Coronavirus Clinical Trial
— DC-COVID-19Official title:
Efficacy and Safety of Darunavir and Cobicistat for Treatment of COVID-19
The study aims to evaluate the efficacy and safety of darunavir and cobistastat in the treatment of COVID-19 pneumonia
Status | Recruiting |
Enrollment | 30 |
Est. completion date | December 31, 2020 |
Est. primary completion date | August 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
China | Shanghai Public Health Clinical Center | Shanghai | Shanghai |
China | Shanghai Public Health Clinical Center | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai Public Health Clinical Center |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 7 | 7 days after randomization | ||
Secondary | The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 3 | 3 days after randomization | ||
Secondary | The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 5 | 5 days after randomization | ||
Secondary | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | 14 days after randomization | ||
Secondary | 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. | 14 days after randomization | |
Secondary | The mortality rate of subjects at weeks 2 | 14 days after randomization |
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