Randomized open pilot study to evaluate the efficacy of subcutaneous sarilumab in patients with moderate-severe COVID-19 infection.

Phase 1

• Conditions: COVID-19 infection requiring hospitalization; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001634-36-ES
• Lead Sponsor: Rosario García de Vicuña

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-13
• Study Completion: 2020-12-04
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

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 <600 mm3
d. Ferritin> 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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified