Anakinra in the Management of COVID-19 Infection

August 15, 2022 updated by: Hamad Medical Corporation

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

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Doha, Qatar
        • Hamad medical corporation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Anakinra Group
Anakinra + Standard of Care
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
Patients will receive the Standard of Care therapy as per the local treatment protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment Success at day 14
Time Frame: Day 14
Defined as WHO Clinical Progression score of ≤3 [Ambulatory mild disease: symptomatic; assistance needed].
Day 14

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)]
Day 7
Time to ICU admission
Time Frame: Day 28
Time to ICU admission up to 28 days
Day 28
Incidence of Adverse Events
Time Frame: Day 28
Incidence of adverse events up to 28 days
Day 28
Length of hospital stay
Time Frame: Day 28
Length of hospital stay up to 28 days
Day 28
All-cause Mortality
Time Frame: Day 28
All-cause mortality rate at hospital discharge or at 28 days, whichever is first
Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 30, 2020

Primary Completion (ACTUAL)

March 1, 2021

Study Completion (ACTUAL)

April 30, 2021

Study Registration Dates

First Submitted

November 24, 2020

First Submitted That Met QC Criteria

November 24, 2020

First Posted (ACTUAL)

November 25, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 16, 2022

Last Update Submitted That Met QC Criteria

August 15, 2022

Last Verified

February 1, 2021

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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