Clinical trials: Respiratory Distress Syndrome, Newborn
- Condition Respiratory Distress Syndrome, Newborn
- Funder type Industry (pharma, biotech, devices)
- Has posted results yes
SARS-CoV-2 (COVID-19) Severe Pneumonia
Study to Evaluate the Safety and Efficacy of ATYR1923 (Efzofitimod) In Participants With Severe Pneumonia Related to COVID-19
To evaluate the safety and preliminary efficacy of efzofitimod, compared to placebo matched to efzofitimod, in hospitalized participants with SARS-CoV-2 (COVID-19) severe pneumonia not requiring mechanical ventilation.
- Trial name
- NCT04412668
- Testing
- Efzofitimod 1 mg/kg, Efzofitimod 3 mg/kg
- Where
- 10 sites in United States, Puerto Rico
- Volunteers
- 36 people
- Sponsor
- aTyr Pharma, Inc.
Lung Injury, Acute and Respiratory Distress Syndrome, Adult
Study of GSK2862277 in Subjects Undergoing Oesophagectomy Surgery
Lung injury in patients undergoing oesophagectomy may occur during surgery (peri-operatively) as a result of One Lung Ventilation (OLV) and/or during the immediate post-operative period when patients receive intensive care.
- Trial name
- NCT02221037
- Testing
- GSK2862277
- Where
- 6 sites in United Kingdom
- Volunteers
- 35 people
- Sponsor
- GlaxoSmithKline
COVID-19, Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)
The Safety and Preliminary Tolerability of Lyophilized Lucinactant in Adults With Coronavirus Disease 2019 (COVID-19)
This is a multicenter, single-treatment study. Subjects will consist of adults with COVID-19 associated acute lung injury who are being cared for in a critical care environment.
- Trial name
- NCT04389671
- Testing
- Lucinactant
- Where
- 11 sites in United States, Argentina
- Volunteers
- 20 people
- Sponsor
- Windtree Therapeutics
COVID, Covid-19
A Study of APL-9 in Adults With Mild to Moderate ARDS Due to COVID-19
The purpose of this study is to evaluate the safety and effectiveness of APL-9 in adults with mild to moderate ARDS (acute respiratory distress syndrome) caused by COVID-19 who are hospitalized and require supplemental oxygen…
- Conditions
- COVID, Covid-19, Coronavirus, Coronavirus Infection
- Trial name
- NCT04402060
- Testing
- APL-9, Vehicle Control
- Where
- 24 sites in United States, Brazil
- Volunteers
- 72 people
- Sponsor
- Apellis Pharmaceuticals, Inc.
Respiratory Distress Syndrome, Newborn, Premature Birth
SURFAXIN® Treatment for Prevention of Bronchopulmonary Dysplasia (BPD) in Very Low Birth Weight (VLBW) Infants.
SURFAXIN® (lucinactant) treatment will be examined in very low birth weight infants to prevent development of chronic lung disease, commonly known as bronchopulmonary dysplasia (BPD), in premature infants who have required…
- Conditions
- Respiratory Distress Syndrome, Newborn, Premature Birth, Bronchopulmonary Dysplasia
- Trial name
- NCT00215540
- Testing
- Lucinactant 175 mg/kg, Lucinactant 90 mg/kg
- Where
- United States
- Volunteers
- 136 people
- Sponsor
- Windtree Therapeutics
Respiratory Distress Syndrome
Trial to Assess the Safety and Tolerability of Lucinactant for Inhalation in Premature Neonates
The primary objective of this study is to evaluate the safety and tolerability of aerosolized surfactant, specifically lucinactant for inhalation, administered in escalating inhaled doses to preterm neonates 29 to 34 weeks…
- Trial name
- NCT02074059
- Testing
- Lucinactant for Inhalation, nCPAP alone
- Where
- 11 sites in United States
- Volunteers
- 80 people
- Sponsor
- Windtree Therapeutics
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
Respiratory Distress Syndrome, Newborn
Comparison of CPAP Machines With Reusable vs Disposable Circuits
The study aims to assess the basic functionality of a newly designed CPAP machine with reusable circuits to existing machines with disposable circuits, for treatment of newborn infants diagnosed with respiratory distress…
- Trial name
- NCT03121612
- Testing
- CPAP
- Where
- India
- Volunteers
- 51 people
- Sponsor
- Medical Technology Transfer and Services Hong Kong Ltd
Acute Respiratory Distress Syndrome, COVID-19
A Study of Brexanolone for Acute Respiratory Distress Syndrome (ARDS) Due to Coronavirus Disease 2019 (COVID-19)
The purpose of this study was to evaluate the efficacy and safety of brexanolone in participants on ventilator support for acute respiratory distress syndrome (ARDS) due to COVID-19.
- Trial name
- NCT04537806
- Testing
- Brexanolone
- Where
- 9 sites in United States
- Volunteers
- 29 people
- Sponsor
- Sage Therapeutics
Respiratory Distress Syndrome, Adult
Efficacy and Safety of FP-1201-lyo (Interferon Beta-1a) in Patients Having Acute Respiratory Distress Syndrome (ARDS)
In this study effectiveness and safety of a new drug FP-1201-lyo (recombinant human interferon beta-1a) is compared to placebo. Investigation is conducted with patients who have acute respiratory distress syndrome (ARDS).
- Trial name
- INTEREST (NCT02622724)
- Testing
- Interferon beta-1a
- Where
- 71 sites in Belgium, Czechia and 6 more
- Volunteers
- 301 people
- Sponsor
- Faron Pharmaceuticals Ltd
Acute Respiratory Distress Syndrome, SARS-CoV-2
Evaluation of the Safety, Tolerability, and Pharmacokinetics of PLN-74809 in Participants With Acute Respiratory Distress Syndrome (ARDS) Associated With at Least Severe COVID-19
Evaluation of the safety, tolerability, and pharmacokinetics of PLN-74809 in participants with acute respiratory distress syndrome (ARDS) associated with at least severe COVID-19
- Trial name
- NCT04565249
- Testing
- PLN-74809
- Where
- 6 sites in United States
- Volunteers
- 6 people
- Sponsor
- Pliant Therapeutics, Inc.
COVID-19, Acute Respiratory Distress Syndrome (ARDS)
Evaluation of the Safety and Efficacy of Razuprotafib in Hospitalized Subjects With Coronavirus Disease 2019
This was a Phase 2, randomized, double-blind, placebo-controlled, parallel-group, multicenter, dose escalation and proof-of-concept study to evaluate the safety and efficacy of razuprotafib, administered 3 times daily (TID)…
- Trial name
- RESCUE (NCT04511650)
- Testing
- Razuprotafib Subcutaneous Solution
- Where
- 7 sites in United States
- Volunteers
- 31 people
- Sponsor
- EyePoint Pharmaceuticals, 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
COVID-19
Evaluation of the Efficacy and Safety of Sarilumab in Hospitalized Patients With COVID-19
Phase 2: The primary objective of the study is to evaluate the clinical efficacy of sarilumab relative to the control arm in adult patients hospitalized with COVID-19 regardless of disease severity strata.
- Trial name
- NCT04315298
- Testing
- Sarilumab
- Where
- 62 sites in United States
- Volunteers
- 1,912 people
- Sponsor
- Regeneron Pharmaceuticals
Severe to Critical COVID 19 With Associated ARDS
A Phase 2/3 Study to Evaluate FP-025 in Patients With Severe to Critical COVID 19
This is a Phase 2/3, randomized, double blind, placebo controlled, multicenter study to evaluate the efficacy and safety of FP-025 in adult patients with severe to critical COVID 19 with associated ARDS.
- Trial name
- NCT04750278
- Testing
- FP-025 100 mg, FP-025 300 mg
- Where
- 8 sites in United States
- Volunteers
- 90 people
- Sponsor
- Foresee Pharmaceuticals Co., Ltd.
Acute Respiratory Failure, Coma
EASiVENT Study Comparing INTELLiVENT-ASV vs Non Automated Ventilation in Adult ICU Patients
The purpose of the study is to assess the safety and efficacy of INTELLiVENT-ASV (Adaptive Support Ventilation) in adult ICU patients comparing to non automated ventilation.
- Conditions
- Acute Respiratory Failure, Coma, Acute Respiratory Distress Syndrome (ARDS), Chronic Obstructive Pulmonary Disease (COPD)
- Trial name
- NCT04400643
- Testing
- INTELLiVENT-ASV, Non-automated ventilation
- Where
- Portugal
- Volunteers
- 62 people
- Sponsor
- Hamilton Medical AG
Acute Respiratory Distress Syndrome
KL₄Surfactant Treatment in Patients With ARDS
Lung wash with KL₄Surfactant of individual lung segments using a bronchoscope compared to usual care alone consisting primarily of assisted (mechanical) ventilation in patients with acute respiratory distress syndrome(ARDS).
- Trial name
- NCT00215553
- Testing
- A.1 Lucinactant, B.3 SoC, A.2 Lucinactant
- Where
- United States
- Volunteers
- 124 people
- Sponsor
- Windtree Therapeutics
Respiratory Distress Syndrome
Trial To Assess The Safety And Tolerability Of Lucinactant For Inhalation In Preterm Neonates 26 to 28 Weeks PMA
This study is to evaluate the safety and tolerability of lucinactant for inhalation, administered as an aerosol in up to four escalating doses to preterm neonates 26 to 28 weeks gestational age who are receiving nCPAP for RDS…
- Trial name
- NCT02528318
- Testing
- Lucinactant for inhalation, nCPAP alone
- Where
- 20 sites in United States, Canada and 2 more
- Volunteers
- 48 people
- Sponsor
- Windtree Therapeutics
Respiratory Distress Syndrome
The Safety and Efficacy of Lucinactant for Inhalation in Premature Neonates 26 to 32 Weeks Gestational Age
The primary objective of this study is to evaluate the safety and efficacy of lucinactant for inhalation administered as an aerosolized dose in two doses to preterm neonates 26 - 32 weeks gestational age who are receiving nasal…
- Trial name
- NCT02636868
- Testing
- Lucinactant delivered via investigational delivery device, nCPAP
- Where
- 54 sites in United States, Canada and 6 more
- Volunteers
- 221 people
- Sponsor
- Windtree Therapeutics
Respiratory Distress Syndrome (RDS)
A Study in Preterm Neonates With Respiratory Distress Syndrome (RDS) Comparing CUROSURF® Administration Through Less Invasive Surfactant Administration (LISA) and Conventional Administration
This study compared the administration of porcine surfactant (poractant alfa, Curosurf®) through a less invasive method (LISA), using a thin catheter, CHF 6440 (LISACATH®), during non-invasive ventilation (CPAP, NIPPV, BiPAP)…
- Trial name
- LISPAP (NCT02772081)
- Testing
- LISA combination product (Curosurf+catheter CHF6440), Curosurf through conventional administration (endotracheal tube)
- Where
- 26 sites in United States
- Volunteers
- 33 people
- Sponsor
- Chiesi Farmaceutici S.p.A.