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Respiratory Insufficiency clinical trials

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NCT ID: NCT04346693 Completed - Pneumonia Clinical Trials

An Open Randomized Study of Dalargin Efectiveness in Combination With Leitragin Drug in Patients With Severe and Critical Manifestations of SARS-COVID-19

Start date: April 8, 2020
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate an effectiveness of the drug Dalargin in combination with Leitragin for the prevention and treatment of severe pulmonary complications symptoms associated with severe and critical coronavirus infection cases (SARS COVID19, expanded as Severe acute respiratory syndrome Cоrona Virus Disease 2019 ). Test drugs that will be administered to patients are: - Leitragin, solution for inhalation administration, - Dalargin, solution for intravenous and intramuscular administration.

NCT ID: NCT04346342 Completed - COVID Clinical Trials

PRactice of VENTilation in COVID-19 Patients (PRoVENT-COVID)

PRoVENT-COVID
Start date: March 6, 2020
Phase:
Study type: Observational

The purpose of this national, multicenter service review is to determine and compare ventilation management in COVID-19 patients in the Netherlands, and to determine whether certain ventilation settings have an independent association with duration of ventilation. In every adult invasively ventilated COVID-19 patient from a participating ICU, granular ventilator settings and parameters will be collected from start of invasive ventilation for up to 72 hours. Follow up is until ICU and hospital discharge, and until day 90. The primary outcome includes main ventilator settings (including tidal volume, airway pressures, oxygen fraction and respiratory rate). Secondary endpoints are ventilator-free days and alive at day 28 (VFD-28); duration of mechanical ventilation; use of prone positioning and recruitment maneuvers; duration of ICU and hospital stay; incidence of kidney injury; and ICU, hospital, 28-day and 90-day mortality.

NCT ID: NCT04335201 Completed - Clinical trials for Patients With COVID-19 Pneumonia Will Allow to Detect an Absolute Reduction in the Rate of Respiratory-failure

Defibrotide in COVID-19 Pneumonia

DEFI-VID19
Start date: May 20, 2020
Phase: Phase 2
Study type: Interventional

Phase II, prospective, interventional, single-arm, multicentric, open label trial, with a parallel retrospective collection of data on not treated patients from IRCCS, San Raffaele Scientific Institute included in the institutional observational study. A sample of 50 patients with COVID-19 pneumonia will allow to detect an absolute reduction in the rate of Respiratory-failure at day+14 after treatment of 20%, assuming that the actual rate of failure in the corresponding not treated patients is 70% (alpha=5%, power=90%, two-sided test). The software PASS15 was used for calculations. The study will also include a parallel retrospective group of temporally concomitant patients from IRCCS, San Raffaele Scientific Institute, who did not receive an experimental treatment and who are enrolled in an already IRB approved observational study

NCT ID: NCT04327336 Completed - Clinical trials for Obesity Hypoventilation Syndrome

Randomized Controlled Trial Between Auto-titration and Manual Titration of Non-invasive Ventilation in Obesity Hypoventilation Syndrome

TITRATION
Start date: April 1, 2020
Phase: N/A
Study type: Interventional

Primary Objectives: To evaluate the effectiveness in the obesity hypoventilation syndrome (OHS) treatment with non-invasive ventilation (NIV) set manually by polysomnography compared to the same treatment with a respirator with automatic NIV adjustment, analyzing as primary variable PaCO2 and as operational variables dropout rate for medical reasons and mortality. Secondary objectives: cost-effectiveness, clinical and functional improvement in wakefulness and during sleep, quality of life, blood pressure monitoring for 24 hours, incidence and evolution of cardiovascular events and use of health resources. Other objectives: 1) effectiveness of treatments in the following subgroups of patients: gender, age, socioeconomic status, severity of sleep apnea, VNI compliance, quality of life and comorbidities; 2) To evaluate the profile of patients with poor adherence to NIV based on clinical severity, gender, age and socioeconomic status in the whole sample and in both intervention groups.

NCT ID: NCT04326920 Completed - COVID-19 Clinical Trials

Sargramostim in Patients With Acute Hypoxic Respiratory Failure Due to COVID-19 (SARPAC)

SARPAC
Start date: March 24, 2020
Phase: Phase 4
Study type: Interventional

Phase IV study to evaluate the effectiveness of additional inhaled sargramostim (GM-CSF) versus standard of care on blood oxygenation in patients with COVID-19 coronavirus infection and acute hypoxic respiratory failure.

NCT ID: NCT04326075 Completed - COVID-19 Clinical Trials

Early CPAP in COVID-19 Patients With Respiratory Failure.

EC-COVID-RCT
Start date: December 1, 2020
Phase: N/A
Study type: Interventional

The study aims at clarifying whether early treatment with continuous positive airway pressure (CPAP) ventilation is able to reduce the need for intubation or death in patients visiting an emergency department (ED) with known or suspected COVID-19 infection and insufficiency respiratory.

NCT ID: NCT04324528 Completed - COVID-19 Clinical Trials

Cytokine Adsorption in Severe COVID-19 Pneumonia Requiring Extracorporeal Membrane Oxygenation

CYCOV
Start date: March 27, 2020
Phase: N/A
Study type: Interventional

In December 2019 in the city of Wuhan in China, a series of patients with unclear pneumonia was noticed, some of whom have died of it. In virological analyses of samples from the patients' deep respiratory tract, a novel coronavirus was isolated (SARS-CoV-2). The disease spread rapidly in the city of Wuhan at the beginning of 2020 and soon beyond in China and, in the coming weeks, around the world. Initial studies described numerous severe courses, particularly those associated with increased patient age and previous cardiovascular, metabolic and respiratory diseases. A small number of the particularly severely ill patients required not only highly invasive ventilation therapy but also extracorporeal membrane oxygenation (vv-ECMO) to supply the patient's blood with sufficient oxygen. Even under maximum intensive care treatment, a very high mortality rate of approximately 80-100% was observed in this patient group. In addition, high levels of interleukin-6 (IL-6) could be detected in the blood of these severely ill patients, which in turn were associated with poor outcome. From experience in the therapy of severely ill patients with severe infections and respiratory failure, we know that treatment with a CytoSorb® adsorber can lead to a reduction of the circulating pro- and anti-inflammatory cytokines and thus improve the course of the disease and the outcome of the patients. Our primary goal is to investigate the efficacy of treatment with a CytoSorb® adsorber in patients with severe COVID-19 disease requiring venous ECMO over 72 hours after initiation of ECMO. The primary endpoint is the reduction of plasma interleukin-6 levels 72 hours after initiation of ECMO support. As secondary endpoints we investigate 30-day survival, vasopressor and volume requirements, lactate in terms of lactate and platelet function. As safety variables, we further investigate the levels of the applied antibiotics (usually ampicillin and sulbactam).

NCT ID: NCT04323878 Completed - Clinical trials for Early CPAP Ventilation in COVID-19 Patients

Early CPAP in COVID-19 Patients With Respiratory Failure. A Prospective Cohort Study.

EC-COVID-PCS
Start date: June 1, 2020
Phase:
Study type: Observational

This cohort study aims at prospectively collecting detailed clinical information on patients positive to or suspected of COVID-19 visiting Italian emergency departments (EDs). The objectives of the study are: 1. To monitor and describe the COVID-19 patients visiting Italian EDs. 2. To assess the prognostic impact of demographics, clinical characteristics, risk factors and pre-existing diseases. 3. To develop a predictive model, providing estimates of the prognosis using multiple relevant factors. 4. To construct a detailed database to enable comparative effectiveness research (CER), with the goal of generating hypothesis of efficacy and effectiveness of treatments, therapies and interventions, in the management and treatment of COVID-19 patients.

NCT ID: NCT04319731 Completed - Clinical trials for SARS CoV-2 Infection

A Pilot Study of Human Amniotic Fluid for COVID19 Associated Respiratory Failure

Start date: March 20, 2020
Phase: Early Phase 1
Study type: Interventional

The purpose of this study is to test the effect of purified (acellular) amniotic fluid as a treatment for SARS CoV-2 (COVID19)-associated respiratory failure. Past use of human amniotic products (i.e., membrane and fluid) is FDA-approved for tissue injury and has been used to reduce inflammation and fibrosis in patients with a variety of medical conditions. The investigators hypothesize that using nebulized and/or intravenous purified (acellular) amniotic fluid will reduce both inflammation in patients hospitalized for in SARS CoV-2 (COVID19)-associated respiratory failure, potentially leading to a decrease in respiratory support.

NCT ID: NCT04311697 Completed - Clinical trials for Corona Virus Infection

Intravenous Aviptadil for Critical COVID-19 With Respiratory Failure

COVID-AIV
Start date: May 15, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

Novel Corona Virus (SARS-CoV-2) is known to cause Respiratory Failure, which is the hallmark of Acute COVID-19, as defined by the new NIH/FDA classification. Approximately 50% of those who develop Critical COVID-19 die, despite intensive care and mechanical ventilation. Patients with Critical COVID-19 and respiratory failure, currently treated with high flow nasal oxygen, non-invasive ventilation or mechanical ventilation will be treated with ZYESAMI (aviptadil), a synthetic form of Human Vasoactive Intestinal Polypeptide (VIP) plus maximal intensive care vs. placebo + maximal intensive care. Patients will be randomized to intravenous Aviptadil will receive escalating doses from 50 -150 pmol/kg/hr over 12 hours.