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

• Sponsor: Shanghai Public Health Clinical Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04252274
• Collaborator: (none)
• Enrollment: 30
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 11
• Patients Per Site: 15
• Patients Per Site Per Month: 1.4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pneumonia, Pneumocystis; Coronavirus	Drug: Darunavir and Cobicistat	Phase 3

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Efficacy and Safety of Darunavir and Cobicistat for Treatment of COVID-19
• Actual Study Start Date: Jan 30, 2020
• Anticipated Primary Completion Date: Aug 31, 2020
• Anticipated Study Completion Date: Dec 31, 2020

Arms and Interventions

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.	Drug: Darunavir and Cobicistat; 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.

Outcome Measures

Primary Outcome Measures

1. The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 7 [7 days after randomization]

Secondary Outcome Measures

1. The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 3 [3 days after randomization]

2. The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 5 [5 days after randomization]

3. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [14 days after randomization]

4. The critical illness rate of subjects at weeks 2 [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.

5. The mortality rate of subjects at weeks 2 [14 days after randomization]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shanghai Public Health Clinical Center	Shanghai	Shanghai	China	201508
2	Shanghai Public Health Clinical Center	Shanghai	Shanghai	China

Sponsors and Collaborators

• Shanghai Public Health Clinical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hongzhou Lu, professor, Shanghai Public Health Clinical Center
• ClinicalTrials.gov Identifier: NCT04252274
• Other Study ID Numbers: DC-COVID-19
• First Posted: Feb 5, 2020
• Last Update Posted: Apr 13, 2020
• Last Verified: Apr 1, 2020

• 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
• Keywords provided by Hongzhou Lu, professor, Shanghai Public Health Clinical Center: Pneumonia; COVID-19; Darunavir; Cobicistat
• Additional relevant MeSH terms: COVID-19; Pneumonia; Pneumonia, Pneumocystis; Darunavir; Cobicistat; Cobicistat mixture with darunavir

Study Results

No Results Posted as of Apr 13, 2020