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

NCT ID: NCT04425382

Last Updated: 2022-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-01

Study Completion Date

2020-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Coronavirus COVID Pneumonia

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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Darunavir/Cobicistat

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

Darunavir/Cobicistat

Intervention Type DRUG

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

Lopinavir/Ritonavir

Intervention Type DRUG

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

Interventions

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Darunavir/Cobicistat

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

Intervention Type DRUG

Lopinavir/Ritonavir

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hamad Medical Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dr. Eman Elmekaty, PharmD

Role: PRINCIPAL_INVESTIGATOR

Hamad Medical Corporation

Locations

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Hamad Medical Corporation

Doha, , Qatar

Site Status

Countries

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Qatar

References

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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.

Reference Type DERIVED
PMID: 35507606 (View on PubMed)

Other Identifiers

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MRC-05-069

Identifier Type: -

Identifier Source: org_study_id

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