Efficacy and Safety of Darunavir and Cobicistat for Treatment of COVID-19 (DC-COVID-19)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04252274 |
Recruitment Status :
Recruiting
First Posted : February 5, 2020
Last Update Posted : April 13, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pneumonia, Pneumocystis Coronavirus | Drug: Darunavir and Cobicistat | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated 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 : | January 30, 2020 |
Estimated Primary Completion Date : | August 31, 2020 |
Estimated Study Completion Date : | December 31, 2020 |

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.
|
- The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 7 [ Time Frame: 7 days after randomization ]
- The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 3 [ Time Frame: 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 ]
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [ Time Frame: 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.
- The mortality rate of subjects at weeks 2 [ Time Frame: 14 days after randomization ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | Child, Adult, Older Adult |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04252274
Contact: Hongzhou Lu, Ph.D | +86-021-37990333 ext 3222 | luhongzhou@fudan.edu.cn | |
Contact: Hongzhou Lu, PI | +86-021-37990333 ext 3222 | luhongzhou@fudan.edu.cn |
China, Shanghai | |
Shanghai Public Health Clinical Center | Recruiting |
Shanghai, Shanghai, China, 201508 | |
Contact: Hongzhou Lu 008602137990333 ext 3222 | |
Shanghai Public Health Clinical Center | Recruiting |
Shanghai, Shanghai, China | |
Contact: Hongzhou Lu, PI +86-021-37990333 ext 3222 luhongzhou@fudan.edu.cn |
Responsible Party: | Hongzhou Lu, professor, Shanghai Public Health Clinical Center |
ClinicalTrials.gov Identifier: | NCT04252274 |
Other Study ID Numbers: |
DC-COVID-19 |
First Posted: | February 5, 2020 Key Record Dates |
Last Update Posted: | April 13, 2020 |
Last Verified: | April 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 |
Pneumonia COVID-19 Darunavir Cobicistat |
Pneumonia, Pneumocystis Pneumonia Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections Lung Diseases, Fungal Mycoses Pneumocystis Infections Darunavir Cobicistat |
HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors |