COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04922827

Sina M Coldewey, Prof. Dr. Dr. med. Andreas Stallmach, Prof. Dr. med.

Not reported

2021-06-11

Completed

RCT

Randomized

Parallel

Open label

multi-center

Treatment

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 - 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 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

- 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

2

Jena University Hospital

18

100

Germany

Severe disease at enrollment

6: Severe disease at enrollment

9

28-day mortality

None

Phase 2

[{"arm_notes": "", "treatment_id": 650, "treatment_name": "Infliximab", "treatment_type": "Other targeted therapies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]