Clinical trials: Hypercytokinemia
Relapsed or Refractory Aggressive B-Cell Non-Hodgkins Lymphoma
Evaluate Optimization of CRS Profile for Glofit Monotherapy and Glofit+GemOx in R/R Aggressive B-NHL
This Phase II trial evaluates the optimization of the cytokine release syndrome (CRS) profile for glofitamab in combination with gemcitabine and oxaliplatin (Glofit-GemOx) followed by glofitamab monotherapy treatment regimen (Cohort…
- Trial name
- NCT06806033
- Testing
- Obinutuzumab, Glofitamab, Gemcitabine
- Where
- 53 sites in United States, Australia and 5 more
- Volunteers
- 130 people
- Sponsor
- Hoffmann-La Roche
Multiple Myeloma
A Study Evaluating the Prophylactic Use of Tocilizumab to Prevent Cytokine Release Syndrome With Ramantamig Administration in Participants With Relapsed/Refractory Multiple Myeloma
The purpose of this study is to find out whether giving a single dose of tocilizumab before treatment with ramantamig can help prevent or reduce the severity of cytokine release syndrome (CRS) within 28 days from ramantamig…
- Trial name
- TRI Pro (NCT07589634)
- Testing
- Ramantamig, Tocilizumab
- Where
- 38 sites in United States, Argentina and 7 more
- Volunteers
- 230 people
- Sponsor
- Janssen Research & Development, LLC
Acute Respiratory Distress Syndrome, Respiratory Failure
MRG-001 as an Immunoregulatory and Regenerative Therapy for ARDS Patients
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.
- Conditions
- Acute Respiratory Distress Syndrome, Respiratory Failure, Respiratory Distress Syndrome, Respiratory Tract Diseases
- Trial name
- SUMMIT (NCT06308926)
- Testing
- MRG-001 (Low-dose), MRG-001 (High-dose)
- Volunteers
- 60 people
- Sponsor
- MedRegen LLC
Febrile Neutropenia
Remote Temperature Monitoring of Adult Subjects Undergoing Outpatient Stem Cell Transplant or CAR-T Cell Therapy
IDION is currently seeking FDA approval for this device- the IDION iTempShield. It is a skin-safe, FDA complaint and non-invasive device that can read and monitor skin temperature.
- Trial name
- NCT05576220
- Testing
- IDION iTempShield
- Where
- United States
- Volunteers
- 210 people
- Sponsor
- IDION Inc.
Septic Shock, Acute Respiratory Distress Syndrome
CytOSorb TreatMent Of Critically Ill PatientS Registry
Registry intended to provide a data repository and reporting infrastructure for the surveillance of CytoSorb device use in real-world critical care settings, and to serve as an objective, comprehensive, and scientifically-based…
- Conditions
- Septic Shock, Acute Respiratory Distress Syndrome, Trauma, Rhabdomyolysis
- Trial name
- COSMOS (NCT05146336)
- Testing
- CytoSorb
- Where
- 28 sites in Austria, Germany and 4 more
- Volunteers
- 3,000 people
- Sponsor
- CytoSorbents, Inc
COVID-19
A Study to Assess the Efficacy and Safety of Gimsilumab in Subjects With Lung Injury or Acute Respiratory Distress Syndrome Secondary to COVID-19 (BREATHE)
Study KIN-1901-2001 is a multi-center, adaptive, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of gimsilumab in subjects with lung injury or acute respiratory distress syndrome (ARDS)…
- Trial name
- NCT04351243
- Testing
- Gimsilumab
- Where
- 33 sites in United States
- Volunteers
- 227 people
- Sponsor
- Kinevant Sciences GmbH
Sars-CoV2
Rhu-pGSN for Severe Covid-19 Pneumonia
Study Objectives: Primary To assess the efficacy (survival without organ failure on Day 14) of three doses of rhu-pGSN administered intravenously (IV) plus standard of care (SOC) to hospitalized subjects with a primary diagnosis…
- Trial name
- NCT04358406
- Testing
- Recombinant human plasma gelsolin (Rhu-pGSN)
- Where
- 3 sites in Romania, Spain
- Volunteers
- 64 people
- Sponsor
- BioAegis Therapeutics Inc.
Cytokine Release Syndrome in COVID-19-induced Pneumonia
Canakinumab MAP in COVID-19 Pneumonia With CRS
This is a global Managed Access Program (MAP) to provide access to canakinumab to patients with cytokine release syndrome resulting from COVID-19 pneumonia
- Trial name
- NCT04476706
- Testing
- canakinumab
- Sponsor
- Novartis Pharmaceuticals
Cytokine Release Syndrome
Study of CTO1681 for the Prevention and Treatment of CRS in Patients Receiving CAR T-Cell Therapy
This is an interventional study to evaluate the use of CTO1681 in preventing or reducing CAR T-cell-induced toxicities like cytokine release syndrome (CRS).
- Trial name
- NCT05905328
- Testing
- CTO1681 10 µg, CTO1681 20 μg, CTO1681 30 μg
- Where
- 6 sites in United States
- Volunteers
- 54 people
- Sponsor
- CytoAgents, Inc.
COVID-19
Assessment of Efficacy and Safety of Ruxolitinib in Participants With COVID-19-Associated ARDS Who Require Mechanical Ventilation (RUXCOVID-DEVENT)
The purpose of this study is to evaluate the efficacy and safety of ruxolitinib in the treatment of participants with COVID-19-associated Acute Respiratory Distress Syndrome (ARDS) who require mechanical ventilation.
- Trial name
- NCT04377620
- Testing
- Ruxolitinib
- Where
- 36 sites in United States, Russia
- Volunteers
- 211 people
- Sponsor
- Incyte Corporation
Cytokine Release Syndrome
Safety and Tolerability Study of IV ST266 in COVID-19 Subjects
The primary aim of the study is to evaluate the safety and tolerability of open-label ST266 given to subjects with confirmed COVID-19 infection through IV administration once a day of 5 consecutive days.
- Trial name
- NCT04720378
- Testing
- ST266
- Where
- 3 sites in United States
- Volunteers
- 12 people
- Sponsor
- Noveome Biotherapeutics, formerly Stemnion
Coronavirus Disease 2019 (COVID-19) Pneumonia
Phase 3 Study to Evaluate Efficacy and Safety of Lenzilumab in Patients With COVID-19
The primary objective of this study is to assess whether the use of lenzilumab in addition to current standard of care can alleviate the immune-mediated cytokine release syndrome (CRS) and improve ventilator-free survival in…
- Trial name
- NCT04351152
- Testing
- Lenzilumab, Standard of Care
- Where
- 29 sites in United States, Brazil
- Volunteers
- 520 people
- Sponsor
- Humanigen, Inc.
COVID-19
Cytokine and Eicosanoid Mediators in Coronavirus Disease 2019 (COVID-19)
This study is a prospective, single center, observational, cohort study of patients to (1) describe the kinetics and temporal relationship of changes in eicosanoid and cytokine mediators in patients with severe COVID-19 admitted…
- Trial name
- NCT04452942
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- EicOsis Human Health Inc.
Cytokine Storm (Covid-19)
Study to Assess the Efficacy and Safety of Ruxolitinib in Patients With COVID-19 Associated Cytokine Storm
This was a randomized, double-blind, placebo-controlled, 29-day, multicenter study to assess the efficacy and safety of ruxolitinib + standard-of-care (SoC) therapy, compared with placebo + SoC therapy, in patients aged ≥12 years…
- Trial name
- RUXCOVID (NCT04362137)
- Testing
- Ruxolitinib
- Where
- 61 sites in United States, Argentina and 10 more
- Volunteers
- 432 people
- Sponsor
- Novartis Pharmaceuticals
COVID-19
A Study to Evaluate OP-101 (Dendrimer N-acetyl-cysteine) in Severe Coronavirus Disease 2019 (COVID-19) Patients
The primary purpose of Stage-I of this study is to evaluate the safety and tolerability of OP-101 in patients with severe COVID-19 and of Stage 2 of this study is to evaluate the efficacy of OP-101 in patients with severe…
- Trial name
- PRANA (NCT04458298)
- Testing
- OP-101
- Where
- 8 sites in United States
- Volunteers
- 28 people
- Sponsor
- Ashvattha Therapeutics, Inc.
Coronavirus Infection, Cytokine Storm
Yoga Pranayama Adjuvant to Treat Burden COVID-19
COronaVIrus Disease or Severe Acute Respiratory Syndrome -CoV-2 or COVID-19, mortality occurs mainly from immunological behavior or by suicide after healing .
- Conditions
- Coronavirus Infection, Cytokine Storm, Mental Disorder
- Trial name
- YOCO (NCT04413747)
- Testing
- morning Yoga-based breathing support, pre_lunch Yoga-based breathing support, pre_dinner Yoga-based breathing support
- Where
- Italy
- Volunteers
- 1,000 people
- Sponsor
- Health Ricerca e Sviluppo S.R.L.
Acute Respiratory Distress Syndrome, Coronavirus
Pemziviptadil (PB1046), a Long-acting, Sustained Release Human VIP Analogue, Intended to Provide Clinical Improvement to Hospitalized COVID-19 Patients at High Risk for Rapid Clinical Deterioration and Acute Respiratory Distress Syndrome (ARDS).
This is a multicenter, randomized, double-blind, parallel group study to investigate the efficacy of pemziviptadil (PB1046) by improving the clinical outcomes in hospitalized COVID-19 patients at high risk for rapid clinical…
- Conditions
- Acute Respiratory Distress Syndrome, Coronavirus, Hypoxic Respiratory Failure, Hypoxemic Respiratory Failure
- Trial name
- VANGARD (NCT04433546)
- Testing
- Pemziviptadil (PB1046), Low Dose (10 mg) Control
- Where
- 4 sites in United States
- Volunteers
- 54 people
- Sponsor
- PhaseBio Pharmaceuticals Inc.
Immunity, Vaccine Reaction
Efficacy and Tolerability of ABBC1 in Volunteers Receiving the Influenza or Covid-19 Vaccine
The immune system response needs to be forceful but also balanced for a rapid recovery from infection which avoids harmful overreactions.
- Conditions
- Immunity, Vaccine Reaction, Influenza, Covid19
- Trial name
- NCT04798677
- Testing
- ABBC1 Immunoessential
- Where
- Spain
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- AB Biotek
COVID-19
101-PGC-005 for the Treatment of COVID-19
This is a prospective, randomized, comparative, multi-centric, adaptive design clinical study to evaluate efficacy, safety, and tolerability of 101-PGC-005 ('005) when used alongside standard of care (SOC) for the treatment of…
- Trial name
- NCT05656521
- Testing
- 101-PGC-005, Dexamethasone
- Where
- 5 sites in India
- Volunteers
- 62 people
- Sponsor
- 101 Therapeutics
COVID-19
A Prospective, Phase II Study to Evaluate Safety of 101-PGC-005 ('005) for Moderate to Severe COVID-19 Disease Along With Standard of Care
In December 2019, a novel pneumonia caused by a previously unknown pathogen emerged in Wuhan, China. The pathogen was soon identified as a novel coronavirus (SARS-CoV-2), which is closely related to severe acute respiratory…
- Trial name
- NCT05195749
- Testing
- 101-PGC-005 ('005) + SOC
- Where
- Israel
- Volunteers
- 3 people
- Sponsor
- 101 Therapeutics