Clinical Trial of the Use of Anakinra in Cytokine Storm Syndrome Secondary to Covid-19 (ANA-COVID-GEAS)

• Status: Completed
• Trial end date: 2021-03-31
• Target enrollment: 0
• Participant gender: All

Summary

Phase 2/3 randomized, parallel group, 2-arm study (treatment vs. control), investigating the efficacy and safety of intravenous administration of anakinra, an interleukin 1 receptor antagonist ( IL-1), added to standard treatment, compared to standard treatment alone, to reduce hyperinflammation and respiratory distress in patients with SARS-CoV-2 infection.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundacion Miguel Servet
• Treatments: Interleukin 1 Receptor Antagonist Protein

Criteria

• Inclusion Criteria:

• Age 18-80 years.

• Severe pneumonia COVID-19 defined as:

• Nasopharyngeal smear with RCP positive for SARS-CoV-2

• X-Rays (or other technique) pulmonary infiltrates compatible with pneumonia.

• 1 or more of the following criteria:

• Ambient air oxygen saturation <= 94% measured with a pulse oximeter.

• Pa:FiO2 (partial pressure O2/fraction of inspired O2) <=300.

• Sa:FiO2 (O2 saturation measured with pulse oximeter/ fraction of inspired O2) <=350.

• High suspicion of CSS that could resemble MAS-like: represented by IL-6 values > 40 pg/mL and/or ferritin >500 ug/L and/or PCR > 30 mg/L (rationale: ≥ 5 upper normal limit) and/or LDH >300 UI/L. We have chosen these parameters because they are implemented in all the participating hospitals, they are a reflection of the cytokine storm and they have also been significant in terms of predicting mortality in patients with COVID-19 (9).

• Written informed consent. The protocol will be explained to the patient in front of a nurse who will act as a legal witness by signing the document on behalf of the patient.

• Exclusion Criteria:

• Need for oro-tracheal intubation and/or invasive mechanical ventilation at the start of the study.

• AST/ALT with values greater than 5 times normal levels.

• Neutrophils < 1.500 cell/mmc.

• Platelets < 50.000 cell/mmc.

• Sepsis or pneumonia documented by other pathogens than SARS-CoV-2.

• Existence of any life-threatening comorbidity or any other medical condition that, in the investigator's opinion, makes the patient unsuitable for inclusion.

• Inability to obtain informed consent.

• Positivity for HBV, HCV or tuberculin test serology.

• Pregnancy.

• Use of other previous or concomitant biological treatments. Patients in concomitant treatment with other biologicals that may interfere will be excluded: tocilizumab, canakinumab, TNFalfa inhibitors, JAKiinibs

• Severe renal dysfunction (estimated glomerular filtration rate ≤ 30 ml / min / 1.73 m2) or receive continuous renal replacement therapy, hemodialysis or peritoneal dialysis.

• Uncontrolled hypertension (sitting systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg).

• Administration of plasma from convalescent patients who have recovered from SARS-CoV-2 infection.

• History of hypersensitivity or allergy to any component of the study drug.

• Enrollment in another concurrent intervention clinical trial, or intake of an investigational medication within three months or 5 half-lives prior to inclusion in this study, if deemed to interfere with the objectives of this study as assessed by the investigator.

• Predictable inability to cooperate with given instructions or study procedures.