Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Real-world disease outcomes and safety in patients with mild to moderate COVID-19 treated with JT001
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JT001 |
| ||
| No anti-SARS-CoV-2 treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JT001 | Drug | oral administration |
|
| 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 |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion 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.
Not provided
Not provided
Not provided
Adult patients with mild to moderate COVID-19
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking university first hospital | Beijing | Beijing Municipality | 100034 | China | ||
| Shanghai Fourth People's Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C000722705 | GS-621763 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| Shanghai |
| Shanghai Municipality |
| 200000 |
| China |
| Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine | Shanghai | Shanghai Municipality | 200032 | China |
| Gongli Hospital, Pudong New Area, Shanghai | Shanghai | Shanghai Municipality | 200135 | China |
| Central Hospital of Minhang District, Shanghai | Shanghai | Shanghai Municipality | 201100 | China |
| Shanghai Pudong Hospital, Fudan University Affiliated Pudong Medical Center | Shanghai | Shanghai Municipality | 201200 | China |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |