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COVID-19Phase 2INFLIXCOVIDNCT04922827

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

A Phase 2 study testing Infliximab in people with COVID-19, run by Jena University Hospital at 4 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In this trial, patients that are severely affected by the disease COVID-19 will either receive infliximab, an anti-inflammatory drug, or standard therapy. Infliximab is a drug that inhibits inflammation by blocking a molecule called TNFα. The patients receive the drug via an infusion into a vein. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
COVID-19
What is being tested?
Infliximab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
4 sitesGermany
Study dates
18 Jun 2021to 1 Jul 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 23Show fewer
  • 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

Trial locations and contacts

4 sites in 1 country.

Germany4 sites

  • Universitätsklinikum Knappschaftskrankenhaus Bochum

    Bochum, 44892

  • Klinikum Fulda

    Fulda, 36043

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, 20246

  • Jena University Hospital

    Jena, 07747

Other trials in Germany

About this study

Official title: A Randomized, Controlled, Multicenter, Open Label Phase II Clinical Study to Evaluate Infliximab in the Treatment of Patients With Severe COVID-19 Disease

In this trial, patients that are severely affected by the disease COVID-19 will either receive infliximab, an anti-inflammatory drug, or standard therapy. Infliximab is a drug that inhibits inflammation by blocking a molecule called TNFα. The patients receive the drug via an infusion into a vein. The primary goal of this trial is to see whether the drug infliximab affects how many people died from COVID-19 after 28 days by comparing patients receiving the drug in addition to standard therapy with patients only receiving standard therapy.

Furthermore, this trial will look at whether the drug is safe to use in these patients, whether it has an effect on the inflammation and whether it can affect how ill patients are after surviving the disease.

The trial is conducted in more than one hospital. As COVID-19 is responsible for a global pandemic, positive results of this trial could affect patients, healthcare and economic systems worldwide.

Read the detailed description

The long-term goal of this research project is to develop a new pharmacological treatment strategy for patients with COVID-19. Its primary aim is the assessment of efficacy and safety of the TNFα antibody infliximab in the treatment of patients with severe COVID-19 in a phase-2 trial. Infliximab is expected to attenuate the inflammatory reaction in patients and thereby positively influence the course of the disease.

The primary endpoint is the difference in 28-day-mortality of patients with severe COVID-19 receiving one dose of 5mg per kg body weight infliximab intravenously in addition to the standard of care (intervention group) compared with patients receiving standard of care (control group).

Secondary aims of this trial include the assessment of the safety of the TNFα antibody infliximab in the treatment of patients with severe COVID-19, of its effect on an excessive immune response and of its effect on the morbidity and prognosis as well as the characterization of the analytical cohorts.

The multi-centre design facilitates the transferability of study results to hospitals of similar healthcare level. Should infliximab prove to be superior to standard therapy, this could be reflected in a reduced disease severity and mortality.

The results of this study could influence the therapy of patients with COVID-19 worldwide and affect the course of the disease worldwide, as infliximab is approved by several international drug agencies and globally available. Due to the high incidence of COVID-19 worldwide and the immense effects of the pandemic on societies, health care and economic systems, any progress in the treatment of this new disease would constitute a great success. This would not only impact individual patients but also have positive economic effects.

Conditions
COVID-19
Being tested
Infliximab, Standard of Care
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • InfliximabDrug

    single intravenous administration of 5 milligrams/kilogram

  • Standard of CareOther

    Standard of Care

Study groups in NCT04922827
Study groupRoleWhat they receive
Infliximab + Standard of CareExperimentalNot described
Receives: Drug: Infliximab; Other: Standard of Care
Standard of CareActive comparatorNot described
Receives: Other: Standard of Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 28-day mortality

    differences in mortality-rates between both study arms (Infliximab + Standard of Care vs. Standard of Care) 28 days after randomisation

    Measured: 28 days after randomization

Secondary outcomes (16)

  1. safety of Infliximab administration

    frequencies of adverse events (AEs) and serious adverse events (SAEs)

    Measured: up to 90 days after randomization

  2. assessment of the effect of infliximab on an excessive immune response in patients with COVID-19: Interleukin 6

    change in the interleukin-6 (IL-6) concentration in the blood from randomization to day 7 and day 14 after randomization

    Measured: day 7 and day 14 after randomization

  3. assessment of the effect of infliximab on an excessive immune response in patients with COVID-19: ferritin

    change in the ferritin concentration in the blood from randomization to day 7 and day 14 after randomization

    Measured: day 7 and day 14 after randomization

  4. assessment of the effect of infliximab on an excessive immune response in patients with COVID-19: lymphocyte count

    change in the lymphocyte count from randomization to day 7 and day 14 after randomization

    Measured: day 7 and day 14 after randomization

  5. assessment of the severity and frequency of organ failure: ventilation-free days

    ventilation-free days until 28 days after randomization

    Measured: day 28 after randomization

  6. assessment of the severity and frequency of organ failure: renal replacement therapy-free days

    renal replacement therapy-free days until 28 days after randomization

    Measured: day 28 after randomization

  7. assessment of the severity and frequency of organ failure: vasopressor-free days

    vasopressor-free days until 28 days after randomization

    Measured: day 28 after randomization

  8. occurence of Acute Respiratory Distress Syndrome (ARDS)

    rate of occurrence of ARDS until 28 days after randomization

    Measured: day 28 after randomization

  9. WHO-COVID-19-Progression Scale

    WHO-COVID-19-Progression Scale on day 7, 14 and 28 after randomization

    Measured: day 7, 14 and 28 after randomization

  10. rate of admission to the intensive care unit

    rate of admission to the intensive care unit after randomization up to day 28

    Measured: day 28 after randomization

  11. length of stay: hospital

    length of hospital stay up to day 28 after randomization

    Measured: day 28 after randomization

  12. length of stay: intensive care unit

    length of intensive care unit stay up to day 28 after randomization

    Measured: day 28 after randomization

  13. mortality

    mortality rates 14 and 90 days after randomization

    Measured: day 14 and 90 after randomization

  14. health related quality of life: visual analogue scale

    EQ5D-3L: visual analog scale value 90 days after randomization

    Measured: day 90 after randomization

  15. health related quality of life: index

    EQ5D-3L: index value 90 days after randomization

    Measured: day 90 after randomization

  16. incidence of cardiomyopathy

    incidence of cardiomyopathy 3 and/or 7 days after randomization

    Measured: day 3 and 7 after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2021
  2. Study start18 Jun 2021
  3. Primary completion31 Mar 2023
  4. Study completion1 Jul 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04922827
Sponsor's protocol ID
ZKSJ0137_INFLIXCOVID
Other IDs
2021-002098-25
Acronym
INFLIXCOVID
Status last verified
Aug 2022
First submitted
10 Jun 2021
Last updated
12 Jul 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Coldewey SM, Neu C, Bloos F, Baumbach P, Schumacher U, Bauer M, Reuken P, Stallmach A. Infliximab in the treatment of patients with severe COVID-19 (INFLIXCOVID): protocol for a randomised, controlled, multicentre, open-label phase II clinical study. Trials. 2022 Sep 2;23(1):737. doi: 10.1186/s13063-022-06566-5.

    PubMed 36056419

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Infliximab in people with COVID-19, run by Jena University Hospital at 4 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

28-day mortality (time frame: 28 days after randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04922827, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2023.

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