Pneumonia Clinical Trial
— DOLCIOfficial title:
Efficacy and Safety of Darunavir/Cobicistat vs. Lopinavir/Ritonavir in the Management of Patients With COVID-19 Pneumonia in Qatar
NCT number | NCT04425382 |
Other study ID # | MRC-05-069 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 1, 2020 |
Est. completion date | September 30, 2020 |
Verified date | May 2020 |
Source | Hamad Medical Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Coronavirus Disease 2019 (COVID-19) is a disease caused by the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) virus. It was first isolated in Wuhan, China in December 2019 and then rapidly spread to the rest of the world posing a severe threat to global health. Many therapeutics have been investigated for the treatment of this disease with inconclusive outcomes. Protease inhibitors are one of the proposed agents, but their use is limited to their significant drug interactions and side effects. The aim of this study is to compare the efficacy and safety outcomes of Darunavir/Cobicistat versus Lopinavir /Ritonavir in the treatment of patients with COVID-19 pneumonia in Qatar.
Status | Completed |
Enrollment | 400 |
Est. completion date | September 30, 2020 |
Est. primary completion date | July 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Adult patients =18 years of age - Laboratory confirmed 2019-nCoV infection as determined by the PCR of the nasopharyngeal/oropharyngeal swab. - Radiologically confirmed pneumonia (Based on the chest x-ray or CT scan imaging). - Have received either Darunavir/Cobicistat or Lopinavir/Ritonavir as part of the treatment regimen for COVID-19 pneumonia Exclusion Criteria: - No exclusion criteria will be applied |
Country | Name | City | State |
---|---|---|---|
Qatar | Hamad Medical Corporation | Doha |
Lead Sponsor | Collaborator |
---|---|
Hamad Medical Corporation |
Qatar,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to Clinical Improvement and/or Virological Clearance (Composite Endpoint) | Clinical Improvement is defined as the time to normalization of fever (defined as temperature <37.8 oC for 72 hours) and/or resolution of baseline sign/symptoms, without the need for symptomatic treatment
Virological clearance is defined as the time to two consecutive negative COVID-19 PCR samples |
Up to 90 days | |
Secondary | Percentage of Virological Clearance | o Defined as two consecutive negative COVID-19 PCR samples | At day 14, day 21, and day 28. | |
Secondary | Percentage of Clinical Deterioration | o Defined as the need for respiratory support, vasopressor use, or corticosteroids/immunomodulation therapy | Up to 28 days | |
Secondary | Incidence of Adverse Events | Up to 28 days | ||
Secondary | Length of Hospital Stay | Up to 90 days | ||
Secondary | All-cause Mortality | At 30 days |
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