Darunavir/Cobicistat vs. Lopinavir/Ritonavir in COVID-19 Pneumonia in Qatar (DOLCI)

Efficacy and Safety of Darunavir/Cobicistat vs. Lopinavir/Ritonavir in the Management of Patients With COVID-19 Pneumonia in Qatar

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.

Study Overview

• Status: Completed
• Conditions: Pneumonia; COVID; Coronavirus
• Intervention / Treatment: Drug: Darunavir/Cobicistat; Drug: Lopinavir/Ritonavir

• Study Type: Observational
• Enrollment (Actual): 400

Contacts and Locations

Study Locations

• Qatar
  • Doha, Qatar
    • Hamad Medical Corporation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Hamad Medical Corporation
• Investigators: Principal Investigator: Dr. Eman Elmekaty, PharmD, Hamad Medical Corporation

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Actual): July 31, 2020
• Study Completion (Actual): September 30, 2020

Study Registration Dates

• First Submitted: May 21, 2020
• First Submitted That Met QC Criteria: June 9, 2020
• First Posted (Actual): June 11, 2020

Study Record Updates

• Last Update Posted (Actual): August 16, 2022
• Last Update Submitted That Met QC Criteria: August 15, 2022
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia; 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; Ritonavir; Lopinavir; Darunavir; Cobicistat mixture with darunavir
• Other Study ID Numbers: MRC-05-069

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No