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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04252274
Other study ID # DC-COVID-19
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date January 30, 2020
Est. completion date December 31, 2020

Study information

Verified date April 2020
Source Shanghai Public Health Clinical Center
Contact Hongzhou Lu, Ph.D
Phone +86-021-37990333
Email luhongzhou@fudan.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Darunavir and Cobicistat
Subjects take darunavir and cobicistat one tablet per day for 5 days, also take conventional treatments

Locations

Country Name City State
China Shanghai Public Health Clinical Center Shanghai Shanghai
China Shanghai Public Health Clinical Center Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Public Health Clinical Center

Country where clinical trial is conducted

China, 

Outcome

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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