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

NCT04425382 | Completed FDA Drug

• 1 other identifier: MRC-05-069
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronavirus; COVID; Pneumonia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Percentage of Virological Clearance

  At day 14, day 21, and day 28.

• Percentage of Clinical Deterioration

  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

Study Arms (2)

Darunavir/Cobicistat

Patients received Darunavir/Cobicistat (Rezolsta®) as part of the treatment regimen for COVID-19 pneumonia

Drug: Darunavir/Cobicistat

Lopinavir/Ritonavir

Patient received Lopinavir/Ritonavir (Kaletra®) as part of the treatment regimen for COVID-19 pneumonia

Drug: Lopinavir/Ritonavir

Interventions

Darunavir/Cobicistat DRUG

Darunavir/Cobicistat (800mg/150mg) 1 tablet PO once daily

Darunavir/Cobicistat

Lopinavir/Ritonavir DRUG

Lopinavir/Ritonavir (200mg/50mg) 2 tablets PO twice daily

Lopinavir/Ritonavir

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

Sponsors & Collaborators

• Hamad Medical Corporation: lead

Study Sites (1)

Hamad Medical Corporation

Doha, Qatar

Location

Related Publications (1)

• 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.

  PMID: 35507606 DERIVED

MeSH Terms

Conditions

Coronavirus Infections; Pneumonia

Interventions

cobicistat mixture with darunavir; Lopinavir

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Dr. Eman Elmekaty, PharmD

  Hamad Medical Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2020
• First Posted: June 11, 2020
• Study Start: March 1, 2020
• Primary Completion: July 31, 2020
• Study Completion: September 30, 2020
• Last Updated: August 16, 2022

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

QA (1)