Multicenter, randomized, open-label study to evaluate the efficacy and safety of SOC + Sarilumab versus Standard of Care for the Early Treatment of COVID-19-pneumonia in Hospitalized Patients
- Conditions
- Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]SARS-CoV-2 infected patients with pneumonia
- Registration Number
- EUCTR2020-002037-15-ES
- Lead Sponsor
- Cristina Avendaño Sola
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 200
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method