- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04252274
Efficacy and Safety of Darunavir and Cobicistat for Treatment of COVID-19 (DC-COVID-19)
April 9, 2020 updated by: Hongzhou Lu, Shanghai Public Health Clinical Center
The study aims to evaluate the efficacy and safety of darunavir and cobistastat in the treatment of COVID-19 pneumonia
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
30
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Hongzhou Lu, PI
- Phone Number: 3222 +86-021-37990333
- Email: luhongzhou@fudan.edu.cn
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China
- Recruiting
- Shanghai Public Health Clinical Center
-
Contact:
- Hongzhou Lu, PI
- Phone Number: 3222 +86-021-37990333
- Email: luhongzhou@fudan.edu.cn
-
Shanghai, Shanghai, China, 201508
- Recruiting
- Shanghai Public Health Clinical Center
-
Contact:
- Hongzhou Lu
- Phone Number: 3222 008602137990333
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 7
Time Frame: 7 days after randomization
|
7 days after randomization
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 3
Time Frame: 3 days after randomization
|
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
|
5 days after randomization
|
|
The mortality rate of subjects at weeks 2
Time Frame: 14 days after randomization
|
14 days after randomization
|
|
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time Frame: 14 days after randomization
|
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.
|
14 days after randomization
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 30, 2020
Primary Completion (Anticipated)
August 31, 2020
Study Completion (Anticipated)
December 31, 2020
Study Registration Dates
First Submitted
January 29, 2020
First Submitted That Met QC Criteria
January 31, 2020
First Posted (Actual)
February 5, 2020
Study Record Updates
Last Update Posted (Actual)
April 13, 2020
Last Update Submitted That Met QC Criteria
April 9, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Lung Diseases
- Bacterial Infections and Mycoses
- Mycoses
- Lung Diseases, Fungal
- Pneumocystis Infections
- COVID-19
- Pneumonia
- Pneumonia, Pneumocystis
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Protease Inhibitors
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- HIV Protease Inhibitors
- Viral Protease Inhibitors
- Cobicistat
- Darunavir
- Cobicistat mixture with darunavir
Other Study ID Numbers
- DC-COVID-19
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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