Hyperinflammation and respiratory distress in patients with SARS- CoV-2
Conditions
Interventions
Trade Name: ANAKINRA
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ANAKINRA
CAS Number: 143090-92-0
Concentration unit: mg milligram(s)
Concentration type: equ
Sponsors
NAVARRABIOMED - FUNDACIÓN MIGUEL SERVET
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Age 18-80 years. ? Severe pneumonia COVID-19 defined as: o Nasopharyngeal smear with RCP positive for SARS-CoV-2 o X-Rays (or other technique) pulmonary infiltrates compatible with pneumonia. o 1 or more of the following criteria: ? Ambient air oxygen saturation 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 80
Exclusion criteria
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect of anakinra in addition to standard treatment on the need for mechanical ventilation in patients with severe COVID-19 and CSS pneumonia.;Secondary Objective: To assess the effect of anakinra in addition to standard treatment on mortality in patients with severe COVID-19 and CSS pneumonia.;Primary end point(s): Treatment success, defined as number of patients not requiring mechanical ventilation by Day 15. Number of patients not requiring mechanical ventilation (day 28).? Time to mechanical ventilation (days) ? Time to oxygen saturation normalization ? Stay in ICU and hospitalization (days);Timepoint(s) of evaluation of this end point: 15 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ? Total mortality rate (day 28) ? Mortality 48 hours, 7 days, in ICU and hospital ? Viral clearance / viral shedding ? Frequency and severity of AEs: o Treatment-emergent severe fatal and life-threatening serious adverse events (SAEs). o Adverse events leading to premature discontinuation of study treatment. o Anaphylactic/anaphylactoid reactions. o Anakinra treatment group: Severe neutropenia. o Treatment-emergent laboratory abnormalities.;Timepoint(s) of evaluation of this end point: 28 days | — |
Countries
Spain
Contacts
Public ContactRUTH GARCIA
CLINICAL TRIAL UNIT
Outcome results
None listed