Clinical trial
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.
Name
2022XLA151-2
Description
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.
Trial arms
Trial start
2023-05-06
Estimated PCD
2024-06-01
Trial end
2024-06-01
Status
Recruiting
Treatment
Huashi Baidu Granule
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.
Arms:
Treatment group
Monapiravir
Monapiravir, manufactured by Merck, an American pharmaceutical company, with the specification of 200mg × 40 capsules, 800mg each time, twice a day.
Arms:
Control group
Size
300
Primary endpoint
Nucleic acid negative rate in 5 days;Virus CT value
The treatment period，Receive the test by PCR once a daily ，for 5 consecutive days
Eligibility criteria
Inclusion Criteria:
1. 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) ；
2. Age ≥ 18 years and ≤ 65 years;
3. The time from the first symptom (or confirmed onset) shall not exceed 5 days;
4. 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:
1. 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.
2. Patients with severe primary respiratory diseases or other pathogenic microorganism pneumonia that needs to be differentiated from COVID-19.
3. Pregnant women, with positive urine pregnancy test, or with pregnancy plan within 12 months.
4. Patients suffering from malignant tumors, mental diseases and other systematic malignant diseases that the researchers consider unsuitable for the study.
5. People who have ever been allergic to the test drug and who do not tolerate the drug.
6. Those who are participating in other clinical trials.
7. Non severe patients in the trial shall not enter the study again after changing the classification.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 300, 'type': 'ESTIMATED'}}
Updated at
2023-05-16
1 organization
2 products
1 indication
Product
Huashi Baidu GranuleIndication
COVID-19Product
Monapiravir