Anakinra for COVID-19 Respiratory Symptoms

NCT04364009 | Terminated Phase 3 DMC

• 3 other identifiers: ANACONDA-COVID-192020-001734-36DR200111
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Treatment success

  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).

  After 14 days of treatment

Secondary Outcomes (16)

• Treatment success

  After 3 days, 10 days and 28 days of treatment

• OMS progression scale (on a 7 point ordinal scale)

  After 3 days, 10 days, 14 days and 28 days of treatment

• Overall survival

  After 3 days, 10 days, 14 days and 28 days of treatment

• Time to ICU admission

  Up to 28 days

• Time to ventilatory support

  Up to 28 days

Study Arms (2)

Optimized Standard of Care (oSOC)

ACTIVE COMPARATOR

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.

Drug: oSOC

Anakinra plus Optimized Standard of Care (oSOC)

EXPERIMENTAL

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

Drug: Anakinra plus oSOC

Interventions

Anakinra plus oSOC DRUG

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

Anakinra plus Optimized Standard of Care (oSOC)

oSOC DRUG

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

Optimized Standard of Care (oSOC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female≥ 18 years of age
• Written informed consent of the patient or a proxy
• Ability for participant to comply with the requirements of the study
• Hospitalized patient with COVID-19 defined as
• Positive SARS-CoV2 RT-PCR
• Or typical COVID-19 Radiographic infiltrates on the CT scan (peripheral ground glass without lung cavitation, lymphadenopathy, or pulmonary nodules) other non COVID-19 diagnosis ruled out.
• Patient with respiratory symptoms and requirement of oxygen therapy as defined:
• Oxygen therapy \>= 4L/min to maintain Sp02\>92% and respiratory rate \>=24/min.
• Or patients under oxygen \>= 1L/min and presenting worsening of oxygen requirement defined by an increase of oxygen therapy \>= 2L/min to maintain Sp02\>92%.
• Inflammatory component C-Reactive Protein ≥ 50mg/L.
• Patients within the first 20 days from the onset of the first COVID-19 symptoms
• Probabilistic antibiotics therapy according to local practice
• Respiratory failure related to other cause than COVID-19
• Infectious diseases such as severe bacterial infections, aspergillosis, HIV, active HCV, active HBV, active tuberculosis
• Contra indication to anti-IL1 receptor

Sponsors & Collaborators

• University Hospital, Tours: lead
• INSERM CIC-P 1415, University Hospital Center of Tours: collaborator
• Swedish Orphan Biovitrum: collaborator

Study Sites (1)

CHRU de TOURS

Tours, 37044, France

Location

MeSH Terms

Conditions

COVID-19

Interventions

Interleukin 1 Receptor Antagonist Protein

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Alexandra AUDEMARD-VERGER, MD-PhD

  University Hospital of Tours

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: ANACONDA study is a French multicentre, open-label, randomized, controlled superiority trial comparing the administration of optimized standard of care and Anakinra versus optimized standard of care alone in patients hospitalized in a medical unit with COVID-19.

Study Record Dates

• First Submitted: April 17, 2020
• First Posted: April 27, 2020
• Study Start: April 27, 2020
• Primary Completion: October 20, 2020
• Study Completion: November 3, 2020
• Last Updated: January 15, 2021

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)