Table 2 Inclusion and exclusion criteria
Inclusion criteria | |
▶ Age ≥ 18 years | |
▶ Infection with SARS-CoV-2 (virus detection by means of a PCR test not older than 72 h) | |
▶ Bipulmonary infiltrates (detection by means of chest X-ray or computed tomography) | |
▶ COVID inflammation score ≥ 10 [25] | |
▶ Serum or plasma ferritin concentration ≥ 500 ng/ml | |
▶ Arterial oxygen saturation ≤ 93% when breathing ambient air | |
▶ Written informed consent from the patient | |
▶ Potentially childbearing women: negative pregnancy test | |
Exclusion criteria | |
Contraindications for infliximab | |
▶ Allergy to infliximab (or any of the other ingredients of the medication) 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 Guillain-Barré syndrome | |
▶ Treatment with other biologics 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 treated with a biological | |
▶ Current treatment with TNF-α antibodies, convalescent plasma, bamlanivimab, or other experimental treatments for COVID-19 not considered in national guidelines | |
▶ High-flow oxygen therapy, non-invasive/invasive ventilation (WHO-COVID-19 progression scale > 5, [26]) | |
▶ Pre-existing long-term ventilation or home oxygen therapy | |
▶ Child-Pugh C liver cirrhosis | |
▶ Pregnancy or breastfeeding | |
▶ 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 |