NCT04335071: CORON-ACT

Tocilizumab in the Treatment of Coronavirus Induced Disease (COVID-19)

Terminated Phase 2 Last updated 14 October 2020

What this trial tests

Phase 2 trial testing Tocilizumab (TCZ) in SARS-CoV-2 Infection in 5 participants. Terminated before completion.

Timeline

26 April 2020

Primary endpoint
27 September 2020

27 September 2020

Quick facts

Lead sponsor	Insel Gruppe AG, University Hospital Bern
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	5
Start date	26 April 2020
Primary completion	27 September 2020
Estimated completion	27 September 2020
Sites	4 locations across Switzerland

Drugs / interventions tested

• Tocilizumab (TCZ) — full drug profile →
• Placebo

Conditions studied

• SARS-CoV-2 Infection — all drugs for SARS-CoV-2 Infection →

Sponsor

Insel Gruppe AG, University Hospital Bern

Who can join

Adults 30 to 80, any sex, with SARS-CoV-2 Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The mortality rate of the disease caused by the corona virus induced disease (COVID-19) has been estimated to be 3.7% (WHO), which is more than 10-fold higher than the mortality of influenza. Patients with certain risk factors seem to die by an overwhelming reaction of the immune system to the virus, causing a cytokine storm with features of Cytokine-Release Syndrome (CRS) and Macrophage Activation Syndrome (MAS) and resulting in Acute Respiratory Distress Syndrome (ARDS). Several pro-inflammatory cytokines are elevated in the plasma of patients and features of MAS in COVID-19, include elevated levels of ferritin, d-dimer, and low platelets.

There is increasing data that cytokine-targeted biological therapies can improve outcomes in CRS or MAS and even in sepsis. Tocilizumab (TCZ), an anti-IL-6R biological therapy, has been approved for the treatment of CRS and is used in patients with MAS. Based on these data, it is hypothesized that TCZ can reduce mortality in patients with severe COVID-19 prone to CRS and ARDS.

The overall purpose of this study is to evaluate whether treatment with TCZ reduces the severity and mortality in patients with COVID-19.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Pathological inflammation in patients with COVID-19: a key role for monocytes and macrophages.
   Merad M, Martin JC. · · 2020 · cited 1909× · PMID 32376901 · DOI 10.1038/s41577-020-0331-4
2. Cardiovascular Considerations for Patients, Health Care Workers, and Health Systems During the COVID-19 Pandemic.
   Driggin E, Madhavan MV, Bikdeli B, Chuich T, et al · · 2020 · cited 1272× · PMID 32201335 · DOI 10.1016/j.jacc.2020.03.031
3. Immunology of COVID-19: Current State of the Science.
   Vabret N, Britton GJ, Gruber C, Hegde S, et al · · 2020 · cited 1248× · PMID 32505227 · DOI 10.1016/j.immuni.2020.05.002
4. Cytokine storm and leukocyte changes in mild versus severe SARS-CoV-2 infection: Review of 3939 COVID-19 patients in China and emerging pathogenesis and therapy concepts.
   Wang J, Jiang M, Chen X, Montaner LJ. · · 2020 · cited 551× · PMID 32534467 · DOI 10.1002/jlb.3covr0520-272r
5. Should we stimulate or suppress immune responses in COVID-19? Cytokine and anti-cytokine interventions.
   Jamilloux Y, Henry T, Belot A, Viel S, et al · · 2020 · cited 486× · PMID 32376392 · DOI 10.1016/j.autrev.2020.102567
6. Immunopathology of Hyperinflammation in COVID-19.
   Gustine JN, Jones D. · · 2021 · cited 371× · PMID 32919977 · DOI 10.1016/j.ajpath.2020.08.009
7. COVID-19 and the elderly: insights into pathogenesis and clinical decision-making.
   Perrotta F, Corbi G, Mazzeo G, Boccia M, et al · · 2020 · cited 248× · PMID 32557332 · DOI 10.1007/s40520-020-01631-y
8. The role of IL-6 and other mediators in the cytokine storm associated with SARS-CoV-2 infection.
   Copaescu A, Smibert O, Gibson A, Phillips EJ, et al · · 2020 · cited 196× · PMID 32896310 · DOI 10.1016/j.jaci.2020.07.001