Clinical trials: Neonatal Respiratory Distress Syndrome
Respiratory Distress Syndrome in Premature Infant
A Dose-Ranging Study to Determine the Efficacy, Safety and Tolerability of AeroFact
The purpose of this two-part Phase 2 study is to assess the safety, tolerability and efficacy of aerosolized SF-RI 1 (AeroFact) when delivered via nCPAP at two different doses.
- Trial name
- NCT03969992
- Testing
- AeroFact, nCPAP
- Where
- 41 sites in United States, Canada
- Volunteers
- 261 people
- Sponsor
- Aerogen Pharma Limited
Acute Respiratory Distress Syndrome, Noninvasive Ventilation
Helmet vs Face Mask in Patients With Acute Respiratory Distress Syndrome
The objective of this study is to evaluate the efficacy of noninvasive ventilation with helmet in reducing endotracheal intubation rates in comparison with Noninvasive Ventilation (NIV) facemask among patients with Acute…
- Conditions
- Acute Respiratory Distress Syndrome, Noninvasive Ventilation, Corona Virus Disease, Acute Respiratory Failure
- Trial name
- NCT04507802
- Testing
- Non invasive ventilation via helmet
- Where
- Qatar
- Volunteers
- 60 people
- Sponsor
- Hamad Medical Corporation
ARDS, ARDS, Human
Efficacy and Safety Evaluation of BZ371B in ARDS Patients
The purpose of this study is to evaluate safety, tolerability and efficacy of BZ371B in intubated patients with severe Acute Respiratory Distress Syndrome.
- Conditions
- ARDS, ARDS, Human, Pulmonary Disease
- Trial name
- NCT05384379
- Testing
- Inhaled BZ371B
- Where
- Brazil
- Volunteers
- 1 people
- Sponsor
- Biozeus Biopharmaceutical S.A.
Acute Respiratory Distress Syndrome
The Safety and Dose Response Relationship of Ulinastatin for Acute Respiratory Distress Syndrome(ARDS)
Compared with placebo, evaluate the effects and safety of Ulinastatin(UTI) added to conventional treatment for ARDS; Evaluate the dose response relationship of Ulinastatin for ARDS.
- Trial name
- NCT02895191
- Testing
- ulinastatin
- Where
- 11 sites in China
- Volunteers
- 60 people
- Sponsor
- Techpool Bio-Pharma Co., Ltd.
Respiratory Distress Syndrome, Adult, Acute Lung Injury
A Phase II Study to Determine the Efficacy and Safety of Sivelestat in Subjects With Acute Lung Injury
The purpose of this study is to determine whether sivelestat will reduce the amount of time a patient must spend on a ventilator and/or increase the chance of survival of patients with acute lung injury.
- Trial name
- NCT00036062
- Testing
- Sivelestat
- Where
- 110 sites in United States, Australia and 4 more
- Volunteers
- 600 people
- Sponsor
- Eli Lilly and Company
ARDS, Human, Covid-19
Use of Mesenchymal Stem Cells in Acute Respiratory Distress Syndrome Caused by COVID-19
This is a pilot phase, open label, non-randomized study for the treatment of ARDS in patients infected with COVID-19. Subjects will be enrolled and treated with one dose of mesenchymal stem cells and follow-up will occur 90 days…
- Trial name
- NCT04456361
- Testing
- Mesenchymal Stem Cells derived from Wharton Jelly of Umbilical cords
- Where
- Mexico
- Volunteers
- 9 people
- Sponsor
- Instituto de Medicina Regenerativa
COVID-19, ARDS
Extracellular Vesicle Infusion Treatment for COVID-19 Associated ARDS
To evaluate the safety and efficacy of intravenous administration of bone marrow derived extracellular vesicles, ExoFlo, versus placebo as treatment for moderate-to-severe Acute Respiratory Distress Syndrome (ARDS) in patients…
- Trial name
- EXIT-COVID19 (NCT04493242)
- Testing
- ExoFlo, Intravenous normal saline
- Where
- 6 sites in United States
- Volunteers
- 102 people
- Sponsor
- Direct Biologics, LLC
Respiratory Distress Syndrome, Bronchopulmonary Dysplasia
The Effect of Surfactant Dose on Outcomes in Preterm Infants With RDS
A prospective observational study using de-identified data from the Neonatal Network Research Database (NNRD) supplemented by additional information on dose, method of surfactant administration and dosing frequency to assess…
- Trial name
- OPTI-SURF (NCT03808402)
- Where
- 29 sites in United Kingdom
- Volunteers
- 2,973 people
- Sponsor
- Chiesi UK
Respiratory Distress Syndrome (Neonatal), Intubation Complication
InfasurfAero™ Versus Sham Treatment in Preterm Newborns With RDS
The purpose of this clinical study is to determine the effectiveness and safety of Infasurf® administered through the InfasurfAero™, a novel oral airway delivery device specifically designed to give Infasurf in a less complicated…
- Conditions
- Respiratory Distress Syndrome (Neonatal), Intubation Complication, Death; Neonatal
- Trial name
- Aero-05 (NCT05960929)
- Testing
- Infasurf Aero™
- Where
- 10 sites in United States
- Volunteers
- 220 people
- Sponsor
- ONY
COVID-19 Acute Respiratory Distress Syndrome, COVID-19
Plerixafor in Acute Respiratory Distress Syndrome Related to COVID-19 (Phase IIb)
This phase IIb study, LEONARDO is a multicenter, randomized, double-blind, placebo- controlled, parallel group study, to assess the therapeutic efficacy and safety of Plerixafor in patients over 18 years of age, with acute…
- Trial name
- LEONARDO (NCT05411575)
- Testing
- Plerixafor 20 MG/ML [Mozobil]
- Where
- 14 sites in Bulgaria, France
- Sponsor
- 4Living Biotech
Respiratory Distress Syndrome, Newborn
A Safety and Efficacy Study of Lucinactant for Inhalation in Preterm Neonates 26 to 32 Weeks Gestational Age
This study is to evaluate the safety and efficacy of lucinactant for inhalation in conjunction with nCPAP, in comparison to nCPAP alone, in preterm neonates with RDS, as assessed by the incidence of and time to respiratory…
- Trial name
- NCT04264156
- Testing
- Lucinactant for Inhalation, nCPAP Only
- Where
- 3 sites in Poland
- Volunteers
- 12 people
- Sponsor
- Windtree Therapeutics
Acute Respiratory Distress Syndrome, ARDS
Extracellular Vesicle Treatment for Acute Respiratory Distress Syndrome (ARDS) (EXTINGUISH ARDS)
To evaluate the safety and efficacy of intravenous (IV) administration of bone marrow mesenchymal stem cell derived extracellular vesicles (EVs), ExoFlo, versus placebo for the treatment of hospitalized patients with…
- Trial name
- NCT05354141
- Testing
- ExoFlo, Intravenous normal saline
- Where
- 32 sites in United States
- Volunteers
- 970 people
- Sponsor
- Direct Biologics, LLC
COVID-19, Pneumonia, Viral
SOLIRIS® (Eculizumab) Treatment of Participants With COVID-19
This protocol provides access to eculizumab treatment for participants with severe COVID-19.
- Conditions
- COVID-19, Pneumonia, Viral, Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)
- Trial name
- NCT04355494
- Testing
- eculizumab
- Where
- 12 sites in United States, France
- Sponsor
- Alexion Pharmaceuticals, Inc.
Acute Respiratory Distress Syndrome
Clinical Study to Assess the Safety and Preliminary Efficacy of HCR040 in Acute Respiratory Distress Syndrome
The main objective of the study is to assess the feasibility, safety, and tolerability of the administration of HCR040, a drug whose active substance is HC016, allogeneic adipose-derived adult mesenchymal stem cells expanded and…
- Trial name
- NCT04289194
- Testing
- HCR040 (Phase 1), HCR040 (Phase 2)
- Where
- 2 sites in Spain
- Volunteers
- 26 people
- Sponsor
- Histocell, S.L.
Acute Respiratory Distress Syndrome
A Phase 2 Study of IC14 in Acute Respiratory Distress Syndrome
Acute Respiratory Distress Syndrome (ARDS) patients will be randomized to receive either IC14 (a single dose of 4 mg/kg followed by 2 mg/kg on Days 2-4) or placebo. Study participation will be for a total of 28 days.
- Trial name
- NCT03017547
- Testing
- IC14
- Sponsor
- Implicit Bioscience
Acute Respiratory Distress Syndrome
Poractant Alfa (Curosurf®)) -- Effect in Adult Patients Diagnosed With 2019 Novel Coronavirus (SARS-COV-19; (Covid-19)) Acute Respiratory Distress Syndrome (ARDS)
The purpose of this study was to evaluate the efficacy and safety of poractant alfa (Curosurf®), administered by endotracheal (ET) instillation in hospitalized adult patients diagnosed with SARS-COV-19 acute respiratory distress…
- Trial name
- NCT04502433
- Testing
- CUROSURF® (poractant alfa)
- Where
- 6 sites in United States, Italy and 1 more
- Volunteers
- 22 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
COVID-19 Pneumonia, COVID-19 Respiratory Infection
A Proof-of-Concept Study Evaluating EOM613 in COVID-19 Infected Patients With Severe Symptoms
The purpose of this study is to evaluate the safety, tolerability and preliminary efficacy of EOM613, a peptide nucleic acid with novel immune-modulating properties, in treating patients with severe COVID-19 infections.
- Conditions
- COVID-19 Pneumonia, COVID-19 Respiratory Infection, COVID-19 Acute Respiratory Distress Syndrome
- Trial name
- NCT05212532
- Testing
- EOM613
- Where
- 4 sites in Brazil
- Volunteers
- 40 people
- Sponsor
- EOM Pharmaceuticals
2019 Novel Coronavirus Infection, COVID-19 Virus Infection
Safety and Efficacy of USB002 for Respiratory Distress Due to COVID-19
This trial will study the use of USB002 given as an intravenous infusion in patients with respiratory distress due to infection with COVID-19.
- Conditions
- 2019 Novel Coronavirus Infection, COVID-19 Virus Infection, SARS Coronavirus 2 Infection, SARS-CoV-2 Infection
- Trial name
- NCT04778059
- Testing
- USB002
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- US Biotest, Inc.
Acute Respiratory Distress Syndrome, Ards
Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells for Non-COVID-19 Acute Respiratory Distress Syndrome
This is a Phase 2 randomized study to assess the safety and efficacy of COVI-MSC in the setting of current standard of care treatments for subjects hospitalized subjects with acute respiratory distress syndrome not related to…
- Trial name
- NCT04909879
- Testing
- COVI-MSC
- Sponsor
- Sorrento Therapeutics, Inc.
Acute Respiratory Distress Syndrome, Infections
Rhu-pGSN for Acute Respiratory Distress Syndrome (ARDS)
BTI-203 is a randomized, double-blind, placebo-controlled, multicenter, Phase 2 proof-of-concept (POC) study to evaluate the efficacy and safety of rhu-pGSN plus standard of care (SOC) in subjects with moderate-to-severe ARDS…
- Trial name
- NCT05947955
- Testing
- Rhu-pGSN, normal saline
- Where
- 65 sites in United States, Belgium and 11 more
- Volunteers
- 600 people
- Sponsor
- BioAegis Therapeutics Inc.