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

Peking University First Hospital210 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

210

Conditions

COVID-19

Interventions

FavipiravirDRUG

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

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (8)

The Second People's Hospital of Fuyang

Fuyang, Anhui, China

NOT_YET_RECRUITING

Ezhou Hospital of Traditional Chinese Medicine

Ezhou, Hubei, China

NOT_YET_RECRUITING

Ezhou Central Hospital

Wuhan, Hubei, China

Outcomes

Primary Outcomes

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).

Time frame: 5 months

Secondary Outcomes

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.

Time frame: 5 months

Central Contacts

Guiqiang Wang

CONTACT

13911405123 john131212@sina.com

Hong Zhao

CONTACT

13810765943 zhaohong_pufh@bjmu.edu.cn

Data from ClinicalTrials.gov

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