A Clinical Trial for Azvudine in the Treatment of Novel Coronavirus Pneumonia (COVID-19）

NCT ID: NCT04425772

Last Updated: 2020-06-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 342 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-12
• Study Completion Date: 2020-08-12

Brief Summary

To evaluate the efficacy and safety of azvudine in treatment of COVID-19

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Experimental Group

FNC+Standard of Care

Group Type: EXPERIMENTAL

FNC+Standard of Care

Intervention Type: DRUG

FNC + Standard of Care according to the to the latest version of the National Health and Medical Commission Diagnostic criteria

Control Group

FNC dummy tablet+ Standard of Care

Group Type: PLACEBO_COMPARATOR

FNC dummy tablet+Standard of Care

Intervention Type: DRUG

FNC dummy tablet+ Standard of Care according to the to the latest version of the National Health and Medical Commission Diagnostic criteria

Interventions

FNC+Standard of Care

FNC + Standard of Care according to the to the latest version of the National Health and Medical Commission Diagnostic criteria

Intervention Type: DRUG

FNC dummy tablet+Standard of Care

FNC dummy tablet+ Standard of Care according to the to the latest version of the National Health and Medical Commission Diagnostic criteria

Intervention Type: DRUG

Other Intervention Names

Azvudine+SOC; Azvudin dummy tablet+SOC

Eligibility Criteria

Inclusion Criteria

1. age ≥18 years old, gender not limited;

2. Laboratory (RT-PCR) confirmed COVID-19;

3. the time from the first positive nucleic acid test to randomization does not exceed more than 4 days;

4. informed consent has been signed.

Exclusion Criteria

1. known or suspected allergies to the components of azivudine tablets;

2. according to the latest version of the National Health and Medical Commission Diagnostic criteria of COVID-19, patients with severe novel coronavirus pneumonia was confirmed;

3. severe liver disease (TBIL>=2 times normal upper limit; ALTAST>=5 times normal upper limit);

4. subjects with severe renal insufficiency (glomerular filtration rate ≤60 mL/min/1.73 m2) or undergoing continuous renal replacement therapy, hemodialysis or peritoneal dialysis;

5. subjects with complication of malabsorption syndrome or any other condition affecting gastrointestinal absorption, requiring intravenous nutrition or not being able to take drugs orally;

6. subjectsis currently receiving anti-hiv treatment;

7. women who are breast-feeding during pregnancy or have a family plan during the trial period and within 6 months after the end of the trial;

8. participating in other clinical trials or using experimental drugs, except traditional Chinese medicine;

9. Other conditions that not appropriate to be enrolled into this study based on investigator's advise.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Henan Genuine Biotech Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

FNC-Hope4

Identifier Type: -

Identifier Source: org_study_id