NCT04412382: NETSINCOVID

Covid-19: Possible Role of Neutrophil Extracellular Traps

Status unknown Last updated 8 July 2020

What this trial tests

trial testing NETosis markers in Covid-19 in 100 participants. Status unknown.

Timeline

1 June 2020

Primary endpoint
31 December 2020

31 December 2021

Quick facts

Lead sponsor	Azienda Ospedaliera Universitaria Integrata Verona
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	100
Start date	1 June 2020
Primary completion	31 December 2020
Estimated completion	31 December 2021
Sites	1 location across Italy

Drugs / interventions tested

• NETosis markers

Conditions studied

• Covid-19 — all drugs for Covid-19 →

Sponsor

Azienda Ospedaliera Universitaria Integrata Verona — full company profile →

Who can join

18 and older, any sex, with Covid-19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The process by which neutrophils expel DNA together with various proteins to the outside, forming a network structure called Neutrophil Extracellular Traps (NETs) constitutes a particular cell death that involves the destruction of the nuclear membrane before the plasmatic one. This process is called NETosis and differs from other known forms of cell death, such as necrosis and apoptosis.

This process, however, if exaggerated, brings local or systemic damage. Viruses are known for their ability to evade the body's immune response. Only recently has it been seen that they can act as triggers for NETosis process.

In fact, many viruses can stimulate neutrophils to produce NETs. Virus-induced NETs can begin to circulate in an uncontrolled manner, leading to an extreme systemic response of the body with the production of immunocomplexes, cytokines, Interferon I etc.

To date, there are no data in the literature on the role of NETs in Covid-19 infection, a viral infection that leads to highly lethal interstitial pneumonia and for which there is currently no vaccine or specific therapy.

Advanced forms of Covid-19 are often characterized by hyperinflammation ("cytokine storm") with the development of an ARDS-like condition. Furthermore, reports of micro and macro thrombotic phenomena such as microangiopathy, pulmonary embolism (which has led to a careful evaluation procedure for antithrombotic prophylaxis and/or coagulation in Covid-19 patients) are increasingly frequent.

The primary objective of the study is to understand if NETs can be implicated in the response to Covid-19 and by which mechanisms. Concrete therapeutic proposals could derive from the knowledge and enhancement of this form of innate immunity.

To do this, it will be necessary to evaluate the activity of NETosis in Covid-19 patients and evaluate whether the clinical course of the disease (worsening vs healing) determines the degree of NETosis activity. Therefore, the association between mortality from Covid-19/survival and NETs activity will be studied.

Secondary objectives concern the possibility of studying the associations among NETosis markers and blood inflammation markers and among NETosis markers and the onset of peripheral or deep vein thrombosis.

Finally, the possibility that the plasma deriving from Covid-19 patients could trigger the NETosis process in vitro will be evaluated.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.