Infliximab in the Treatment of Patients With Severe COVID-19 Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 25 July 2023
• Main ID: NCT04922827
• Date of registration: 10/06/2021
• Prospective Registration: Yes
• Primary sponsor: Jena University Hospital
• Public title: Infliximab in the Treatment of Patients With Severe COVID-19 Disease INFLIXCOVID
• Scientific title: A Randomized, Controlled, Multicenter, Open Label Phase II Clinical Study to Evaluate Infliximab in the Treatment of Patients With Severe COVID-19 Disease
• Date of first enrolment: June 18, 2021
• Target sample size: 9
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT04922827
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Germany

Contacts

• Name: Andreas Stallmach, Prof. Dr. med.
• Affiliation: Department of Internal Medicine IV (Gastroenterology, Hepatology, and Infectious Diseases), Jena University Hospital

• Name: Sina M Coldewey, Prof. Dr. Dr. med.
• Affiliation: Department of Anaesthesiology and Intensive Care Medicine, Jena University Hospital

Key inclusion & exclusion 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

- 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 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

COVID-19

Intervention(s)

Drug: Infliximab

Other: Standard of Care

Primary Outcome(s)

28-day mortality [Time Frame: 28 days after randomization]

Secondary Outcome(s)

assessment of the severity and frequency of organ failure: vasopressor-free days [Time Frame: day 28 after randomization]

assessment of the effect of infliximab on an excessive immune response in patients with COVID-19: Interleukin 6 [Time Frame: day 7 and day 14 after randomization]

assessment of the severity and frequency of organ failure: renal replacement therapy-free days [Time Frame: day 28 after randomization]

assessment of the severity and frequency of organ failure: ventilation-free days [Time Frame: day 28 after randomization]

health related quality of life: index [Time Frame: day 90 after randomization]

health related quality of life: visual analogue scale [Time Frame: day 90 after randomization]

incidence of cardiomyopathy [Time Frame: day 3 and 7 after randomization]

length of stay: hospital [Time Frame: day 28 after randomization]

assessment of the effect of infliximab on an excessive immune response in patients with COVID-19: ferritin [Time Frame: day 7 and day 14 after randomization]

occurence of Acute Respiratory Distress Syndrome (ARDS) [Time Frame: day 28 after randomization]

rate of admission to the intensive care unit [Time Frame: day 28 after randomization]

safety of Infliximab administration [Time Frame: up to 90 days after randomization]

assessment of the effect of infliximab on an excessive immune response in patients with COVID-19: lymphocyte count [Time Frame: day 7 and day 14 after randomization]

length of stay: intensive care unit [Time Frame: day 28 after randomization]

WHO-COVID-19-Progression Scale [Time Frame: day 7, 14 and 28 after randomization]

mortality [Time Frame: day 14 and 90 after randomization]

Secondary ID(s)

2021-002098-25

ZKSJ0137_INFLIXCOVID

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Celltrion

German Federal Ministry of Education and Research