Clinical trials: Cytokine Release Syndrome
Diabetes Mellitus, Type 1
Investigation of Otelixizumab in New-Onset, Autoimmune Type 1 Diabetes Mellitus Patients
The aim of this Phase I/IIa study is to identify a safe and tolerable dosage regimen of intravenously administered otelixizumab.
- Trial name
- NCT02000817
- Testing
- Otelixizumab
- Where
- 6 sites in Belgium
- Volunteers
- 30 people
- Sponsor
- GlaxoSmithKline
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
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
Severe COVID-19 Disease
RAPA-501-Allo Therapy of COVID-19-ARDS
The first-in-human Phase 1 study component will evaluate two dose levels of RAPA-501-ALLO off the shelf cells in patients with COVID-19-related ARDS, with key endpoints of safety, biologic and potential disease-modifying effects.
- Trial name
- NCT04482699
- Testing
- RAPA-501-Allo off-the-shelf Therapy of COVID-19
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Rapa Therapeutics LLC
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.
COVID-19
Expanded Access Program of Ruxolitinib for the Emergency Treatment of Cytokine Storm From COVID-19 Infection
To provide ruxolitinib through an expanded access program for the treatment of cytokine storm due to COVID-19 in the United States to patients who are eligible but not able to be hospitalized or who are hospitalized with a…
- Trial name
- NCT04355793
- Testing
- Ruxolitinib
- Sponsor
- Incyte Corporation
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.
SARS-CoV-2, Influenza, Human
Study on Safety and Efficacy of Two Doses of PRS CK STORM in the Modulation of the Cytokine Storm in Patients With Acute Respiratory Infection Caused by SARS-Cov-2, Influenza A, Influenza B and Respiratory Syncytial Virus (RSV)
The purpose of this clinical trial is to evaluate the safety, tolerability and efficacy of two doses (dose A and dose B) of Standardized Conditioned Medium Obtained by Coculture of M2-macrophages and fat-derived Mesenchymal…
- Conditions
- SARS-CoV-2, Influenza, Human, Respiratory Syncytial Virus Infections, Respiratory Distress Syndrome
- Trial name
- NCT06684379
- Testing
- PRS CK STORM
- Where
- 3 sites in Spain
- Volunteers
- 50 people
- Sponsor
- PEACHES BIOTECH
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.
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
A Study of Itacitinib for the Prevention of Cytokine Release Syndrome Induced by Immune Effector Cell Therapy
"The purpose of this study is to assess the safety and efficacy of oral administration of itacitinib for the prevention of cytokine release syndrome (CRS) in male or female participants aged 12 years or older and who are planning…
- Trial name
- NCT04071366
- Testing
- Itacitinib, Immune effector cell therapy, Yescarta
- Where
- 10 sites in United States
- Volunteers
- 112 people
- Sponsor
- Incyte Corporation
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.
Acute Respiratory Distress Syndrome, Cytokine Release Syndrome
Efficacy and Safety of Itolizumab in COVID-19 Complications
Randomized, Parallel Group, Active Controlled Trial
- Conditions
- Acute Respiratory Distress Syndrome, Cytokine Release Syndrome, Covid19
- Trial name
- NCT04475588
- Testing
- Itolizumab IV infusion, Best supportive care (BSC)
- Where
- 4 sites in India
- Volunteers
- 32 people
- Sponsor
- Biocon Limited
SARS-CoV2 Infection
Efficacy and Safety of EXOSOME-MSC Therapy to Reduce Hyper-inflammation In Moderate COVID-19 Patients
In COVID-19 infection caused by the Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), there is a dysregulation of the immune system response that causes cytokine storm syndrome.
- Trial name
- EXOMSC-COV19 (NCT05216562)
- Testing
- Exosome-MSC Intravenous injection, COVID-19 Standard Treatment
- Where
- 3 sites in Indonesia
- Volunteers
- 60 people
- Sponsor
- Dermama Bioteknologi Laboratorium
Cytokine Release Syndrome, Immune Effector Cell-Associated Neurotoxicity Syndrome
RPM Signals in Outpatient CAR T Therapy
The goal of this observational study is to learn how patients' vital signs and symptoms change during outpatient CAR T-cell therapy with lisocabtagene maraleucel (liso-cel), a type of cancer treatment.
- Conditions
- Cytokine Release Syndrome, Immune Effector Cell-Associated Neurotoxicity Syndrome, B-Cell Lymphoma, Chronic Lymphocytic Leukemia
- Trial name
- NCT07882732
- Volunteers
- 125 people
- Sponsor
- Current Health
Coronavirus, COVID
A Phase 2 Study to Evaluate Axatilimab for Hospitalized Participants With Respiratory Involvement Secondary to COVID-19
This was a randomized, double-blind, placebo-controlled, 29-day study to assess the efficacy and safety of axatilimab plus standard of care (SOC), compared with placebo plus SOC, in participants with respiratory signs and…
- Conditions
- Coronavirus, COVID, ARDS, Cytokine Storm
- Trial name
- NCT04415073
- Testing
- SNDX-6352
- Where
- 2 sites in United States
- Volunteers
- 1 people
- Sponsor
- Syndax Pharmaceuticals
Covid19, Cytokine Release Syndrome
Safety and Efficacy of Dapansutrile for Treatment of Moderate COVID-19 Symptoms and Evidence of Early Cytokine Release Syndrome
The purpose of this study is to assess the safety and efficacy of orally administered NLRP3 inhibitor, dapansutrile, for the treatment of moderate COVID-19 symptoms and early cytokine release syndrome (CRS) in patients with…
- Trial name
- NCT04540120
- Testing
- dapansutrile capsules
- Where
- 10 sites in United States, Switzerland
- Volunteers
- 49 people
- Sponsor
- Olatec Therapeutics, 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.
Covid19, ARDS
Expanded Access for Use of bmMSC-Derived Extracellular Vesicles in Patients With COVID-19 Associated ARDS
ExoFlo, Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles Allograft Product, Infusion Treatment is currently being studied in Protocol DB-EF-PhaseIII-0001 in patients COVID-19 associated moderate to severe acute…
- Conditions
- Covid19, ARDS, Hypoxia, Cytokine Storm
- Trial name
- NCT04657458
- Testing
- ExoFlo
- Sponsor
- Direct Biologics, LLC