COVID-19
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age =65 years 2. Diagnostic criteria for new coronavirus pneumonia (severe) in severe patients meeting the diagnosis and treatment protocol for new coronavirus pneumonia (9th edition): ?1 Shortness of breath, RR=30 times/min; ?2 Under resting state, oxygen saturation =93% when inhaling air; ?3 PaO2/FiO2 =300mmHg. ?4 Patients with progressive aggravation of clinical symptoms, and lung imaging shows that the lesion has obviously expanded by more than 50% within 24~48 hours. 3. Patients meeting the indications for Paxlovid treatment in the New Coronavirus Diagnosis and Treatment Protocol (Ninth Edition);
Exclusion criteria
Exclusion criteria: 1. Left ventricular ejection fraction less than 30%, sick sinus syndrome; Severe sinus bradycardia ( 5 times the upper limit of normal value; Serum total bilirubin 1.5 × ULN upper limit of normal, estimated glomerular filtration rate (eGFR) 30 mL/min (including patients on hemodialysis or hemofiltration), coagulation disorders, history of immune system disorders. 3. Suspected serious active bacterial, fungal, viral or other infections (except COVID-19); 4. Patients with known history of HIV, active hepatitis B or active hepatitis C were excluded; 5. Pregnant or lactating women; 6. Patients with end-stage underlying diseases who are not suitable for the study as assessed by doctors; 7. Patients who cannot cooperate with the treatment 8. Participating in other clinical trials within 3 months before inclusion in the study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of conversion of severe to critical type of novel coronavirus pneumonia; | — |
Secondary
| Measure | Time frame |
|---|---|
| In-hospital intubation rate;30-day mortality;Daily Prone Position Time;Hemodynamic parameters (blood pressure, heart rate, pulse oxygen saturation);Changes in inflammatory markers (CRP, PCT, IL-6, SAA, ferritin);Changes in immune parameters (cytokines, CD4, CD8, TNF);Oxygenation index change;Incidence of Adverse Events; | — |
Countries
CHINA
Contacts
Shanghai Fourth People's Hospital affiliated to Tongji University