Clinical trial

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

Name
JT001-PMS-CO02-COVID-19
Description
Real-world disease outcomes and safety in patients with mild to moderate COVID-19 treated with JT001
Trial arms
Trial start
2023-08-31
Estimated PCD
2024-05-31
Trial end
2024-08-31
Status
Recruiting
Treatment
JT001
oral administration
Arms:
JT001, No anti-SARS-CoV-2 treatment
Other names:
DeuremidevirHydrobromideTablets
Size
20000
Primary endpoint
Incidence of COVID-19 disease progression (severe COVID-19 or all-cause death) by day 28
Within 28 days
Eligibility criteria
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.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'OTHER', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 20000, 'type': 'ESTIMATED'}}
Updated at
2023-11-21

1 organization

1 product

1 indication

Product
JT001
Indication
COVID-19