A Real-World Study of JT001 for COVID-19

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06142201
• Other study ID #: JT001-PMS-CO02-COVID-19
• Status: Recruiting
• Start date: August 31, 2023
• Est. completion date: August 31, 2024

Study information

• Verified date: November 2023
• Source: Shanghai Vinnerna Biosciences Co., Ltd.
• Contact: Jiaming Li, Project Manager
• Phone: 86 13250088177
• Email: jiamin_li1[@]junshipharma.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20000
• Est. completion date: August 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• JT001
oral administration

Locations

Country	Name	City	State
China	Peking university first hospital	Beijing	Beijing
China	Central Hospital of Minhang District, Shanghai	Shanghai	Shanghai
China	Gongli Hospital, Pudong New Area, Shanghai	Shanghai	Shanghai
China	Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine	Shanghai	Shanghai
China	Shanghai Fourth People's Hospital	Shanghai	Shanghai
China	Shanghai Pudong Hospital, Fudan University Affiliated Pudong Medical Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Vinnerna Biosciences Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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
Secondary	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
Secondary	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