Clinical trial NCT04252274: Efficacy and Safety of Darunavir and Cobicistat for Treatment of COVID-19
Official title: Efficacy and Safety of Darunavir and Cobicistat for Treatment of COVID-19
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Pneumonia, Pneumocystis
Coronavirus
Keywords: Pneumonia
COVID-19
Darunavir
Cobicistat
Lead sponsor: Shanghai Public Health Clinical Center
Sponsor class: OTHER_GOV
First posted: 2020-02-05
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 7
timeFrame: 7 days after randomization
Secondary outcomes:
measure: The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 3
timeFrame: 3 days after randomization
measure: The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 5
timeFrame: 5 days after randomization
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
timeFrame: 14 days after randomization
measure: The critical illness rate of subjects at weeks 2
timeFrame: 14 days after randomization
measure: The mortality rate of subjects at weeks 2
timeFrame: 14 days after randomization
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Public Health Clinical Center
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Public Health Clinical Center
state: Shanghai
Study officials:
References:
citation: Chen J, Xia L, Liu L, Xu Q, Ling Y, Huang D, Huang W, Song S, Xu S, Shen Y, Lu H. Antiviral Activity and Safety of Darunavir/Cobicistat for the Treatment of COVID-19. Open Forum Infect Dis. 2020 Jun 21;7(7):ofaa241. doi: 10.1093/ofid/ofaa241. eCollection 2020 Jul.