Clinical trial NCT04333589: Corona Virus Disease 2019 Patients Whose Nucleic Acids Changed From Negative to Positive
Official title: The Mechanism, Clinical Outcome and Therapeutic Intervention of Corona Virus Disease 2019 Patients Whose Nucleic Acids Changed From Negative to Positive
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COVID-19
Keywords: Favipiravir
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2020-04-03
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Viral nucleic acid test negative conversion rate
timeFrame: 5 months
Secondary outcomes:
measure: Clinical cure rate
timeFrame: 5 months
Other outcomes:
Locations:
city: Fuyang
country: China
facility: The Second People's Hospital of Fuyang
state: Anhui
city: Ezhou
country: China
facility: Ezhou Hospital of Traditional Chinese Medicine
state: Hubei
city: Wuhan
country: China
facility: Ezhou Central Hospital
state: Hubei
city: Wuhan
country: China
facility: Huoshenshan Hospital of Wuhan
state: Hubei
city: Wuhan
country: China
facility: Jinyintan Hospital of Wuhan
state: Hubei
city: Wuhan
country: China
facility: Wuhan Pulmonary Hospital
state: Hubei
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
state: Hubei
city: Wenzhou
country: China
facility: Wenzhou Medical University Affiliated First Hospital
state: Zhejiang
Study officials:
affiliation: Peking University First Hospital
name: Guiqiang Wang
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.