Anakinra in the Management of COVID-19 Infection

Phase 2

Completed

• Conditions: Covid19; Pneumonia; Cytokine Release Syndrome; Corona Virus Infection; Viral Infection
• Interventions: Other: Standard of Care; Drug: Anakinra

• Registration Number: NCT04643678
• Lead Sponsor: Hamad Medical Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-30
• Study First Submitted: 2020-11-24
• Study First Submitted QC: 2020-11-24
• Study First Posted: 2020-11-25
• Status Verified: 2021-02
• Primary Completion: 2021-03-01
• Study Completion: 2021-04-30
• Last Update Submitted: 2022-08-15
• Last Update Posted: 2022-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care Group	Standard of Care	Standard of Care Alone
Anakinra Group	Anakinra	Anakinra + Standard of Care

Primary Outcome Measures

Name	Time	Method
Treatment Success at day 14	Day 14	Defined as WHO Clinical Progression score of ≤3 \[Ambulatory mild disease: symptomatic; assistance needed\].

Secondary Outcome Measures

Name	Time	Method
Incidence of Adverse Events	Day 28	Incidence of adverse events up to 28 days
Time to ICU admission	Day 28	Time to ICU admission up to 28 days
Length of hospital stay	Day 28	Length of hospital stay up to 28 days
Change in WHO Clinical Progression Score	Day 7	Change in WHO Clinical Progression Score between day 1 and day 7 \[WHO Clinical Progression score: 0 (Uninfected) - 10 (Dead)\]
All-cause Mortality	Day 28	All-cause mortality rate at hospital discharge or at 28 days, whichever is first

Trial Locations

Locations (1)

Hamad Medical Corporation; 🇶🇦 Doha, Qatar