Anakinra in the Management of COVID-19 Infection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-30

Study Completion Date

2021-04-30

Brief Summary

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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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Detailed Description

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Conditions

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Covid19 Pneumonia Cytokine Release Syndrome Corona Virus Infection Viral Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Anakinra Group

Anakinra + Standard of Care

Group Type ACTIVE_COMPARATOR

Anakinra

Intervention Type 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

Standard of Care Group

Standard of Care Alone

Group Type OTHER

Standard of Care

Intervention Type OTHER

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

Interventions

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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

Intervention Type DRUG

Standard of Care

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

Intervention Type OTHER

Other Intervention Names

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Kineret®

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No