COVID-19Phase 3NCT05341609

Efficacy and Safety of JT001 (VV116) Compared With Paxlovid

A Phase 3 study testing JT001 and Paxlovid in people with COVID-19, run by Vigonvita Life Sciences at 7 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to evaluate the efficacy and safety of JT001 (VV116) Compared With Paxlovid for the Treatment of Coronavirus Disease 2019 (COVID-19) 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: COVID-19
What is being tested?: JT001 and Paxlovid
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 822 participants
Where: 7 sitesChina
Study dates: 4 Apr 2022to 31 May 2022
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 who have a positive SARS-CoV-2 test result.
Participants who have one or more mild or moderate COVID-19 symptoms, and total symptom score ≥ 2.
Participants who have one or more of the following requirements: ≤7 days from the first positive test for SARS-COV-2 virus infection to the first dose; ≤5 days from the first onset of COVID-19 symptoms to the first dose; SARS-CoV-2 Ct Value ≤20 within 24 hours prior to the first dose.
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 or legally authorized representatives can give written informed consent approved by the Ethical Review Board governing the site.
Capable of giving signed informed consent as described in Appendix 1 which includes compliance 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.
Participants who require mechanical ventilation or anticipated impending need for mechanical ventilation.
Participants who have eye disease.
Participants who have any of the following conditions when screening: ALT or AST>1.5 ULN; e GFR <60 mL/min.
Participants who have known allergies to any of the components used in the formulation of the interventions.

Show all 14Show fewer

Any medical condition, which in the opinion of the Investigator, will compromise the safety of the participant.
Participants who have received a SARS-CoV-2 monoclonal antibody treatment or prevention, or antiviral treatment (including the investigational treatment).
Participants who have received convalescent COVID-19 plasma treatment.
Participant's use of contraindicated drugs in the Package Insert of Nirmatrelvir Tablet/Ritonavir Tablets.
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.
Participants who are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
Female who is pregnant or breast-feeding or plan to be pregnant within this study period.
Male whose wife or partner plan to be pregnant within this study period.

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

China7 sites

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200020
Shanghai Tongren Hospital
Shanghai, Shanghai Municipality, 200050
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, 200093
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200127
ShuGuang Hospital
Shanghai, Shanghai Municipality, 201203
Shanghai Pudong Hospital
Shanghai, Shanghai Municipality, 201399
Huashan Hospital affiliated to Fudan University
Shanghai, Shanghai Municipality, 201900

Other trials in China

About this study

Official title: A Multicenter, Single-blind, Randomized, Controlled Study to Evaluate the Efficacy and Safety of JT001 (VV116) Compared With Paxlovid for the Early Treatment of COVID-19 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, risk factors and other non-invasive inclusion and exclusion criteria prior to any invasive procedures.

Treatment and Assessment Period

This is the general sequence of events during the 28-day treatment and assessment period:

Complete baseline procedures Participants are randomized to an intervention group Participants receive study intervention (Q12H X 5 days), and Complete all safety monitoring

Conditions: COVID-19
Being tested: JT001, Paxlovid
Keywords: JT001(VV116), Mild to Moderate COVID-19
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

JT001Drug
Also called VV116
Day 1: 600mg, Q12H X 1 day; Day 2~5: 300mg, Q12H X 4 days
PaxlovidDrug
Also called Nirmatrelvir / ritonavir
Day 1~5: 300 mg of Nirmatrelvir and 100 mg of ritonavir, Q12H X 5 days

Study groups in NCT05341609
Study group	Role	What they receive
JT001(VV116)	Experimental	Day 1: 600mg, Q12H X 1 day; Day 2~5: 300mg, Q12H X 4 days Receives: Drug: JT001
Paxlovid	Active comparator	Day 1~5: 300 mg of Nirmatrelvir and 100 mg of ritonavir, Q12H X 5 days Receives: Drug: Paxlovid

What is being measured

The primary outcome is the main question the study is designed to answer.

Time to sustained clinical recovery
Time to sustained clinical recovery up to 28 days.
Measured: Up to 28 days

Secondary outcomes (12)

AEs and SAEs through Day 28
AEs and SAEs through Day 28
Measured: Up to 28 days
Percentage of participants who experience these events by Day 28
Percentage of participants who experience these events by Day 28
Progress to severe and/or critical COVID-19; Death from any cause
Measured: Day 1 to 28 days
Percentage of clinical recovery participants
Percentage of clinical recovery participants from baseline to Days 3, 5, 7, 10, 14, 21 and 28
Measured: Days 3, 5, 7, 10, 14, 21 and 28
The change of COVID-19 symptom scores
The change of "COVID-19 symptom scores" from baseline to Days 3, 5, 7, 10, 14, 21 and 28, the score ranges from 0 to 33 and higher scores mean a worse symptom.
Measured: Days 3, 5, 7, 10, 14, 21 and 28
The change of WHO clinical progression scale
The change of "WHO clinical progression scale" from baseline to Days 3, 5, 7, 10, 14, 21 and 28, the score ranges from 0 to 10 and higher scores mean a worse clinical progression.
Measured: Days 3, 5, 7, 10, 14, 21 and 28
Percentage of participants with SARS-CoV-2 clearance
Percentage of participants with SARS-CoV-2 clearance on Days 3, 5, 7, 10 and 14
Measured: Days 3, 5, 7, 10, 14
The change of SARS-COV-2 Ct value
The change of SARS-COV-2 Ct value at Days 3, 5, 7, 10, 14
Measured: Days 3, 5, 7, 10, 14
The change of Chest CT scan
The change of Chest CT scan from baseline to Days 7 or 10. The change from baseline involves not changed, getting worse, getting better as assessed by the investigator.
Measured: Days 7 or 10
Percentage of the participants who have progression of COVID-19 though Day 28
Progress to severe and/or critical COVID-19; Death from any cause
Measured: Up to 28 days
Percentage of participants whose "WHO clinical progression scale" reduced at least one level
Percentage of participants whose "WHO clinical progression scale" reduced at least one level from baseline to Days 3, 5, 7, 10, 14, 21 and 28. The score ranges from 0 to 10 and the higher scores mean a worse clinical progression level.
Measured: Days 3, 5, 7, 10, 14, 21 and 28
Time to sustained clinical symptom resolution
Time to sustained clinical symptom resolution
Measured: Up to 28 days
Percentage of participants with clinical symptom resolution
Percentage of participants with clinical symptom resolution from baseline to Days 3, 5, 7, 10, 14, 21 and 28
Measured: Days 3, 5, 7, 10, 14, 21 and 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Apr 202231 May 2022

First posted22 Apr 2022
Study start4 Apr 2022
Primary completion13 May 2022
Study completion31 May 2022

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 COVID-19Studies of the same condition, open and under way.
More trials run by Vigonvita Life SciencesThe sponsor's other registered studies.
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: Triple blind
Who is masked: Care provider, Investigator, Outcomes assessor
Enrolment: 822 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05341609
Sponsor's protocol ID: JT001-010-COVID-19
Status last verified: Sep 2022
First submitted: 16 Apr 2022
Last updated: 21 Sep 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Cao Z, Gao W, Bao H, Feng H, Mei S, Chen P, Gao Y, Cui Z, Zhang Q, Meng X, Gui H, Wang W, Jiang Y, Song Z, Shi Y, Sun J, Zhang Y, Xie Q, Xu Y, Ning G, Gao Y, Zhao R. VV116 versus Nirmatrelvir-Ritonavir for Oral Treatment of Covid-19. N Engl J Med. 2023 Feb 2;388(5):406-417. doi: 10.1056/NEJMoa2208822. Epub 2022 Dec 28.
PubMed 36577095

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All COVID-19 trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Single-blind, Randomized, Controlled Study to Evaluate the Efficacy and Safety of JT001 (VV116) Compared With Paxlovid for the Early Treatment of COVID-19 in Participants With Mild to Moderate COVID-19
ClinicalTrials.gov ID: NCT05341609
Acronym / sponsor ID: JT001-010-COVID-19
Conditions: COVID-19
Keywords: JT001(VV116), Mild to Moderate COVID-19
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 822 participants (actual)
Lead sponsor: Vigonvita Life SciencesIndustry (pharma, biotech, devices)
Study start: 4 Apr 2022 (actual)
Primary completion: 13 May 2022 (actual)
Study completion: 31 May 2022 (actual)
First posted: 22 Apr 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.

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.

Treatment and Assessment Period

This is the general sequence of events during the 28-day treatment and assessment period:

Complete baseline procedures Participants are randomized to an intervention group Participants receive study intervention (Q12H X 5 days), and Complete all safety monitoring

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: Parallel

Arm	Type	Receives
JT001(VV116)	Experimental	Drug: JT001Day 1: 600mg, Q12H X 1 day; Day 2~5: 300mg, Q12H X 4 days
Paxlovid	Active comparator	Drug: PaxlovidDay 1~5: 300 mg of Nirmatrelvir and 100 mg of ritonavir, Q12H X 5 days

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 who have a positive SARS-CoV-2 test result.
Participants who have one or more mild or moderate COVID-19 symptoms, and total symptom score ≥ 2.
Participants who have one or more of the following requirements: ≤7 days from the first positive test for SARS-COV-2 virus infection to the first dose; ≤5 days from the first onset of COVID-19 symptoms to the first dose; SARS-CoV-2 Ct Value ≤20 within 24 hours prior to the first dose.
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.

Key exclusion criteria (14 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.
Participants who require mechanical ventilation or anticipated impending need for mechanical ventilation.
Participants who have eye disease.
Participants who have any of the following conditions when screening: ALT or AST>1.5 ULN; e GFR <60 mL/min.

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: VV116Day 1: 600mg, Q12H X 1 day; Day 2~5: 300mg, Q12H X 4 days	Drug	JT001(VV116)
PaxlovidAlso: Nirmatrelvir / ritonavirDay 1~5: 300 mg of Nirmatrelvir and 100 mg of ritonavir, Q12H X 5 days	Drug	Paxlovid

Primary outcome

Time to sustained clinical recovery
Time frame: Up to 28 days
Time to sustained clinical recovery up to 28 days.

12 secondary outcomes

AEs and SAEs through Day 28
Time frame: Up to 28 days
Percentage of participants who experience these events by Day 28
Time frame: Day 1 to 28 days
Percentage of clinical recovery participants
Time frame: Days 3, 5, 7, 10, 14, 21 and 28
The change of COVID-19 symptom scores
Time frame: Days 3, 5, 7, 10, 14, 21 and 28
The change of WHO clinical progression scale
Time frame: Days 3, 5, 7, 10, 14, 21 and 28
Percentage of participants with SARS-CoV-2 clearance
Time frame: Days 3, 5, 7, 10, 14
The change of SARS-COV-2 Ct value
Time frame: Days 3, 5, 7, 10, 14
The change of Chest CT scan
Time frame: Days 7 or 10
Percentage of the participants who have progression of COVID-19 though Day 28
Time frame: Up to 28 days
Percentage of participants whose "WHO clinical progression scale" reduced at least one level
Time frame: Days 3, 5, 7, 10, 14, 21 and 28
Time to sustained clinical symptom resolution
Time frame: Up to 28 days
Percentage of participants with clinical symptom resolution
Time frame: Days 3, 5, 7, 10, 14, 21 and 28

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 21 Sep 2022.
Derived from this study: PubMed 36577095Cao Z, Gao W, Bao H, Feng H, Mei S, Chen P, Gao Y, Cui Z, Zhang Q, Meng X, Gui H, Wang W, Jiang Y, Song Z, Shi Y, Sun J, Zhang Y, Xie Q, Xu Y, Ning G, Gao Y, Zhao R. VV116 versus Nirmatrelvir-Ritonavir for Oral Treatment of Covid-19. N Engl J Med. 2023 Feb 2;388(5):406-417. doi: 10.1056/NEJMoa2208822. Epub 2022 Dec 28.
Individual participant dataSharing planned: No

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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.

Guang Ning principal investigator

Ruijin Hospital

7 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 and Paxlovid in people with COVID-19, run by Vigonvita Life Sciences at 7 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 8 inclusion and 14 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 21 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 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. 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?

Time to sustained 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 NCT05341609, 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 21 Sep 2022.