- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04643678
Anakinra in the Management of COVID-19 Infection
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
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Doha, Qatar
- Hamad medical corporation
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
|
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
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Systemic Inflammatory Response Syndrome
- Inflammation
- Disease Attributes
- Shock
- COVID-19
- Coronavirus Infections
- Infections
- Communicable Diseases
- Virus Diseases
- Cytokine Release Syndrome
- Antirheumatic Agents
- Interleukin 1 Receptor Antagonist Protein
Other Study ID Numbers
- MRC-05-140
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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