Clinical Study Evaluating Huashi Baidu Formula in the Treatment of Mild and Moderate Types of COVID-19 Disease.

Conditions
-----------------
COVID-19

Intervention / Treatment
-----------------
* Drug: Huashi Baidu Granule
* Drug: Monapiravir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Conform to the diagnostic criteria for COVID-19 mild and moderate in the Guidelines for the Diagnosis and Treatment of Novel Coronavirus (COVID-19) Infection (Trial Version 10) ； Age ≥ 18 years and ≤ 65 years; The time from the first symptom (or confirmed onset) shall not exceed 5 days; If the patient agrees to participate in the study, he/she will sign the informed consent form through paper signature, electronic signature of mobile software or voice authorization. Exclusion Criteria: Patients who cannot guarantee the compliance of taking medicine during the treatment period, and who are difficult to take medicine by oral or nasal feeding. Patients with severe primary respiratory diseases or other pathogenic microorganism pneumonia that needs to be differentiated from COVID-19. Pregnant women, with positive urine pregnancy test, or with pregnancy plan within 12 months. Patients suffering from malignant tumors, mental diseases and other systematic malignant diseases that the researchers consider unsuitable for the study. People who have ever been allergic to the test drug and who do not tolerate the drug. Those who are participating in other clinical trials. Non severe patients in the trial shall not enter the study again after changing the classification.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>Huashi Baidu Granule+Monapiravir simulant | Drug: Huashi Baidu Granule<br>* Granule is produced by Guangdong Yifang Pharmaceutical Co., Ltd. with a specification of 5g × 12 bags, twice a day, take 2 sachets each time with boiling water.<br>|
| Active Comparator: Control group<br>Monapiravir+Huashi Baidu Granule Simulator | Drug: Monapiravir<br>* Monapiravir, manufactured by Merck, an American pharmaceutical company, with the specification of 200mg × 40 capsules, 800mg each time, twice a day.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nucleic acid negative rate in 5 days;Virus CT value | Quantitative standard of viral CT value for nucleic acid detection： According to the Technical guidelines for laboratory testing of novel coronavirus, the Ct value of nucleic acid testing of novel coronavirus is less than 37, which can be reported is positive; No Ct value or Ct value greater than 40 was negative. If the Ct value was between 37 and 40, it is recommended to repeat the experiment. If Ct If the value is less than 40, the amplification curve has obvious peak, and the sample is judged as positive, otherwise it is negative. | The treatment period，Receive the test by PCR once a daily ，for 5 consecutive days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease score | Therapeutic efficacy evaluation scale of traditional Chinese medicine in treating COVID-19 | The treatment period, including 5 days after administration, and the follow-up period, which is day 11, day 21, and day 30 after administration, respectively | 
| Score of individual symptom | fever, asthenia, cough, dyspnea, generalized aches and pains, abnormal taste and smell, diarrhea, nasal congestion, runny nose and headache | The treatment period, including 5 days after administration, and the follow-up period, which is day 11, day 21, and day 30 after administration, respectively | 
| TCM symptom score | Quantitative table of TCM syndrome score of novel coronavirus pneumonia | The treatment period, including 5 days after administration, and the follow-up period, which is day 11, day 21, and day 30 after administration, respectively | 
| Hematological parameters | C-reactive protein, erythrocyte sedimentation rate, lymphocyte count, lymphocyte/neutrophil ratio, coagulation, D-Di and IL-6 | The treatment period, day one and day five after administration | 
| Symptom relief rate | Time when symptom disappears | 30days | 
| Rate of progression to severe COVID-19 cases | Refer to the severe diagnostic criteria for COVID-19 issued by the National Health Commission and the National Administration of Traditional Chinese Medicine: Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (Trial Version 10) | 30days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Huashi Baidu Granule, Randomized controlled trial, Evidence-based