Clinical trials: Acute Inflammatory Response
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
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.
Acute Renal Failure
Open-Label Study To Evaluate the Safety and Efficacy of the Renal Assist Device In Patients With Acute Renal Failure
Although conventional hemodialysis removes waste products and corrects fluid imbalance, it does not replace critical absorptive, metabolic, endocrine, and immunologic functions performed by healthy renal tubule cells.
- Trial name
- NCT00511407
- Testing
- Renal tubule assist device
- Where
- 13 sites in United States
- Volunteers
- 58 people
- Sponsor
- RenaMed Biologics
Sepsis, Acute Kidney Injury
A Study Looking at the Use of Biomarkers to Provide Early Indication of Acute Kidney Injury in Patients With Sepsis (Limiting AKI Progression In Sepsis)
Biomarkers that provide an early indicator of kidney stress could be useful in clinical practice to detect silent episodes of acute kidney injury (AKI) or for early identification of subjects at risk of AKI.
- Conditions
- Sepsis, Acute Kidney Injury, Septic Shock
- Trial name
- LAPIS (NCT04434209)
- Testing
- Subject management guided by NephroCheck® test, Standard of Care
- Where
- 12 sites in United States, Belgium and 2 more
- Volunteers
- 19 people
- Sponsor
- BioMérieux
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
Acute Respiratory Distress Syndrome, Acute Lung Injury
Efficacy Study of CytoSorb Hemoperfusion Device on IL-6 Removal in ARDS/ALI Patients With Sepsis
The hypothesis of this study is use of CytoSorb hemoperfusion device as an adjunctive therapy to the standard of care in treating ARDS/ALI patients in the setting of sepsis will result in improved clearance of cytokines when…
- Conditions
- Acute Respiratory Distress Syndrome, Acute Lung Injury, Sepsis
- Trial name
- NCT00559130
- Testing
- CytoSorb Hemoperfusion
- Where
- 6 sites in Germany
- Volunteers
- 100 people
- Sponsor
- MedaSorb Technologies, Inc
Cardiac Arrest, Renal Failure
The Vital Signs to Identify, Target, and Assess Level (VITAL) Care Study III
To evaluate the effect of automated recording on frequency of recorded scores, number of automated notifications and serious events.
- Conditions
- Cardiac Arrest, Renal Failure, Respiration Failure, Myocardial Infarction
- Trial name
- NCT02973243
- Testing
- Automatic RR Measurement
- Where
- United Kingdom
- Volunteers
- 446 people
- Sponsor
- Philips Healthcare
Acute Lung Injury, Systemic Inflammatory Response Syndrome
Study of Sivelestat Sodium Hydrate in Acute Lung Injury (ALI) Associated With Systemic Inflammatory Response Syndrome (SIRS) in Japan
The purpose of this study is to confirm the efficacy and safety of sivelestat in patients with acute lung injury associated with systemic inflammatory response syndrome.
- Trial name
- NCT00219375
- Testing
- Sivelestat sodium hydrate
- Where
- 9 sites in Japan
- Volunteers
- 649 people
- Sponsor
- Ono Pharmaceutical Co., Ltd.
COVID-19, Acute Kidney Injury
A Study of Cell Therapy in COVID-19 Subjects With Acute Kidney Injury Who Are Receiving Renal Replacement Therapy
The purpose of this study is to assess the safety and tolerability of the investigational product, SBI-101, in subjects with an infectious etiology of Acute Kidney Injury (AKI).
- Conditions
- COVID-19, Acute Kidney Injury, Sepsis
- Trial name
- NCT04445220
- Testing
- SBI-101
- Where
- 2 sites in United States
- Volunteers
- 22 people
- Sponsor
- Sentien Biotechnologies, Inc.
Infections, Sepsis
A Blood Test to Diagnose Sepsis in Symptomatic Adults and Children
A case-control cohort study to develop and validate the performance of a whole blood gene expression test to distinguish sepsis infection from uninfected systemic inflammatory response syndrome cases in symptomatic adults and…
- Conditions
- Infections, Sepsis, SIRS
- Trial name
- NCT05142813
- Testing
- Diagnostic Test: Blood specimen collection
- Volunteers
- 1,100 people
- Sponsor
- mProbe Inc.
Acute Pancreatitis, Systemic Inflammatory Response Syndrome
CM4620 Injectable Emulsion Versus Supportive Care in Patients With Acute Pancreatitis and SIRS
This open-label, dose-response study will evaluate the safety and efficacy of CM4620-IE in patients with acute pancreatitis and accompanying SIRS. The study will consist of two phases.
- Trial name
- NCT03401190
- Testing
- CM4620 Injectable Emulsion (Low Dose), CM4620 Injectable Emulsion (High Dose)
- Where
- 9 sites in United States
- Volunteers
- 21 people
- Sponsor
- CalciMedica, Inc.
Respiratory Distress Syndrome, Adult
Evaluation of Safety & Efficacy of BIO-11006 Inhalation Solution in Patients With ARDS
This Phase IIa pilot study is a placebo controlled, multicenter study to evaluate safety and efficacy of aerosolized BIO-11006 Inhalation Solution in ARDS patients.
- Trial name
- NCT03202394
- Testing
- BIO-11006
- Where
- 5 sites in United States
- Volunteers
- 38 people
- Sponsor
- BioMarck Pharmaceuticals, Ltd.
Acute Kidney Injury Due to Sepsis
Pharmacokinetics and Safety of TIN816 in Patients With Sepsis-associated Acute Kidney Injury
The purpose of this study was to characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profile and to evaluate the safety and tolerability of TIN816 in hospitalized adult participants in an intensive care setting with a…
- Trial name
- NCT05507437
- Testing
- TIN816 70 mg lyophilisate powder
- Where
- 7 sites in Belgium, France and 3 more
- Volunteers
- 20 people
- Sponsor
- Novartis Pharmaceuticals
Severe Sepsis
Recovery From Acute Immune Failure in Septic Shock by Immune Cell Extracorporeal Therapy - Observational Long-term Outcome Follow up
Subjects previously enrolled / randomized in the ReActIF-ICE (Recovery from acute immune failure in septic shock by immune cell extracorporeal terapy - immune competence enhancement) study received either standard sepsis…
- Trial name
- ReActIF- LTO (NCT06143137)
- Where
- 2 sites in Germany
- Volunteers
- 142 people
- Sponsor
- Artcline GmbH
Cure Rate
A Study to Assess Efficacy, Safety of KAE609 in Adult Patients With Acute Malaria Mono-infection
This study will assess efficacy, safety , tolerability and PK in uncomplicated adult malaria patients with acute P. falciparum infection after single dose with KAE609 at 75 mg, 150mg, 225mg and 300mg/day
- Trial name
- NCT01860989
- Testing
- KAE609
- Where
- 4 sites in Thailand, Vietnam
- Volunteers
- 11 people
- Sponsor
- Novartis Pharmaceuticals
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
Acute Myocardial Infarction, Heart Failure
Inflammation-mediated Coronary Plaque Vulnerability, Myocardial Viability and Ventricular Remodeling
VIABILITY study aims to investigate the link between systemic inflammation, pancoronary plaque vulnerability (referring to the plaque vulnerability within the entire coronary tree), myocardial viability and ventricular remodeling…
- Trial name
- VIABILITY (NCT03830944)
- Testing
- Blood sampling, transthoracic echocardiography, Late Gadolinium-Enhancement Cardiac Magnetic Resonance
- Where
- Romania
- Volunteers
- 150 people
- Sponsor
- Cardio Med Medical Center
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.
Acute Wound
Cleanser for Acute Wounds
The proposed study will be a prospective trial of management of acute traumatic wounds (less than 24 hours from injury and without previous intervention aside from a dressing for coverage).
- Trial name
- NCT05422144
- Testing
- Antimicrobial Skin & Wound Cleanser (AWC), Antimicrobial Wound Gel (AWG)
- Where
- United States
- Sponsor
- Rochal Industries LLC
Bloodstream Infections (BSI) Due to CRE, Hospital-Acquired Bacterial Pneumonia (HABP) Due to CRE
A Study of Plazomicin Compared With Colistin in Patients With Infection Due to Carbapenem-Resistant Enterobacteriaceae (CRE)
This was a Phase 3 study containing a randomized open-label superiority cohort (Cohort 1) comparing the efficacy and safety of plazomicin with colistin when combined with a second antibiotic (either meropenem or tigecycline) in…
- Conditions
- Bloodstream Infections (BSI) Due to CRE, Hospital-Acquired Bacterial Pneumonia (HABP) Due to CRE, Ventilator-Associated Bacterial Pneumonia (VABP) Due to CRE, Complicated Urinary Tract Infection (cUTI) Due to CRE
- Trial name
- CARE (NCT01970371)
- Testing
- plazomicin, colistin, meropenem
- Volunteers
- 69 people
- Sponsor
- Achaogen, Inc.