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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04425382
Other study ID # MRC-05-069
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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