COVID-19
Conditions
Brief summary
Real-world disease outcomes and safety in patients with mild to moderate COVID-19 treated with JT001
Interventions
DRUGJT001
oral administration
Sponsors
Shanghai Vinnerna Biosciences Co., Ltd.
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Outcome results
None listed