Efficacy and Safety of Darunavir and Cobicistat for Treatment of COVID-19
NCT ID: NCT04252274
Last Updated: 2020-04-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
30 participants
INTERVENTIONAL
2020-01-30
2020-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Darunavir, Cobicistat and conventional treatments
After randomization, subjects take darunavir and cobicistat one tablet per day for 5 days, also take conventional treatments.
Darunavir and Cobicistat
Subjects take darunavir and cobicistat one tablet per day for 5 days, also take conventional treatments
Conventional treatments
After randomization, subjects take conventional treatments without darunavir and cobicistat.
No interventions assigned to this group
Interventions
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Darunavir and Cobicistat
Subjects take darunavir and cobicistat one tablet per day for 5 days, also take conventional treatments
Eligibility Criteria
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Inclusion Criteria
* Written the informed consent
Exclusion Criteria
* 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
ALL
No
Sponsors
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Shanghai Public Health Clinical Center
OTHER_GOV
Responsible Party
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Hongzhou Lu
professor
Locations
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Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, China
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Hongzhou Lu
Role: primary
References
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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.
Other Identifiers
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DC-COVID-19
Identifier Type: -
Identifier Source: org_study_id
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