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

• Sponsor: Peking University First Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04333589
• Collaborator: (none)
• Enrollment: 210
• Locations: 8
• Arms: 2
• Anticipated Duration (Months): 5.5
• Patients Per Site: 26.3
• Patients Per Site Per Month: 4.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19	Drug: Favipiravir	N/A

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).

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 210 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Mechanism, Clinical Outcome and Therapeutic Intervention of Corona Virus Disease 2019 Patients Whose Nucleic Acids Changed From Negative to Positive
• Actual Study Start Date: Apr 1, 2020
• Anticipated Primary Completion Date: Jun 1, 2020
• Anticipated Study Completion Date: Sep 15, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Favipiravir group 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.	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.
No Intervention: Regular treatment group Treatments other than lopinavir and ritonavir, chloroquine phosphate, hydroxychloroquine sulfate, arbidol, and colomycin can be given.

Outcome Measures

Primary Outcome Measures

1. Viral nucleic acid test negative conversion rate [5 months]

   Proportion of subjects who tested negative for nucleic acid from sputum or nasopharyngeal swabs for two consecutive times(sampling time at least 24 hours).

Secondary Outcome Measures

1. Clinical cure rate [5 months]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Second People's Hospital of Fuyang	Fuyang	Anhui	China	230022
2	Ezhou Hospital of Traditional Chinese Medicine	Ezhou	Hubei	China	436000
3	Ezhou Central Hospital	Wuhan	Hubei	China	430000
4	Huoshenshan Hospital of Wuhan	Wuhan	Hubei	China	430000
5	Jinyintan Hospital of Wuhan	Wuhan	Hubei	China	430000
6	Wuhan Pulmonary Hospital	Wuhan	Hubei	China	430000
7	Zhongnan Hospital of Wuhan University	Wuhan	Hubei	China	430000
8	Wenzhou Medical University Affiliated First Hospital	Wenzhou	Zhejiang	China	325000

Sponsors and Collaborators

• Peking University First Hospital

Investigators

• Principal Investigator: Guiqiang Wang, Peking University First Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Guiqiang Wang, Principal Investigator, Peking University First Hospital
• ClinicalTrials.gov Identifier: NCT04333589
• Other Study ID Numbers: 2020 research 112
• First Posted: Apr 3, 2020
• Last Update Posted: Apr 24, 2020
• Last Verified: Apr 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Guiqiang Wang, Principal Investigator, Peking University First Hospital: Favipiravir
• Additional relevant MeSH terms: Virus Diseases; Coronavirus Infections; COVID-19; Favipiravir

Study Results

No Results Posted as of Apr 24, 2020