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

HeNan Sincere Biotech

Status: Unknown

Conditions: COVID-19

Treatments: Drug: FNC dummy tablet+Standard of Care; Drug: FNC+Standard of Care

Study type: Interventional

Funder types: Industry

Identifiers

NCT04425772

FNC-Hope4

Details and patient eligibility

About

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

Enrollment: 342 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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342 participants in 2 patient groups, including a placebo group

Experimental Group

Experimental group

Description:

FNC+Standard of Care

Treatment:

Drug: FNC+Standard of Care

Control Group

Placebo Comparator group

Description:

FNC dummy tablet+ Standard of Care

Treatment:

Drug: FNC dummy tablet+Standard of Care