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

Completed

• Conditions: Coronavirus; COVID; Pneumonia
• Interventions: Drug: Lopinavir/Ritonavir; Drug: Darunavir/Cobicistat

• Registration Number: NCT04425382
• Lead Sponsor: Hamad Medical Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-01
• Status Verified: 2020-05
• Study First Submitted: 2020-05-21
• Study First Submitted QC: 2020-06-09
• Study First Posted: 2020-06-11
• Primary Completion: 2020-07-31
• Study Completion: 2020-09-30
• Last Update Submitted: 2022-08-15
• Last Update Posted: 2022-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lopinavir/Ritonavir	Lopinavir/Ritonavir	Patient received Lopinavir/Ritonavir (Kaletra®) as part of the treatment regimen for COVID-19 pneumonia
Darunavir/Cobicistat	Darunavir/Cobicistat	Patients received Darunavir/Cobicistat (Rezolsta®) as part of the treatment regimen for COVID-19 pneumonia

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Hamad Medical Corporation; 🇶🇦 Doha, Qatar