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Clinical Trial of Sarilumab in Adults With COVID-19

NCT04357860 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2021-07-07

No results posted yet for this study

Summary

Early administration of sarilumab in hospitalized patients infected with COVID-19 who have pulmonary infiltrates and are at high risk of unfavorable evolution could decrease/prevent progression to acute respiratory distress syndrome (ARDS) requiring high flow nasal oxygenation (HFNO) or either invasive or non-invasive mechanical ventilation.

Conditions

  • SARS-CoV 2
  • SARS

Interventions

DRUG

Sarilumab 200 MG/1.14 ML Subcutaneous Solution [KEVZARA]

Best available treatment up to 14 days plus Sarilumab 200 mg

DRUG

Sarilumab 400 MG/2.28 ML Subcutaneous Solution [KEVZARA]

Best available treatment up to 14 days plus Sarilumab 400 mg

DRUG

Best available treatment

Best available treatment up to 14 days

Sponsors & Collaborators

  • Junta de Andalucia

    collaborator OTHER_GOV

  • Red Andaluza de Ensayos Clínicos en Enfermedades Infecciosas (Red ANCRAID)

    collaborator UNKNOWN

  • Maimónides Biomedical Research Institute of Córdoba

    lead OTHER

Principal Investigators

  • Julián de la Torre Cisneros, MD · Hospital Universitario Reina Sofía

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-28
Primary Completion
2021-03-09
Completion
2021-04-06

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04357860 on ClinicalTrials.gov