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 |