Anakinra for COVID-19 Respiratory Symptoms

NCT ID: NCT04364009

Last Updated: 2021-01-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-27
• Study Completion Date: 2020-11-03

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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Optimized Standard of Care (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.

Group Type: ACTIVE_COMPARATOR

oSOC

Intervention Type: DRUG

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

Anakinra plus Optimized Standard of Care (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

Group Type: EXPERIMENTAL

Anakinra plus oSOC

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

oSOC

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

Intervention Type: DRUG

Eligibility 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

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

INSERM CIC-P 1415, University Hospital Center of Tours

UNKNOWN

Sponsor Role: collaborator

Swedish Orphan Biovitrum

INDUSTRY

Sponsor Role: collaborator

University Hospital, Tours

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alexandra AUDEMARD-VERGER, MD-PhD

Role: STUDY_DIRECTOR

University Hospital of Tours

Locations

CHRU de TOURS

Tours, , France

Countries

France

Other Identifiers

2020-001734-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

DR200111

Identifier Type: OTHER

Identifier Source: secondary_id

ANACONDA-COVID-19

Identifier Type: -

Identifier Source: org_study_id