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Mavrilimumab in Severe COVID-19 Pneumonia and Hyper-inflammation (COMBAT-19)

NCT04397497 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2020-05-26

No results posted yet for this study

Summary

This study is a prospective, phase II, multi-center, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of mavrilimumab in hospitalized patients with acute respiratory failure requiring oxygen supplementation in COVID- 19 pneumonia and a hyper-inflammatory status. The study will randomize patients to mavrilimumab or placebo, in addition to standard of care per local practice. The total trial duration will be 12 weeks after single mavrilimumab or placebo dose.

Conditions

  • Covid-19
  • Acute Respiratory Failure
  • ARDS, Human
  • Sars-CoV2
  • Viral Pneumonia

Interventions

DRUG

Mavrilimumab

human monoclonal antibody targeting GM-CSF receptor-alpha

DRUG

Placebo

matching volume of diluent

Sponsors & Collaborators

  • Ospedale San Raffaele

    lead OTHER

Principal Investigators

  • Lorenzo Dagna, MD · Ospedale San Raffaele

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-22
Primary Completion
2020-09-22
Completion
2020-11-22
FDA Drug
Yes

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs
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 NCT04397497 on ClinicalTrials.gov