Back to resultsAnakinra in the Management of COVID-19 Infection
Primary Purpose
Covid19, Pneumonia, Cytokine Release Syndrome
Status
Completed
Phase
Phase 2
Locations
Qatar
Study Type
Interventional
Intervention
Anakinra
Standard of Care
Sponsored by
About this trial
This is an interventional treatment trial for Covid19
Eligibility Criteria
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
Sites / Locations
- Hamad Medical Corporation
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
Anakinra Group
Standard of Care Group
Arm Description
Anakinra + Standard of Care
Standard of Care Alone
Outcomes
Primary Outcome Measures
Treatment Success at 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
Change in WHO Clinical Progression Score between day 1 and day 7 [WHO Clinical Progression score: 0 (Uninfected) - 10 (Dead)]
Time to ICU admission
Time to ICU admission up to 28 days
Incidence of Adverse Events
Incidence of adverse events up to 28 days
Length of hospital stay
Length of hospital stay up to 28 days
All-cause Mortality
All-cause mortality rate at hospital discharge or at 28 days, whichever is first
Full Information
NCT ID
NCT04643678
First Posted
November 24, 2020
Last Updated
August 15, 2022
Sponsor
Hamad Medical Corporation
1. Study Identification
Unique Protocol Identification Number
NCT04643678
Brief Title
Anakinra in the Management of COVID-19 Infection
Official Title
Efficacy of Anakinra in the Management of Patients With COVID-19 Infection in Qatar: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
October 30, 2020 (Actual)
Primary Completion Date
March 1, 2021 (Actual)
Study Completion Date
April 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hamad Medical Corporation
4. Oversight
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
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Pneumonia, Cytokine Release Syndrome, Corona Virus Infection, Viral Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Anakinra Group
Arm Type
Active Comparator
Arm Description
Anakinra + Standard of Care
Arm Title
Standard of Care Group
Arm Type
Other
Arm Description
Standard of Care Alone
Intervention Type
Drug
Intervention Name(s)
Anakinra
Other Intervention Name(s)
Kineret®
Intervention Description
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
Other
Intervention Name(s)
Standard of Care
Intervention Description
Patients will receive the Standard of Care therapy as per the local treatment protocol
Primary Outcome Measure Information:
Title
Treatment Success at day 14
Description
Defined as WHO Clinical Progression score of ≤3 [Ambulatory mild disease: symptomatic; assistance needed].
Time Frame
Day 14
Secondary Outcome Measure Information:
Title
Change in WHO Clinical Progression Score
Description
Change in WHO Clinical Progression Score between day 1 and day 7 [WHO Clinical Progression score: 0 (Uninfected) - 10 (Dead)]
Time Frame
Day 7
Title
Time to ICU admission
Description
Time to ICU admission up to 28 days
Time Frame
Day 28
Title
Incidence of Adverse Events
Description
Incidence of adverse events up to 28 days
Time Frame
Day 28
Title
Length of hospital stay
Description
Length of hospital stay up to 28 days
Time Frame
Day 28
Title
All-cause Mortality
Description
All-cause mortality rate at hospital discharge or at 28 days, whichever is first
Time Frame
Day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hamad Medical Corporation
City
Doha
Country
Qatar
12. IPD Sharing Statement
Learn more about this trial
Anakinra in the Management of COVID-19 Infection
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