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TerminatedNCT05279235Updated Feb 8, 2023

Efficacy and Safety of JT001 (VV116) Compared With Favipiravir

A Phase 3 interventional study of JT001 and JT001 placebo in Moderate to Severe COVID-19, sponsored by Shanghai Vinnerna Biosciences Co., Ltd.. Terminated at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-08.

Sponsored by Shanghai Vinnerna Biosciences Co., Ltd. · Phase 3, Interventional, and Treatment

Why this study was terminated
Development strategy adjustment
Phase
Phase 3
Study type
Interventional
Enrollment
290
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to evaluate the efficacy and safety of JT001 (VV116) for the Treatment of Coronavirus Disease 2019 (COVID-19) in participants with moderate to severe 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. If the participant is eligible after this review, then the site will perform the invasive procedures to confirm eligibility.

Treatment and Assessment Period

This is the general sequence of events during the 29-day 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), and
  • Complete all safety monitoring.
  • Blood samples collection
02

Conditions studied

  • Moderate to Severe COVID-19

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03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 290 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Shanghai Vinnerna Biosciences Co., Ltd. is the lead sponsor of 10 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Participants of 18 years of age or older, at the time of signing of informed consent
  2. Participants who have a positive SARS-CoV-2 test result
  3. Participants who have one or more COVID-19 symptoms, such as fever, cough, sore throat, malaise, headache, muscle pain, nausea, vomiting, diarrhea, shortness of breath with exertion
  4. Participants who have SpO2≤93% on room air at sea level or PaO2/FiO2≤ 300
  5. Participants who must agree to adhere to contraception restrictions
  6. Participants who understand and agree to comply with planned study procedures
  7. Participants or legally authorized representatives can give written informed consent approved by the Ethical Review Board governing the site
  8. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol

Exclusion criteria

Exclusion Criteria:

  1. Participants who are judged by the investigator as likely to progress to critical COVID-19 prior to randomization.
  2. Participants who require mechanical ventilation or anticipated impending need for mechanical ventilation
  3. 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
  4. Participants who have eye disease (such as inflammation, Vessel deformity, retinal hemorrhage or decollement, optic nerve lesion, or fundus lesion)
  5. Participants who have any of the following conditions when screening:

    • ALT or AST>1.5 ULN
    • Systolic blood pressure \< 90 mm Hg
    • Diastolic blood pressure \< 60 mm Hg
    • Requiring vasopressors
    • Multi-organ dysfunction/failure
  6. Participants who have known allergies to any of the components used in the formulation of the interventions
  7. Any medical condition, which in the opinion of the Investigator, will compromise the safety of the participant
  8. Participants who have received a SARS-CoV-2 monoclonal antibody treatment or prevention, or antiviral treatment (including the investigational treatment)
  9. Participants who have received convalescent COVID-19 plasma treatment
  10. Participants who have received SARS-CoV-2 vaccine prior to randomization.
  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
  14. Male whose wife or partner plan to be pregnant within this study period
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
290 participants (actual)

Study arms

  • Experimental
    JT001& Favipiravir Placebo

    JT001 (VV116):Day 1: 600mg, Q12H X 1 day; Day 2\~5: 300mg, Q12H X 4 days Favipiravir placebo:Day 1: 1600mg, Q12H X 1 day; Day 2\~5: 600mg, Q12H X 4 days

    Drug: JT001 · Drug: Favipiravir placebo

  • Active comparator
    Favipiravir & JT001 Placebo

    Favipiravir:Day 1: 1600mg, Q12H X 1 day; Day 2\~5: 600mg, Q12H X 4 days JT001 (VV116) placebo:Day 1: 600mg, Q12H X 1 day; Day 2\~5: 300mg, Q12H X 4 days

    Drug: JT001 placebo · Drug: Favipiravir

Interventions

  • DrugJT001

    Day 1: 600mg, Q12H X 1 day; Day 2\~5: 300mg, Q12H X 4 days

    Also known as: VV116

  • DrugJT001 placebo

    Day 1: 600mg, Q12H X 1 day; Day 2\~5: 300mg, Q12H X 4 days

    Also known as: VV116 placebo

  • DrugFavipiravir

    Day 1: 1600mg, Q12H X 1 day; Day 2\~5: 600mg, Q12H X 4 days

  • DrugFavipiravir placebo

    Day 1: 1600mg, Q12H X 1 day; Day 2\~5: 600mg, Q12H X 4 days

06

What researchers measure

Primary outcomes

  1. progression of COVID-19

    Percentage of the participants who have progression of COVID-19, defined as progress to critical COVID-19\* or death from any cause, through Day 29

    Time frame: Up to 29 days

Secondary outcomes

  1. AEs and SAEs

    Safety assessments such as AEs and SAEs through Day 29

    Time frame: Up to 29 days

  2. Progress, Death

    Percentage of participants who experience these events by Day 29 * Progress to critical COVID-19 * Death from any cause

    Time frame: Up to 29 days

  3. WHO 11-point ordinal outcome scale

    The change of WHO 11-point ordinal outcome scale from baseline to Day 3, 5, 7, 10 and 29(0-uninfected,10-dead)

    Time frame: Day 3, 5, 7, 10 and 29

  4. The change of Chest CT scan

    The change of Chest CT scan from baseline to Day 7 and 10(Percentage of lung involved)

    Time frame: Day 7 and 10

  5. SARS-CoV-2 clearance

    Percentage of participants achieve SARS-CoV-2 clearance at Day 3, 5 ,7 and 10

    Time frame: Day 3, 5 ,7 and 10

Other outcomes

  1. SARS-CoV-2 viral genetic variation

    SARS-CoV-2 viral genetic variation

    Time frame: Day 1

07

Study locations

2 sites
  • Shanghai Public Health Clinical Center
    Shanghai, Shanghai 201508, China
  • Specialized lnfectious Diseases Hospital No2 of Zangiota District
    Tashkent, Tashkent Province 1118, Uzbekistan
08

References and documents

Individual participant data

Plan to share: Undecided — Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05279235
Lead sponsor
Shanghai Vinnerna Biosciences Co., Ltd.
Collaborators
Sponsor GmbH
Responsible party
Sponsor
First posted
Mar 15, 2022
Start date
Mar 14, 2022
Primary completion
Dec 15, 2022
Completion
Dec 15, 2022
Last update
Feb 8, 2023

Study contacts

Juan Ma, Master
study director · Shanghai Junshi Bioscience Co., Ltd.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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