Clinical trials: Surfactant Deficiency Syndrome Neonatal
Non-invasive Ventilatory Support, Infant Respiratory Distress Syndrome
Observational Study in Preterm Neonates Who Are Sufficiently Stable on Non-Invasive Ventilatory Support
The purpose of this observational study is to collect data on vital signs, oxygen requirements and other data related to ventilator care in preterm neonates under standard of care treatment.
- Trial name
- NCT01861795
- Testing
- Preterm Neonates
- Where
- 3 sites in Germany
- Volunteers
- 40 people
- Sponsor
- Takeda
Lung Cancer Diagnosis
Clinical Validation of Freenome Multiomics Blood Test for Lung Cancer Screening
The PROACT LUNG study is a prospective multi-center observational study to validate a blood-based test for the early detection of lung cancer by collecting blood samples from high-risk participants who will undergo a routine…
- Trial name
- PROACT-LUNG (NCT06122077)
- Testing
- blood draw
- Where
- 36 sites in United States
- Volunteers
- 20,000 people
- Sponsor
- Freenome Holdings Inc.
Lung Ultrasound, Respiratory Distress Syndrome, Newborn
Bedside Ultrasound to Monitor Lung Function and Blood Flow in Newborns Treated With Surfactant
The ULISSES study looks at how doctors use bedside ultrasound to help treat premature babies with breathing problems caused by Respiratory Distress Syndrome (RDS).
- Trial name
- ULISSES (NCT07070167)
- Testing
- Intratracheal administration of surfactant
- Where
- 2 sites in Poland
- Volunteers
- 200 people
- Sponsor
- Chiesi Poland Sp. z o.o.
Covid19
Efficacy and Safety of Trimodulin in Subjects With Severe COVID-19
The objectives of the trial are to evaluate the efficacy and safety of trimodulin as add-on therapy to standard of care (SoC) compared to placebo treatment in adult hospitalized subjects with severe COVID-19.
- Trial name
- ESsCOVID (NCT04576728)
- Testing
- Trimodulin
- Where
- 17 sites in Brazil, France and 2 more
- Volunteers
- 166 people
- Sponsor
- Biotest
COVID-19 Acute Respiratory Distress Syndrome
Safety and Efficacy of Inhaled XW001 For Hospitalized COVID-19 Patients Requiring Oxygen Therapy
This is a multiregional, randomized, double-blind, placebo-controlled Phase 2 study in patients with confirmed symptomatic COVID-19, designed to evaluate the safety, tolerability, efficacy, and PK of XW001 (IL-29 analog)…
- Trial name
- NCT05083117
- Testing
- XW001
- Where
- 2 sites in Argentina, Peru
- Sponsor
- Sciwind Biosciences APAC CO Pty. Ltd.
Acute Respiratory Distress Syndrome, Adult
Add-on Reparixin in Adult Patients With ARDS
Study objectives 1. To characterize the efficacy of reparixin in ameliorating lung injury and systemic inflammation and expediting clinical recovery and liberation from mechanical ventilation in adult patients with moderate to…
- Trial name
- NCT05496868
- Testing
- Reparixin 600mg
- Where
- 40 sites in United States, Germany and 1 more
- Volunteers
- 66 people
- Sponsor
- Dompé Farmaceutici S.p.A
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, Severe Respiratory Distress Syndrome
suPAR Michigan M2C2 Heterogeneity Validation Cohort Study
This is a retrospective, non interventional cohort study using stored plasma samples from appoximately 300 adults hospitalized with confirmed COVID 19.
- Conditions
- COVID-19, Severe Respiratory Distress Syndrome, Acute Respiratory Distress Syndrome
- Trial name
- NCT07466524
- Testing
- suPARnostic® TurbiLatex Assay on Roche cobas c501
- Where
- United States
- Volunteers
- 367 people
- Sponsor
- ViroGates A/S
RDS of Prematurity, Surfactant Protein B Deficiency
Administration of Surfactant Through an Instillation Device Infasurf® (Calfactant) in Neonates- A Pilot Study
A pilot study to explore and determine feasibility and safety of the administration of surfactant through a new supraglottic device in patients from 500 to 5000 grams with RDS.
- Conditions
- RDS of Prematurity, Surfactant Protein B Deficiency, Chronic Lung Disease
- Trial name
- NCT04056741
- Testing
- surfactant airway device
- Where
- 4 sites in United States
- Volunteers
- 55 people
- Sponsor
- ONY
Respiratory Failure, Respiratory Arrest
Postoperative Respiratory Abnormalities
The study aims to determine how historical cases of respiratory abnormalities are documented by clinicians in the electronic health records (EHR) of Memorial Hermann Healthcare System (MHHS) inpatient facilities.
- Conditions
- Respiratory Failure, Respiratory Arrest, Respiratory Distress Syndrome, Acute Respiratory Failure
- Trial name
- AI-ARF (NCT04079829)
- Testing
- Observational retrospective cohort to describe data validity; and Data reliability; and Completeness of the data
- Where
- United States
- Volunteers
- 50,000 people, healthy volunteers welcome
- Sponsor
- Efficacy Care R&D Ltd
Pulmonary Alveolar Proteinosis, COPD
Use of cSVF Via IV Deployment for Residual Lung Damage After Symptomatic COVID-19 Infection
COVID-19 Viral Global Pandemic resulting in post-infection pulmonary damage, including Fibrotic Lung Disease due to inflammatory and reactive protein secretions damaging pulmonary alveolar structure and functionality.
- Conditions
- Pulmonary Alveolar Proteinosis, COPD, Idiopathic Pulmonary Fibrosis, Viral Pneumonia
- Trial name
- GARM-COVID19 (NCT04326036)
- Testing
- Microcannula Harvest Adipose Derived tissue stromal vascular fraction (tSVF), Centricyte 1000, IV Deployment Of cSVF In Sterile Normal Saline IV Solution
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Black Tie Medical, Inc.
Acute Respiratory Distress Syndrome
Study to Find the Highest Safe Dose of Soluble Guanylate Cyclase (sGC) Activator, BAY 1211163 Administered as Multiple Doses by Inhalation to Patients Who Cannot Breathe by Their Own and Suffer From a Type of Lung Failure That Causes Fluid to Build up in the Lungs Making Breathing Difficult (ARDS)
With this study researchers want to find the highest safe dose of the soluble Guanylate Cyclase (sGC) Activator, BAY 1211163 and how safe and well the study drug works.
- Trial name
- NCT04609943
- Testing
- BAY1211163
- Where
- 4 sites in Germany
- Volunteers
- 16 people
- Sponsor
- Bayer
Respiratory Distress Syndrome, Adult
COVID-19 Treatment of Severe Acute Respiratory Syndrome With Veru-111
To demonstrate the efficacy of VERU-111 in the treatment of SARS-Cov-2 Infection by assessing its effect on the proportion of subjects that are alive without respiratory failure at Day 22.
- Trial name
- NCT04388826
- Testing
- Veru-111
- Where
- 5 sites in United States
- Volunteers
- 39 people
- Sponsor
- Veru Inc.
ARDS (Acute Respiratory Distress Syndrome)
Safety and Efficacy Study of GKL-006RTU in Moderate to Severe Acute Respiratory Distress Syndrome (ARDS)
This is a Phase I/II, multicenter study designed to evaluate the safety, tolerability, and preliminary efficacy of GKL-006RTU injection in participants with moderate to severe Acute Respiratory Distress Syndrome (ARDS).
- Trial name
- NCT07706855
- Testing
- GKL-006RTU injection
- Volunteers
- 52 people
- Sponsor
- Beijing Gene Key Life Technology Co., Ltd
ARDS Due to COVID-19
Surfactant-BL in Adult Acute Respiratory Distress Syndrome Due to COVID-19
The purpose of this study is to prove the efficacy and safety Surfactant-BL, administered by inhalation in adult hospitalized patients with ARDS due to COVID-19.
- Trial name
- NCT04568018
- Testing
- Surfactant
- Where
- Russia
- Volunteers
- 120 people
- Sponsor
- Biosurf LLC.
SARS-CoV Infection
VERU-111 in the Treatment of SARS-Cov-2 Infection by Assessing Its Effect on the Proportion of Patients Who Die on Study
To demonstrate the efficacy of VERU-111 in the treatment of SARS-Cov-2 Infection by assessing its effect on the proportion of patients who die on study (prior to Day 60).
- Trial name
- VERU-111 (NCT04842747)
- Testing
- VERU-111
- Where
- 58 sites in United States, Argentina and 4 more
- Volunteers
- 204 people
- Sponsor
- Veru Inc.
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.
Respiratory Distress Syndrome
Comparison of Aerosol Delivery of Infasurf to Usual Care in Spontaneously Breathing RDS Patients
Study to test the hypothesis that aerosolized Infasurf can decrease the need for intubation and instillation of liquid surfactant to the airway.
- Trial name
- NCT03058666
- Testing
- Aerosolized Calfactant, Solarys
- Where
- 22 sites in United States
- Volunteers
- 477 people
- Sponsor
- ONY
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
Acute Respiratory Distress Syndrome (ARDS)
Study of Safety and Efficacy of ALT-100mAb in Participants With Moderate/Severe ARDS
A Phase 2a, multi-center, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of ALT-100mAb in patients with moderate to severe ARDS.
- Trial name
- NCT05938036
- Testing
- ALT-100 mAb
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Aqualung Therapeutics Corp.