severe COVID-19 MedDRA version: 23.0 Level: PT Classification code 10084268 Term: COVID-19 System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Remsima
Product Name: Remsima
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Other descriptive name: Inflixim
Sponsors
Friedrich-Schiller-Universität Jena
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: •Assessment of the effect of infliximab on the morbidity and prognosis of patients with COVID-19. • Assessment of the effect of infliximab on an excessive immune response in patients with COVID-19. • Assessment of the effect of infliximab on the morbidity and prognosis of patients with COVID-19. • Characterization of the study cohort and course of the disease •Assessment of the effect of infliximab on the incidence of a cardiomyopathy on days 3 and 7 after randomization in patients with COVID-19.;Primary end point(s): 28-day mortality;Timepoint(s) of evaluation of this end point: Time of primary analysis after day 90 of last patient (LVLS) ;Main Objective: Evaluation of the efficacy of the TNF-a antibody infliximab in the treatment of patients with severe COVID-19 compared with the standard of care (SOC). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Frequencies of adverse events (AEs) and serious adverse events (SAEs) • Assessing the effect of infliximab in patients with COVID-19 on an excessive immune response: o Change in the interleukin-6 (IL-6) concentration in the blood from randomization to day 7 (V2) and day 14 (V3) after randomization o Change in ferritin concentration in the blood from randomization to day 7 (V2) and 14 (V3) after randomization o Change in the lymphocyte count from randomization to day 7 (V2) and 14 (V3) after randomization • Assessment of the effect of infliximab in patients with COVID-19 on morbidity and prognosis: o Assessment of the severity and frequency of organ failure: ventilation-free days, vasopressor-free days, renal replacement therapy-free days up to day 28 (V4) after randomization o Rate of occurrence of severe acute respiratory failure (ARDS) up to day 28 (V4) after randomization o WHO-COVID-19-Progression Scale on 7./14./28. Day (V2–4) after randomization o Rate of admission to the intensive care unit after randomization up to day 28 (V4) o Duration of the hospital and intensive care unit stay after randomization up to day 28 (V4) o Mortality rate 14 (V3) and 90 days (V5) after randomization o Quality of life and long-term consequences 90 days (V5) after randomization • Assessment of the effect of infliximab in patients with COVID-19 on the incidence of cardiomyopathy on days 3 (V1) and 7 (V2) after randomization Aims of the substudy: •Collection and storage of blood and urine sample for the investigation of translational research questions by analysing biomarkers of organ, metabolic, genetic and immunological function and regulation. •Comparison of the course of disease of patients with severe COVID-19 and previously generated datasets from patients with sepsis and health subjects. ;Timepoint(s) of evaluation of this end point: Time of primary analysis after day 90 of last patient (LVLS) | — |
Countries
Germany
Contacts
Public ContactZentrum für Klinische Studien
Universitätsklinikum Jena
Outcome results
None listed