Official Title
The Mechanism, Clinical Outcome and Therapeutic Intervention of Corona Virus Disease 2019 Patients Whose Nucleic Acids Changed From Negative to Positive
Brief Summary

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.

Detailed Description

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).

Unknown status
COVID-19

Drug: Favipiravir

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.

Eligibility Criteria

Inclusion Criteria:

1. COVID-19 has been diagnosed, and the nucleic acid test of respiratory specimens such
as sputum or nasopharyngeal swabs has been negative for two consecutive times after
treatment (sampling time interval of at least 24 hours);

2. The nucleic acid test of specimens such as sputum, throat swabs, blood, feces and
other specimens was positive for COVID-19 during screening visits;

3. Voluntarily participate in research and sign informed consent.

Exclusion Criteria:

1. Those allergic to fapilavir;

2. Pregnant or lactating women;

3. Unstable liver, kidney, and heart diseases;

4. History of mental disorders, substance abuse or dependence;

5. Researchers consider it inappropriate to participate in research;

6. Participating in other clinical research.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 80 Years
Countries
China
Locations

The Second People's Hospital of Fuyang
Fuyang, Anhui, China

Ezhou Hospital of Traditional Chinese Medicine
Ezhou, Hubei, China

Ezhou Central Hospital
Wuhan, Hubei, China

Huoshenshan Hospital of Wuhan
Wuhan, Hubei, China

Jinyintan Hospital of Wuhan
Wuhan, Hubei, China

Wuhan Pulmonary Hospital
Wuhan, Hubei, China

Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China

Wenzhou Medical University Affiliated First Hospital
Wenzhou, Zhejiang, China

Contacts

Guiqiang Wang
13911405123
john131212@sina.com

Hong Zhao
13810765943
zhaohong_pufh@bjmu.edu.cn

Guiqiang Wang, Principal Investigator
Peking University First Hospital

Peking University First Hospital
NCT Number
Keywords
Favipiravir
MeSH Terms
Virus Diseases
Coronavirus Infections
COVID-19
Favipiravir