MedTrace Logo

SILtuximab in Viral ARds (SILVAR) Study

NCT04616586 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 555

Last updated 2021-04-19

No results posted yet for this study

Summary

This study will evaluate the efficacy and safety of siltuximab compared with normal saline in combination with standard of care (SOC) in selected hospitalized patients with COVID-19 previously treated with corticosteroids or another respiratory virus infection associated with acute respiratory distress syndrome (ARDS) and elevated C-reactive protein (CRP) levels.

Conditions

  • Acute Respiratory Distress Syndrome
  • Lung Diseases
  • Pneumonia
  • Respiratory Tract Infections
  • Respiratory Tract Disease

Interventions

DRUG

Siltuximab

11 mg/kg IV administered over 1 hour

OTHER

Normal Saline

IV administered over 1 hour

Sponsors & Collaborators

Principal Investigators

  • Zainab Shahid, MD, Ph.D · Participating Site

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-13
Primary Completion
2021-04-01
Completion
2021-04-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT04616586 on ClinicalTrials.gov