A Real-World Study of JT001 for COVID-19

A Real-world Study：Disease Outcome and Safety of JT001 in Patients With Coronavirus Disease 2019 (COVID-19)

Real-world disease outcomes and safety in patients with mild to moderate COVID-19 treated with JT001

Study Overview

• Status: Active, not recruiting
• Conditions: COVID-19
• Intervention / Treatment: Drug: JT001

• Study Type: Observational
• Enrollment (Actual): 7656

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100034
      • Peking University First Hospital
  • Shanghai
    • Shanghai, Shanghai, China, 200000
      • Shanghai Fourth People's Hospital
    • Shanghai, Shanghai, China, 200032
      • Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
    • Shanghai, Shanghai, China, 200135
      • Gongli Hospital, Pudong New Area, Shanghai
    • Shanghai, Shanghai, China, 201100
      • Central Hospital of Minhang District, Shanghai
    • Shanghai, Shanghai, China, 201200
      • Shanghai Pudong Hospital, Fudan University Affiliated Pudong Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with mild to moderate COVID-19

Description

Inclusion Criteria:

1. Age ≥18 years old.
2. The novel coronavirus infection (COVID-19) meets at least one of the following five criteria:

1) Diagnosis of novel coronavirus infection; 2) Diagnosed with novel coronavirus pneumonia; 3) The novel coronavirus nucleic acid test is positive; 4) Test positive for novel coronavirus antigen; 5) Culture positive for novel coronavirus.

3. Patients who have not developed severe COVID-19 or died within 28 days of COVID-19 diagnosis, or who have developed severe COVID-19 or died within 28 days of COVID-19 diagnosis, were treated with deuterimodivir hydrobromide tablets or were not treated with anti-novel coronavirus before disease progression.

Exclusion Criteria:

· Patients who have not developed severe COVID-19 or died within 28 days of COVID-19 diagnosis, or those who have developed severe COVID-19 or died within 28 days of COVID-19 diagnosis, received the following anti-novel coronavirus treatments before disease progression, including: Nematavir tablet/Ritonavir tablet, Azvudine tablet, Monoravir capsule, Zenotavir tablet/Ritonavir tablet, Leritvir tablet, Ambavirzumab/Romisivir injection, human immunoglobulin for COVID-19 or convalescent plasma for COVID-19 survivors.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
JT001	Drug: JT001; oral administration; Other Names: DeuremidevirHydrobromideTablets
No anti-SARS-CoV-2 treatment	Drug: JT001; oral administration; Other Names: DeuremidevirHydrobromideTablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of COVID-19 disease progression (severe COVID-19 or all-cause death) by day 28	Incidence of COVID-19 disease progression (severe COVID-19 or death from any cause) at day 28 from COVID-19 diagnosis. According to the diagnosis of severe COVID-19 and indicators meeting the diagnostic definition of severe COVID-19, the evaluation and analysis were performed.	Within 28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of the following COVID-19 disease progression events by day 28	Severe COVID-19 or all-cause death in patients with high-risk factors,Elderly patients (≥65 years) with severe COVID-19 or all-cause death,All enrolled patients had severe COVID-19,All enrolled patients died from all causes,COVID-19 related hospitalizations in non-hospitalized patients,Hospitalized patients with severe COVID-19 or all-cause death.	Within 28 days
Incidence of severe Covid-19-related events up to day 28	Incidence of severe Covid-19-related events up to day 28,Respiratory rate ≥30 times/min, Oxygen saturation (SpO2) ≤93% ,Partial oxygen pressure (PaO2)/Oxygen concentration (FiO2) ≤300mmHg,Lung imaging showed significant lesion progression > 50% within 24 to 48 hours,Mechanical ventilation o Respiratory failure and mechanical ventilation,Shock,Stay in ICU,Organ failure and admission to ICU.	Within 28 days
The incidence of all aes and abnormal laboratory changes on day 28, etc	The incidence of all aes and abnormal laboratory changes on day 28, etc	Within 28 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of SARS-CoV-2 through Day 28	Percentage of patients who achieve SARS-CoV-2 nucleic acid negative through Day 28，Change of SARS-CoV-2 viral load from baseline to Day 28	Within 28 days

Collaborators and Investigators

• Sponsor: Shanghai Vinnerna Biosciences Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2023
• Primary Completion (Estimated): November 30, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: November 20, 2023
• First Submitted That Met QC Criteria: November 20, 2023
• First Posted (Actual): November 21, 2023

Study Record Updates

• Last Update Posted (Actual): August 26, 2024
• Last Update Submitted That Met QC Criteria: August 23, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: JT001-PMS-CO02-COVID-19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No