A Real-World Study of JT001 for COVID-19

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

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

Conditions
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COVID-19

Intervention / Treatment
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* Drug: JT001


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years old. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| JT001<br> | Drug: JT001<br>* oral administration<br>* Other names: DeuremidevirHydrobromideTablets;|
| No anti-SARS-CoV-2 treatment<br> | Drug: JT001<br>* oral administration<br>* Other names: DeuremidevirHydrobromideTablets;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 |