Clinical trial NCT05638672: COVID-19 Huashi Baidu Formula Clinical Study
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COVID-19
Keywords: Huashi Baidu Granule
Randomized controlled trial
Evidence-based
Lead sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
Collaborators: name: Beijing YouAn Hospital
name: Kossamak Hospital
name: Kamuzu University of Health Sciences
First posted: 2022-12-06
Enrollment: 300
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: 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.

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.

Primary outcomes:
measure: Nucleic acid negative rate in 5 days;Virus CT value
timeFrame: The treatment period，Receive the test by PCR once a daily ，for 5 consecutive days
Secondary outcomes:
measure: Disease score
timeFrame: 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
measure: Score of individual symptom
timeFrame: 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
measure: TCM symptom score
timeFrame: 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
measure: Hematological parameters
timeFrame: The treatment period, day one and day five after administration
measure: Symptom relief rate
timeFrame: 30days
measure: Rate of progression to severe COVID-19 cases
timeFrame: 30days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing You'an Hospital, Capital Medical University
state: Beijing
Study officials:
References: