COVID-19 Huashi Baidu Formula Clinical Study

NCT05638672 | Unknown

• 1 other identifier: 2022XLA151-2
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Keywords

Huashi Baidu Granule; Randomized controlled trial; Evidence-based

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Disease score

  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

  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

  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

  The treatment period, day one and day five after administration

• Symptom relief rate

  30days

Study Arms (2)

Treatment group

EXPERIMENTAL

Huashi Baidu Granule+Monapiravir simulant

Drug: Huashi Baidu Granule

Control group

ACTIVE COMPARATOR

Monapiravir+Huashi Baidu Granule Simulator

Drug: Monapiravir

Interventions

Huashi Baidu Granule DRUG

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.

Treatment group

Monapiravir DRUG

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

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xiyuan Hospital of China Academy of Chinese Medical Sciences: lead
• Beijing YouAn Hospital: collaborator
• Kossamak Hospital: collaborator
• Kamuzu University of Health Sciences: collaborator

Study Sites (1)

Beijing You'an Hospital, Capital Medical University

Beijing, Beijing Municipality, 100069, China

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2022
• First Posted: December 6, 2022
• Study Start: May 6, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: May 16, 2023

Record last verified: 2022-12

Locations

CN (1)