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OpenTrials
Completed

NCT Number: NCT04425382

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

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.

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Key information

Conditions

Coronavirus COVID Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hamad Medical Corporation

Doha, Qatar

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Darunavir/Cobicistat

Drug

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

Lopinavir/ritonavir

Drug

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hamad Medical Corporation

Industry

Registry information

Official study title

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

Acronym: DOLCI

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 11, 2020
Registry last updated
Aug 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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