COVID-19
Conditions
Interventions
None listed
Sponsors
Zhongshan Hospital Fudan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients (or legally authorized representatives) should sign an informed consent form before starting any procedure; 2. Men and women aged 18 and over; 3. SARS-COV-2 infection confirmed by laboratory examination; 4. Severe or critically ill patients who meet the (Novel Coronavirus Pneumonia Diagnosis and Treatment Plan (Trial Ninth Edition): (1) Severe patients are defined as: no matter how long the disease lasts, at least one of the following conditions occurs: 1) Shortness of breath, RR >= 30 times/min; 2) In a resting state, when inhaling air, the oxygen saturation is 50% lung infiltration within 24 to 48 hours; (2) Definition of critically ill patients: The criteria for progressing to critically ill COVID-19 are defined by at least one of the following: 1) Respiratory failure, defined as the need for at least one of the following treatments (according to local medical resources/conditions): endotracheal intubation and mechanical ventilation, high-flow nasal cannula oxygen (heated, humidified, intensive nasal cannula, flow rate > 20 l/min, oxygen ratio >= 0.5), non-invasive positive pressure ventilation, extracorporeal membrane oxygenation (ECMO), or clinically diagnosed respiratory failure (that is, there is a clinical need for one of the above treatments, but it cannot be done under the condition of limited medical resources) given any of the above treatments); 2) Shock (defined as systolic blood pressure < 90 mmHg, or diastolic blood pressure < 60 mmHg or requiring vasopressors; 3) Multiple organ dysfunction/failure; Note: Progression to critical COVID-19 can be adjusted according to clinical diagnosis and treatment guidelines; 5. Keep contraception during the medication period and within 90 days after the last medication.
Exclusion criteria
Exclusion criteria: 1. Participated in other clinical studies of GT0918; Upper limit of 2.ALT/AST > 5 times normal value; 3. Serum total bilirubin > 1.5 x ULN (upper limit of normal); 4. Estimated glomerular filtration rate (eGFR) < 30 mL/min (including patients receiving hemodialysis or hemofiltration); 5. Suspected serious active bacteria, fungi, viruses or other infections (except COVID-19), which the researcher thinks may pose risks when taking the research drug; 6. Exclude patients with known history of HIV, active hepatitis B or active hepatitis C; 7. Pregnant or breastfeeding women; 8. Patients with end-stage basic diseases who are not suitable for study by doctors; 9. Have a pregnancy plan in the near future (within 90 days).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All-cause mortality within 30 days of dosing; | — |
Secondary
| Measure | Time frame |
|---|---|
| All-cause mortality from day 1 to day 60;Proportion of subjects with clinical deterioration within 30 days after dosing;Mean change in 8-point sequential scale scores from day 1 to day 15 and 22 (optional);Time to sustained clinical recovery (8-point sequential scale);The percentage of days 5, 8, 15, 22 (optional) that achieved sustained clinical recovery (8-point sequential scale);Changes in oxygenation index;Percentage of subjects who SARS-CoV-2 turned negative;The time to SARS-CoV-2 turning negative; | — |
Countries
China
Contacts
Public ContactJia Fan
Zhongshan Hospital Fudan University
Outcome results
None listed