Corona Virus Disease 2019 Patients Whose Nucleic Acids Changed From Negative to Positive

Peking University

Status: Unknown

Conditions: COVID-19

Treatments: Drug: Favipiravir

Study type: Interventional

Funder types: Other

Identifiers

NCT04333589

2020 research 112

Details and patient eligibility

About

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.

Full 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).

Enrollment: 210 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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210 participants in 2 patient groups

Favipiravir group

Experimental group

Description:

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.

Treatment:

Drug: Favipiravir

Regular treatment group

No Intervention group

Description:

Treatments other than lopinavir and ritonavir, chloroquine phosphate, hydroxychloroquine sulfate, arbidol, and colomycin can be given.