SARS-CoV-2 infected patients with pneumonia
Conditions
Interventions
Trade Name: Kevzara 200 mg solution for injection in pre-filled syringe
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: SARILUMAB
Other descriptive name: SARILUM
Sponsors
Cristina Avendaño Sola
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria 1. Patients willing to provide written informed consent to participate in this study. Witnessed oral consent will be accepted in order to avoid paper handling. Written consent by patient or representatives will be obtained as soon as possible. 2. The patient is at least 18 years of age. 3. The patient is positive for novel coronavirus by real-time RT-PCR 4. The patient is hospitalized for COVID-19 without either mechanical ventilation (invasive or non-invasive) or oxygen mask with reservoir bag and at least one of the following: -Radiographic evidence of pulmonary infiltrates by imaging (chest x-ray, CT scan, etc.), OR clinical assessment (evidence of rales/crackles on exam) - AND SpO2 = 94% on room air that requires supplemental oxygen. 5. More than 7 days between the onset of symptoms (fever, dysnea, and/or cough) and treatment administration day. In the absence of fever, cough, or dyspnea, other symptoms like asthenia, headache, or gastrointestinal symptoms may be considered 6. The patients presents progressive elevation of inflammatory parameters suggestive of a hyperinflammatory syndrome: Presence of elevated IL-6 (>40pg/ml) or Elevated d-dimer (>1.0 mcg/ml), or alternatively, progressive worsening in at least two of these inflammatory parameters in the prior 48h: CRP, LDH, serum ferritin, lymphopenia, or d-dimer. 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 160 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: Exclusion Criteria 1. Requiring mechanical ventilation (invasive or non-invasive) or oxygen mask with reservoir bag at screening. 2. Participation in any other clinical trial of an experimental treatment for COVID-19. 3. In the opinion of the clinical team, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments. 4. Any incompatibility or allergy to the administration of sarilumab or corticosteroids.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of an early intervention with sarilumab in the prevention of progression to severe respiratory failure/ICU admission or death in SARS-CoV-2 infected patients with pneumonia and regular oxygen supplement requirements -(Brescia-COVID Score= 1).;Secondary Objective: 1.To assess differences between both strategies in the following: •Time to respiratory failure •Time to reduction of supplemental oxygen requirements •Time to non-invasive or invasive ventilation. •The duration of hospitalization •Mortality rate and survival. •Rate of ICU admission 2.To evaluate the efficacy of sarilumab in in COVID-19 infected patients with pneumonia Brescia-COVID- >2 (open-label follow up phase). 3.To evaluate safety of sarilumab treatment in treating patients with COVID-19 pneumonia. 4.To evaluate differences in the effect of sarilumab on the serum levels of inflammatory cytokines. 5.To evaluate differences in the proportion of patients showing more than >1 organ failure, e.g. cardiovascular, liver and kidney failure 6.To identify prognosis factors of sarilumab efficacy related to laboratory parameters or disease features.;Primary end point(s): The primary endpoint is the proportion of patients progressing to severe respiratory failure (Brescia-COVID Scale =2), ICU admission, or death.;Timepoint(s) of evaluation of this end point: From baseline up to Day-15 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Time to progression to severe respiratory failure (Brescia-COVID =2) Time to reduction of supplemental oxygen requirements Time to non-invasive or invasive mechanical ventilation. Rate of hospital discharge and duration of hospitalization Mortality rate and survival time Rate of ICU admissionProportion of patients with at least 1 point progression in the 7-point ordinal scale Ordinal scale: 1) Not hospitalized, no limitations on activities. 2) Not hospitalized, limitation on activities. 3) Hospitalized, not requiring supplemental oxygen. 4) Hospitalized, requiring supplemental oxygen. 5) Hospitalized, on non-invasive ventilation or high flow oxygen devices or oxygen mask with reservoir bag. 6) Hospitalized, on invasive mechanical ventilation or ECMO. 7) Death. Changes from baseline to day 15th in serum levels of inflammatory cytokines. Proportion of patients showing more than >1 organ failure, e.g. cardiovascular, liver and kidney failure Safety and tolerability – Adverse events;Timepoint(s) of evaluation of this end point: From baseline up to day-15 | — |
Countries
Spain
Contacts
Public ContactBelen Ruiz Antorán
Hospital Universitario Puerta de Hierro Majadahonda
Outcome results
None listed