Pneumonia, Pneumocystis, Coronavirus
Conditions
Keywords
Pneumonia, COVID-19, Darunavir, Cobicistat
Brief summary
The study aims to evaluate the efficacy and safety of darunavir and cobistastat in the treatment of COVID-19 pneumonia
Detailed description
There is no vaccine or antiviral treatment for human coronavirus, so this study aims to evaluate the efficacy and safety of darunavir and cobistastat in the treatment of COVID-19 pneumonia.
Interventions
Subjects take darunavir and cobicistat one tablet per day for 5 days, also take conventional treatments
Sponsors
Shanghai Public Health Clinical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* The participants were diagnosed as COVID-19 pneumonia, according to the notice on printing and distributing the diagnosis and treatment plan of pneumonia with new coronavirus infection (trial version 4 or update version) made by National Health Commission of the People's Republic of China. * Written the informed consent
Exclusion criteria
* Hypersensitivity to darunavir, cobicistat, or any excipients * Patients with severe liver injury (Child-Pugh Class C) * Concomitant medications that are highly dependent on CYP3A clearance, and the elevated plasma concentrations are associated with serious or life-threatening events. * Subjects were considered to be unable to complete the study, or not suitable for the study by researchers Exit criteria: * Subjects asked to withdraw the study * Subject will benefit if withdraw according to researchers' suggestions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 7 | 7 days after randomization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 3 | 3 days after randomization | — |
| The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 5 | 5 days after randomization | — |
| Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | 14 days after randomization | — |
| The critical illness rate of subjects at weeks 2 | 14 days after randomization | The diagnosis of critical illness case was based on the notice on printing and distributing the diagnosis and treatment plan of pneumonia with new coronavirus infection (trial version 4) made by National Health Commission of the People's Republic of China. |
| The mortality rate of subjects at weeks 2 | 14 days after randomization | — |
Countries
China
Contacts
Primary ContactHongzhou Lu, Ph.D
Backup ContactHongzhou Lu, PI
Outcome results
None listed