Anakinra in the Management of COVID-19 Infection

Sponsor

Hamad Medical Corporation (Industry)

Overall Status

Completed

CT.gov ID

NCT04643678

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

13.4

Patients Per Site Per Month

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
Covid19 Pneumonia Cytokine Release Syndrome Corona Virus Infection Viral Infection	Drug: Anakinra Other: Standard of Care	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

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

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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