COVID-19 Huashi Baidu Formula Clinical Study

COVID-19 Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05638672
• Other study ID #: 2022XLA151-2
• Status: Recruiting
• Phase: N/A
• Start date: May 6, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: December 2022
• Source: Xiyuan Hospital of China Academy of Chinese Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• 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.
• Monapiravir
Monapiravir, manufactured by Merck, an American pharmaceutical company, with the specification of 200mg × 40 capsules, 800mg each time, twice a day.

Locations

Country	Name	City	State
China	Beijing You'an Hospital, Capital Medical University	Beijing	Beijing

Sponsors (4)

Lead Sponsor	Collaborator
Xiyuan Hospital of China Academy of Chinese Medical Sciences	Beijing YouAn Hospital, Kamuzu University of Health Sciences, Kossamak Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Symptom relief rate	Time when symptom disappears	30days
Secondary	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