Clinical Trials Logo

Cytokine Storm clinical trials

View clinical trials related to Cytokine Storm.

Filter by:

NCT ID: NCT04377308 Completed - COVID-19 Clinical Trials

Fluoxetine to Reduce Intubation and Death After COVID19 Infection

Start date: May 1, 2020
Phase: Phase 4
Study type: Interventional

This project will test the efficacy of fluoxetine to prevent serious consequences of COVID-19 infection, especially death. Becoming sick with COVID-19 virus or any other serious respiratory condition is not fun. However, the dramatic effects of the COVID-19 pandemic on human society stem from its significant mortality, not the number of individuals who become sick. This project aims to prevent serious outcomes such as hospitalization, respiratory failure and death during the time it takes to develop vaccinations and other strategies to prevent COVID-19 infectionPoor outcomes with COVID-19 infection such as hospitalization, respiratory failure, organ failure and death are associated with a dysfunctional exaggerated immune response, called a cytokine storm, that is triggered by Interleukin-6 expression (IL-6) and seems to occur around day 5 to 7 of symptoms. Fluoxetine has extraordinarily strong evidence in its action as a blocker of IL-6 and cytokine storms in both animal models of infection and in human illness such as rheumatoid arthritis and others. This action of fluoxetine is an entirely separate pathway than the serotonergic pathway that allows fluoxetine to act as an antidepressant. This pathway has been demonstrated in cell culture, in animal models, in human illness and by novel bioinformatics analyses of protein transcripts to be relatively unique for fluoxetine and appears to be a novel pathway. This project aims to inhibit the increase in IL-6 expression and thereby prevent the cytokine storm that causes poor outcomes. Patients who have tested positive or are presumptively positive for COVID-19 will be entered into the study and given the option to start the medication fluoxetine, which is demonstrated to prevent IL-6 surges in infectious and inflammatory conditions. Participants will be monitored daily for COVID-19 symptoms and weekly for side effects and tolerance of fluoxetine. A subset of patients will have blood drawn weekly and stored to monitor IL-6 and other cytokine levels at a later date. This project aims to reduce the serious outcomes of COVID-19 infection by preventing or inhibiting the cytokine storm associated with organ failure, respiratory failure and death.

NCT ID: NCT04366908 Completed - COVID19 Clinical Trials

Prevention and Treatment With Calcifediol of COVID-19 Induced Acute Respiratory Syndrome

COVIDIOL
Start date: May 7, 2020
Phase: Phase 2
Study type: Interventional

The administration of Calcifediol in patients with COVID-19, will reduce the development of SARS and the worsening of the various phases of the syndrome. Reducing at least 25% in ICU admission and death from the process, reducing days of hospitalization, facilitating the recovery of the same, acting significantly and positively, in any of its phases throughout the natural history of illness. As a treatment with extensive experience of clinical use, safe, inexpensive, and potentially very effective, it will have a highly efficient cost-benefit impact on the prevention of SARS.

NCT ID: NCT04362111 Completed - COVID-19 Clinical Trials

Early Treatment of Cytokine Storm Syndrome in Covid-19

Start date: August 1, 2020
Phase: Phase 3
Study type: Interventional

This proposal addresses the problem of preventing the very high mortality and morbidity associated with the development of Cytokine Storm Syndrome (CSS) associated respiratory failure in Covid-19 infection.

NCT ID: NCT04324528 Completed - COVID-19 Clinical Trials

Cytokine Adsorption in Severe COVID-19 Pneumonia Requiring Extracorporeal Membrane Oxygenation

CYCOV
Start date: March 27, 2020
Phase: N/A
Study type: Interventional

In December 2019 in the city of Wuhan in China, a series of patients with unclear pneumonia was noticed, some of whom have died of it. In virological analyses of samples from the patients' deep respiratory tract, a novel coronavirus was isolated (SARS-CoV-2). The disease spread rapidly in the city of Wuhan at the beginning of 2020 and soon beyond in China and, in the coming weeks, around the world. Initial studies described numerous severe courses, particularly those associated with increased patient age and previous cardiovascular, metabolic and respiratory diseases. A small number of the particularly severely ill patients required not only highly invasive ventilation therapy but also extracorporeal membrane oxygenation (vv-ECMO) to supply the patient's blood with sufficient oxygen. Even under maximum intensive care treatment, a very high mortality rate of approximately 80-100% was observed in this patient group. In addition, high levels of interleukin-6 (IL-6) could be detected in the blood of these severely ill patients, which in turn were associated with poor outcome. From experience in the therapy of severely ill patients with severe infections and respiratory failure, we know that treatment with a CytoSorb® adsorber can lead to a reduction of the circulating pro- and anti-inflammatory cytokines and thus improve the course of the disease and the outcome of the patients. Our primary goal is to investigate the efficacy of treatment with a CytoSorb® adsorber in patients with severe COVID-19 disease requiring venous ECMO over 72 hours after initiation of ECMO. The primary endpoint is the reduction of plasma interleukin-6 levels 72 hours after initiation of ECMO support. As secondary endpoints we investigate 30-day survival, vasopressor and volume requirements, lactate in terms of lactate and platelet function. As safety variables, we further investigate the levels of the applied antibiotics (usually ampicillin and sulbactam).

NCT ID: NCT04226430 Completed - Sepsis Clinical Trials

Effect of Cytosorb on Blood Levels of Inflammatory Biomarkers of Sepsis.

Start date: June 1, 2016
Phase:
Study type: Observational [Patient Registry]

Background: There is still an evident need for useful biomarkers and effective therapeutic approaches regarding the challenging management of sepsis. The aim of the study is to evaluate the effect of each Cytosorb hemoadsorption therapy course on blood levels of inflammatory biomarkers of sepsis including endocan, copeptin, interleukin-6, procalcitonin, C-reactive protein.

NCT ID: NCT03685383 Completed - Cardiac Arrest Clinical Trials

Cytokine Adsorption in Post-cardiac Arrest Syndrome in Patients Requiring Extracorporeal Cardiopulmonary Resuscitation

CYTER
Start date: September 25, 2019
Phase: N/A
Study type: Interventional

Almost all patients with refractory cardiac arrest, who are primarily stabilized under ongoing cardiopulmonary resuscitation by transcutaneous implantation of a venoarterial extracorporeal membrane oxygenation system (va-ECMO for eCPR) develop post-cardiac arrest syndrome (PCAS). PCAS is characterised by cytokine storm resulting in vasodilation and membrane leakage, which is poorly controlled and often fatal. Case reports and data from the investigators' single-center registry indicate that cytokine adsorption with the CytoSorb removal column can be safely added to va-ECMO, but its efficacy and safety have not been examined systematically. This pilot study will assign all comers undergoing eCPR to va-ECMO with or without cytokine adsorber in a 1:1 fashion. This will ensure comparability and allow analysing clinical endpoints, but is limited by sample size (according to their experience the investigators expect approximately 20 cases per year). The investigators will however be able to generate important data about safety, secondary endpoints such as Interleukin-6-removal or vasopressor use and low-power data about efficacy concerning the primary endpoint 30-day survival.

NCT ID: NCT02020525 Completed - Surgery Clinical Trials

Blood Transfusions and Immune Response

Start date: December 2004
Phase: N/A
Study type: Interventional

- We have previously reported the results of the primary and secondary outcomes of a randomized study aiming to investigate the impact of a restrictive transfusion protocol on the magnitude of reduction in blood transfusion in a typically mixed general surgery population subjected to major abdominal surgery. - The main finding of that study was a reduction in red blood cell usage with the implementation of a restrictive transfusion regimen. This was achieved without adversely affecting clinical outcome in the population studied. - The aim of this secondary analysis performed on a subgroup of 20 patients from the original study was to determine whether there are any differences in the postoperative immunologic response, as expressed by the production of inflammatory mediators, between a restrictive approach to red cell transfusion and a more liberal strategy.

NCT ID: NCT01302223 Completed - Inflammation Clinical Trials

Keratinocyte Growth Factor and Cytokines in Burns.

Start date: October 2011
Phase: N/A
Study type: Observational

KERATINOCYTE GROWTH FACTOR AND CYTOKINES IN SKIN BURNS. INTRODUCTION: Intense inflammatory responses are activated by burns that affect a large total body surface area. Changes in plasma levels of cytokines after burns occur before metabolic abnormalities unsettle the patient. So it may be possible to develop therapeutic interventions that may attenuate the acute inflammatory response by decreasing the expression of these cytokines. The importance of growth factors in the healing process was demonstrated in cultured keratinocytes and fibroblasts. The keratinocyte growth factor (KGF) is a growth factor active in the repair of wounds, being the most potent stimulator of mitotic cells. PURPOSE: To assess the level of keratinocyte growth factor (KGF) and IL-1ß, IL-6, IL-8, IL-10, IL-12 and TNF-alfa of patients with burns produced by cultured primary dermal fibroblasts and the gene expression. METHODS: 10 patients will be include (05 patients in the study group and 05 patients in the control group) admitted to the Burns Care Unit of the Discipline of Plastic Surgery, Federal University of São Paulo (UNIFESP) between 25% and 50% of total body surface area (TBSA), deep second-degree or third degree, with need to perform surgical debridement. The control group will be constituted by patients with less than 5% of TBSA, deep second-degree or third degree, with need to perform surgical debridement. The authors will evaluate the levels of IL-1ß, IL-6, IL-8, IL-10, IL-12p70 and tumor necrosis factor alpha (TNF-alfa) in samples of the culture media of primary dermal fibroblasts of patients selected using flow cytometry. The level of keratinocyte growth factor (KGF), in the same samples will be evaluated by ELISA. The keratinocyte growth factor (KGF) and TNF-alfa gene expression will be evaluated in the culture of primary dermal fibroblasts from the same patients. The gene expression of KGF and cytokines will be done by qRT-PCR and RT-PCR array. The experiments will be done in duplicate.