A Real-World Study of JT001 for COVID-19
Study Details
Study Description
Brief Summary
Real-world disease outcomes and safety in patients with mild to moderate COVID-19 treated with JT001
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| JT001
|
Drug: JT001
oral administration
Other Names:
|
| No anti-SARS-CoV-2 treatment
|
Drug: JT001
oral administration
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
- 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
Other Outcome Measures
- Changes of SARS-CoV-2 through Day 28 [Within 28 days]
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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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;
- 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.
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Peking university first hospital | Beijing | Beijing | China | 100034 |
| 2 | Shanghai Fourth People's Hospital | Shanghai | Shanghai | China | 200000 |
| 3 | Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine | Shanghai | Shanghai | China | 200032 |
| 4 | Gongli Hospital, Pudong New Area, Shanghai | Shanghai | Shanghai | China | 200135 |
| 5 | Central Hospital of Minhang District, Shanghai | Shanghai | Shanghai | China | 201100 |
| 6 | Shanghai Pudong Hospital, Fudan University Affiliated Pudong Medical Center | Shanghai | Shanghai | China | 201200 |
Sponsors and Collaborators
- Shanghai Vinnerna Biosciences Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- JT001-PMS-CO02-COVID-19