Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Darunavir/Cobicistat | Patients received Darunavir/Cobicistat (Rezolsta®) as part of the treatment regimen for COVID-19 pneumonia |
| |
| Lopinavir/Ritonavir | Patient received Lopinavir/Ritonavir (Kaletra®) as part of the treatment regimen for COVID-19 pneumonia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Darunavir/Cobicistat | Drug | Darunavir/Cobicistat (800mg/150mg) 1 tablet PO once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Clinical Improvement and/or Virological Clearance (Composite Endpoint) |
| Up to 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Virological Clearance | o Defined as two consecutive negative COVID-19 PCR samples | At day 14, day 21, and day 28. |
| Percentage of Clinical Deterioration | o Defined as the need for respiratory support, vasopressor use, or corticosteroids/immunomodulation therapy |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Adult patient who were admitted to HMC hospitals with laboratory confirmed 2019-nCoV infection who meet the inclusion criteria during the review period will be included.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dr. Eman Elmekaty, PharmD | Hamad Medical Corporation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hamad Medical Corporation | Doha | Qatar |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35507606 | Derived | Elmekaty EZI, Alibrahim R, Hassanin R, Eltaib S, Elsayed A, Rustom F, Mohamed Ibrahim MI, Abu Khattab M, Al Soub H, Al Maslamani M, Al-Khal A. Darunavir-cobicistat versus lopinavir-ritonavir in the treatment of COVID-19 infection (DOLCI): A multicenter observational study. PLoS One. 2022 May 4;17(5):e0267884. doi: 10.1371/journal.pone.0267884. eCollection 2022. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000711687 | cobicistat mixture with darunavir |
| D061466 | Lopinavir |
| ID | Term |
|---|---|
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
| Lopinavir/Ritonavir | Drug | Lopinavir/Ritonavir (200mg/50mg) 2 tablets PO twice daily |
|
| Up to 28 days |
| Incidence of Adverse Events | Up to 28 days |
| Length of Hospital Stay | Up to 90 days |
| All-cause Mortality | At 30 days |
| D007239 |
| Infections |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |