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

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

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

Study Overview

• Status: Unknown
• Conditions: COVID-19
• Intervention / Treatment: Drug: FNC+Standard of Care; Drug: FNC dummy tablet+Standard of Care

• Study Type: Interventional
• Enrollment (Anticipated): 342
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; FNC+Standard of Care	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; Other Names: Azvudine+SOC
Placebo Comparator: Control Group; FNC dummy tablet+ Standard of Care	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; Other Names: Azvudin dummy tablet+SOC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change (reduction) in viral load from baseline	(reduction) in viral load from baseline	On day 7 and 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
proportion of subjects change from severe type to critical type	proportion of subjects change from severe type to critical type	up to 21 days
novel coronavirus nucleic acid conversion rate	novel coronavirus nucleic acid conversion rate	up to 21 days
Novel coronavirus nucleic acid negative conversion time	Novel coronavirus nucleic acid negative conversion time	up to 21 days
The time and proportion of improvement in pulmonary imaging	TIme(Days);Proportion(percent)	up to 21 days
Time and proportion of temperature return to normal	TIme(Days);Proportion(percent)	up to 21 days
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
time and rate of improvement of diarrhea, myalgia, fatigue and other symptoms	TIme(Days);Proportion(percent)	up to 21 days
Changes of blood oxygen detection index	Changes of blood oxygen detection index	up to 21 days
Frequency of requirement for supplemental oxygen or non-invasive ventilation	Frequency of requirement for supplemental oxygen or non-invasive ventilation	up to 21 days
Frequency of adverse events	Frequency of adverse events	up to 21 days

Collaborators and Investigators

• Sponsor: HeNan Sincere Biotech Co., Ltd

Study record dates

Study Major Dates

• Study Start (Anticipated): June 12, 2020
• Primary Completion (Anticipated): August 12, 2020
• Study Completion (Anticipated): August 12, 2020

Study Registration Dates

• First Submitted: May 9, 2020
• First Submitted That Met QC Criteria: June 8, 2020
• First Posted (Actual): June 11, 2020

Study Record Updates

• Last Update Posted (Actual): June 11, 2020
• Last Update Submitted That Met QC Criteria: June 8, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Lung Diseases; COVID-19; Pneumonia
• Other Study ID Numbers: FNC-Hope4

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No