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

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ClinicalTrials.gov Identifier: NCT04425382
Recruitment Status : Recruiting
First Posted : June 11, 2020
Last Update Posted : June 11, 2020
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Coronavirus COVID Pneumonia Drug: Darunavir/Cobicistat Drug: Lopinavir/Ritonavir

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Efficacy and Safety of Darunavir/Cobicistat vs. Lopinavir/Ritonavir in the Management of Patients With COVID-19 Pneumonia in Qatar
Actual Study Start Date : March 1, 2020
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Group/Cohort Intervention/treatment
Darunavir/Cobicistat
Patients received Darunavir/Cobicistat (Rezolsta®) as part of the treatment regimen for COVID-19 pneumonia
Drug: Darunavir/Cobicistat
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
Drug: Lopinavir/Ritonavir
Lopinavir/Ritonavir (200mg/50mg) 2 tablets PO twice daily




Primary Outcome Measures :
  1. Time to Clinical Improvement and/or Virological Clearance (Composite Endpoint) [ Time Frame: 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 :
  1. Percentage of Virological Clearance [ Time Frame: At day 14, day 21, and day 28. ]
    o Defined as two consecutive negative COVID-19 PCR samples

  2. Percentage of Clinical Deterioration [ Time Frame: Up to 28 days ]
    o Defined as the need for respiratory support, vasopressor use, or corticosteroids/immunomodulation therapy

  3. Incidence of Adverse Events [ Time Frame: Up to 28 days ]
  4. Length of Hospital Stay [ Time Frame: Up to 90 days ]
  5. All-cause Mortality [ Time Frame: At 30 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04425382


Contacts
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Contact: Dr. Eman Elmekaty, PharmD 40254259 Eelmekaty@hamad.qa

Locations
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Qatar
Hamad Medical Corporation Recruiting
Doha, Qatar
Contact: Dr. Eman Elmekaty, PharmD       eelmekaty@hamad.qa   
Sponsors and Collaborators
Hamad Medical Corporation
Investigators
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Principal Investigator: Dr. Eman Elmekaty, PharmD Hamad Medical Corporation
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Responsible Party: Hamad Medical Corporation
ClinicalTrials.gov Identifier: NCT04425382    
Other Study ID Numbers: MRC-05-069
First Posted: June 11, 2020    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Ritonavir
Lopinavir
Darunavir
Cobicistat
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors