Mild to Moderate COVID-19Phase 2/3NCT05242042
JT001 (VV116) for the Early Treatment of COVID-19
A Phase 2/3 study testing JT001 in people with Mild to Moderate COVID-19, run by Shanghai JunTop Biosciences Co., LTD at 8 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of JT001 (VV116) for the early Treatment of Coronavirus Disease 2019 (COVID-19) in participants with mild to moderate COVID-19, at high risk for progression to severe COVID-19, including death. 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
- 381 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 28 Jan 2022to 23 Mar 2023
- Phase
- Phase 2/3
- 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
- Participants who have a positive SARS-CoV-2 test result, and have sample collection for first positive SARS-CoV-2 viral infection determination ≤5 days prior to randomization
- Participants who have one or more mild or moderate COVID-19 symptoms as follows and have a COVID-19 Related Symptom score ≥3
- Participants with the onset of symptoms of COVID-19 ≤5 days prior to randomization
- Participants who satisfy one or more than one of the following high risks for progression to severe COVID-19, including death:
- Participants who must agree to adhere to contraception restrictions
- Participants who understand and agree to comply with planned study procedures
- Participants 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
- Participants who are judged by the investigator as likely to progress to severe/critical COVID-19 prior to randomization.
- Participants who have SpO2≤93% on room air at sea level or PaO2/FiO2≤ 300, or respiratory rate ≥30 per minute, or heart rate ≥125 per minute
- Participants who require mechanical ventilation or anticipated impending need for mechanical ventilation
- Participants who 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
- Participants who have eye disease
- Participants who have ALT or AST>2 ULN at screening
Show all 13Show fewer
- 7 Participants who have known allergies to any of the components used in the formulation of the interventions
- 8 Any medical condition, which in the opinion of the Investigator, will compromise the safety of the participant
- 9. Participants who have received a SARS-CoV-2 monoclonal antibody treatment or prevention, or antiviral treatment (including the investigational treatment) within 180 days prior to screening visit
- 10. Participants who have received convalescent COVID-19 plasma treatment
- 11. Participants who have participated, within the last 30 days, in a clinical study involving an investigational intervention. If the previous investigational intervention has a long half-life, 5 half-lives or 30 days, whichever is longer, should have passed
- 12.Participants who are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
- 13. Female who is pregnant or breast-feeding or plan to be pregnant within this study period
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
China6 sites
Chongqing Public Health Medical Center
Chongqing, Chongqing Municipality
The Ninth Hospital of Nanchang
Nanchang, Jiangxi
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, 201508
The Sixth People's Hospital of ShenYang
Shenyang, Liaoning
Wuxi No.5 People's Hospital
Wuxi, Jiangsu
Thesixth peoples Hospital Of ZhengZhou
Zhengzhou, Henan
Hong Kong2 sites
CUHK Medical Centre
Hong Kong
CUHK Phase 1 Clinical Trial Centre
Hong Kong
About this study
Official title: A Multicenter, Double-blind, Randomized, Placebo-Controlled, Phase II/III Study to Evaluate the Efficacy, Safety and Pharmacokinetics of JT001 (VV116) for the Early Treatment of Coronavirus Disease 2019 (COVID-19) in Participants With Mild to Moderate COVID-19.
The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of JT001 (VV116) for the early Treatment of Coronavirus Disease 2019 (COVID-19) in participants with mild to moderate COVID-19, at high risk for progression to severe COVID-19, including death.
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, risk factors 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 Period
- Complete baseline procedures and sample collection
- Participants are randomized to an intervention group
- 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 (10 doses total)
PlaceboDrug
Placebo matching JT001 administered orally in tablet form every 12 hours for 5 days (10 doses total)
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: JT001 |
| Arm 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression of COVID-19:defined as progress to severe/critical COVID-19 or death from any cause
- Percentage of the participants who have progression of COVID-19
- Time to sustained clinical symptom resolution
Measured: Up to 28 days
Secondary outcomes (8)
Overall participant clinical status
Percentage of participants who experience these events by Day 28
- Progress to severe COVID-19
- Progress to critical COVID-19
- Death from any cause
Measured: Up to 28 days
COVID-19-related hospitalization rate of non-hospitalized participants
Percentage of participants who experience COVID-19-related hospitalization by Day 28
Measured: Up to 28 days
SARS-CoV-2 negative rate through Day7
Percentage of participants who achieve SARS-CoV-2 negative at Day 5 and 7
Measured: Baseline through Day 7
The plasma concentration
The plasma concentration of JT001 (VV116) and major metabolites
Measured: Baseline through Day 5
Safety assessments
Safety assessments such as AEs and SAEs
Measured: Up to 28 days
SARS-CoV-2 viral load
The SARS-CoV-2 viral load change from baseline to Day 5 and 7
Measured: Baseline through Day 7
SARS-CoV-2 viral load
SARS-CoV-2 viral load area under the response time curve (AUC) assessed through Day 7
Measured: Baseline through Day 7
To assess SARS-CoV-2 viral genetic variation
SARS-CoV-2 viral genetic variation
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2022
- Study start28 Jan 2022
- Primary completion23 Mar 2023
- Study completion23 Mar 2023
Why it stopped: Based on the current number of COVID-19 cases and the approval of COVID-19 treatment drugs , the research team is facing great challenges, and it is decided to terminate this study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2/3
- 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
- 381 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai JunTop Biosciences Co., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sponsor GmbH
- Responsible party
- Sponsor
- Investigators
- Juan Ma, Medical Director, Study director, Shanghai JunTop Biosciences Co., LTD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05242042
- Sponsor's protocol ID
- JT001-004-II/III-COVID-19
- Status last verified
- Sep 2023
- First submitted
- 11 Feb 2022
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-blind, Randomized, Placebo-Controlled, Phase II/III Study to Evaluate the Efficacy, Safety and Pharmacokinetics of JT001 (VV116) for the Early Treatment of Coronavirus Disease 2019 (COVID-19) in Participants With Mild to Moderate COVID-19.
- ClinicalTrials.gov ID
- NCT05242042
- Acronym / sponsor ID
- JT001-004-II/III-COVID-19
- Conditions
- Mild to Moderate COVID-19
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Based on the current number of COVID-19 cases and the approval of COVID-19 treatment drugs , the research team is facing great challenges, and it is decided to terminate this study
- Enrolment
- 381 participants (actual)
- Lead sponsor
- Shanghai JunTop Biosciences Co., LTDIndustry (pharma, biotech, devices)
- Collaborators
- Sponsor GmbH
- Study start
- 28 Jan 2022 (actual)
- Primary completion
- 23 Mar 2023 (actual)
- Study completion
- 23 Mar 2023 (actual)
- First posted
- 16 Feb 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, safety and pharmacokinetics of JT001 (VV116) for the early Treatment of Coronavirus Disease 2019 (COVID-19) in participants with mild to moderate COVID-19, at high risk for progression to severe COVID-19, including death.
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, risk factors 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 Period
- Complete baseline procedures and sample collection
- Participants are randomized to an intervention group
- 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: JT001 |
| Arm 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participants of 18 years of age or older
- Participants who have a positive SARS-CoV-2 test result, and have sample collection for first positive SARS-CoV-2 viral infection determination ≤5 days prior to randomization
- Participants who have one or more mild or moderate COVID-19 symptoms as follows and have a COVID-19 Related Symptom score ≥3
- Participants with the onset of symptoms of COVID-19 ≤5 days prior to randomization
- Participants who satisfy one or more than one of the following high risks for progression to severe COVID-19, including death:
Key exclusion criteria (13 listed)
- Participants who are judged by the investigator as likely to progress to severe/critical COVID-19 prior to randomization.
- Participants who have SpO2≤93% on room air at sea level or PaO2/FiO2≤ 300, or respiratory rate ≥30 per minute, or heart rate ≥125 per minute
- Participants who require mechanical ventilation or anticipated impending need for mechanical ventilation
- Participants who 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
- Participants who have eye disease
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 (10 doses total) | Drug | Arm 1 |
| PlaceboPlacebo matching JT001 administered orally in tablet form every 12 hours for 5 days (10 doses total) | Drug | Arm 2 |
Primary outcome
progression of COVID-19:defined as progress to severe/critical COVID-19 or death from any cause
Time frame: Up to 28 days
1. Percentage of the participants who have progression of COVID-19 2. Time to sustained clinical symptom resolution
8 secondary outcomes
Overall participant clinical status
Time frame: Up to 28 days
COVID-19-related hospitalization rate of non-hospitalized participants
Time frame: Up to 28 days
SARS-CoV-2 negative rate through Day7
Time frame: Baseline through Day 7
The plasma concentration
Time frame: Baseline through Day 5
Safety assessments
Time frame: Up to 28 days
SARS-CoV-2 viral load
Time frame: Baseline through Day 7
SARS-CoV-2 viral load
Time frame: Baseline through Day 7
To assess SARS-CoV-2 viral genetic variation
Time frame: Day 1
Results and safety
The study was stopped early (reason given: Based on the current number of COVID-19 cases and the approval of COVID-19 treatment drugs , the research team is facing great challenges, and it is decided to terminate this study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
- Individual participant dataSharing planned: Undecided. Undecided
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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.
Juan Ma, Medical Director study director
Shanghai JunTop Biosciences Co., LTD
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing JT001 in people with Mild to Moderate COVID-19, run by Shanghai JunTop Biosciences Co., LTD at 8 sites in 2 countries.
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 8 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: stopped early, as of the sponsor's last update on 22 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in China, Hong Kong. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: Based on the current number of COVID-19 cases and the approval of COVID-19 treatment drugs , the research team is facing great challenges, and it is decided to terminate 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?
progression of COVID-19:defined as progress to severe/critical COVID-19 or death from any cause (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?
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 22 Sep 2023.