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Completed

NCT Number: NCT04643678

Anakinra in the Management of COVID-19 Infection

Coronavirus Disease 2019 (COVID-19) was first isolated in Wuhan, China in December 2019. It is rapidly spreading worldwide, posing a severe threat to global health. Many therapeutics have been investigated for the treatment of this disease with inconclusive outcomes.

Anakinra - an interleukin (IL)-1 receptor antagonist - had showed survival benefits in patients with macrophage activation syndrome (MAS) and sepsis and was investigated for the use in COVID-19 infection with promising outcomes.

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Key information

Conditions

Covid19 COVID-19 Corona Virus Infection Coronaviridae Infections Coronavirus Infections Cytokine Release Syndrome Infections Inflammation Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Shock Systemic Inflammatory Response Syndrome Viral Infection Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

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

  • Hospitalized adult (age ≥ 18yrs)
  • Confirmed COVID-19 diagnosis
  • Presence of respiratory distress in addition to signs of cytokine release syndrome
  • Radiological evidence of pneumonia
  • Signed informed consent

Exclusion criteria

  • Known allergic reactions to the study medication or any component of the product.
  • Active bacterial, viral, TB, fungal infectious diseases
  • Received immunosuppressant or immunomodulatory in the past 30 days
  • Neutrophil count < 500 cells/microliter
  • Platelets < 50,000/microliter
  • Pregnant or breastfeeding females

Treatment and study plan

Anakinra

Drug

Patient will receive Anakinra 100 mg SC injection every 12 hours for 3 days, then 100 mg once daily from day 4 to day 7 plus Standard of Care

Other names: Kineret®

Standard of care

Other

Patients will receive the Standard of Care therapy as per the local treatment protocol

Primary outcomes

  1. Treatment Success at day 14

    Time frame: Day 14

    Defined as WHO Clinical Progression score of ≤3 [Ambulatory mild disease: symptomatic; assistance needed].

Secondary outcomes

  1. Change in WHO Clinical Progression Score

    Time frame: Day 7

    Change in WHO Clinical Progression Score between day 1 and day 7 [WHO Clinical Progression score: 0 (Uninfected) - 10 (Dead)]

  2. Time to ICU admission

    Time frame: Day 28

    Time to ICU admission up to 28 days

  3. Incidence of Adverse Events

    Time frame: Day 28

    Incidence of adverse events up to 28 days

  4. Length of hospital stay

    Time frame: Day 28

    Length of hospital stay up to 28 days

  5. All-cause Mortality

    Time frame: Day 28

    All-cause mortality rate at hospital discharge or at 28 days, whichever is first

Sponsors and collaborators

Lead sponsor

Hamad Medical Corporation

Industry

Registry information

Official study title

Efficacy of Anakinra in the Management of Patients With COVID-19 Infection in Qatar: A Randomized Clinical Trial

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 25, 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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