Clinical trials: Infant Respiratory Distress Syndrome
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, ARDS, Human
Compassionate Use Open-Label Anti-CD14 Treatment in Patients With SARS-CoV-2 (COVID-19)
This protocol proposes to use IC14, a recombinant chimeric monoclonal antibody (mAb) recognizing human CD14, to block CD14-mediated cellular activation in patients early in the development of ARDS.
- Conditions
- COVID, ARDS, Human, Ards, SARS-CoV2
- Trial name
- NCT04346277
- Testing
- IC14, a monoclonal antibody against CD14
- Where
- Italy
- Sponsor
- Implicit Bioscience
Respiratory Infection, Pneumonia
Efficacy and Safety of Trimodulin (BT588) in Subjects With CAP Including COVID-19 Pneumonia
The main objectives of the trial are to assess the efficacy and safety of trimodulin as adjunctive treatment to standard of care (SoC) compared to placebo plus SoC in adult hospitalized subjects with non-severe community-acquired…
- Conditions
- Respiratory Infection, Pneumonia, Community-acquired Pneumonia, Acute Respiratory Distress Syndrome
- Trial name
- TRICOVID (NCT05531149)
- Testing
- Trimodulin
- Where
- 64 sites in Argentina, Austria and 12 more
- Volunteers
- 107 people
- Sponsor
- Biotest
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
ARDS (Acute Respiratory Distress Syndrome)
Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HT31-1 for Treating ARDS
This Phase 1/2A, randomized, double-blind study will evaluate the safety, tolerability, and pharmacokinetics (PK) of HT31-1 (hCitH3-mAb) in healthy adult volunteers and in patients with mild-to-moderate acute respiratory distress…
- Trial name
- NCT07449572
- Testing
- HT31-1, Saline (0.9%, sterile, for infusion)
- Where
- 2 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- HTIC, Inc
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 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
Lung Injury, Acute
The Safety, Tolerability, PK and PD of GSK2586881 in Patients With Acute Lung Injury
This is an early phase (phase IIa), randomized, multi-center study in subjects with acute lung injury (ALI) or acute respiratory distress syndrome (ARDS).
- Trial name
- NCT01597635
- Testing
- Dose 1 GSK2586881, Dose 2 GSK2586881, Dose 3 GSK2586881
- Where
- 19 sites in United States, Canada
- Volunteers
- 44 people
- Sponsor
- GlaxoSmithKline
Respiratory Distress Syndrome, Newborn
Infant Respiratory Interface and Accessories Evaluation Study
Determine the usability of an interface and its accessories to provide non-invasive respiratory therapy to neonates and infants.
- Trial name
- NCT05719298
- Testing
- Respiratory interface
- Where
- Australia
- Volunteers
- 150 people
- Sponsor
- Fisher and Paykel Healthcare
Respiratory Distress Syndrome
Feasibility Study of Aerosolized Surfaxin in the Prevention of Respiratory Distress Syndrome (RDS) in Premature Infants
To evaluate the feasibility, safety and tolerability of aerosolized lucinactant delivered by nasal continuous positive airway pressure (nCPAP) for the prevention of respiratory distress syndrome (RDS) in premature infants.
- Trial name
- NCT00807235
- Testing
- Aerosolized lucinactant
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Windtree Therapeutics
COVID-19, Coronavirus Disease 2019
Tigerase® Efficacy and Safety as Part of Complex Therapy in Patients With COVID-19
It is a multicenter, open-label, randomized, parallel-group study of the efficacy and safety of Tigerase® (GENERIUM JSC, Russia) with standard therapy versus standard therapy in patients with COVID-19.
- Trial name
- NCT04459325
- Testing
- Tigerase® and best available care, Best available care
- Where
- 6 sites in Russia
- Volunteers
- 100 people
- Sponsor
- AO GENERIUM
ARDS
MultiStem Administration for COVID-19 Induced ARDS (MACoVIA)
Multicenter investigation featuring an open-label lead-in followed by a double blinded, randomized, placebo-controlled Phase 2/3 part to evaluate the safety and efficacy of MultiStem therapy in subjects with moderate to severe…
- Trial name
- MACoVIA (NCT04367077)
- Testing
- MultiStem
- Where
- 4 sites in United States
- Volunteers
- 22 people
- Sponsor
- Healios K.K.
Covid19, Corona Virus Infection
Expanded Access to Zofin for Patients With COVID-19
This expanded access protocol will provide access to the investigational product Zofin for patients in outpatient facilities infected with SARS-CoV-2 who have mild to moderate COVID-19, or who are judged by a healthcare provider…
- Conditions
- Covid19, Corona Virus Infection, SARS (Severe Acute Respiratory Syndrome), Acute Respiratory Distress Syndrome
- Trial name
- NCT04657406
- Testing
- Zofin
- Sponsor
- ZEO ScientifiX, Inc.
Acute Respiratory Distress Syndrome
A Study to Test Whether Different Doses of Alteplase Help People With Severe Breathing Problems Because of COVID-19
This is a study in adults with severe breathing problems because of COVID-19. People who are in hospital on breathing support can participate in the study.
- Trial name
- TRISTARDS (NCT04640194)
- Testing
- Standard of care, Alteplase low dose, Alteplase high dose
- Where
- 37 sites in Austria, Belgium and 11 more
- Volunteers
- 104 people
- Sponsor
- Boehringer Ingelheim
Viral Lung Infection and Acute Respiratory Failure
Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen
The purpose of this study is to evaluate the effect of tozorakimab, as an add-on to SoC in patients with viral lung infection requiring supplemental oxygen, on the prevention of death or progression to IMV/ECMO.
- Trial name
- TILIA (NCT05624450)
- Testing
- Tozorakimab
- Where
- 473 sites in United States, Argentina and 37 more
- Volunteers
- 3,527 people
- Sponsor
- AstraZeneca
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.
COVID-19, ARDS
Use of hUC-MSC Product (BX-U001) for the Treatment of COVID-19 With ARDS
This is a phase 1/2a study including 2 parts, phase 1 and phase 2a. The phase 1 part is an open-label, single-arm, dose-escalating study to evaluate the safety and explore the dose limiting toxicity and maximum tolerated dose of…
- Conditions
- COVID-19, ARDS, Acute Respiratory Distress Syndrome
- Trial name
- NCT04452097
- Testing
- Human umbilical cord mesenchymal stem cells + best supportive care
- Sponsor
- Baylx Inc.
Acute Respiratory Distress Syndrome (ARDS), Post Intensive Care Syndrome (PICS)
An Observational Study to Identify New Health Problems Arising After an Intensive Care Unit Admission in People With Acute Respiratory Distress Syndrome in the United States
This is an observational study in which data already collected from people with acute respiratory distress syndrome (ARDS) admitted to an intensive care unit (ICU) are studied.
- Trial name
- SeeMe Tool (NCT06272942)
- Testing
- An ICU admission and a temporally related ARDS diagnosis
- Where
- United States
- Volunteers
- 640,058 people
- Sponsor
- Bayer
Covid19, Novel Coronavirus Pneumonia
The Use of Exosomes for the Treatment of Acute Respiratory Distress Syndrome or Novel Coronavirus Pneumonia Caused by COVID-19
Novel coronavirus pneumonia (NCP) and acute respiratory distress syndrome (ARDS) are both associated with the prevailing upper respiratory tract infections caused by the RNA-containing SARS-CoV2 virus of the genius…
- Conditions
- Covid19, Novel Coronavirus Pneumonia, Acute Respiratory Distress Syndrome
- Trial name
- ARDOXSO (NCT04798716)
- Testing
- MSC-exosomes delivered intravenously every other day on an escalating dose: (2:4:8), MSC-exosomes delivered intravenously every other day on an escalating dose (8:4:8), MSC-exosomes delivered intravenously every other day (8:8:8)
- Where
- United States
- Volunteers
- 55 people
- Sponsor
- AVEM HealthCare
Respiratory Distress Syndrome, Adult
Efficacy and Safety Study of HLCM051(MultiStem®) for Pneumonic Acute Respiratory Distress Syndrome
The primary object of this clinical study is to investigate the efficacy of HLCM051 in patients with ARDS caused by pneumonitis.
- Trial name
- ONE-BRIDGE (NCT03807804)
- Testing
- HLCM051
- Where
- 29 sites in Japan
- Volunteers
- 35 people
- Sponsor
- Healios K.K.