NCT05341609

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
822

participants targeted

Target at P50-P75 for phase_3 covid19

Timeline
Completed

Started Apr 2022

Shorter than P25 for phase_3 covid19

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 4, 2022

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

April 16, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 22, 2022

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 13, 2022

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
Last Updated

September 21, 2022

Status Verified

September 1, 2022

Enrollment Period

1 month

First QC Date

April 16, 2022

Last Update Submit

September 18, 2022

Conditions

COVID-19

Keywords

JT001(VV116)Mild to Moderate COVID-19

Outcome Measures

Primary Outcomes (1)

  • Time to sustained clinical recovery

    Time to sustained clinical recovery up to 28 days.

    Up to 28 days

Secondary Outcomes (12)

  • AEs and SAEs through Day 28

    Up to 28 days

  • Percentage of participants who experience these events by Day 28

    Day 1 to 28 days

  • Percentage of clinical recovery participants

    Days 3, 5, 7, 10, 14, 21 and 28

  • The change of COVID-19 symptom scores

    Days 3, 5, 7, 10, 14, 21 and 28

  • The change of WHO clinical progression scale

    Days 3, 5, 7, 10, 14, 21 and 28

  • +7 more secondary outcomes

Study Arms (2)

JT001(VV116)

EXPERIMENTAL

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

Drug: JT001

Paxlovid

ACTIVE COMPARATOR

Day 1\~5: 300 mg of Nirmatrelvir and 100 mg of ritonavir, Q12H X 5 days

Drug: Paxlovid

Interventions

JT001DRUG

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

Also known as: VV116
JT001(VV116)
PaxlovidDRUG

Day 1\~5: 300 mg of Nirmatrelvir and 100 mg of ritonavir, Q12H X 5 days

Also known as: Nirmatrelvir / ritonavir
Paxlovid

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200020, China

Location

Shanghai Tongren Hospital

Shanghai, Shanghai Municipality, 200050, China

Location

Shanghai Public Health Clinical Center

Shanghai, Shanghai Municipality, 200093, China

Location

Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200127, China

Location

ShuGuang Hospital

Shanghai, Shanghai Municipality, 201203, China

Location

Shanghai Pudong Hospital

Shanghai, Shanghai Municipality, 201399, China

Location

Huashan Hospital affiliated to Fudan University

Shanghai, Shanghai Municipality, 201900, China

Location

Related Publications (1)

  • 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.

    PMID: 36577095DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

GS-621763nirmatrelvir and ritonavir drug combination

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Guang Ning

    Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2022

First Posted

April 22, 2022

Study Start

April 4, 2022

Primary Completion

May 13, 2022

Study Completion

May 31, 2022

Last Updated

September 21, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(7)