Efficacy and Safety of Darunavir and Cobicistat for Treatment of COVID-19 (DC-COVID-19)

April 9, 2020 updated by: Hongzhou Lu, Shanghai Public Health Clinical Center
The study aims to evaluate the efficacy and safety of darunavir and cobistastat in the treatment of COVID-19 pneumonia

Study Overview

Status

Unknown

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Shanghai
      • Shanghai, Shanghai, China
        • Recruiting
        • Shanghai Public Health Clinical Center
        • Contact:
      • Shanghai, Shanghai, China, 201508
        • Recruiting
        • Shanghai Public Health Clinical Center
        • Contact:
          • Hongzhou Lu
          • Phone Number: 3222 008602137990333

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Darunavir, Cobicistat and conventional treatments
After randomization, subjects take darunavir and cobicistat one tablet per day for 5 days, also take conventional treatments.
Subjects take darunavir and cobicistat one tablet per day for 5 days, also take conventional treatments
No Intervention: Conventional treatments
After randomization, subjects take conventional treatments without darunavir and cobicistat.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 7
Time Frame: 7 days after randomization
7 days after randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 3
Time Frame: 3 days after randomization
3 days after randomization
The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 5
Time Frame: 5 days after randomization
5 days after randomization
The mortality rate of subjects at weeks 2
Time Frame: 14 days after randomization
14 days after randomization
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time Frame: 14 days after randomization
14 days after randomization
The critical illness rate of subjects at weeks 2
Time Frame: 14 days after randomization
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2020

Primary Completion (Anticipated)

August 31, 2020

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

January 29, 2020

First Submitted That Met QC Criteria

January 31, 2020

First Posted (Actual)

February 5, 2020

Study Record Updates

Last Update Posted (Actual)

April 13, 2020

Last Update Submitted That Met QC Criteria

April 9, 2020

Last Verified

April 1, 2020

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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