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

Not Applicable

• Conditions: COVID-19
• Interventions: Drug: FNC dummy tablet+Standard of Care; Drug: FNC+Standard of Care

• Registration Number: NCT04425772
• Lead Sponsor: HeNan Sincere Biotech Co., Ltd

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-09
• Status Verified: 2020-06
• Study First Submitted QC: 2020-06-08
• Last Update Submitted: 2020-06-08
• Study First Posted: 2020-06-11
• Last Update Posted: 2020-06-11
• Study Start: 2020-06-12
• Primary Completion: 2020-08-12
• Study Completion: 2020-08-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 342

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	FNC dummy tablet+Standard of Care	FNC dummy tablet+ Standard of Care
Experimental Group	FNC+Standard of Care	FNC+Standard of Care

Primary Outcome Measures

Name	Time	Method
Change (reduction) in viral load from baseline	On day 7 and 14	(reduction) in viral load from baseline

Secondary Outcome Measures

Name	Time	Method
proportion of subjects change from mild or moderate type to severe type	up to 21 days	proportion of subjects change from mild or moderate type to severe type
proportion of subjects change from severe type to critical type	up to 21 days	proportion of subjects change from severe type to critical type
time and rate of improvement of respiratory symptoms and signs (lung rhones, cough, sputum, sore throat, etc.)	up to 21 days	TIme(Days);Proportion(percent)
novel coronavirus nucleic acid conversion rate	up to 21 days	novel coronavirus nucleic acid conversion rate
Novel coronavirus nucleic acid negative conversion time	up to 21 days	Novel coronavirus nucleic acid negative conversion time
Time and proportion of temperature return to normal	up to 21 days	TIme(Days);Proportion(percent)
time and rate of improvement of diarrhea, myalgia, fatigue and other symptoms	up to 21 days	TIme(Days);Proportion(percent)
The time and proportion of improvement in pulmonary imaging	up to 21 days	TIme(Days);Proportion(percent)
Frequency of adverse events	up to 21 days	Frequency of adverse events
Changes of blood oxygen detection index	up to 21 days	Changes of blood oxygen detection index
Frequency of requirement for supplemental oxygen or non-invasive ventilation	up to 21 days	Frequency of requirement for supplemental oxygen or non-invasive ventilation