Anakinra for COVID-19 Respiratory Symptoms (ANACONDA)

Regional University Hospital Center (CHRU)

Status and phase: Terminated; Phase 3

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

Treatments: Drug: Anakinra plus oSOC; Drug: oSOC

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04364009

DR200111 (Other Identifier)

2020-001734-36 (EudraCT Number)

ANACONDA-COVID-19

Details and patient eligibility

About

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.

Enrollment: 71 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria:

• 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

Non-inclusion criteria:

• Respiratory failure related to other cause than COVID-19

• Patients requiring mechanical ventilation at inclusion or requiring oxygen therapy equal or more than 11 liters per min to maintain Sp02>92%

• Infectious diseases such as severe bacterial infections, aspergillosis, HIV, active HCV, active HBV, active tuberculosis

• Contra indication to anti-IL1 receptor

  • Known hypersensitivity to Anakinra
  • Absolute neutrophil count (ANC)< 1500/mm3
  • Liver cirrhosis Child-Pugh Score C
  • Live or attenuated vaccine in the past 8 weeks
  • Pregnant or breast-feeding women

• Patients with either legally protected status or who have been deprived of their freedom

• Patient included in other interventional therapeutic research (e.g. = concurrent participation in French CoVID-19 is accepted)

• Patients who have received previous treatment by anti-IL6R, anti-IL-6, anti-IL1R, anti-IL1 or anti-TNFα within 21 days preceding inclusion

• Absence of Health Insurance

• Existence of any life-threatening co-morbidity or any other medical condition which,in the opinion of the investigator, makes the patient unsuitable for inclusion.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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71 participants in 2 patient groups

Optimized Standard of Care (oSOC)

Active Comparator group

Description:

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.

Treatment:

Drug: oSOC

Anakinra plus Optimized Standard of Care (oSOC)

Experimental group

Description:

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

Treatment:

Drug: Anakinra plus oSOC