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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04333589
• Other study ID #: 2020 research 112
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2020
• Est. completion date: September 15, 2020

Study information

• Verified date: April 2020
• Source: Peking University First Hospital
• Contact: Guiqiang Wang
• Phone: 13911405123
• Email: john131212[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: September 15, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Virus Diseases

Intervention

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.

Locations

Country	Name	City	State
China	Ezhou Hospital of Traditional Chinese Medicine	Ezhou	Hubei
China	The Second People's Hospital of Fuyang	Fuyang	Anhui
China	Wenzhou Medical University Affiliated First Hospital	Wenzhou	Zhejiang
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

Sponsors (1)

Lead Sponsor	Collaborator
Peking University First Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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