Anakinra for COVID-19 Respiratory Symptoms

Phase 3

Terminated

• Conditions: ANAKINRA Treatment; Optimized Standard of Care (oSOC); COVID-19 Infection
• Interventions: Drug: Anakinra plus oSOC; Drug: oSOC

• Registration Number: NCT04364009
• Lead Sponsor: University Hospital, Tours

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-04
• Study First Submitted: 2020-04-17
• Study First Submitted QC: 2020-04-24
• Study Start: 2020-04-27
• Study First Posted: 2020-04-27
• Primary Completion: 2020-10-20
• Study Completion: 2020-11-03
• Last Update Submitted: 2021-01-14
• Last Update Posted: 2021-01-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 71

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Anakinra plus Optimized Standard of Care (oSOC)	Anakinra plus oSOC	The experimental group will receive Anakinra plus optimized Standard of Care. The patients will receive Intravenous injection (IV) of Anakinra 400mg/day (100mg IV every 6 hours) at Day 1, 2 and 3. From Day 4 to Day 10, the patient will receive IV injection of Anakinra 200mg/day (100mg every 12 hours). The total duration of Anakinra is 10 Days
Optimized Standard of Care (oSOC)	oSOC	The control group will receive optimized standard of care alone, including all treatments authorized for COVID-19 by the French Health Ministry and/or the center COVID-19 therapeutic committees at inclusion and during the follow-up.

Primary Outcome Measures

Name	Time	Method
Treatment success	After 14 days of treatment	The primary endpoint is treatment success at Day 14, defined as a patient alive and not requiring any of the following: Invasive mechanical ventilation (IMV) or Extracorporeal membrane oxygenation (ECMO).

Secondary Outcome Measures

Name	Time	Method
Change in inflammatory parameter	From baseline to Day 3, Day 10, Day 14 and Day 28	fibrinogen (g/l)
Overall survival	After 3 days, 10 days, 14 days and 28 days of treatment	Overall survival
Change in National Early Warning Score (NEW)from baseline to Day 3, Day 10, Day 14 and Day 28	After 3 days, 10 days, 14 days and 28 days of treatment	The National Early Warning Score (NEWS) determines the degree of illness of a patient using six physiological findings and one observation. Score from 0 to 20, 0 mean a worse outcome, 20 mean a better outcome
Hospital length of stay	Up to 28 days	Hospital length of stay
Time to ICU admission	Up to 28 days	Time to ICU admission
OMS progression scale (on a 7 point ordinal scale)	After 3 days, 10 days, 14 days and 28 days of treatment	1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities; 3. Hospitalized, not requiring supplemental oxygen; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices;6. Hospitalized, on invasive mechanical ventilation or ECMO;7. Death.
Treatment success	After 3 days, 10 days and 28 days of treatment	Defined as a patient alive and not requiring any of the following: Invasive mechanical ventilation (IMV) or Extracorporeal membrane oxygenation (ECMO).
Time to ventilatory support	Up to 28 days	Time to ventilatory support : extracorporeal membrane oxygenation (ECMO), invasive mechanical ventilation, non-invasive ventilation, high flow oxygen therapy)
Predictors of efficacy of Anakinra	After 14 days of treatment	The correlation between several of clinical parameters at inclusion (including level of oxygen requirement (saturation), respiratory rate (per min), temperature (°C)...), biological parameters :including, CRP (mg/L), ferritin (µg/L), LDH (UI/L), lymphocyte count (G/L), eosinophil count (G/L), Ddimers (ng/mM), platelet count (G/L), polymorphonuclear count (G/L)...with the primary end point will be explored.
ICU parameter	Up to 28 days	Evolution of PaO2/FiO2 ratio (no unit)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	Up to 28 days	Occurrence of serious adverse events during the study, including infection (bacterial, parasitic, mycotic and viral infection), septic shock, Ankanira hypersensitivity, hepatic damages (SGOT/SGPT, alkaline phosphatase, gammaGT) and neutropenia (Blood count).

Trial Locations

Locations (1)

CHRU de TOURS; 🇫🇷 Tours, France