Anakinra in the Management of COVID-19 Infection

Hamad Medical Corporation (Industry)
Overall Status
Completed ID

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

Study Design

Study Type:
Actual Enrollment :
80 participants
Intervention Model:
Parallel Assignment
None (Open Label)
Primary Purpose:
Official Title:
Efficacy of Anakinra in the Management of Patients With COVID-19 Infection in Qatar: A Randomized Clinical Trial
Actual Study Start Date :
Oct 30, 2020
Actual Primary Completion Date :
Mar 1, 2021
Actual Study Completion Date :
Apr 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Anakinra Group

Anakinra + Standard of Care

Drug: Anakinra
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®
  • Other: Standard of Care Group

    Standard of Care Alone

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

    Outcome Measures

    Primary Outcome Measures

    1. Treatment Success at day 14 [Day 14]

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

    Secondary Outcome Measures

    1. Change in WHO Clinical Progression Score [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 [Day 28]

      Time to ICU admission up to 28 days

    3. Incidence of Adverse Events [Day 28]

      Incidence of adverse events up to 28 days

    4. Length of hospital stay [Day 28]

      Length of hospital stay up to 28 days

    5. All-cause Mortality [Day 28]

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

    Eligibility Criteria


    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Accepts Healthy Volunteers:
    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

    Contacts and Locations


    Site City State Country Postal Code
    1 Hamad Medical Corporation Doha Qatar

    Sponsors and Collaborators

    • Hamad Medical Corporation


    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information


    None provided.
    Responsible Party:
    Hamad Medical Corporation Identifier:
    Other Study ID Numbers:
    • MRC-05-140
    First Posted:
    Nov 25, 2020
    Last Update Posted:
    Aug 16, 2022
    Last Verified:
    Feb 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Studies a U.S. FDA-regulated Device Product:
    Product Manufactured in and Exported from the U.S.:
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 16, 2022