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Anakinra for COVID-19 Respiratory Symptoms

NCT04364009 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2021-01-15

No results posted yet for this study

Summary

The main objective of the ANACONDA-COVID-19 trial is to assess the efficacy of Anakinra + optimized Standard of Care (oSOC) as compared to oSOC alone on the condition of patients with COVID-19 infection and worsening respiratory symptoms. Success defined as patient alive and free of invasive mechanical ventilation (IMV) and free of Extracorporeal Membrane Oxygenation (ECMO) at Day 14.

Conditions

  • COVID-19 Infection
  • ANAKINRA Treatment
  • Optimized Standard of Care (oSOC)

Interventions

DRUG

Anakinra plus oSOC

Anakinra plus Optimized Standard of Care (oSOC) on the condition of patients with COVID-19 infection and worsening respiratory symptoms. The patients will receive intraveinous injection of Anakinra 400mg from Day 1 to Day 3 (two injections of 100 mg each 12 hours) and 200mg the remaining 7 days. The total duration of Anakinra is 10 Days. Efficient dosage of Anakinra as previously described will be continued until Day 10

DRUG

oSOC

Optimized Standard of Care (oSOC) on the condition of patients with COVID-19 infection and worsening respiratory symptoms.

Sponsors & Collaborators

  • INSERM CIC-P 1415, University Hospital Center of Tours

    collaborator UNKNOWN

  • Swedish Orphan Biovitrum

    collaborator INDUSTRY

  • University Hospital, Tours

    lead OTHER

Principal Investigators

  • Alexandra AUDEMARD-VERGER, MD-PhD · University Hospital of Tours

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-27
Primary Completion
2020-10-20
Completion
2020-11-03

Countries

  • France

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 NCT04364009 on ClinicalTrials.gov