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Clinical Trials/EUCTR2020-001634-36-ES
EUCTR2020-001634-36-ES
Active, not recruiting
Phase 1

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

Rosario García de Vicuña0 sites30 target enrollmentApril 13, 2020
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Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Rosario García de Vicuña
Enrollment
30
Status
Active, not recruiting
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 13, 2020
End Date
December 4, 2020
Last Updated
3 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Rosario García de Vicuña

Eligibility 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 \<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.

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.

Outcomes

Primary Outcomes

Not specified

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