Efficacy and Safety of Darunavir and Cobicistat for Treatment of COVID-19

NCT ID: NCT04252274

Last Updated: 2020-04-13

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-30

Study Completion Date

2020-12-31

Brief Summary

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The study aims to evaluate the efficacy and safety of darunavir and cobistastat in the treatment of COVID-19 pneumonia

Detailed Description

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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.

Conditions

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Pneumonia, Pneumocystis Coronavirus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

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.

Group Type EXPERIMENTAL

Darunavir and Cobicistat

Intervention Type DRUG

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.

Group Type NO_INTERVENTION

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

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Public Health Clinical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Hongzhou Lu

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Shanghai Public Health Clinical Center

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Shanghai Public Health Clinical Center

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hongzhou Lu, Ph.D

Role: CONTACT

+86-021-37990333 ext. 3222

Hongzhou Lu, PI

Role: CONTACT

+86-021-37990333 ext. 3222

Facility Contacts

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Hongzhou Lu

Role: primary

008602137990333 ext. 3222

Hongzhou Lu, PI

Role: primary

+86-021-37990333 ext. 3222

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.

Reference Type DERIVED
PMID: 32671131 (View on PubMed)

Other Identifiers

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DC-COVID-19

Identifier Type: -

Identifier Source: org_study_id

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