DOLCI: Darunavir/Cobicistat vs. Lopinavir/Ritonavir in COVID-19 Pneumonia in Qatar
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Darunavir/Cobicistat Patients received Darunavir/Cobicistat (Rezolsta®) as part of the treatment regimen for COVID-19 pneumonia |
Drug: Darunavir/Cobicistat
Darunavir/Cobicistat (800mg/150mg) 1 tablet PO once daily
|
| Lopinavir/Ritonavir Patient received Lopinavir/Ritonavir (Kaletra®) as part of the treatment regimen for COVID-19 pneumonia |
Drug: Lopinavir/Ritonavir
Lopinavir/Ritonavir (200mg/50mg) 2 tablets PO twice daily
|
Outcome Measures
Primary Outcome Measures
- Time to Clinical Improvement and/or Virological Clearance (Composite Endpoint) [Up to 90 days]
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
Secondary Outcome Measures
- Percentage of Virological Clearance [At day 14, day 21, and day 28.]
o Defined as two consecutive negative COVID-19 PCR samples
- Percentage of Clinical Deterioration [Up to 28 days]
o Defined as the need for respiratory support, vasopressor use, or corticosteroids/immunomodulation therapy
- Incidence of Adverse Events [Up to 28 days]
- Length of Hospital Stay [Up to 90 days]
- All-cause Mortality [At 30 days]
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hamad Medical Corporation | Doha | Qatar |
Sponsors and Collaborators
- Hamad Medical Corporation
Investigators
- Principal Investigator: Dr. Eman Elmekaty, PharmD, Hamad Medical Corporation
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MRC-05-069