Novel Coronavirus Pneumonia (COVID-19)
Conditions
Interventions
Experimental group:Nirmatrelvir Tablets/Ritonavir Tablets
Control group:None
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >=18 years, no gender limit; 2. Etiologically confirmed patients with novel coronavirus infection, including asymptomatic infected patients (in accordance with the NIH Guidelines for the Treatment of Novel Coronavirus Infection 2019), mild and common types (in accordance with the diagnostic criteria of the Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (Trial Version 9)); 3. SpO2>=93%; 4. Patients with maintenance dialysis, including peritoneal dialysis and hemodialysis; 5. Nematavir tablets/Ritonavir tablets were used for treatment (not applicable to control group); 6. Meet any of the following conditions: (1) Start treatment within 5 days after the first positive nucleic acid or the first clinical symptoms; (2) If the course of disease exceeds 5 days at the time of initial medication, Ct value should be less than 30; 7. The patient and legal representative sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with known allergy to Nematavir tablets/Ritonavir tablets active ingredients or any excipients; 2. Medications contraindicated in combination with Nematavir tablets/Ritonavir tablets for long-term use (including afurazosin, piperidine, piroxicam, propoxen, Renozine, Neratinib, Venetoclax, amiodarone, benzepidil, dronedarone, Encarni, Flucarni, propafenone, quinidine, Fusidic acid, voriconazole, asimidazole, terphenadine, colchicine, rifambutin, Lulazidone, Clozapine, Pimoxide, quetiapine, dihydroergotamine, ergotrine, ergotamine, methylergotrine, Cisapride, Lovastatin, Simvastatin, Lomitapide, Avanafil, sildenafil, Vardenafil, Clorazepam, diazepam, Sulazepam, Fluzepam, oral midazolam and triazolam, St. John's wort (Hypericum perforatum), carbamazepine, phenobarbital, phenytoin, rifamequal); 3. Patients with coma and dysphagia; 4. Pregnant and lactating patients; 5. Patients with uncontrolled HIV-1 infection; 6. Patients suffering from mental disorders; 7. Platelets less than 50x10^9/L; 8. Patients judged by the investigator to be unsuitable for this clinical study; 9. Patients with severe liver injury, 10. Drugs (including anti-novel coronavirus monoclonal antibodies) that have been used or are being used since the onset of the disease; 11. Have participated in or are participating in clinical studies of other new anti-novel coronavirus drugs since the onset of the disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of adverse events with CTCAE grade 3 or higher after treatment with Nirmatrelvir Tablets/Ritonavir Tablets;Changes in ALT, AST and total bilirubin of liver function from baseline after treatment with Nematavir Tablets/Ritonavir Tablets;Whether to change from asymptomatic/mild/common to severe/critical within 28 days; | — |
Secondary
| Measure | Time frame |
|---|---|
| Whether to temporarily discontinue Nirmatrelvir Tablets/Ritonavir Tablets due to safety;Whether to permanently discontinue Nirmatrelvir Tablets/Ritonavir Tablets due to safety;Whether CTCAE grade 3 or above adverse events occurred;Whether serious adverse events have occurred;28-day all-cause mortality; | — |
Countries
China
Contacts
Public ContactXue Jun
Huashan Hospital, Fudan University
Outcome results
None listed