A Clinical Trial for Azvudine in the Treatment of Novel Coronavirus Pneumonia (COVID-19)
Primary Purpose
COVID-19
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
FNC+Standard of Care
FNC dummy tablet+Standard of Care
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19
Eligibility Criteria
Inclusion Criteria:
- age ≥18 years old, gender not limited;
- Laboratory (RT-PCR) confirmed COVID-19;
- the time from the first positive nucleic acid test to randomization does not exceed more than 4 days;
- informed consent has been signed.
Exclusion Criteria:
- known or suspected allergies to the components of azivudine tablets;
- 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;
- severe liver disease (TBIL>=2 times normal upper limit; ALTAST>=5 times normal upper limit);
- subjects with severe renal insufficiency (glomerular filtration rate ≤60 mL/min/1.73 m2) or undergoing continuous renal replacement therapy, hemodialysis or peritoneal dialysis;
- subjects with complication of malabsorption syndrome or any other condition affecting gastrointestinal absorption, requiring intravenous nutrition or not being able to take drugs orally;
- subjectsis currently receiving anti-hiv treatment;
- 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;
- participating in other clinical trials or using experimental drugs, except traditional Chinese medicine;
- Other conditions that not appropriate to be enrolled into this study based on investigator's advise.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Experimental Group
Control Group
Arm Description
FNC+Standard of Care
FNC dummy tablet+ Standard of Care
Outcomes
Primary Outcome Measures
Change (reduction) in viral load from baseline
(reduction) in viral load from baseline
Secondary Outcome Measures
proportion of subjects change from mild or moderate type to severe type
proportion of subjects change from mild or moderate type to severe type
proportion of subjects change from severe type to critical type
proportion of subjects change from severe type to critical type
novel coronavirus nucleic acid conversion rate
novel coronavirus nucleic acid conversion rate
Novel coronavirus nucleic acid negative conversion time
Novel coronavirus nucleic acid negative conversion time
The time and proportion of improvement in pulmonary imaging
TIme(Days);Proportion(percent)
Time and proportion of temperature return to normal
TIme(Days);Proportion(percent)
time and rate of improvement of respiratory symptoms and signs (lung rhones, cough, sputum, sore throat, etc.)
TIme(Days);Proportion(percent)
time and rate of improvement of diarrhea, myalgia, fatigue and other symptoms
TIme(Days);Proportion(percent)
Changes of blood oxygen detection index
Changes of blood oxygen detection index
Frequency of requirement for supplemental oxygen or non-invasive ventilation
Frequency of requirement for supplemental oxygen or non-invasive ventilation
Frequency of adverse events
Frequency of adverse events
Full Information
NCT ID
NCT04425772
First Posted
May 9, 2020
Last Updated
June 8, 2020
Sponsor
HeNan Sincere Biotech Co., Ltd
1. Study Identification
Unique Protocol Identification Number
NCT04425772
Brief Title
A Clinical Trial for Azvudine in the Treatment of Novel Coronavirus Pneumonia (COVID-19)
Official Title
A Randomized,Double Blinded, Double Dummy, Parallel Controlled Clinical Trial for Azvudine in the Treatment of Novel Coronavirus Pneumonia (COVID-19)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 12, 2020 (Anticipated)
Primary Completion Date
August 12, 2020 (Anticipated)
Study Completion Date
August 12, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HeNan Sincere Biotech Co., Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To evaluate the efficacy and safety of azvudine in treatment of COVID-19
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
342 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
FNC+Standard of Care
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
FNC dummy tablet+ Standard of Care
Intervention Type
Drug
Intervention Name(s)
FNC+Standard of Care
Other Intervention Name(s)
Azvudine+SOC
Intervention Description
FNC + Standard of Care according to the to the latest version of the National Health and Medical Commission Diagnostic criteria
Intervention Type
Drug
Intervention Name(s)
FNC dummy tablet+Standard of Care
Other Intervention Name(s)
Azvudin dummy tablet+SOC
Intervention Description
FNC dummy tablet+ Standard of Care according to the to the latest version of the National Health and Medical Commission Diagnostic criteria
Primary Outcome Measure Information:
Title
Change (reduction) in viral load from baseline
Description
(reduction) in viral load from baseline
Time Frame
On day 7 and 14
Secondary Outcome Measure Information:
Title
proportion of subjects change from mild or moderate type to severe type
Description
proportion of subjects change from mild or moderate type to severe type
Time Frame
up to 21 days
Title
proportion of subjects change from severe type to critical type
Description
proportion of subjects change from severe type to critical type
Time Frame
up to 21 days
Title
novel coronavirus nucleic acid conversion rate
Description
novel coronavirus nucleic acid conversion rate
Time Frame
up to 21 days
Title
Novel coronavirus nucleic acid negative conversion time
Description
Novel coronavirus nucleic acid negative conversion time
Time Frame
up to 21 days
Title
The time and proportion of improvement in pulmonary imaging
Description
TIme(Days);Proportion(percent)
Time Frame
up to 21 days
Title
Time and proportion of temperature return to normal
Description
TIme(Days);Proportion(percent)
Time Frame
up to 21 days
Title
time and rate of improvement of respiratory symptoms and signs (lung rhones, cough, sputum, sore throat, etc.)
Description
TIme(Days);Proportion(percent)
Time Frame
up to 21 days
Title
time and rate of improvement of diarrhea, myalgia, fatigue and other symptoms
Description
TIme(Days);Proportion(percent)
Time Frame
up to 21 days
Title
Changes of blood oxygen detection index
Description
Changes of blood oxygen detection index
Time Frame
up to 21 days
Title
Frequency of requirement for supplemental oxygen or non-invasive ventilation
Description
Frequency of requirement for supplemental oxygen or non-invasive ventilation
Time Frame
up to 21 days
Title
Frequency of adverse events
Description
Frequency of adverse events
Time Frame
up to 21 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age ≥18 years old, gender not limited;
Laboratory (RT-PCR) confirmed COVID-19;
the time from the first positive nucleic acid test to randomization does not exceed more than 4 days;
informed consent has been signed.
Exclusion Criteria:
known or suspected allergies to the components of azivudine tablets;
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;
severe liver disease (TBIL>=2 times normal upper limit; ALTAST>=5 times normal upper limit);
subjects with severe renal insufficiency (glomerular filtration rate ≤60 mL/min/1.73 m2) or undergoing continuous renal replacement therapy, hemodialysis or peritoneal dialysis;
subjects with complication of malabsorption syndrome or any other condition affecting gastrointestinal absorption, requiring intravenous nutrition or not being able to take drugs orally;
subjectsis currently receiving anti-hiv treatment;
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;
participating in other clinical trials or using experimental drugs, except traditional Chinese medicine;
Other conditions that not appropriate to be enrolled into this study based on investigator's advise.
12. IPD Sharing Statement
Learn more about this trial
A Clinical Trial for Azvudine in the Treatment of Novel Coronavirus Pneumonia (COVID-19)
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