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

Pneumonia Clinical Trial

— DOLCI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04425382
• Other study ID #: MRC-05-069
• Status: Completed
• Start date: March 1, 2020
• Est. completion date: September 30, 2020

Study information

• Verified date: May 2020
• Source: Hamad Medical Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: September 30, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus
• COVID
• Pneumonia

Intervention

Drug:
• Darunavir/Cobicistat
Darunavir/Cobicistat (800mg/150mg) 1 tablet PO once daily
• Lopinavir/Ritonavir
Lopinavir/Ritonavir (200mg/50mg) 2 tablets PO twice daily

Locations

Country	Name	City	State
Qatar	Hamad Medical Corporation	Doha

Sponsors (1)

Lead Sponsor	Collaborator
Hamad Medical Corporation

Country where clinical trial is conducted

Qatar, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of Virological Clearance	o Defined as two consecutive negative COVID-19 PCR samples	At day 14, day 21, and day 28.
Secondary	Percentage of Clinical Deterioration	o Defined as the need for respiratory support, vasopressor use, or corticosteroids/immunomodulation therapy	Up to 28 days
Secondary	Incidence of Adverse Events		Up to 28 days
Secondary	Length of Hospital Stay		Up to 90 days
Secondary	All-cause Mortality		At 30 days