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

NCT04922827 | Completed Phase 2 DMC

• 2 other identifiers: ZKSJ0137_INFLIXCOVID2021-002098-25
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 4

Brief 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

COVID-19

Outcome Measures

Primary Outcomes (1)

• 28-day mortality

  differences in mortality-rates between both study arms (Infliximab + Standard of Care vs. Standard of Care) 28 days after randomisation

  28 days after randomization

Secondary Outcomes (16)

• safety of Infliximab administration

  up to 90 days after randomization

• assessment of the effect of infliximab on an excessive immune response in patients with COVID-19: Interleukin 6

  day 7 and day 14 after randomization

• assessment of the effect of infliximab on an excessive immune response in patients with COVID-19: ferritin

  day 7 and day 14 after randomization

• assessment of the effect of infliximab on an excessive immune response in patients with COVID-19: lymphocyte count

  day 7 and day 14 after randomization

• assessment of the severity and frequency of organ failure: ventilation-free days

  day 28 after randomization

Other Outcomes (2)

• collection and storage of blood and urine sample

  day 3, 7 and 14 after randomization

• comparison with other cohorts

  up to day 90 after randomization

Study Arms (2)

Infliximab + Standard of Care

EXPERIMENTAL

Drug: Infliximab; Other: Standard of Care

Standard of Care

ACTIVE COMPARATOR

Other: Standard of Care

Interventions

Infliximab DRUG

single intravenous administration of 5 milligrams/kilogram

Infliximab + Standard of Care

Standard of Care OTHER

Standard of Care

Infliximab + Standard of Care; Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Infection with SARS-CoV-2 (virus detection by means of a PCR test not older than 72 hours)
• Bipulmonary infiltrates (detection by means of X-rays or computed tomography)
• COVID inflammation score ≥ 10
• Ferritin concentration (serum or plasma) ≥ 500 ng / ml
• Arterial oxygen saturation ≤ 93% when breathing room air
• written informed consent from the patient
• Potentially childbearing women: negative pregnancy test

You may not qualify if:

• Contraindications study medication:
• Hypersensitivity to the active substance infliximab (or any of the other ingredients of the medicine) or to other murine proteins
• active or latent tuberculosis
• acute or chronic hepatitis B
• severe infections such as invasive fungal infections, bacterial sepsis, or abscesses
• opportunistic infections (e.g. pneumocystosis, listeriosis)
• moderate or severe heart failure (NYHA class III / IV)
• Immunosuppression (e.g. organ transplantation, AIDS, leukopenia)
• Malignancies or lymphoproliferative diseases or chemotherapy within the last 4 weeks
• Multiple sclerosis or peripheral demyelinating diseases, including the Guillain-Barré syndrome
• Treatment with other biologics for therapy for approved indications of infliximab (e.g. for rheumatoid arthritis, Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, psoriasis)
• Autoimmune disease with biologics therapy
• Current treatment with TNF antibodies, convalescent plasma, bamlanivimab, or other experimental treatments for COVID-19
• High-flow oxygen therapy, non-invasive / invasive ventilation (WHO-COVID-19 PROGRESSION Scale \> 5)
• pre-existing long-term ventilation or home oxygen therapy

Sponsors & Collaborators

• Jena University Hospital: lead
• German Federal Ministry of Education and Research: collaborator
• Celltrion: collaborator

Study Sites (4)

Universitätsklinikum Knappschaftskrankenhaus Bochum

Bochum, 44892, Germany

Location

Klinikum Fulda

Fulda, 36043, Germany

Location

Universitätsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Jena University Hospital

Jena, 07747, Germany

Location

Related Publications (1)

• Coldewey SM, Neu C, Bloos F, Baumbach P, Schumacher U, Bauer M, Reuken P, Stallmach A. Infliximab in the treatment of patients with severe COVID-19 (INFLIXCOVID): protocol for a randomised, controlled, multicentre, open-label phase II clinical study. Trials. 2022 Sep 2;23(1):737. doi: 10.1186/s13063-022-06566-5.

  PMID: 36056419 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Infliximab; Standard of Care

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Sina M Coldewey, Prof. Dr. Dr. med.

  Department of Anaesthesiology and Intensive Care Medicine, Jena University Hospital

  PRINCIPAL INVESTIGATOR

• Andreas Stallmach, Prof. Dr. med.

  Department of Internal Medicine IV (Gastroenterology, Hepatology, and Infectious Diseases), Jena University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2021
• First Posted: June 11, 2021
• Study Start: June 18, 2021
• Primary Completion: March 31, 2023
• Study Completion: July 1, 2023
• Last Updated: July 12, 2023

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (4)