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| Name | Class |
|---|---|
| Beijing YouAn Hospital | OTHER |
| Kossamak Hospital | UNKNOWN |
| Kamuzu University of Health Sciences | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | Huashi Baidu Granule+Monapiravir simulant |
|
| Control group | Active Comparator | Monapiravir+Huashi Baidu Granule Simulator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing You'an Hospital, Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100069 | China |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| Monapiravir | Drug | Monapiravir, manufactured by Merck, an American pharmaceutical company, with the specification of 200mg × 40 capsules, 800mg each time, twice a day. |
|
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 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |