NCT04643678

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P25-P50 for phase_2 covid19

Timeline
Completed

Started Oct 2020

Shorter than P25 for phase_2 covid19

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 30, 2020

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

November 24, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 25, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
Last Updated

August 16, 2022

Status Verified

February 1, 2021

Enrollment Period

4 months

First QC Date

November 24, 2020

Last Update Submit

August 15, 2022

Conditions

Covid19PneumoniaCytokine Release SyndromeCorona Virus InfectionViral Infection

Outcome Measures

Primary Outcomes (1)

  • Treatment Success at day 14

    Defined as WHO Clinical Progression score of ≤3 \[Ambulatory mild disease: symptomatic; assistance needed\].

    Day 14

Secondary Outcomes (5)

  • Change in WHO Clinical Progression Score

    Day 7

  • Time to ICU admission

    Day 28

  • Incidence of Adverse Events

    Day 28

  • Length of hospital stay

    Day 28

  • All-cause Mortality

    Day 28

Study Arms (2)

Anakinra Group

ACTIVE COMPARATOR

Anakinra + Standard of Care

Drug: Anakinra

Standard of Care Group

OTHER

Standard of Care Alone

Other: Standard of Care

Interventions

AnakinraDRUG

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

Also known as: Kineret®
Anakinra Group
Standard of CareOTHER

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

Standard of Care Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hamad Medical Corporation

Doha, Qatar

Location

Related Publications (1)

  • Elmekaty EZI, Maklad A, Abouelhassan R, Munir W, Ibrahim MIM, Nair A, Alibrahim R, Iqbal F, Al Bishawi A, Abdelmajid A, Aboukamar M, Hadi HA, Khattab MA, Al Soub H, Al Maslamani M. Evaluation of anakinra in the management of patients with COVID-19 infection: A randomized clinical trial. Front Microbiol. 2023 Jan 26;14:1098703. doi: 10.3389/fmicb.2023.1098703. eCollection 2023.

    PMID: 36778864DERIVED

MeSH Terms

Conditions

COVID-19PneumoniaCytokine Release SyndromeCoronavirus InfectionsVirus Diseases

Interventions

Interleukin 1 Receptor Antagonist ProteinStandard of Care

Condition Hierarchy (Ancestors)

Pneumonia, ViralRespiratory Tract InfectionsInfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Intervention Hierarchy (Ancestors)

CytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2020

First Posted

November 25, 2020

Study Start

October 30, 2020

Primary Completion

March 1, 2021

Study Completion

April 30, 2021

Last Updated

August 16, 2022

Record last verified: 2021-02

Locations

QA(1)