Mild to Moderate COVID-19Phase 3NCT05582629
JT001 (VV116) for the Treatment of COVID-19
A Phase 3 study testing JT001 in people with Mild to Moderate COVID-19, run by Shanghai Vinnerna Biosciences Co., Ltd. at 9 sites in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of JT001 (VV116) in participants with mild to moderate COVID-19. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mild to Moderate COVID-19
- What is being tested?
- JT001
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,369 participants
- Where
- 9 sitesChina
- Study dates
- 21 Oct 2022to 14 Feb 2023
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants of 18 years of age or older, at the time of signing of informed consent.
- Have a positive SARS-CoV-2 test result, and sample collection for the first positive SARS-CoV-2 viral infection determination ≤5 days prior to the first dose.
- Note: PCR is the preferred method; however, with evolving approaches to laboratory confirmation of SARS-CoV-2 infection, other molecular or antigen tests that detect viral RNA or protein are allowed if authorized for use in the country. Serological tests that detect host antibodies generated in response to recent or prior infection are not allowed.
- Initial onset of symptoms of COVID-19 ≤3 days prior to the first dose.
- Have any of the following targeted COVID-19-related symptoms with COVID-19 Related Symptoms score ≥2 within 24 hours before the first dose:
- fever
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- cough
- sore throat
- stuffy or running nose,
- headache
- muscle or body aches
- shortness of breath or difficulty breathing
- nausea
- chills or shivering
- vomiting
- diarrhea
- Agree to adhere to contraception restrictions.Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Understand and agree to comply with planned study procedures.
- Can give written informed consent approved by the Ethical Review Board governing the site and comply with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Who cannot join
- Severe or critical COVID-19.
- SpO2≤93% on room air at sea level or PaO2/FiO2≤ 300 (with oxygen inhalation), or respiratory rate ≥30 per minute, or heart rate ≥125 per minute.
- Require mechanical ventilation or anticipated impending need for mechanical ventilation.
- Are suspected or proven serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking intervention.
- Current eye disease (such as inflammation, vessel deformity, retinal hemorrhage or decollement, optic nerve lesion, or fundus lesion).
- ALT or AST>2 ULN at screening.
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- Allergies to any of the components used in the formulation of the interventions.
- Any medical condition, which in the opinion of the Investigator, will compromise the safety of the participant.
- Received a SARS-CoV-2 monoclonal antibody treatment or prevention, or antiviral treatment (including the investigational treatment) within 30 days prior to screening.
- Received convalescent COVID-19 plasma treatment within 30 days prior to screening.
- Participated in a clinical study involving an investigational intervention within the last 30 days. If the previous investigational intervention has a long half-life, 5 half-lives or 30 days, whichever is longer, should have passed.
- Are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
- Female who are pregnant or breast-feeding or plan to be pregnant within this study period.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites
Fuzhou Pulmonary Hospital Of Fujian
Fuzhou, Fujian
Shulan (Hangzhou) Hospital
Hangzhou, Zhejiang, 310022
The Fourth Hospital in Inner Mongolia
Hohhot, Inner Mongolia
Shandong Public Health Clinical Center
Jinan, Shandong
Quzhou People's Hospital
Quzhou, Zhejiang
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality
The Sixth People's Hospital of ShenYang
Shenyang, Liaoning
The third people's hospital of Shenzhen
Shenzhen, Guangdong
Wuhan Infections Diseases Hospital
Wuhan, Hubei
About this study
Official title: A Multicenter, Double-blind, Randomized, Placebo-Controlled, Phase III Clinical Study to Evaluate the Efficacy and Safety of JT001 (VV116) in Participants With Mild to Moderate COVID-19
The purpose of this study is to evaluate the efficacy and safety of JT001 (VV116) in participants with mild to moderate COVID-19.
Read the detailed description
Screening Interested participants will sign the appropriate informed consent form (ICF) prior to completion of any study procedures.
The investigator will review symptoms and other non-invasive inclusion and exclusion criteria prior to any invasive procedures. If the participant is eligible after this review, then the site will perform the invasive procedures to confirm eligibility.
Treatment and Assessment
This is the general sequence of events during the 28-day treatment and assessment period:
Complete baseline procedures and samples collection； Participants are randomized to experimental arm or placebo arm； Participants receive study intervention (Q12H X 5 days)； Complete all safety monitoring； Complete all efficacy data collection； Blood samples collection
- Conditions
- Mild to Moderate COVID-19
- Being tested
- JT001, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JT001Drug
Also called VV116
JT001 administered orally in tablet form every 12 hours for 5 days
PlaceboDrug
Placebo matching JT001 administered orally in tablet form every 12 hours for 5 days
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | JT001 (VV116) Day 1: 0.6g, Q12H X 2 times Day 2-5: 0.3g, Q12H X 8 times Oral tablet Receives: Drug: JT001 |
| Arm 2 | Placebo comparator | Placebo Day 1: 6 tablets, Q12H X 2 times Day 2-5: 3 tablets, Q12H X 8 times Oral tablet Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterize the effect of JT001 (VV116) compared to placebo on clinical recovery
Time to sustained clinical symptoms resolution
Measured: Up to 28 days
Secondary outcomes (4)
Clinical alleviation
Time to sustained clinical symptoms alleviation
Measured: Up to 28 days
Disease progression
Percentage of participants who experience the following events of disease progression through Day 28 COVID-19-related hospitalization in non-hospitalized participants Progression to severe COVID-19 Progression to critical COVID-19 Death from any cause
Measured: Up to 28 days
SARS-CoV-2 nucleic acid and viral load
Percentage of participants who achieve SARS-CoV-2 negative through Days 5 and 7 Change of SARS-CoV-2 Ct Value from baseline to Days 5 and 7 Change of SARS-CoV-2 viral load from baseline to Days 5 and 7 SARS-CoV-2 viral load area under the response time curve (AUC) assessed through Day 7
Measured: Up to 28 days
Safety
Safety assessments such as AEs and SAEs through Day 28
Measured: Up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2022
- Study start21 Oct 2022
- Primary completion14 Feb 2023
- Study completion14 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild to Moderate 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,369 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Vinnerna Biosciences Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sponsor GmbH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05582629
- Sponsor's protocol ID
- JT001-015-III-COVID-19
- Status last verified
- Jun 2023
- First submitted
- 12 Oct 2022
- Last updated
- 28 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Complete de-identified patient data set
Publications
Fan X, Dai X, Ling Y, Wu L, Tang L, Peng C, Huang C, Liu H, Lu H, Shen X, Zhang W, Wang F, Li G, Li M, Huang Y, Zhang H, Li M, Ren F, Li Y, Liu C, Zhou Z, Sun W, Yi Y, Zhou D, Gao H, Pan Q, Liu H, Zhao J, Ding Z, Ma Y, Li W, Wang Q, Wang X, Bai Y, Jiang X, Ma J, Xie B, Zhang K, Li L. Oral VV116 versus placebo in patients with mild-to-moderate COVID-19 in China: a multicentre, double-blind, phase 3, randomised controlled study. Lancet Infect Dis. 2024 Feb;24(2):129-139. doi: 10.1016/S1473-3099(23)00577-7. Epub 2023 Nov 22.
PubMed 38006892
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-blind, Randomized, Placebo-Controlled, Phase III Clinical Study to Evaluate the Efficacy and Safety of JT001 (VV116) in Participants With Mild to Moderate COVID-19
- ClinicalTrials.gov ID
- NCT05582629
- Acronym / sponsor ID
- JT001-015-III-COVID-19
- Conditions
- Mild to Moderate COVID-19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,369 participants (actual)
- Lead sponsor
- Shanghai Vinnerna Biosciences Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Sponsor GmbH
- Study start
- 21 Oct 2022 (actual)
- Primary completion
- 14 Feb 2023 (actual)
- Study completion
- 14 Feb 2023 (actual)
- First posted
- 17 Oct 2022 (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.
The purpose of this study is to evaluate the efficacy and safety of JT001 (VV116) in participants with mild to moderate COVID-19.
Detailed description
Screening Interested participants will sign the appropriate informed consent form (ICF) prior to completion of any study procedures.
The investigator will review symptoms and other non-invasive inclusion and exclusion criteria prior to any invasive procedures. If the participant is eligible after this review, then the site will perform the invasive procedures to confirm eligibility.
Treatment and Assessment
This is the general sequence of events during the 28-day treatment and assessment period:
Complete baseline procedures and samples collection； Participants are randomized to experimental arm or placebo arm； Participants receive study intervention (Q12H X 5 days)； Complete all safety monitoring； Complete all efficacy data collection； Blood samples collection
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: JT001JT001 (VV116) Day 1: 0.6g, Q12H X 2 times Day 2-5: 0.3g, Q12H X 8 times Oral tablet |
| Arm 2 | Placebo comparator | Drug: PlaceboPlacebo Day 1: 6 tablets, Q12H X 2 times Day 2-5: 3 tablets, Q12H X 8 times Oral tablet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Participants of 18 years of age or older, at the time of signing of informed consent.
- Have a positive SARS-CoV-2 test result, and sample collection for the first positive SARS-CoV-2 viral infection determination ≤5 days prior to the first dose.
- Note: PCR is the preferred method; however, with evolving approaches to laboratory confirmation of SARS-CoV-2 infection, other molecular or antigen tests that detect viral RNA or protein are allowed if authorized for use in the country. Serological tests that detect host antibodies generated in response to recent or prior infection are not allowed.
- Initial onset of symptoms of COVID-19 ≤3 days prior to the first dose.
- Have any of the following targeted COVID-19-related symptoms with COVID-19 Related Symptoms score ≥2 within 24 hours before the first dose:
Key exclusion criteria (13 listed)
- Severe or critical COVID-19.
- SpO2≤93% on room air at sea level or PaO2/FiO2≤ 300 (with oxygen inhalation), or respiratory rate ≥30 per minute, or heart rate ≥125 per minute.
- Require mechanical ventilation or anticipated impending need for mechanical ventilation.
- Are suspected or proven serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking intervention.
- Current eye disease (such as inflammation, vessel deformity, retinal hemorrhage or decollement, optic nerve lesion, or fundus lesion).
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 |
|---|---|---|
| JT001Also: VV116JT001 administered orally in tablet form every 12 hours for 5 days | Drug | Arm 1 |
| PlaceboPlacebo matching JT001 administered orally in tablet form every 12 hours for 5 days | Drug | Arm 2 |
Primary outcome
Characterize the effect of JT001 (VV116) compared to placebo on clinical recovery
Time frame: Up to 28 days
Time to sustained clinical symptoms resolution
4 secondary outcomes
Clinical alleviation
Time frame: Up to 28 days
Disease progression
Time frame: Up to 28 days
SARS-CoV-2 nucleic acid and viral load
Time frame: Up to 28 days
Safety
Time frame: Up to 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2023.
- Derived from this study: PubMed 38006892Fan X, Dai X, Ling Y, Wu L, Tang L, Peng C, Huang C, Liu H, Lu H, Shen X, Zhang W, Wang F, Li G, Li M, Huang Y, Zhang H, Li M, Ren F, Li Y, Liu C, Zhou Z, Sun W, Yi Y, Zhou D, Gao H, Pan Q, Liu H, Zhao J, Ding Z, Ma Y, Li W, Wang Q, Wang X, Bai Y, Jiang X, Ma J, Xie B, Zhang K, Li L. Oral VV116 versus placebo in patients with mild-to-moderate COVID-19 in China: a multicentre, double-blind, phase 3, randomised controlled study. Lancet Infect Dis. 2024 Feb;24(2):129-139. doi: 10.1016/S1473-3099(23)00577-7. Epub 2023 Nov 22.
- Individual participant dataSharing planned: Yes. Complete de-identified patient data set
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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.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing JT001 in people with Mild to Moderate COVID-19, run by Shanghai Vinnerna Biosciences Co., Ltd. at 9 sites in China.
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 19 inclusion and 13 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: finished, as of the sponsor's last update on 28 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Characterize the effect of JT001 (VV116) compared to placebo on clinical recovery (time frame: Up to 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05582629, which also lists 1 linked publication.
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 28 Jun 2023.