COVID-19 infection requiring hospitalization
Conditions
Interventions
Trade Name: Kevzara
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: SARILUMAB
CAS Number: 1189541-98-7
Concentration unit: mg milligram(s)
Concentration type: ra
Sponsors
Rosario García de Vicuña
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age> 18 years 2. COVID-19 positive documented by PCR 3. Documented interstitial pneumonia requiring admission and at least two of the following parameters: a. Fever = 37.8ºC in ear b. IL-6 in serum = 25 ng / mL (in the absence of a previous dose of prednisone or equivalent> 1 mg / kg) or PCR> 5mg / dL c. Lymphocytes 300 mcg / L that doubles in 24 hours e. Ferritin> 600 mcg / L in the first determination and LDH> 250 U / L f. D-dimer (> 1 mg / L) 4. Informed verbal or administration consent under urgent conditions, documented in the medical record. 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 30 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients who require mechanical ventilation at the time of inclusion. 2. AST / ALT values greater than 5 times the upper limit of normal. 3. Neutrophil values below 500 cells / mm3 4. Platelet values of less than 50,000 cells / mm3 5. Documented sepsis or high suspicion by pathogens other than COVID-19. 6. Presence of comorbidities related, according to clinical judgment, with an unfavorable result. 7. Complicated diverticulitis or intestinal perforation. 8. Current skin infection (eg, uncontrolled dermopiodermitis). 9. Immunosuppressive anti-rejection therapy. 10. Pregnancy or lactation. 11. Previous treatment with tocilizumab or sarilumab. 12. Patients participating in some other clinical trial for SARS-CoV-2 infection. 13. Patients with known hypersensitivity or contraindication to sarilumab or excipients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: -To evaluate the efficacy of the early administration of sarilumab subcutaneously in patients with moderate-severe COVID-19 infection in early stages compared to the current treatment standard. -To compare the baseline clinical and biological parameters, including serum IL-6, of the intervention population against historical controls, to search for possible markers that identify candidates for treatment with subcutaneous IL-6 inhibitors and attempt an approximation to the time frame of “window of opportunity”.;Secondary Objective: Not applicable;Primary end point(s): - Time to become afebrile for a minimum period of 48 hours, without antipyretics - Average change in the ordinal scale of 7 points from the inclusion in the study until day 7 (after randomization): 1. Death 2. Hospitalized, with mechanical ventilation or extracorporeal membrane oxygenation (ECMO). 3. Hospitalized, with non-invasive mechanical ventilation, a mask with a reservoir or oxygen with high flow nasal goggles. 4. Hospitalized with oxygen supplement 5. Hospitalized, without oxygen supplement, but in need of continued medical care (related or not with COVID) 6. Hospitalized, without oxygen supplement and without the need for continued medical care 7. Not hospitalized - Duration of hospitalization (days) - Death ;Timepoint(s) of evaluation of this end point: The expected duration of subject participation in the trial is until resolution of the COVID-19 infection pattern, approximately 1 month. The overall duration of the study is estimated to be about 2 months, from the recruitment of the first patient to the end of the follow-up of the last patient included. The duration can be shortened if the current rate of income is maintained for at least one month. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Time to become afebrile for a minimum period of 48 hours, without antipyretics - Time to non-invasive mechanical ventilation (days) - Time to invasive mechanical ventilation (days) - Time to withdraw oxygen therapy (days) - Average change in the ordinal scale of 7 points from the inclusion in the study until day 14 (after randomization): 1. Death 2. Hospitalized, with mechanical ventilation or extracorporeal membrane oxygenation (ECMO). 3. Hospitalized, with non-invasive mechanical ventilation, a mask with a reservoir or oxygen with high flow nasal goggles. 4. Hospitalized with oxygen supplement 5. Hospitalized, without oxygen supplement, but in need of continued medical care (related or not with COVID) 6. Hospitalized, without oxygen supplement and without the need for continued medical care 7. Not hospitalized;Timepoint(s) of evaluation of this end point: The expected duration of subject participation in the trial is until resolution of the COVID-19 infection pattern, approximately 1 month. The overall duration of the study is estimated to be about 2 months, from the recruitment of the first patient to the end of the follow-up of the last patient included. The duration can be shortened if the current rate of income is maintained for at least one month. | — |
Countries
Spain
Contacts
Public ContactRosario García de Vicuña
Rosario García de Vicuña
Outcome results
None listed