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)
1 other identifier
observational
7,656
1 country
6
Brief Summary
Real-world disease outcomes and safety in patients with mild to moderate COVID-19 treated with JT001
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2023
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 31, 2023
CompletedFirst Submitted
Initial submission to the registry
November 20, 2023
CompletedFirst Posted
Study publicly available on registry
November 21, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedAugust 26, 2024
August 1, 2024
1.3 years
November 20, 2023
August 23, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Incidence of the following COVID-19 disease progression events by day 28
Within 28 days
Incidence of severe Covid-19-related events up to day 28
Within 28 days
The incidence of all aes and abnormal laboratory changes on day 28, etc
Within 28 days
Other Outcomes (1)
Changes of SARS-CoV-2 through Day 28
Within 28 days
Study Arms (2)
JT001
No anti-SARS-CoV-2 treatment
Interventions
oral administration
Eligibility Criteria
Adult patients with mild to moderate COVID-19
You may qualify if:
- Age ≥18 years old.
- The novel coronavirus infection (COVID-19) meets at least one of the following five criteria:
- \) 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.
- \. 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.
You may not qualify if:
- · 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Peking university first hospital
Beijing, Beijing Municipality, 100034, China
Shanghai Fourth People's Hospital
Shanghai, Shanghai Municipality, 200000, China
Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 200032, China
Gongli Hospital, Pudong New Area, Shanghai
Shanghai, Shanghai Municipality, 200135, China
Central Hospital of Minhang District, Shanghai
Shanghai, Shanghai Municipality, 201100, China
Shanghai Pudong Hospital, Fudan University Affiliated Pudong Medical Center
Shanghai, Shanghai Municipality, 201200, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 20, 2023
First Posted
November 21, 2023
Study Start
August 31, 2023
Primary Completion
November 30, 2024
Study Completion
December 31, 2024
Last Updated
August 26, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share