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Efficacy of Intravenous Anakinra and Ruxolitinib During COVID-19 Inflammation

NCT04366232 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2020-12-16

No results posted yet for this study

Summary

During SARS-Cov2 infection with serious respiratory implication and high systemic inflammation level, intravenous ANAKINRA alone or associated with RUXOLITINIB for severe cases might reduce inappropriate systemic inflammatory response, improve breathing and decrease occurrence or duration of ARDS and associated mortality.

Conditions

Interventions

DRUG

Anakinra alone (stages 2b/3)

Anakinra 300 mg 1/d Intravenous 5 days then dose tapering

DRUG

Anakinra and Ruxolitinib (overcome stage 3)

Anakinra 300 mg od Intravenous (maximum14 days) Ruxolitinib 5 mg bid per os (maximum 28 days)

OTHER

Standard of care

Routine clinical care for Covid-19

Sponsors & Collaborators

  • Hôpital d'instruction des armées Sainte-Anne

    collaborator UNKNOWN

  • Assistance Publique Hopitaux De Marseille

    collaborator OTHER

  • Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

    lead OTHER

Principal Investigators

  • David DELARBRE, MD · French Army Health Service

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-19
Primary Completion
2020-10-02
Completion
2020-10-02

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

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 NCT04366232 on ClinicalTrials.gov