An unblinded clinical trial investigating the active substance infliximab in the treatment of severe COVID-19 at multiple study centers

Phase 1

• Conditions: severe COVID-19; MedDRA version: 23.0Level: PTClassification code 10084268Term: COVID-19System Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2021-002098-25-DE
• Lead Sponsor: Friedrich-Schiller-Universität Jena

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-19
• Last Update Posted: 24 January 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

•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 (see Appendix of study protocol 14.1)
• 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 44
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 44

Exclusion Criteria

In medical history:
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)

Further exclusion criteria:
• 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
• Child-Pugh C liver cirrhosis
• Pregnancy or breastfeeding
• Patients with a life expectancy <90 days due to other medical conditions
• Limitation or discontinuation of therapy (e.g. refusal of artificial ventilation)
• Participation in another interventional study
• Previous participation in this study
• Interdependence between the patient and the coordinating investigator or other members of the study team

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified