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Efficacy and Safety of Darunavir and Cobicistat for Treatment of Pneumonia Caused by 2019-nCoV (DACO-nCoV)

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 : March 4, 2020
Sponsor:
Information provided by (Responsible Party):
Hongzhou Lu, Shanghai Public Health Clinical Center

Study Description
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Brief Summary:
The study aims to evaluate the efficacy and safety of darunavir and cobistastat in the treatment of pneumonia caused by the 2019 novel coronavirus

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 pneumonia caused by the 2019 novel coronavirus.
Study Design
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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 Pneumonia Caused by 2019-nCoV
Actual Study Start Date : January 30, 2020
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 7 [ Time Frame: 7 days after randomization ]

Secondary Outcome Measures :
  1. The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 3 [ Time Frame: 3 days after randomization ]
  2. The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 5 [ Time Frame: 5 days after randomization ]
  3. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [ Time Frame: 14 days after randomization ]
  4. 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.

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

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The participants were diagnosed as pneumonia caused by 2019-nCoV, 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, colibrestat, 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
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Information from the National Library of Medicine

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


Contacts
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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

Locations
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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   
Sponsors and Collaborators
Shanghai Public Health Clinical Center
More Information
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Responsible Party: Hongzhou Lu, professor, Shanghai Public Health Clinical Center
ClinicalTrials.gov Identifier: NCT04252274    
Other Study ID Numbers: DACO-nCoV
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: March 4, 2020
Last Verified: March 2020

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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, Shanghai Public Health Clinical Center:
Pneumonia
2019-new coronavirus
Darunavir
Cobicistat
Additional relevant MeSH terms:
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Pneumonia, Pneumocystis
Coronavirus Infections
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
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