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To investigate the mechanism, clinical outcome and therapeutic efficacy with favipiravir of Corona Virus Disease 2019 patients whose nucleic acids changed from negative to positive.
In clinical institutions that enroll corona virus disease 2019 patients whose nucleic acids changed from negative to positive, two arms, multi-center, randomized and controlled methods are adopted. Patients are divided into two groups, favipiravir group and regular treatment group. 210 patients are expected to be enrolled and the cases are allocated according to the ratio of 2( favipiravir group): 1(regular treatment group).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Favipiravir group | Experimental | On the 1st day, 1600mg each time, twice a day; from the 2nd to the 7th day, 600mg each time, twice a day. Oral administration, the maximum number of days taken is not more than 14 days. |
|
| Regular treatment group | No Intervention | Treatments other than lopinavir and ritonavir, chloroquine phosphate, hydroxychloroquine sulfate, arbidol, and colomycin can be given. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Favipiravir | Drug | On the 1st day, 1600mg each time, twice a day; from the 2nd to the 7th day, 600mg each time, twice a day. Oral administration, the maximum number of days taken is not more than 14 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Viral nucleic acid test negative conversion rate | Proportion of subjects who tested negative for nucleic acid from sputum or nasopharyngeal swabs for two consecutive times(sampling time at least 24 hours). | 5 months |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical cure rate | Definition of clinical cure: The viral load of the respiratory specimen was negative for two consecutive times (the interval between the two tests was greater than or equal to one day), the lung image improved, and the body temperature returned to normal for more than 3 days, and the clinical manifestation improved. | 5 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guiqiang Wang | Contact | 13911405123 | john131212@sina.com | |
| Hong Zhao | Contact | 13810765943 | zhaohong_pufh@bjmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Guiqiang Wang | Peking University First Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second People's Hospital of Fuyang | Not yet recruiting | Fuyang | Anhui | 230022 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32503657 | Derived | Li J, Zhang C, Wu Z, Wang G, Zhao H. The Mechanism and Clinical Outcome of patients with Corona Virus Disease 2019 Whose Nucleic Acid Test has changed from negative to positive, and the therapeutic efficacy of Favipiravir: A structured summary of a study protocol for a randomised controlled trial. Trials. 2020 Jun 5;21(1):488. doi: 10.1186/s13063-020-04430-y. |
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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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| ID | Term |
|---|---|
| C462182 | favipiravir |
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| Ezhou Hospital of Traditional Chinese Medicine | Not yet recruiting | Ezhou | Hubei | 436000 | China |
|
| Ezhou Central Hospital | Not yet recruiting | Wuhan | Hubei | 430000 | China |
|
| Huoshenshan Hospital of Wuhan | Not yet recruiting | Wuhan | Hubei | 430000 | China |
|
| Jinyintan Hospital of Wuhan | Recruiting | Wuhan | Hubei | 430000 | China |
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| Wuhan Pulmonary Hospital | Not yet recruiting | Wuhan | Hubei | 430000 | China |
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| Zhongnan Hospital of Wuhan University | Not yet recruiting | Wuhan | Hubei | 430000 | China |
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| Wenzhou Medical University Affiliated First Hospital | Not yet recruiting | Wenzhou | Zhejiang | 325000 | China |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |