Clinical trial NCT06142201: A Real-World Study of JT001 for COVID-19
Official title: A Real-world Study：Disease Outcome and Safety of JT001 in Patients With Coronavirus Disease 2019 (COVID-19)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: COVID-19
Lead sponsor: Shanghai Vinnerna Biosciences Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-11-21
Enrollment: 7656
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with mild to moderate COVID-19

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


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.

Primary outcomes:
measure: Incidence of COVID-19 disease progression (severe COVID-19 or all-cause death) by day 28
timeFrame: Within 28 days
Secondary outcomes:
measure: Incidence of the following COVID-19 disease progression events by day 28
timeFrame: Within 28 days
measure: Incidence of severe Covid-19-related events up to day 28
timeFrame: Within 28 days
measure: The incidence of all aes and abnormal laboratory changes on day 28, etc
timeFrame: Within 28 days
Other outcomes:
measure: Changes of SARS-CoV-2 through Day 28
timeFrame: Within 28 days
Locations:
city: Beijing
country: China
facility: Peking university first hospital
state: Beijing
city: Shanghai
country: China
facility: Shanghai Fourth People's Hospital
state: Shanghai
city: Shanghai
country: China
facility: Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
state: Shanghai
city: Shanghai
country: China
facility: Gongli Hospital, Pudong New Area, Shanghai
state: Shanghai
city: Shanghai
country: China
facility: Central Hospital of Minhang District, Shanghai
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Pudong Hospital, Fudan University Affiliated Pudong Medical Center
state: Shanghai
Study officials:
References: