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Cytokine Storm clinical trials

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NCT ID: NCT06308926 Not yet recruiting - Clinical trials for Acute Respiratory Distress Syndrome

MRG-001 as an Immunoregulatory and Regenerative Therapy for ARDS Patients

SUMMIT
Start date: July 1, 2024
Phase: Phase 2
Study type: Interventional

This is a phase IIa, dose-ranging, proof-of-concept study of MRG-001 in patients with ARDS. The aim is to determine the safety and preliminary efficacy of MRG-001 across two dose ranges.

NCT ID: NCT06052774 Completed - Cytokine Storm Clinical Trials

Interleukin-34 in Stage I and II Periodontitis

Start date: January 1, 2023
Phase: N/A
Study type: Interventional

Interleukin 34 (IL-34) is the second active component of (colony-stimulating factor receptor) CSF-1R. With regards to periodontal disease, It is debatable whether IL-34 is a pro-inflammatory cytokine (as seen in rheumatic arthritis and Sjogren syndrome) or an anti-inflammatory cytokine( as seen in Alzheimer's disease) so further studies could be conducted to better understand whether IL-34 is a proinflammatory or anti-inflammatory cytokine in the pathogenesis of periodontal diseases and to evaluate the change of its levels in Gingival crevicular fluid (GCF) in patients with periodontal disease after non-surgical periodontal therapy (NSPT).

NCT ID: NCT06003972 Completed - Heart Failure Clinical Trials

Asses the Anti-inflammatory Effects of Short Term Copaxone Therapy on Patients the Acute Decompensated Heart Failure

Copaxone
Start date: January 4, 2021
Phase: Phase 2
Study type: Interventional

Assess the anti-inflammatory effects of short-term Copaxone therapy on patients with acute decompensated heart failure. Trial Design - An open-label, randomized, prospective trial of patients hospitalized due to acute decompensation of heart failure with reduced ejection fraction. - Patients will be enrolled within 24 hours from hospital admission. - Randomization and intervention will begin within 24 hours of enrollment (and at least 24 hours after admission). - Patients will be randomized in a 1:1 ratio either to receive guideline directed medical therapy (GDMT) or GDMT plus Copaxone. - Patients assigned to intervention group will receive daily SC Copaxone 20 mg for 14 days. - Patients will be assessed during 4 time points(screening/randomization, visit 3 day, visit 14 day, visit 30 day) as elaborated in article "monitoring". - Changes in inflammatory cytokines will be compared between control and intervention group throughout 3 time points. - The trial will be approved by the institutional view board and conducted in accordance with the principles or Good Clinical Practice guidelines and the Declaration of Helsinki.

NCT ID: NCT05611710 Recruiting - Dengue Clinical Trials

Anakinra in Dengue With Hyperinflammation ( AnaDen )

Start date: January 2, 2023
Phase: Phase 2
Study type: Interventional

This study aims to evaluate the effect of anakinra in dengue patients with hyperinflammation as compared to placebo Primary Objective: To evaluate the efficacy of Anakinra in moderate-severe dengue patients with hyperinflammation. Secondary Objectives: - To assess the safety of anakinra therapy in dengue with hyperinflammation - To assess the effect of anakinra therapy in patients with dengue on physiological, clinical and virological parameters - To assess the immunomodulation effects of anakinra in dengue - Immune cell signatures in dengue with and without anakinra - To assess difference in gene expression between treatment group compared to non-treatment population

NCT ID: NCT05491304 Recruiting - Cytokine Storm Clinical Trials

Cytokine Guided Risk Stratification and Treatment in Pediatric Hemophagocytic Lymphohistiocytosis

Start date: September 1, 2022
Phase: Phase 4
Study type: Interventional

Hemophagocytic lymphohistiocytosis (HLH) is a rapidly fatal disease caused by immune-dysregulation characterized by hypercytokinemia, with about 30%-40% of patients suffering death in children. Stratification strategy and individualized treatment is important to improve the survival. In our recent retrospective study, risk stratification based on IL-10 and IFN-γ levels well distinguished patients with different outcomes. In this multicenter prospective study, we will enroll the newly diagnosed pediatric HLH patients and divide them into low, intermediate and high-risk cytokine groups according to IFN-γ and IL-10 levels. The patients'clinical manifestation and laboratory findings will be further evaluated into severe and non-severe groups. For low/intermediate risk and non-severe patients, steroid or ruxolitinib will be used initially; while those with high risk or severe diseases, DXM+VP16±ruxolitinib will be administered. The treatment strategy could be adjusted after evaluation 48-72 hours later.

NCT ID: NCT05476848 Completed - COVID-19 Clinical Trials

Relationship Between Oral Findings and Salivary Factors in Sars-Cov-2 Patients

Start date: March 1, 2022
Phase: N/A
Study type: Interventional

Two hundred individuals will be formed according to the study and control groups: Group-1: coronavirus 2 (Covid-19) (+) patients (n=100) and Group-2: Healthy individuals (in which the volunteers will be included due to group-1) (n=100). Oral examinations including DMFT scores, salivary flow rate, visible gingival index scores and radiographs (OPG) will be performed on both groups on the 1st appointment. Oral swap samples will be collected with sterile swap brushes (Six sample for each person) on the 1st, 7th and 30th days to evaluate the salivary immunoglobulins (Immunoglobulin A (IgA), Immunoglobulin G (IgG), Immunoglobulin M (IgM)) and cytokine (IL-1, IL-6, IL-10) levels. Blood samples will be collected to validate the oral swap test results.

NCT ID: NCT05408325 Completed - COVID-19 Clinical Trials

Intercellular Adhesion Molecule-1 and TNF-α in Patients With COVID-19

Start date: February 1, 2021
Phase:
Study type: Observational

This study aimed to assess the cytokine profile in COVID 19 patients and its relation with disease progression & severity using COVID reporting and data system (CORADS) score.

NCT ID: NCT05307601 Completed - COVID-19 Clinical Trials

Immune Response Following COVID-19 in Hemodialysis Patients

IMMUNOVIDIAL
Start date: September 1, 2020
Phase:
Study type: Observational

Patients with chronic kidney disease (CKD), particularly those undergoing hemodialysis (HD), are at high risk of a severe form of COVID-19. This study aims to characterize the inflammatory and antiviral response during SarsCov2 infection in adult

NCT ID: NCT05136183 Recruiting - Septic Shock Clinical Trials

CLinical Efficacy of Hemoperfusion With a Cytokine Adsorber in Norepinephrine-Resistant SEptic Shock

CLEANSE
Start date: December 15, 2021
Phase: N/A
Study type: Interventional

Sepsis and septic shock are major causes of ICU admission worldwide. Despite recent advances in treatment, including targeted resuscitation and timely use of antimicrobial agents, mortality of ICU patients with septic shock remains steadily high. Especially in those requiring high dosage of vasopressors, whose 28-day mortality rate could reach 60%. The pathophysiology of septic shock emphasizes on the role of dysregulated host immune response towards inciting microbes, producing excessive inflammatory cytokines which lead to tissue damage and subsequent organ failures. Multiple therapies targeting the overwhelming inflammatory response in patients with septic shock have been studied (ref). While some showed promising results in modulating inflammation in observational studies (ref), none other than systemic corticosteroids lead to better clinical outcomes in the randomized controlled studies. The reasons for their failures are the complexity of the inflammation cascades, where treatments specifically targeting parts of the process may not be able to achieve meaningful effects. Extracorporeal blood purification therapy is an adjunctive treatment option more extensively studied over the last decade. By passing patients' blood or plasma through specifically developed absorber, various inflammatory cytokines are absorbed to resins inside the devices and removed from the circulation. Decreasing levels of inflammatory cytokines may subsequently attenuate systemic inflammation leading to shock reversal and better survival. HA-330 disposable hemoperfusion cartridge (Jafron®, China) is an absorber targeting hyper-inflammatory states including septic shock. It is designed to nonspecifically absorb molecules with molecular weight 10-60 kilo-Dalton, making it effective for removing various pro-inflammatory cytokines and potentially modulating the inflammatory cascade. Previous randomized study in patients with sepsis compared between the add-on 3 daily session of hemoperfusion with HA-330 adsorber and the standard therapy . .Circulating interleukin-6 and interleukin-8 levels of patients underwent hemoperfusion significantly reduced after two sessions when compared to baseline. Their values on day 3 were also significantly lower than those of the control group. Adjunctive hemoperfusion were associated with lower ICU mortality, butno significant difference in hospital and 28-day mortality between the two groups(ref). However, approximately 50% of enrolled patients had sepsis without shock. Generalization of the findings to more severe cohorts of septic shock patients are therefore limited. Patients with septic shock have higher cytokines level than septic patients without shock. Hence, they are theoretically more likely to benefit from therapies aiming to reduce cytokine levels. We hypothesize that adjunctive hemoperfusion with HA-330 adsorber would be associated with better outcomes in a more severe group of patients with septic shock.

NCT ID: NCT05133635 Withdrawn - Cytokine Storm Clinical Trials

High-Dose Corticosteroid or Tocilizumab for Clinical Worsening of COVID-19

Start date: February 1, 2021
Phase: Phase 4
Study type: Interventional

COVID-19 pandemic has spread all over the world, and hospitalization of the patients with COVİD-19 Pneumonia has become a great burden to the Intensive Care Units. Unfortunately there is still no curative method for the disease yet. Intensive Care Units provide general care for the patients; including oxygen therapy, maintenance of the organ systems (e.g., cardiovascular, renal), nutrition, antibiotic therapy for secondary infections, and etc. One of the major problems in COVID-19 is macrophage activation syndrome, also known as cytokine storm. It stems from exaggerated inflammatory response, which causes increased cytokine release and results in clinical deterioration of the patients. Many drugs have been used to prevent this exaggerated inflammation, like corticosteroids, interleukin (IL) receptor blockers, plasma exchange, etc. In this study our aim is to investigate the effectiveness of high dose corticosteroid (methylprednisolone 250 mg for 3 days) and an IL-6 receptor antagonist (tocilizumab) in the treatment of the cytokine storm of the COVID-19 patients.