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

Primary Purpose

Pneumonia, Pneumocystis, Coronavirus

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Darunavir and Cobicistat
Sponsored by
Shanghai Public Health Clinical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumonia, Pneumocystis focused on measuring Pneumonia, COVID-19, Darunavir, Cobicistat

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shanghai Public Health Clinical CenterRecruiting
  • Shanghai Public Health Clinical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Darunavir, Cobicistat and conventional treatments

Conventional treatments

Arm Description

After randomization, subjects take darunavir and cobicistat one tablet per day for 5 days, also take conventional treatments.

After randomization, subjects take conventional treatments without darunavir and cobicistat.

Outcomes

Primary Outcome Measures

The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 7

Secondary Outcome Measures

The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 3
The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 5
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
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.
The mortality rate of subjects at weeks 2

Full Information

First Posted
January 29, 2020
Last Updated
April 9, 2020
Sponsor
Shanghai Public Health Clinical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04252274
Brief Title
Efficacy and Safety of Darunavir and Cobicistat for Treatment of COVID-19
Acronym
DC-COVID-19
Official Title
Efficacy and Safety of Darunavir and Cobicistat for Treatment of COVID-19
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 30, 2020 (Actual)
Primary Completion Date
August 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Public Health Clinical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia, Pneumocystis, Coronavirus
Keywords
Pneumonia, COVID-19, Darunavir, Cobicistat

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Darunavir, Cobicistat and conventional treatments
Arm Type
Experimental
Arm Description
After randomization, subjects take darunavir and cobicistat one tablet per day for 5 days, also take conventional treatments.
Arm Title
Conventional treatments
Arm Type
No Intervention
Arm Description
After randomization, subjects take conventional treatments without darunavir and cobicistat.
Intervention Type
Drug
Intervention Name(s)
Darunavir and Cobicistat
Intervention Description
Subjects take darunavir and cobicistat one tablet per day for 5 days, also take conventional treatments
Primary Outcome Measure Information:
Title
The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 7
Time Frame
7 days after randomization
Secondary Outcome Measure Information:
Title
The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 3
Time Frame
3 days after randomization
Title
The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 5
Time Frame
5 days after randomization
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time Frame
14 days after randomization
Title
The critical illness rate of subjects at weeks 2
Description
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.
Time Frame
14 days after randomization
Title
The mortality rate of subjects at weeks 2
Time Frame
14 days after randomization

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hongzhou Lu, Ph.D
Phone
+86-021-37990333
Ext
3222
Email
luhongzhou@fudan.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Hongzhou Lu, PI
Phone
+86-021-37990333
Ext
3222
Email
luhongzhou@fudan.edu.cn
Facility Information:
Facility Name
Shanghai Public Health Clinical Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201508
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongzhou Lu
Phone
008602137990333
Ext
3222
Facility Name
Shanghai Public Health Clinical Center
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongzhou Lu, PI
Phone
+86-021-37990333
Ext
3222
Email
luhongzhou@fudan.edu.cn

12. IPD Sharing Statement

Citations:
PubMed Identifier
32671131
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.
Results Reference
derived

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

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