A Phase 3 interventional study of Darunavir and Cobicistat in Pneumonia, Pneumocystis and Coronavirus, sponsored by Shanghai Public Health Clinical Center. Status unknown at 2 sites in China. Per ClinicalTrials.gov, last updated 2020-04-13.
Sponsored by Shanghai Public Health Clinical Center · Phase 3, Interventional, and Treatment
The study aims to evaluate the efficacy and safety of darunavir and cobistastat in the treatment of COVID-19 pneumonia
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.
7,641 studies on the registry are indexed under COVID-19; 487 are open to participants now.
This study's planned enrollment of 30 is below the median of 100 across 4,100 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Shanghai Public Health Clinical Center is the lead sponsor of 37 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Exit criteria:
After randomization, subjects take darunavir and cobicistat one tablet per day for 5 days, also take conventional treatments.
Drug: Darunavir and Cobicistat
After randomization, subjects take conventional treatments without darunavir and cobicistat.
Subjects take darunavir and cobicistat one tablet per day for 5 days, also take conventional treatments
The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 7
Time frame: 7 days after randomization
The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 3
Time frame: 3 days after randomization
The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 5
Time frame: 5 days after randomization
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: 14 days after randomization
The critical illness rate of subjects at weeks 2
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.
Time frame: 14 days after randomization
The mortality rate of subjects at weeks 2
Time frame: 14 days after randomization
This study is status unknown, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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Shanghai Public Health Clinical Center