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Clinical Trial of the Use of Anakinra in Cytokine Storm Syndrome Secondary to Covid-19 (ANA-COVID-GEAS)

NCT04443881 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 179

Last updated 2021-06-01

No results posted yet for this study

Summary

Phase 2/3 randomized, parallel group, 2-arm study (treatment vs. control), investigating the efficacy and safety of intravenous administration of anakinra, an interleukin 1 receptor antagonist ( IL-1), added to standard treatment, compared to standard treatment alone, to reduce hyperinflammation and respiratory distress in patients with SARS-CoV-2 infection.

Conditions

  • COVID-19 Pnemonia

Interventions

DRUG

Anakinra 149 MG/ML Prefilled Syringe [Kineret]

Anakinra (100 mg/ 6 hours) i.v infusión during 15 days

Sponsors & Collaborators

  • Fundacion Miguel Servet

    lead OTHER

Principal Investigators

  • Patricia Fanlo Mateo, PhD · Complejo Hospitalario de Navarra

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-08
Primary Completion
2021-03-31
Completion
2021-03-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04443881 on ClinicalTrials.gov