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Glucocorticoids in COVID-19 (CORTIVID)

NCT04438980 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2021-05-17

No results posted yet for this study

Summary

Around 30% of admitted patients with COVID-19 pneumonia develop a hyper-inflammatory state whose progression to an acute respiratory distress syndrome (ARSD) could be prevented by the early initiation of immune-modulatory agents. The role of glucocorticoids (GC) in this setting remains controversial. This study aims to assess the safety and effectiveness of GC pulses to improve the clinical outcomes of patients with COVID-19 pneumonia with risen inflammatory biomarkers.

Conditions

Interventions

DRUG

Methylprednisolone

-A dose of 120 mg/day of methylprednisolone for 3 days, administered by intravenous infusión

OTHER

Placebo

-An infusion bag of 100 mL of 0.9% saline

Sponsors & Collaborators

  • Complejo Hospitalario de Navarra

    collaborator OTHER

  • Hospital Sant Joan Despí Moisès Broggi

    collaborator UNKNOWN

  • Fundacion Miguel Servet

    lead OTHER

Principal Investigators

  • Iñigo Les Bujanda, PhD · Complejo Hospitalario de Navarra

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-05-15
Primary Completion
2021-03-12
Completion
2021-04-09

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

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 NCT04438980 on ClinicalTrials.gov