Anakinra in the Management of COVID-19 Infection

Covid19 Clinical Trial

Official title:

Efficacy of Anakinra in the Management of Patients With COVID-19 Infection in Qatar: A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04643678
• Other study ID #: MRC-05-140
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: October 30, 2020
• Est. completion date: April 30, 2021

Study information

• Verified date: February 2021
• Source: Hamad Medical Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: April 30, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Corona Virus Infection
• Coronavirus Infections
• COVID-19
• Covid19
• Cytokine Release Syndrome
• Infections
• Pneumonia
• Viral Infection
• Virus Diseases

Intervention

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

Locations

Country	Name	City	State
Qatar	Hamad Medical Corporation	Doha

Sponsors (1)

Lead Sponsor	Collaborator
Hamad Medical Corporation

Country where clinical trial is conducted

Qatar, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment Success at day 14	Defined as WHO Clinical Progression score of =3 [Ambulatory mild disease: symptomatic; assistance needed].	Day 14
Secondary	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)]	Day 7
Secondary	Time to ICU admission	Time to ICU admission up to 28 days	Day 28
Secondary	Incidence of Adverse Events	Incidence of adverse events up to 28 days	Day 28
Secondary	Length of hospital stay	Length of hospital stay up to 28 days	Day 28
Secondary	All-cause Mortality	All-cause mortality rate at hospital discharge or at 28 days, whichever is first	Day 28