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The study aims to evaluate the efficacy and safety of darunavir and cobistastat in the treatment of COVID-19 pneumonia
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Darunavir, Cobicistat and conventional treatments | Experimental | After randomization, subjects take darunavir and cobicistat one tablet per day for 5 days, also take conventional treatments. |
|
| Conventional treatments | No Intervention | After randomization, subjects take conventional treatments without darunavir and cobicistat. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Darunavir and Cobicistat | Drug | Subjects take darunavir and cobicistat one tablet per day for 5 days, also take conventional treatments |
|
| Measure | Description | Time Frame |
|---|---|---|
| The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 7 | 7 days after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 3 | 3 days after randomization | |
| The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 5 | 5 days after randomization |
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Inclusion Criteria:
Exclusion Criteria:
Exit criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hongzhou Lu, Ph.D | Contact | +86-021-37990333 | 3222 | luhongzhou@fudan.edu.cn |
| Hongzhou Lu, PI | Contact | +86-021-37990333 | 3222 | luhongzhou@fudan.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Public Health Clinical Center | Recruiting | Shanghai | Shanghai Municipality | 201508 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32671131 | Derived | 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. |
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| ID | Term |
|---|---|
| D011020 | Pneumonia, Pneumocystis |
| D018352 | Coronavirus Infections |
| D011014 | Pneumonia |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D008172 | Lung Diseases, Fungal |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000711687 | cobicistat mixture with darunavir |
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| Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | 14 days after randomization |
| 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 |
| The mortality rate of subjects at weeks 2 | 14 days after randomization |
| Shanghai Public Health Clinical Center | Recruiting | Shanghai | Shanghai Municipality | China |
|
| D016720 |
| Pneumocystis Infections |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D011024 | Pneumonia, Viral |