A Real-World Study of JT001 for COVID-19
- Registration Number
- NCT06142201
- Lead Sponsor
- Shanghai Vinnerna Biosciences Co., Ltd.
- Brief Summary
Real-world disease outcomes and safety in patients with mild to moderate COVID-19 treated with JT001
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 7656
- 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.
· 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description No anti-SARS-CoV-2 treatment JT001 - JT001 JT001 -
- Primary Outcome Measures
Name Time Method Incidence of COVID-19 disease progression (severe COVID-19 or all-cause death) by day 28 Within 28 days 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.
- Secondary Outcome Measures
Name Time Method The incidence of all aes and abnormal laboratory changes on day 28, etc Within 28 days The incidence of all aes and abnormal laboratory changes on day 28, etc
Incidence of the following COVID-19 disease progression events by day 28 Within 28 days 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.
Incidence of severe Covid-19-related events up to day 28 Within 28 days 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.
Trial Locations
- Locations (6)
Peking university first hospital
🇨🇳Beijing, Beijing, China
Gongli Hospital, Pudong New Area, Shanghai
🇨🇳Shanghai, Shanghai, China
Shanghai Fourth People's Hospital
🇨🇳Shanghai, Shanghai, China
Central Hospital of Minhang District, Shanghai
🇨🇳Shanghai, Shanghai, China
Shanghai Pudong Hospital, Fudan University Affiliated Pudong Medical Center
🇨🇳Shanghai, Shanghai, China
Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
🇨🇳Shanghai, Shanghai, China