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Infliximab in the Treatment of Patients With Severe COVID-19 Disease

NCT04922827 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2023-07-12

No results posted yet for this study

Summary

In this trial, patients that are severely affected by the disease COVID-19 will either receive infliximab, an anti-inflammatory drug, or standard therapy. Infliximab is a drug that inhibits inflammation by blocking a molecule called TNFα. The patients receive the drug via an infusion into a vein. The primary goal of this trial is to see whether the drug infliximab affects how many people died from COVID-19 after 28 days by comparing patients receiving the drug in addition to standard therapy with patients only receiving standard therapy.

Furthermore, this trial will look at whether the drug is safe to use in these patients, whether it has an effect on the inflammation and whether it can affect how ill patients are after surviving the disease.

The trial is conducted in more than one hospital. As COVID-19 is responsible for a global pandemic, positive results of this trial could affect patients, healthcare and economic systems worldwide.

Conditions

Interventions

DRUG

Infliximab

single intravenous administration of 5 milligrams/kilogram

OTHER

Standard of Care

Standard of Care

Sponsors & Collaborators

  • German Federal Ministry of Education and Research

    collaborator OTHER_GOV

  • Celltrion

    collaborator INDUSTRY

  • Jena University Hospital

    lead OTHER

Principal Investigators

  • Sina M Coldewey, Prof. Dr. Dr. med. · Department of Anaesthesiology and Intensive Care Medicine, Jena University Hospital

  • Andreas Stallmach, Prof. Dr. med. · Department of Internal Medicine IV (Gastroenterology, Hepatology, and Infectious Diseases), Jena University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-18
Primary Completion
2023-03-31
Completion
2023-07-01

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs
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 NCT04922827 on ClinicalTrials.gov