Clinical trials: Difficulty Breathing
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
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
SARS-CoV-2
Efficacy and Safety of Emapalumab and Anakinra in Reducing Hyperinflammation and Respiratory Distress in Patients With COVID-19 Infection.
Hyper-inflammation, caused by a cytokine storm resulting from an exaggerated response of the immune system in the presence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is considered to represent one of the…
- Trial name
- NCT04324021
- Testing
- Emapalumab, Anakinra
- Where
- 12 sites in United States, Italy
- Volunteers
- 16 people
- Sponsor
- Swedish Orphan Biovitrum
Mild to Moderate Acute Respiratory Distress Syndrome
Post-Market Study of Low-flow ECCO2R Using PrismaLung+
PrismaLung+ is intended to provide extracorporeal carbon dioxide removal (ECCO2R) as a standalone therapy or in combination with continuous renal replacement therapy (CRRT).
- Trial name
- NCT04617093
- Testing
- PrismaLung+
- Where
- 10 sites in France
- Volunteers
- 63 people
- Sponsor
- Vantive Health LLC
Atrial Fibrillation Paroxysmal, Atrial Fibrillation, Persistent
Assert-IQ Implantable Cardiac Monitor (ICM) Post Market Study
This is a prospective, non-randomized, multi-center, real-world post-market study to collect and evaluate data regarding the performance of the enhanced atrial fibrillation detection algorithm of the Assert-IQTM Implantable…
- Conditions
- Atrial Fibrillation Paroxysmal, Atrial Fibrillation, Persistent, Cardiac Arrhythmia, Ablation
- Trial name
- Assert-IQ (NCT06172699)
- Testing
- Holter monitoring in patients who have been successfully implanted with an Abbott Assert-IQ ICM device
- Where
- 11 sites in United States
- Volunteers
- 151 people
- Sponsor
- Abbott Medical Devices
Heart Failure
Study to Evaluate the Safety and Efficacy of IV Infusion Treatment With Omecamtiv Mecarbil in Subjects With Left Ventricular Systolic Dysfunction Hospitalized for Acute Heart Failure (ATOMIC-AHF)
The primary objective of the study is to evaluate the effect of 48 hours of intravenous (IV) omecamtiv mecarbil compared with placebo on dyspnea in subjects with left ventricular systolic dysfunction hospitalized for acute heart…
- Trial name
- NCT01300013
- Testing
- Omecamtiv mecarbil
- Where
- 150 sites in United States, Australia and 17 more
- Volunteers
- 614 people
- Sponsor
- Cytokinetics
Asthma
Study of JNJ-39758979 in Symptomatic Adult Patients With Uncontrolled Asthma
The purpose of this study is to evaluate the efficacy, safety and tolerability of JNJ-39758979 compared with placebo in patients with uncontrolled asthma despite current treatment with inhaled corticosteroids and/or long-acting…
- Trial name
- NCT01493882
- Testing
- JNJ-39758979 30 mg/d, JNJ-39758979 100 mg/d, JNJ-39758979 300 mg/d
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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
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.
COVID-19, ARDS, Human
MRG-001 as an Immunoregulatory and Regenerative Therapy for COVID-19 Patients
This study consists of two parts. Part A (Phase I): A Phase I Double-blind Randomized Placebo-controlled Study in Healthy Subjects to Assess the Safety, Pharmacokinetics, Pharmacodynamics of MRG-001 Part B (Phase 2): A Phase IIa…
- Conditions
- COVID-19, ARDS, Human, Stem Cells, Regeneration
- Trial name
- NCT04646603
- Testing
- MRG-001
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- MedRegen LLC
Severe Acute Respiratory Syndrome Coronavirus 2
Vagus Nerve Stimulation ARDS Prevention Trial for COVID-19 Hospitalized Patients
This trial is designed to determine if the inflammation modulating effect of vagus nerve stimulation can improve pulmonary function and limit progression to ARDS in hospitalized COVID-19 hospitalized patients.
- Trial name
- NCT04379037
- Testing
- Transcutaneous Auricular Vagus Nerve Stimulation
- Where
- Argentina
- Volunteers
- 50 people
- Sponsor
- Nemechek Technologies
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
Acute Respiratory Distress Syndrome, Ventilation Therapy; Complications
Phrenic Nerve Stimulation-Induced Lung ReAeration Trial
The Lungpacer PROTECT Diaphragm Pacing Therapy System (DPTS) is a temporary, percutaneously-placed, transvenous, phrenic nerve-stimulating device intended to stimulate the diaphragm to preserve and improve inspiratory muscle…
- Trial name
- PIRAT (NCT04844892)
- Testing
- Lungpacer PROTECT Diaphragm Pacing Therapy
- Where
- France
- Volunteers
- 13 people
- Sponsor
- Lungpacer Medical Inc.
COVID-19 Severe Pneumonia, Acute Lung Injury
Efficacy and Safety Study of IV Ravulizumab in Patients With COVID-19 Severe Pneumonia
This study evaluated the efficacy, safety, pharmacokinetics, and pharmacodynamics of ravulizumab administered in adult participants with coronavirus disease 2019 (COVID-19) severe pneumonia, acute lung injury, or acute…
- Conditions
- COVID-19 Severe Pneumonia, Acute Lung Injury, Acute Respiratory Distress Syndrome, Pneumonia, Viral
- Trial name
- NCT04369469
- Testing
- Ravulizumab, BSC
- Where
- 39 sites in United States, France and 3 more
- Volunteers
- 202 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Respiratory Distress Syndrome, Pre-term Infants
Safety and Efficacy of APC-0101 in Preterm Infants With Respiratory Distress Syndrome
This is a 2-part, prospective, randomized, blinded, sham-controlled, multi-center study comparing preterm subjects with RDS who are treated with APC-0101 and nCPAP/NIV to subjects treated with nCPAP/NIV alone (Sham).
- Trial name
- NCT06776783
- Testing
- APC-0101 (SF-RI 1 surfactant for inhalation combined with a dedicated delivery system), Control
- Where
- 31 sites in United States, Canada and 1 more
- Volunteers
- 520 people
- Sponsor
- Aerogen Pharma Limited
Acute Respiratory Distress Syndrome, Coronavirus
Pemziviptadil (PB1046), a Long-acting, Sustained Release Human VIP Analogue, Intended to Provide Clinical Improvement to Hospitalized COVID-19 Patients at High Risk for Rapid Clinical Deterioration and Acute Respiratory Distress Syndrome (ARDS).
This is a multicenter, randomized, double-blind, parallel group study to investigate the efficacy of pemziviptadil (PB1046) by improving the clinical outcomes in hospitalized COVID-19 patients at high risk for rapid clinical…
- Conditions
- Acute Respiratory Distress Syndrome, Coronavirus, Hypoxic Respiratory Failure, Hypoxemic Respiratory Failure
- Trial name
- VANGARD (NCT04433546)
- Testing
- Pemziviptadil (PB1046), Low Dose (10 mg) Control
- Where
- 4 sites in United States
- Volunteers
- 54 people
- Sponsor
- PhaseBio Pharmaceuticals Inc.
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.
Asthma (Diagnosis)
Longitudinal Phenotyping and Endotyping Study in Adult Patients With Mild, Moderate, or Severe Asthma
Background and study aims: The purpose of this research registry is to understand how asthma varies from person to person and monitor changes that may occur over time.
- Trial name
- MAPLE-UK (NCT07189806)
- Where
- United Kingdom
- Volunteers
- 250 people
- Sponsor
- Hvivo
Chronic Obstructive Pulmonary Disease (COPD)
Safety and Efficacy of Indacaterol Once Daily Versus Salmeterol Twice Daily in Chronic Obstructive Pulmonary Disease (COPD)
This study compared the safety and efficacy of indacaterol 150 µg taken once daily (o.d.) versus salmeterol 50 µg taken twice daily (b.i.d) in patients 40 years old or older with chronic obstructive pulmonary disease.
- Trial name
- INSIST (NCT00821093)
- Testing
- Indacaterol 150 µg, Salmeterol 50 µg
- Where
- 144 sites in United States, Czechia and 6 more
- Volunteers
- 1,123 people
- Sponsor
- Novartis Pharmaceuticals
Moderate to Severe Chronic Obstructive Pulmonary Disease
A Continuation Study of Tilrekimig in Adults With Moderate-to-Severe Long-Term Breathing Difficulty, Known by the Medical Term of Chronic Obstructive Pulmonary Disease (COPD) to Learn About This Medicine When Used for a Long Period of Time
A Continuation Study of Tilrekimig in Adults with Moderate-to-Severe Long-Term Breathing Difficulty, Known by the Medical Term of Chronic Obstructive Pulmonary Disease (COPD) to Learn About this Medicine when Used for a Long…
- Trial name
- NCT07839884
- Testing
- Tilrekimig
- Volunteers
- 1,360 people
- Sponsor
- Pfizer