COVID-19NCT04425772
A Clinical Trial for Azvudine in the Treatment of Novel Coronavirus Pneumonia (COVID-19）
A study of COVID-19, run by Henan Genuine Biotech Co., Ltd..
Trial summary
To evaluate the efficacy and safety of azvudine in treatment of COVID-19 Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- COVID-19
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 342 participants
- Where
- No sites listed yet
- Study dates
- 12 Jun 2020to 12 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
About this study
Official title: 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
- Conditions
- COVID-19
- Being tested
- FNC+Standard of Care, FNC dummy tablet+Standard of Care
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FNC+Standard of CareDrug
Also called Azvudine+SOC
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 CareDrug
Also called Azvudin dummy tablet+SOC
FNC dummy tablet+ Standard of Care according to the to the latest version of the National Health and Medical Commission Diagnostic criteria
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | FNC+Standard of Care Receives: Drug: FNC+Standard of Care |
| Control Group | Placebo comparator | FNC dummy tablet+ Standard of Care Receives: Drug: FNC dummy tablet+Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change (reduction) in viral load from baseline
(reduction) in viral load from baseline
Measured: On day 7 and 14
Secondary outcomes (11)
proportion of subjects change from mild or moderate type to severe type
proportion of subjects change from mild or moderate type to severe type
Measured: up to 21 days
proportion of subjects change from severe type to critical type
proportion of subjects change from severe type to critical type
Measured: up to 21 days
novel coronavirus nucleic acid conversion rate
novel coronavirus nucleic acid conversion rate
Measured: up to 21 days
Novel coronavirus nucleic acid negative conversion time
Novel coronavirus nucleic acid negative conversion time
Measured: up to 21 days
The time and proportion of improvement in pulmonary imaging
TIme(Days);Proportion(percent)
Measured: up to 21 days
Time and proportion of temperature return to normal
TIme(Days);Proportion(percent)
Measured: 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)
Measured: up to 21 days
time and rate of improvement of diarrhea, myalgia, fatigue and other symptoms
TIme(Days);Proportion(percent)
Measured: up to 21 days
Changes of blood oxygen detection index
Changes of blood oxygen detection index
Measured: up to 21 days
Frequency of requirement for supplemental oxygen or non-invasive ventilation
Frequency of requirement for supplemental oxygen or non-invasive ventilation
Measured: up to 21 days
Frequency of adverse events
Frequency of adverse events
Measured: up to 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start12 Jun 2020 (estimated)
- Primary completion12 Aug 2020 (estimated)
- Study completion12 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 342 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Genuine Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04425772
- Sponsor's protocol ID
- FNC-Hope4
- Status last verified
- Jun 2020
- First submitted
- 9 May 2020
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized,Double Blinded, Double Dummy, Parallel Controlled Clinical Trial for Azvudine in the Treatment of Novel Coronavirus Pneumonia (COVID-19）
- ClinicalTrials.gov ID
- NCT04425772
- Acronym / sponsor ID
- FNC-Hope4
- Conditions
- COVID-19
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 342 participants (estimated)
- Lead sponsor
- Henan Genuine Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Jun 2020 (estimated)
- Primary completion
- 12 Aug 2020 (estimated)
- Study completion
- 12 Aug 2020 (estimated)
- First posted
- 11 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy and safety of azvudine in treatment of COVID-19
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Drug: FNC+Standard of CareFNC+Standard of Care |
| Control Group | Placebo comparator | Drug: FNC dummy tablet+Standard of CareFNC dummy tablet+ Standard of Care |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FNC+Standard of CareAlso: Azvudine+SOCFNC + Standard of Care according to the to the latest version of the National Health and Medical Commission Diagnostic criteria | Drug | Experimental Group |
| FNC dummy tablet+Standard of CareAlso: Azvudin dummy tablet+SOCFNC dummy tablet+ Standard of Care according to the to the latest version of the National Health and Medical Commission Diagnostic criteria | Drug | Control Group |
Primary outcome
Change (reduction) in viral load from baseline
Time frame: On day 7 and 14
(reduction) in viral load from baseline
11 secondary outcomes
proportion of subjects change from mild or moderate type to severe type
Time frame: up to 21 days
proportion of subjects change from severe type to critical type
Time frame: up to 21 days
novel coronavirus nucleic acid conversion rate
Time frame: up to 21 days
Novel coronavirus nucleic acid negative conversion time
Time frame: up to 21 days
The time and proportion of improvement in pulmonary imaging
Time frame: up to 21 days
Time and proportion of temperature return to normal
Time frame: up to 21 days
time and rate of improvement of respiratory symptoms and signs (lung rhones, cough, sputum, sore throat, etc.)
Time frame: up to 21 days
time and rate of improvement of diarrhea, myalgia, fatigue and other symptoms
Time frame: up to 21 days
Changes of blood oxygen detection index
Time frame: up to 21 days
Frequency of requirement for supplemental oxygen or non-invasive ventilation
Time frame: up to 21 days
Frequency of adverse events
Time frame: up to 21 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study of COVID-19, run by Henan Genuine Biotech Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change (reduction) in viral load from baseline (time frame: On day 7 and 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2020.