NCT04364009

Anakinra for COVID-19 Respiratory Symptoms

Efficacy and Safety of ANAkinra During Adult " COVID-19 " With Aggravating Respiratory Symptoms: a Multicenter Open-label Controlled Randomized Trial

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: University Hospital, Tours · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2020-04-27
• Primary completion: 2020-10-20
• Completion: 2020-11-03
• First posted: 2020-04-27
• Last updated: 2021-01-15

Locations

1 site across 1 country: France