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

COVID-19 Clinical Trial

Official title:

A Randomized,Double Blinded, Double Dummy, Parallel Controlled Clinical Trial for Azvudine in the Treatment of Novel Coronavirus Pneumonia (COVID-19）

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04425772
• Other study ID #: FNC-Hope4
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 12, 2020
• Est. completion date: August 12, 2020

Study information

• Verified date: June 2020
• Source: HeNan Sincere Biotech Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 342
• Est. completion date: August 12, 2020
• Est. primary completion date: August 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Pneumonia

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
HeNan Sincere Biotech Co., Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change (reduction) in viral load from baseline	(reduction) in viral load from baseline	On day 7 and 14
Secondary	proportion of subjects change from mild or moderate type to severe type	proportion of subjects change from mild or moderate type to severe type	up to 21 days
Secondary	proportion of subjects change from severe type to critical type	proportion of subjects change from severe type to critical type	up to 21 days
Secondary	novel coronavirus nucleic acid conversion rate	novel coronavirus nucleic acid conversion rate	up to 21 days
Secondary	Novel coronavirus nucleic acid negative conversion time	Novel coronavirus nucleic acid negative conversion time	up to 21 days
Secondary	The time and proportion of improvement in pulmonary imaging	TIme(Days);Proportion(percent)	up to 21 days
Secondary	Time and proportion of temperature return to normal	TIme(Days);Proportion(percent)	up to 21 days
Secondary	time and rate of improvement of respiratory symptoms and signs (lung rhones, cough, sputum, sore throat, etc.)	TIme(Days);Proportion(percent)	up to 21 days
Secondary	time and rate of improvement of diarrhea, myalgia, fatigue and other symptoms	TIme(Days);Proportion(percent)	up to 21 days
Secondary	Changes of blood oxygen detection index	Changes of blood oxygen detection index	up to 21 days
Secondary	Frequency of requirement for supplemental oxygen or non-invasive ventilation	Frequency of requirement for supplemental oxygen or non-invasive ventilation	up to 21 days
Secondary	Frequency of adverse events	Frequency of adverse events	up to 21 days