We have to be aware of the challenge and concerns brought by 2019-nCoV to our healthcare workers. Front-line healthcare workers can become infected in the management of patients with COVID-19; the high viral load in the atmosphere, and infected medical equipment are sources for the spread of SARS-CoV-2. If prevention and control measures are not in place, these healthcare workers are at great risk of infection and become the inadvertent carriers to patients who are in hospital for other diseases. Nowadays a question that has not yet been clarified by science has been arises: is hydroxychloroquine associated with zinc compared to ivermectin associated with zinc effective as a prophylaxis for asymptomatic professionals involved in the treatment of suspected or confirmed case of COVID-19?

NCT04384458

Conditions

1. Coronavirus Infections

Interventions

1. Drug: Hydroxychloroquine
2. Drug: Ivermectin

MeSH:Coro Coronavirus Infections Severe Acute Respiratory Syndrome

Triple blinded, phase III randomized controlled trial with parallel groups (200mg of hydroxychloroquine per day vs. placebo) aiming to prove hydroxychloroquine's security and efficacy as prophylaxis treatment for healthcare personnel exposed to COVID-19 patients.

NCT04318015

Conditions

1. COVID-19
2. Severe Acute Respiratory Syndrome

Interventions

1. Drug: Hydroxychloroquine
2. Drug: Placebo oral tablet

MeSH:Severe Acute Respiratory Syndrome Corona Coronavirus Infections

To develop and validate a machine-learning model based on clinical, laboratory, and radiological characteristics alone or combination of COVID-19 patients to facilitate risk Assessment before and after symptoms and triage (home, hospitalization inward or ICU).

NCT04337502

Conditions

1. Coronavirus
2. Machine Learning

Interventions

1. Diagnostic Test: Machine learning model

MeSH:Coronavi Coronavirus Infections

Posttraumatic Stress Disorder (PTSD) is a common cause of morbidity in combat veterans, but current treatments are often inadequate. Reconsolidation of Traumatic Memories (RTM) is a novel treatment that seeks to alter key aspects of the target memory (e.g., color, clarity, speed, distance, perspective) to make it less impactful, and reduce nightmares, flashbacks, and other features of PTSD. The memory is reviewed in the context of an imaginal movie theater, presenting a fast (~45 sec) black and white movie of the trauma memory, with further adjustment as needed so the patient can comfortably watch it. Open and waitlist studies of RTM have reported high response rates and rapid remission, setting the stage for this randomized, controlled, single-blind trial comparing RTM versus prolonged exposure (PE), the PTSD therapy with the strongest current evidence base. The investigators hypothesize that RTM will be non-inferior to PE in reducing PTSD symptom severity post-treatment and at 1-year follow up; will achieve faster remission, with fewer dropouts; will improve cognitive function; and that epigenetic markers will correlate with treatment response. The investigators will randomize 108 active or retired service members (SMs) with PTSD to ≤10 sessions of RTM or PE, affording power to test our hypotheses while allowing for ≤ 25% dropouts. The investigators will use an intent to treat analysis, and the Clinician Administered PTSD Scale for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition, or DSM5 (CAPS-5), conducted by blinded assessors, will be the primary outcome measure. Secondary measures of depression (PHQ-9), anxiety (GAD-7), sleep (PSQI), and functional status (WHOQOL-100), will be assessed pre- and post-treatment, and at 2, 6, and 12 months. ANOVA will compare symptom severity over time within and between groups. Blood draws will be obtained pre- and posttreatment to assess predictors of treatment response and epigenetic markers of change. The NIH Toolbox Neurocognitive Assessment, pre- and post-treatment, will assess impact on cognitive function. The investigators will track comorbid TBI, anticipating it will not adversely impact response. More effective therapies for PTSD, with and without TBI, must be developed and evaluated. RTM is safe and promising, but requires testing against evidence-based interventions in well-designed randomized clinical trials (RCTs). The full study can now be conducted via video conferencing due to COVID-19.

NCT03827057

Conditions

1. Posttraumatic Stress Disorder
2. Traumatic Brain Injury

Interventions

1. Behavioral: Reconsolidation of Traumatic Memories (RTM)
2. Behavioral: Prolonged Exposure (PE)

MeSH:Brain Injuries Brain Injuries, Traumatic Dis Disease Stress Disorders, Traumatic Stress Disorders, Post-Traumatic

Eating disorders are psychopathologies with serious repercussions on the somatic, psychological and social level. Currently available treatments are unfortunately for now not fully efficient, therefore researchers have recommended to develop prevention initiatives. Until now, no study has been carried out in Switzerland to evaluate the efficacy of an intervention for the prevention of eating disorders. The goal of the present study is to evaluate two eating disorders prevention intervention that have been largely validated in the US, called the Body Project (BP) and the Healthy Weight Program (HW). Both interventions target body dissatisfaction, which is a well-identified risk factor of eating disorders. They will be compared to a one-month waiting list. Because of the pandemic situation due to the Severe Acute Respiratory Syndrome coronavirus (COVID-19), both interventions will be delivered virtually via a collaborative platform. The sessions will be recorded to carry out a quality control. To compare the BP and HW interventions to a waiting list, a three-arm randomized controlled study will be carried out, including female students from French-speaking Switzerland. Recruitment will include 90 participants. Participants will be randomly assigned to one of the three arms of the study. They will be evaluated before (T0) and after (T1) the interventions or the waiting list. Following the interventions, the participants will have one month of follow-up before a final evaluation (T2). Participants on the waiting list will receive the BP following the one-month waiting period and will then be evaluated (T2). After having signed the consent form, the participant will be randomized to one of the three study arms, with a 1: 1: 1 allocation ratio. Interventions will be given in groups of six participants. Randomization will be blocked to ensure groups of equal size, and that groups of six participants for each arm are regularly formed. The blocks will be of variable size (3, 6, 9) to protect the concealment. The hypotheses are as follows: 1. The two interventions BP and HW will have an effect on body dissatisfaction (primary outcome) as well as on the thin-ideal internalization, dietary restraint, negative affect, and eating disorders psychopathology (secondary outcomes), compared to the waiting list; 2. There will be no differences between the BP and the HW on the primary and secondary outcomes; 3. The effects observed thanks to the interventions will be maintained after one month of follow-up.

NCT04558073

Conditions

1. Body Dissatisfaction

Interventions

1. Behavioral: Body Project (BP)
2. Behavioral: Healthy Weight Program (HW)

MeSH:Feeding and Feeding and Eating Disorders

The COVID-19 attack is polymorphic with otorhinolaryngological, pneumological, cardiac, digestive, neurological, muscular attacks with a higher mortality in subjects with comorbidity [> 70 years old, cardiovascular history in particular Arterial hypertension (hypertension ), heart disease…]. This polymorphism is linked to vasculitis and the immune response. Patients with cardiovascular disease are particularly at risk of decompensating, particularly due to the increased metabolism induced by viral infection and reduced cardiovascular capacities. On the cardiovascular level, two sides can be considered. On the one hand, cardiovascular disease (hypertension, coronary artery disease) is a comorbid factor. On the other hand, the myocardial damage reflected by the increase in troponin or an alteration of the ejection fraction is a very clear risk factor for death or severe form. Cardiovascular involvement is particularly high in hospitalized and deceased patients. The odds ratio calculated in a meta-analysis of severe forms of covid-19 with hypertension is 3 [1.9; 3.1], for cardiovascular pathologies of 2.93 [1.73; 4.96]. Recommendations were made for pulmonary rehabilitation but not for cardiovascular rehabilitation. Cardiac rehabilitation is indicated in most cardiovascular pathologies (after acute coronary syndrome, after coronary angioplasty, in heart failure, after coronary or valve heart surgery, etc.). It consists of a multidisciplinary approach combining therapeutic pharmacological adjustment, physical activity, therapeutic education in order to improve physical capacities for exertion and reduce morbidity and mortality. The physical exercises can be endurance or resistance type. Capacity gain at the end of rehabilitation is measured by visual scales, quality of life questionnaires, and a stress test at the start and end of rehabilitation. Most often, rehabilitation centers only do the stress test and estimate through questioning for subjective improvement. The hypothesis is that patients who contracted COVID-19 would have lower cardiac capacities after recovery from the infection than patients without COVID-19 or that their capacity for recovery would be less. There could be a difference in recovery after cardiac rehabilitation between the two populations regardless of whether the cardiac damage requiring rehabilitation was triggered by COVID-19 or was pre-existing.

NCT04513964

Conditions

1. Heart Failure
2. Covid19

MeSH:Hea Heart Failure

HPO:Congestive heart failure Left ventricular dysfunction Right ventricular failure

Introduction: Survivors of acute respiratory failure develop persistent muscle weakness and deficits in cardiopulmonary endurance combining to limit physical functioning. Early data from the Covid-19 pandemic suggest a high incidence of critically ill patients admitted to intensive care units (ICU) will require mechanical ventilation for acute respiratory failure. Covid-19 patients surviving an admission to the ICU are expected to suffer from physical and cognitive impairments that will limit quality of life and return to pre-hospital level of functioning. In this present study, the investigators will evaluate the safety and feasibility of providing a novel clinical pathway combining ICU after-care at an ICU Recovery clinic with physical therapy interventions. Methods and Analysis: In this single-center, prospective (pre, post cohort) trial in patients surviving ICU admission for Covid-19. The investigators hypothesize that this novel combination is a) safe and feasible to provide for patients surviving Covid-19; b) improve physical function and exercise capacity measured by performance on 6-minute walk test and Short Performance Physical battery; and c) reduce incidence of anxiety, depression and post-traumatic stress assessed with Hospital Anxiety and Depression Scale and the Impact of Events Scale-revised. Safety will be assessed by pooled adverse events and reason for early termination of interventions. Feasibility will be assessed by rate of adherence and attrition. Repeated measures ANOVA will be utilized to assess change in outcomes from at first ICU Recovery Clinic follow-up (2-weeks) and 3- and 6-months post hospital discharge. Ethics and Dissemination: The trial has received ethics approval at the University of Kentucky and enrollment has begun. The results of this trial will support the feasibility of providing ICU follow-up and physical therapy interventions for patients surviving critical illness for Covid-19 and may begin to support effectiveness of such interventions. Investigators plan to disseminate trial results in peer-reviewed journals, as well as presentation at physical therapy and critical care national and international conferences.

NCT04412330

Conditions

1. Covid-19
2. Critical Illness
3. Post Intensive Care Unit Syndrome
4. Muscle Weakness

Interventions

1. Other: ICU Recovery + Physical Therapy

MeSH:Muscle Weakness Critical Illness

While "conditioning" by exercise training has been widely evaluated, the available literature on "passive deconditioning" (i.e. forced deconditioning) is predominately limited to studies with or with almost complete mechanical and/or metabolic immobilization/sedation of the respective functional system (e.g. paralysis, bedriddenness). Vice versa, the effects of moderately long interruptions of dedicated types of exercise while maintaining everyday activity are rarely addressed. However, this topic is of high relevance, e.g. considering that breaks of health-related exercise programs due to increased family/occupational stress, vacation or temporary orthopedic limitation are rather frequent in everyday life. In the present project we aimed to determine the effects of 3 months of physical deconditioning due to COVID-19 induced lockdown after 13 month of high intensity endurance and resistance exercise in early postmenopausal women on parameters related to health and physical fitness.

NCT04420806

Conditions

1. Exercise
2. Detraining
3. Muscle Weakness
4. Muscle Atrophy

Interventions

1. Other: HIT-exercise
2. Other: Sham intervention

MeSH:Muscle Weakness Muscular Atrophy Atrophy

HPO:Skeletal muscle atrophy

After a hospitalization in Intensive Care Unit (ICU), approximately 50% of patients usually have a ICU-Weakness, i.e. nerves and muscles injury secondary to immobilization and to treatments which had to be used. This disease is expected to be similar or even higher in patients suffering from COVID-19 and hospitalized in ICU due to the average length of hospitalization of several weeks in this population. This condition will delay the return-to-walk of these patients, their discharge from hospitalization and may deteriorate their autonomy in daily life activities. Virtual Reality (VR) environments are already used and have proven their worth for the assessment and rehabilitation of patients with neurological diseases. It therefore seems appropriate to offer the use of virtual environments for this type of population. VR represents a unique opportunity for the rehabilitation care of these patients, and in particular those who have been reached by COVID-19, due to the possible mismatch between the amount of motor rehabilitation to be provided and the fatigability and breathlessness at the slightest effort which seem particularly intense in this population. The main objective of our project is to improve and to accelerate gait recovery in patients hospitalized in Physical and Rehabilitation Medicine after discharge from Resuscitation or Continuous Care Unit and in patients hospitalized in ICU and presenting ICU-weakness secondary to resuscitation, notably due to COVID-19 infection, thanks to the use of Virtual Reality tools. The VR tool will consist of virtual environments presented using a Virtual Reality headset where an avatar (double) of the patient hospitalized in Physical and Rehabilitation Medicine or in ICU will be represented, who will perform different motor tasks involving their lower limbs (ex: walking, or kicking a ball) in several different virtual environments (settings). The patient will be asked to observe actions, then to imagine carrying out their actions which will be performed by the avatar in the virtual environment, then they will be able to control the actions of the avatar using their legs thanks to sensors, then feel walking sensations through the use of haptic devices.

NCT04441164

Conditions

1. Weakness of the Lower Limbs

Interventions

1. Other: Observation of Virtual Actions
2. Other: Relaxation
3. Other: Acceptability questionnaire
4. Other: Observation of Virtual Actions (step 4)
5. Other: Performing Virtual Actions
6. Other: Haptic stimulation
7. Other: Without haptic stimulation

MeSH:Muscle Weakness Paresis

HPO:Hemiparesis

Menopause usually have a serious impact on a woman's life, associated with negative consequences for health and quality of life. Early preventive assessments are very difficult to implement due to the complex hormone-deficiency-induced effects on a large variety of organs and systems with estrogen receptors. In fact, only a few types of interventions have the potential to comprehensively improve the various risk factors and complaints of the menopausal transition. In detail, however, not every form of exercise training or every training protocol is effective for exerting positive effects on selected risk factors. In particular, the training concept for addressing musculoskeletal or cardio-metabolic risk factors differ fundamentally. In several studies, we confirmed the effect of different complex training programs on risk factors of different postmenopausal female cohorts with special consideration of osteoporotic aspects. The training programs applied in this context were characterized by the consistent implementation of recognized training principles and an in general exercise intensity-oriented approach. Recent studies confirmed the effectiveness of this proceeding for women with relevant postmenopausal risk factors including low bone strength. However, the crucial issue of the most effective, feasible and easily customizable training protocol for addressing postmenopausal risk factors remains to be answered, taking into account that the majority of exercise programs were realized in an ambulatory group setting. The aim of the study will be to evaluate the effects of an optimized physical training on risk factors and complaints of (early) postmenopausal women with special consideration of the osseous fracture risk. Note (05.06.2020): Of importance, the intervention has to be cancelled due to COVID-19 lockdown in March 2020 after 13 months of intervention.

NCT03959995

Conditions

1. Osteopenia, Osteoporosis

Interventions

1. Other: High Intensity Resistance (HIT-RT) and Endurance exercise (HIIT)
2. Other: Wellness

MeSH:Osteoporosis Bone Diseases, Metabolic

HPO:Osteopenia

In the context of quarantine with COVID-19, we wish to study the experience and psychological impact in adult patients living with osteoporosis.

NCT04351633

Conditions

1. Sars-CoV2
2. Osteoporosis

Interventions

1. Other: questionnaire assesment

MeSH:Osteoporosis

Osteosarcopenia designates the simultaneous presence of sarcopenia and osteopenia; both chronic conditions of advanced age. Dynamic-resistance exercise (DRT) might be the most powerful agent to fight osteosarcopenia. Indeed, in the present FrOST study, we clearly determine the positive effect of slightly adapted 18 month high-intensity (HIT)-DRT on bone mineral density (BMD), sarcopenia and other health related parameters in osteosarcopenic men. However, after a short training break, COVID-19 induced lock down prevented a re-start of the HIT resistance exercise training in the FrOST cohort. The aim of the present observational study is thus to determine the effects of 6 months of deconditioning on health related parameters under special regard of osteosarcopenia in this cohort of older men with osteosarcopenia.

NCT04444661

Conditions

1. Osteoporosis
2. Sarcopenia

MeSH:Osteoporosis Sarcopenia

The overarching aim of this project is to implement and evaluate a proven cognitive training regimen in combination with a community exercise program among older adults who attend wellness exercise programs at the YMCA. To support this aim, the investigators have developed a collaboration with the YMCA of Kitchener-Waterloo, which offer exercise programs targeted to older adults. The specific objectives are: (1) to evaluate the feasibility of a combined exercise and cognitive training in a community-setting among older adults; and (2) to conduct a preliminary evaluation and comparison of changes in cognitive function, physical function, well-being and self-efficacy with 12-weeks of combined exercise and cognitive training versus exercise alone. The hypothesis for each objective are as follows: (1) It is anticipated that this program will be feasible to implement and will be well accepted by the participants and exercise providers. (2) The investigators may not have the power to find statistically significant differences between the control and experimental groups for physical and cognitive function. However, the investigators expect to observe positive changes between the pre- and post-assessments, suggesting improved cognitive function and mobility as a result of the 12-week program.

NCT04515758

Conditions

1. Osteo Arthritis
2. Osteoporosis
3. Joint Replacement
4. Fibromyalgia
5. High Blood Pressure
6. Stable Heart Conditions
7. Chronic Obstructive Pulmonary Disease
8. Diabetes
9. Obesity

Interventions

1. Other: Exercise and Cognitive Training
2. Other: Exercise Training Only

MeSH:Osteoporosis Fibromyalgia Osteoarthritis Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Hypertension

HPO:Chronic pulmonary obstruction Hypertension Osteoarthritis Pulmonary obstruction

This multi-center, open, randomized study will evaluate the efficacy and safety of BDB-001 injection in severe COVID-19 with severe pneumonia, or acute lung injury/acute respiratory distress syndrome. Patients will be randomized to two treatment arms (Arm A: Conventional treatment + BDB-001; Arm B: Conventional treatment alone).

NCT04449588

Conditions

1. COVID-19 Pneumonia

Interventions

1. Drug: BDB-001 Injection
2. Other: Conventional treatment

MeSH:Pn Pneumonia

HPO:Pneumonia

The host response against the coronavirus 2 (SARS-CoV-2) appears to be mediated by a 'cytoquine storm' developing a systemic inflammatory mechanism and an acute respiratory distress syndrome (ARDS), in the form of a bilateral pneumonitis, requiring invasive mechanical ventilation (IMV) in an important group of patients. In terms of preventing progression to the critical phase with the consequent need of admission to the intensive care units (ICU), it has been recently proposed that this inflammatory cytoquine-mediated process can be safely treated by a single course of ultra-low radiotherapy (RT) dose < 1 Gy. The main purpose of the study was to analyze the efficacy of ultra low-dose pulmonary RT, as an anti-inflammatory intention in patients with SARS-Cov-2 pneumonia with a poor or no response to standard medical treatment and without IMV.

NCT04394182

Conditions

1. Pneumonia, Viral
2. Cytokine Storm

Interventions

1. Radiation: Ultra-Low-dose radiotherapy
2. Device: ventilatory support with oxygen therapy
3. Drug: Lopinavir/ritonavir
4. Drug: Hydroxychloroquine
5. Drug: Azithromycin
6. Drug: Piperacillin/tazobactam
7. Drug: Low molecular weight heparin
8. Drug: Corticosteroid injection
9. Drug: Tocilizumab

MeSH:Pneumonia, Viral Pne Pneumonia

HPO:Pneumonia

Randomized, double-blind, parallel, two-arms clinical trial to assess the efficacy and safety of 2 infusions of Wharton-Jelly mesenchymal stromal cells (day 1 and day 3, endovenously at 1E6cells/Kg per dose) in patients with moderate acute respiratory distress syndrome (ARDS) secondary to SARS-CoV-2 infection. Follow-up will be established on days 3, 5, 7, 14, 21, and 28. Long term follow-up will be performed at 3, 6 and 12 months.

NCT04390139

Conditions

1. COVID-19
2. SARS-CoV 2
3. Adult Respiratory Distress Syndrome

Interventions

1. Drug: XCEL-UMC-BETA
2. Other: Placebo

MeSH:Respiratory Distress Syndrome, Newborn Respi Respiratory Distress Syndrome, Adult Acute Lung Injury Syndrome

The aim of the study is to clinically use bovine Lf as a safe antiviral adjuvant for treatment and to assess the potential in reducing mortality and morbidity rates in COVID-19 patients. The study was approved by the ethical committee of the Egyptian Center for Research and Regenerative Medicine in 11-5-2020.

NCT04412395

Conditions

1. Corona Virus Infection
2. Middle East Respiratory Syndrome (MERS)
3. Acute Respiratory Distress Syndrome
4. Coronavirus Infection
5. COVID-19
6. SARS-CoV 2

Interventions

1. Dietary Supplement: Lactoferrin (Apolactoferrin)
2. Drug: Placebo of excipient(s) will be administered

MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Distress Syndrome, Newborn Respira Respiratory Distress Syndrome, Adult Acute Lung Injury Syndrome

This is a quality improvement study with the purpose of observing and measuring the effects of implementation of a proven standardized lung protective ventilation protocol in the new electronic medical record system iCentra across all Intermountain Healthcare hospitals. Approximately 14,000 records will be accessed for this study from a database of mechanically ventilated patients established for quality improvement purposes. The investigators hypothesize that implementation of a standardized computerized lung protective ventilation protocol across all Intermountain Healthcare hospitals will be feasible, will decrease initial tidal volumes to the target 6 ml/kg PBW, and will improve outcomes. The objectives of this study are to: - Determine if the implementation of lung protective ventilation (with a 6 ml/kg PBW tidal volume ventilation protocol on initiation of mechanical ventilation) improves outcomes in patients with acute respiratory failure requiring mechanical ventilation - Determine if the implementation of lung protective ventilation (with a 6 ml/kg PBW tidal volume ventilation protocol on initiation of mechanical ventilation) improves outcomes in the sub-group of patients with the acute respiratory distress syndrome (ARDS) - Measure compliance with the implementation of a computerized lung protective ventilation protocol at 12 Intermountain Healthcare hospitals

NCT03225807

Conditions

1. Acute Respiratory Distress Syndrome
2. ARDS
3. Respiratory Distress Syndrome, Acute
4. Respiratory Insufficiency
5. Respiratory Distress Syndrome
6. Shock Lung
7. Severe Acute Respiratory Syndrome

MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Respiratory Insufficiency Acute Lung Injury Pulmonary Valve Insufficiency Syndrome

HPO:Pulmonary insufficiency

This research study seeks to establish the effectiveness of a combination of an inhaled corticosteroid and a beta agonist compared to placebo for the prevention of acute respiratory failure (ARF) in hospitalized patients with pneumonia and hypoxemia.

NCT04193878

Conditions

1. Pneumonia
2. Hypoxemia
3. Acute Respiratory Failure

Interventions

1. Drug: Inhaled budesonide and formoterol
2. Drug: Inhaled placebo

MeSH:Pneumonia Respiratory Insufficiency Hypoxia

HPO:Hypoxemia Pneumonia

In December 2019 a new kind of virus was identified in China as the responsible of severe acute respiratory syndrome (SARS) and interstitial pneumonia. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) quickly spread around the world and in February 2020 became a pandemia in Europe. No pharmacological treatment is actually licensed for the SARS-CoV2 infection and at the current state of art there is a lack of data about the clinical management of the coronavirus 2019 disease (COVID-19). The aim of this observational study is to collect the data and the outcomes of COVID-19 patients admitted in the H. Sacco Respiratory Unit treated according to the Standard Operating Procedures and the Good Clinical Practice.

NCT04307459

Conditions

1. Coronavirus Infections
2. Respiratory Failure
3. Ventilator Lung

Interventions

1. Other: standard operating procedures

MeSH:Infection Coronavirus Infections Severe Acu Severe Acute Respiratory Syndrome Respiratory Insufficiency

Opioids can decrease breathing and co-administration of benzodiazepines with opioids can further decrease breathing. It is unknown whether certain other drugs also decrease breathing when co-administered with opioids. The objective of this study is to determine whether certain drugs combined with an opioid decrease breathing compared to breathing with an opioid alone. In order to assess this, this study will utilize the Read Rebreathing method, where study participants breathe increased levels of oxygen and carbon dioxide. The increased levels of carbon dioxide cause the study participants to increase breathing. This increased breathing response can be decreased by opioids and benzodiazepines, and potentially other drugs. Using this procedure, low doses of opioids or benzodiazepines can be administered that have minimal-to-no effects on breathing when study participants are going about normal activities breathing room air, however breathing increases less than expected as carbon dioxide levels are increased. This study will also obtain quantitative pupillometry measurements before and after each rebreathing assessment to allow for comparisons of pupillary changes to ventilatory changes when subjects receive different drugs and drug combinations. This study includes three parts: A Lead-In Reproducibility Phase and two main parts (Part 1 and Part 2). The Lead-In Reproducibility Phase will measure the variability between study participants and between repeated uses of the method in the same study participant within a day and between days. Part 1 will study an opioid alone, benzodiazepine alone, and their combination to show the methodology will detect changes in breathing at low doses of the drugs that are known to affect breathing. Part 2 will assess whether two drugs, selected due to their effects on breathing in a nonclinical model, decrease the breathing response when combined with an opioid compared to when an opioid is administered alone.

NCT04310579

Conditions

1. Hypercapnia
2. Ventilatory Depression

Interventions

1. Drug: Oxycodone and Midazolam
2. Drug: Oxycodone, Paroxetine, and Quetiapine

MeSH:Respiratory Insufficiency Hypercapnia

HPO:Hypercapnia

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 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.

NCT04311697

Conditions

1. Critical COVID-19 With Respiratory Failure
2. Acute Respiratory Distress Syndrome (ARDS)
3. Corona Virus Infection
4. Acute Lung Injury

Interventions

1. Drug: Aviptadil by intravenous infusion + standard of care
2. Drug: Normal Saline Infusion + standard of care

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Respiratory Insufficiency Acute Lung Injury Lung Injury

The emergence of SARS-CoV-2 is currently engaging and consuming most of resources of efficient healthcare systems in Europe, and several hospitals are currently experiencing a shortage of ICU beds for critically-ill patients with SARS-CoV-2 pneumonia. A risk stratification based on clinical, radiological and laboratory parameters seems necessary in order to better identify those patients who may need ICU admission and/or those who may benefit from a prompt antiviral therapy

NCT04316949

Conditions

1. SARS-CoV-2 Pneumonia

MeSH:Pneumonia Respiratory Insufficiency

HPO:Pneumonia

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.

NCT04323878

Conditions

1. Early CPAP Ventilation in COVID-19 Patients

MeSH:Respiratory Insufficiency

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).

NCT04324528

Conditions

1. Coronavirus
2. COVID-19
3. SARS-CoV Infection
4. Respiratory Failure
5. Cytokine Storm

Interventions

1. Device: vv-ECMO + cytokine adsorption (Cytosorb adsorber)
2. Device: vv-ECMO only (no cytokine adsorption)

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia Respiratory Insufficiency

HPO:Pneumonia

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.

NCT04326075

Conditions

1. CPAP Ventilation
2. COVID-19
3. Emergency Departments

Interventions

1. Device: CPAP treatment

MeSH:Respiratory Insufficiency Emergencies

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.

NCT04326920

Conditions

1. COVID-19

Interventions

1. Drug: Sargramostim
2. Other: Control

MeSH:Respiratory Insufficiency

COVID-19 may cause severe pneumonitis that require ventilatory support in some patients, the ICU mortality is as high as 62%. Hospitals do not have enough ICU beds to handle the demand and to date there is no effective cure. We explore a treatment administered in a randomized clinical trial that could prevent ICU admission and reduce mortality. The overall hypothesis to be evaluated is that HBO reduce mortality, increase hypoxia tolerance and prevent organ failure in patients with COVID19 pneumonitis by attenuating the inflammatory response.

NCT04327505

Conditions

1. SARS (Severe Acute Respiratory Syndrome)
2. Cytokine Storm
3. ARDS, Human
4. COVID-19
5. Sars-CoV2
6. Acute Respiratory Failure

Interventions

1. Drug: Hyperbaric oxygen

MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections Respiratory Insufficiency Respiratory Distress Syndrome, Adult

Background: A novel Coronavirus (SARS-CoV-2) described in late 2019 in Wuhan, China, has led to a pandemic and to a specific coronavirus-related disease (COVID-19), which is mainly characterized by a respiratory involvement. While researching for a vaccine has been started, effective therapeutic solutions are urgently needed to face this threaten. The renin-angiotensin system (RAS) has a relevant role in COVID-19, as the virus will enter host 's cells via the angiotensin-converting enzyme 2 (ACE2); RAS disequilibrium might also play a key role in the modulation of the inflammatory response that characterizes the lung involvement. Angiotensin-(1-7) is a peptide that is downregulated in COVID-19 patient and it may potentially improve respiratory function in this setting. Methods/Design: The Investigators describe herein the methodology of a randomized, controlled, adaptive Phase II/Phase III trial to test the safety, efficacy and clinical impact of the infusion of angiotensin-(1-7) in COVID-19 patients with respiratory failure requiring mechanical ventilation. A first phase of the study, including a limited number of patients (n=20), will serve to confirm the safety of the study drug, by observing the number of the severe adverse events. In a second phase, the enrollment will continue to investigate the primary endpoint of the study (i.e. number of days where the patient is alive and not on mechanical ventilation up to day 28) to evaluate the efficacy and the clinical impact of this drug. Secondary outcomes will include the hospital length of stay, ICU length of stay, ICU and hospital mortality, time to weaning from mechanical ventilation, reintubation rate, secondary infections, needs for vasopressors, PaO2/FiO2 changes, incidence of deep vein thrombosis, changes in inflammatory markers, angiotensins plasmatic levels and changes in radiological findings. The estimated sample size to demonstrate a reduction in the primary outcome from a median of 14 to 11 days is 56 patients, 60 including a dropout rate of 3% (i.e. 30 per group), but a preplanned recalculation of the study sample size is previewed after the enrollment of 30 patients. Expected outcomes/Discussion: This controlled trial will assess the efficacy, safety and clinical impact of the Angiotensin-(1-7) infusion in a cohort of COVID-19 patients requiring mechanical ventilation. The results of this trial may provide useful information for the management of this disease.

NCT04332666

Conditions

1. Coronavirus
2. Respiratory Failure
3. Coronavirus Sars-Associated as Cause of Disease Classified Elsewhere
4. SARS-CoV-2

Interventions

1. Drug: Angiotensin 1-7
2. Drug: Placebos

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Insufficiency

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

NCT04335201

Conditions

1. Patients With COVID-19 Pneumonia Will Allow to Detect an Absolute Reduction in the Rate of Respiratory-failure

Interventions

1. Drug: Defibrotide Injection

MeSH:Pneumonia Respiratory Insufficiency

HPO:Pneumonia

Trial design: Prospective, multi-centre, randomised, pragmatic, double blind trial Methods: Participants: Adult (>18 years) within 24 hours of admission to intensive care unit with proven or suspected COVID-19 infection, whether or not mechanically ventilated. Exclusion criteria: symptoms of febrile disease for ≥1 week, treatment limitations in place or moribund patients, allergy or intolerance of any study treatment, incl. long QT syndromes, participation in another outcome-based interventional trial within last 30 days, patients taking Hydrochloroquine for other indication than COVID-19, pregnancy. Interventions: Patients will be randomised in 1:1:1 ratio to receive Hydrochloroquine 800mg orally in two doses followed by 400mg daily in two doses and Azithromycin 500 mg orally in one dose followed by 250 mg in one dose for a total of 5 days (HC-A group) or Hydrochloroquine+ placebo (HC group) or placebo + placebo (C-group) in addition to best standard of care, which may evolve during the trial period but will not differ between groups. Objective: To test the hypothesis that early administration of combination therapy slows disease progression and improves mechanical-ventilation free survival. Outcomes: Primary outcome: Composite percentage of patients alive and not on end-of-life pathway who are free of mechanical ventilation at day 14. Secondary outcomes: Composite percentage of patients alive and not on end-of-life pathway who are free of mechanical ventilation at day 14 in the subgroup of patients without the need of mechanical ventilation at baseline. ICU-LOS D28 and D 90 mortality (in hospital) Tertiary (exploratory) outcomes: Viral load at D7 of study enrolment (No of viral RNA copies/ml of blood), proportion of patients alive and rtPCR negative from nasal swab at D14, Difference of FiO2 requirement and respiratory system compliance between day 0 and 7. Randomization: In 1:1:1 ratio and stratified according to study centre and patients age (cut-off 70 years) Blinding (masking): Patients, treating clinicians, outcome assessors and data analyst will be blinded to study treatment allocation. Unblinded study pharmacist or research nurse will prepare investigational products.

NCT04339816

Conditions

1. COVID-19
2. Respiratory Failure

Interventions

1. Drug: Azithromycin
2. Drug: Hydroxychloroquine
3. Drug: Placebo

MeSH:Respiratory Insufficiency

Evaluate HACOR socre utility and efficacy in predicting NIV and/or CPAP failure in patients with COVID-19 associated respiratory failure. Propose adaptations to HACOR score based on the "state of art" of COVID-19

NCT04342104

Conditions

1. Respiratory Failure
2. Covid-19

Interventions

1. Other: Monitoring for aggravation
2. Other: Evaluate HACOR score effectivity in this patients

MeSH:Respiratory Insufficiency

COVID-19 is a respiratory illness caused by SARS-CoV-2 with a range of symptoms from mild, self-limiting respiratory tract infections to severe progressive pneumonia, multiorgan dysfunction and death. A portion of individuals with COVID-19 experience life-threatening hypoxia requiring supplemental oxygen and mechanical ventilation. Management of hypoxia in this population is complicated by contraindication of non-invasive ventilation and limitations in access to mechanical ventilation and critical care staff given the clinical burden of disease. Positional therapy is readily deployable and may ultimately be used to treat COVID-19 related respiratory failure in resources limited settings; and, it has been demonstrated to improve oxygenation and is easy to implement in the clinical setting. The overall goal of this randomized controlled trial is to establish the feasibility of performing a randomized trial using a simple, minimally invasive positional therapy approach to improve hypoxia and reduce progression to mechanical ventilation. The objectives are to examine the effectiveness and feasibility of maintaining an inclined position in patients with confirmed or suspected COVID-19 associated hypoxemic respiratory failure. The investigators hypothesize that (1) oxyhemoglobin saturation will improve with therapy, (2) participants will tolerate and adhere to the intervention, and that (3) participants who adhere to positional therapy will have reduced rates of mechanical ventilation at 72 hours. If successful, this feasibility trial will demonstrate that a simple, readily deployed nocturnal postural maneuver is well tolerated and reverses underlying defects in ventilation and oxygenation due to COVID-19. It will also inform the design of a pivotal Phase III trial with estimates of sample sizes for clinically relevant outcomes.

NCT04344561

Conditions

1. COVID
2. Hypoxic Respiratory Failure

Interventions

1. Other: Postural Positioning

MeSH:Respiratory Insufficiency

The main manifestation of COVID-19 is acute hypoxemic respiratory failure (AHRF). In patients with AHRF, the need for invasive mechanical ventilation is associated with high mortality. Two hypotheses will be tested in this study. The first hypothesis is the benefit of corticosteroid therapy on severe COVID-19 infection admitted in ICU in terms of survival. The second hypothesis is that, in the subset of patients free of mechanical ventilation at admission, either Continuous Positive Airway Pressure (CPAP) or High-Flow Nasal Oxygen (HFNO) allows to reduce intubation rate safely during COVID-19 related acute hypoxemic respiratory failure.

NCT04344730

Conditions

1. Acute Hypoxemic Respiratory Failure
2. COVID-19

Interventions

1. Drug: Dexamethasone injection
2. Drug: placebo
3. Procedure: conventional oxygen
4. Procedure: CPAP
5. Procedure: HFNO
6. Procedure: mechanical ventilation

MeSH:Pneumonia Respiratory Insufficiency

HPO:Pneumonia

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.

NCT04346342

Conditions

1. COVID
2. Mechanical Ventilation
3. Acute Respiratory Failure

MeSH:Respiratory Insufficiency

The purpose of the study is to evaluate an effectiveness of the drug Dalargin 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 drug that will be administered to patients are: - Dalargin, solution for inhalation administration, - Dalargin, solution for intravenous and intramuscular administration.

NCT04346693

Conditions

1. Acute Respiratory Tract Infection
2. Acute Respiratory Insufficiency
3. Pneumonia
4. Septic Shock
5. Hypoxemia

Interventions

1. Procedure: Standard therapy recommended by the Ministry of Health of the Russian Federation.
2. Procedure: Standard therapy recommended by the Ministry of Health of the Russian Federation and Dalargin intramuscular injection
3. Procedure: Standard therapy recommended by the Ministry of Health of the Russian Federation and Dalargin inhalation
4. Procedure: Standard therapy recommended by the Ministry of Health of the Russian Federation and Dalargin intramuscular injection combined with Dalargin inhalation

MeSH:Infection Respiratory Tract Infections Pneumonia Respiratory Insufficiency Pulmonary Valve Insufficiency Hypoxia

HPO:Hypoxemia Pneumonia Pulmonary insufficiency Respiratory tract infection

Study of the effectiveness and safety of the drug Mefloquine, tablets 250 mg, produced by FSUE "SPC" Farmzaschita " FMBA of Russia (Russia), in comparison with the drug Hydroxychloroquine, tablets 200 mg, for the treatment of patients with coronavirus infection, in the "off-label" mode, to make a decision on the possibility of expanding the indications for use.

NCT04347031

Conditions

1. Pneumonia, Viral
2. Respiratory Failure

Interventions

1. Drug: Mefloquine
2. Drug: Hydroxychloroquine
3. Combination Product: Mefloquine + azithromycin + / - tocilizumab
4. Combination Product: Hydroxychloroquine + azithromycin + / - tocilizumab

MeSH:Pneumonia, Viral Pneumonia Respiratory Insufficiency

HPO:Pneumonia

Prone positioning (PP) is an effective first-line intervention to treat moderate-severe acute respiratory distress syndrome (ARDS) patients receiving invasive mechanical ventilation, as it improves gas exchanges and lowers mortality.The use of PP in awake self-ventilating patients with (e.g. COVID-19 induced) ARDS could improve gas exchange and reduce the need for invasive mechanical ventilation, but has not been studied outside of case series.The investigators will conduct a randomized controlled study of patients with COVID-19 induced respiratory failure to determine if prone positioning reduces the need for mechanical ventilation compared to standard management.

NCT04347941

Conditions

1. ARDS, Human
2. Mechanical Ventilation Complication
3. COVID19

Interventions

1. Procedure: Prone Positioning
2. Procedure: Standard of care.

MeSH:Respiratory Insufficiency Respiratory Distress Syndrome, Adult

COVID-19's mechanism to enter the cell is initiated by its interaction with its cellular receptor, the angiotensin-converting enzyme. As a result of this union, a clathrin-mediated endocytosis process begins. This route is one of the therapeutic targets for which available drugs are being investigated in order to treat COVID-19 infection. This is one of the mechanisms blocked by drugs like ruxolitinib and chloroquine. Various drugs approved for clinical use that block the clathrin-mediated endocytosis pathway have been explored. It has been found that the best in vitro and in vivo results were obtained with statins, which also allowed generating a greater potent adaptive immune response. Therefore, statins and specifically simvastatin make it possible to block the entry process used by COVID-19, block inflammation by various mechanisms and increase the adaptive immune response. All of these processes are desirable in patients infected with COVID-19. Statins have been proposed to have beneficial effects in patients infected with MERS-COV, another coronavirus similar to COVID-19, but there have been no randomized studies supporting the use of statins in patients with COVID-19 infection. In this project we propose the combined use of one of these drugs, ruxolitinib with simvastatin, looking for a synergistic effect in the inhibition of viral entry and in the anti-inflammatory effect.

NCT04348695

Conditions

1. Coronavirus Infection

Interventions

1. Drug: Ruxolitinib plus simvastatin
2. Other: Standard of Care

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Insufficiency

The objective of the study is to evaluate the efficacy of helmet NIV in reducing the duration of invasive mechanical ventilation in order to minimize ventilator needs during the COVID-19 pandemic.

NCT04349332

Conditions

1. Mechanical Ventilation
2. Corona Virus Infection

Interventions

1. Device: Helmet non-invasive ventilation (NIV)

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Insufficiency

The current sars-cov-2 epidemic is responsible for severe respiratory infections leading to end-of-life situations. Dexmedetomidine may be indicated in mild to moderate sedation in palliative patients, due to its pharmacological characteristics. The hypothesis of this study is that Dexmedetomidine would allow effective and safe light sedation in patients with respiratory failure in palliative situations suffering from Covid-19 infection.

NCT04350086

Conditions

1. COVID-19 Infection
2. Sars-cov-2
3. Respiratory Failure
4. Palliative Situation

Interventions

1. Drug: Treatment with Dexmedetomidine

MeSH:Infection Communicable Diseases Respiratory Insufficiency

This is an international, multicenter, parallel-group, randomized, double-blind, placebo controlled, study in hospitalized adult patients with COVID-19 in the US and other countries with high prevalence of COVID-19. The study is evaluating the effect of dapagliflozin 10 mg versus placebo, given once daily for 30 days in addition to background local standard of care therapy, in reducing disease progression, complications, and all-cause mortality.

NCT04350593

Conditions

1. COVID-19

Interventions

1. Drug: Dapagliflozin 10 MG
2. Drug: Placebo

MeSH:Respiratory Insufficiency

The study aims to investigate the efficacy of extracorporeal CO2 removal for correction of hypercapnia in coronavirus disease 19 (COVID-19)-associated acute respiratory distress syndrome

NCT04351906

Conditions

1. ARDS
2. Hypercapnic Respiratory Failure
3. AKI

Interventions

1. Device: ECCO2R

MeSH:Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Respiratory Insufficiency Acute Lung Injury

This study will assess the feasibility of administering multiple doses of convalescent plasma (from people who have recovered form SARS-CoV-2) to Covid-19 positive patients in the Intensive Care Unit receiving mechanical ventilation. Donor plasma will not be obtained under this protocol, but all plasma used will follow FDA guidelines for Investigational COVID-19 Convalescent Plasma use. Patients may receive single or double plasma units infused on days 0, 3, and 6. This decision may be based on availability of blood plasma. The primary objective of this study is feasibility. Feasibility will be assessed based on the proportion of subjects who consent and receive at least one dose of convalescent plasma. The study will be declared 'feasible' if at least 80% of subjects who consent receive at least one dose. The secondary study endpoint is overall survival at day 60 after first dose of convalescent plasma. Respiratory status and overall clinical status will be reviewed during follow up on days 14, 28, and 60.

NCT04353206

Conditions

1. Covid-19
2. Sars-CoV2

Interventions

1. Biological: Multiple Doses of Anti-SARS-CoV-2 convalescent plasma

MeSH:Respiratory Insufficiency

The aim of the present study is to examine the inflammatory response in the pulmonary compartment and blood of critically ill patients admitted to the ICU with COVID-19.

NCT04354584

Conditions

1. COVID-19
2. Respiratory Failure

MeSH:Respiratory Insufficiency Inflammation

During Covid-19 pandemic many patients require mechanical ventilation due to disastrous impact of SARS-CoV-2 on lungs. In several countries there is a shortage of ICU beds and ventilators. Critically ill patients are treated outside ICUs. Doctors are facing ethical dilemmas who they should treat with ventilation, who should receive ventilator and who should but will not. In ICUs or step down units or in nursery homes there are also patients beyond hope treated - very often they are dependent on mechanical ventilation. Some attempts to invent a device that could replace complex machines in patients with anticipated poor outcome have been made. Ventil was used in clinical scenarios for separate lung ventilation with good effect. As a flow divider it has a potential to ventilate 2 patients at the same time. In the study Ventil will ventilate one patient and instead of the second there will be an artificial lung. Tidal volumes, minute ventilation, PEEP set and final will be checked. Ppeak, Pmean, Pplat, Cdyn, airway resistance, EtCO2, Sat O2, HR, SAP, DAP will be monitored every 2 hrs, as well as blood-gas analysis (every 8 hrs).

NCT04355754

Conditions

1. Respiratory Insufficiency

Interventions

1. Device: Ventil - a gas flow divider

MeSH:Respiratory Insufficiency Pulmonary Valve Insufficiency

HPO:Pulmonary insufficiency

This study uses the AirGo band to monitor changes in tidal ventilation in spontaneously breathing patients with COVID-19 associated respiratory failure. It aims to recognize patterns of ventilation associated with worsening respiratory failure in this patient population. If successful, this study will lead to the development of new robust methods for real-time, continuous monitoring of respiratory function in patients with respiratory failure. In turn, such monitoring methods may enable improvements in the medical management of respiratory failure and timing of interventions.

NCT04356443

Conditions

1. Respiratory Failure
2. Ventilatory Failure
3. COVID-19
4. Pneumonia
5. ARDS, Human

Interventions

1. Device: AirGo Respiratory Monitor

MeSH:Pneumonia Respiratory Insufficiency Respiratory Distress Syndrome, Adult Hypoventilation

HPO:Hypoventilation Pneumonia

In the SAVE study patients with lower respiratory tract infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at high risk for progression to serious respiratory failure will be detected using the suPAR biomarker. They will begin early treatment with anakinra in the effort to prevent progression in serious respiratory failure. Also due to the potential co-existing immunodysfunction in the context of SARS-CoV-2 infection patients will also receive trimethoprim/sulfamethoxazole as part of chemoprophylaxis.

NCT04357366

Conditions

1. COVID-19
2. Virus Dis
3. Virus Diseases
4. Corona Virus Infection
5. Lower Respiratory Tract Infection Viral

Interventions

1. Drug: Anakinra
2. Drug: trimethoprim/sulfamethoxazole

MeSH:Infection Communicable Diseases Respiratory Tract Infections Virus Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Insufficiency

HPO:Respiratory tract infection

The COVID-19 outbreak is associated with a surge in ICU bed requirement and substantial mortality (estimated between 0.5% and 3.6%). Admission in the intensive care unit (ICU) and need for mechanical ventilation is reportedly associated with an estimated hospital mortality of more than 30%. Furthermore, the surge in ICU bed requirement is a worldwide-shared issue, leading to sub-optimal ICU management. In acute respiratory failure due to COVID-19-related pneumonia, vasoplegia with vascular enlargement inside the lung lesions and dilation of small vessels seen on chest CT scan largely account for severe hypoxemia whose physiological response is hyperventilation leading to hypocapnia. Almitrine, initially described to reduce intrapulmonary shunt by enhancement of hypoxic pulmonary vasoconstriction in combination with inhaled nitric oxide (iNO), redistributes pulmonary blood flow from shunt areas to lung units with normal ventilation/perfusion (VA/Q) ratio. Low dose of intravenous almitrine (2 µg.kg-1.min-1) alone also improves oxygenation (without combination with iNO) by selective pulmonary vasoconstriction of precapillary pulmonary arteries perfusing lung areas exposed to a hypoxic challenge with a slight increase in mean arterial pulmonary. Therefore, our hypothesis is that 5 days of low dose of almitrine therapy may improve the ventilation-perfusion (VA/Q) ratio at a relatively early stage of this specific lung disease and limit respiratory worsening and subsequent need for mechanical ventilation.

NCT04357457

Conditions

1. Covid 19
2. Hypoxemic Respiratory Failure

Interventions

1. Drug: Almitrine
2. Drug: Placebo

MeSH:Pneumonia Respiratory Insufficiency

HPO:Pneumonia

The global pandemic COVID-19 has overwhelmed the medical capacity to accommodate a large surge of patients with acute respiratory distress syndrome (ARDS). In the United States, the number of cases of COVID-19 ARDS is projected to exceed the number of available ventilators. Reports from China and Italy indicate that 22-64% of critically ill COVID-19 patients with ARDS will die. ARDS currently has no evidence-based treatments other than low tidal ventilation to limit mechanical stress on the lung and prone positioning. A new therapeutic approach capable of rapidly treating and attenuating ARDS secondary to COVID-19 is urgently needed. The dominant pathologic feature of viral-induced ARDS is fibrin accumulation in the microvasculature and airspaces. Substantial preclinical work suggests antifibrinolytic therapy attenuates infection provoked ARDS. In 2001, a phase I trial 7 demonstrated the urokinase and streptokinase were effective in patients with terminal ARDS, markedly improving oxygen delivery and reducing an expected mortality in that specific patient cohort from 100% to 70%. A more contemporary approach to thrombolytic therapy is tissue plasminogen activator (tPA) due to its higher efficacy of clot lysis with comparable bleeding risk 8. We therefore propose a phase IIa clinical trial with two intravenous (IV) tPA treatment arms and a control arm to test the efficacy and safety of IV tPA in improving respiratory function and oxygenation, and consequently, successful extubation, duration of mechanical ventilation and survival.

NCT04357730

Conditions

1. Severe Acute Respiratory Syndrome
2. Respiratory Failure
3. Acute Respiratory Distress Syndrome

Interventions

1. Drug: Alteplase 50 MG [Activase]
2. Drug: Alteplase 100 MG [Activase]

MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Respiratory Insufficiency Acute Lung Injury Syndrome

To characterize the ability of the D2000 Cartridge in combination with the Optia SPD Protocol to reduce the morbidity and mortality associated with SARS-CoV-2 infection in patients admitted to the ICU.

NCT04358003

Conditions

1. Respiratory Failure
2. ARDS

Interventions

1. Device: Marker Therapeutics D2000 Cartridge (D2000) for use with the Spectra Optia® Apheresis System (Optia SPD Protocol)

MeSH:Respiratory Insufficiency

The investigators hypothesize that those with respiratory failure due to COVID-19 will have different burdens of mental and physical disability than those with respiratory failure who do not have COVID-19. Detecting these potential differences will lay an important foundation for treating long term sequelae of respiratory failure in these two cohorts.

NCT04360538

Conditions

1. Critical Illness
2. Corona Virus Infection
3. Respiratory Failure
4. Covid-19

Interventions

1. Other: Quality of Life
2. Other: Impact Event Score
3. Other: Hospital anxiety and depression scale

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Insufficiency Critical Illness

Prospective observational study aimed at analyzing the incidence, clinical characteristics and outcomes of COVID-19 in LT in Spain.

NCT04361591

Conditions

1. Liver Transplant; Complications
2. COVID19
3. Respiratory Failure

Interventions

1. Other: Observational only

MeSH:Respiratory Insufficiency

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the cause of the current pandemic of coronavirus disease (COVID-19) that can lead to respiratory failure requiring oxygen therapy. Some patients develop acute respiratory distress syndrome (ARDS) and may die despite intensive care therapy. Currently it is unknown a) how fast patients recover after being discharged from hospital and b) what underlying predictors may influence recovery.

NCT04365595

Conditions

1. SARS-CoV 2
2. COVID

Interventions

1. Other: Questionnaires, spirometry

MeSH:Respiratory Insufficiency

Acute respiratory distress syndrome (ARDS) is a major complication among patients with severe disease. In a report of 138 patients with COVID-19, 20% developed ARDS at a median of 8 days after the onset of symptoms, with 12.3% of patients requiring mechanical ventilation. Efficacious therapies are desperately needed. Supportive care combined with intermittent prone positioning may improve outcomes. Prone positioning (PP) of patients with severe ARDS (when combined with other lung-protective ventilation strategies) is associated with a significant mortality benefit. In addition, PP for >12 hours in severe ARDS is strongly recommended by clinical practice guidelines. The aim of this study is to compare the outcomes of prone positioning versus usual care positioning in non-intubated patients hospitalized for COVID-19.

NCT04368000

Conditions

1. Respiratory Failure
2. COVID-19

Interventions

1. Behavioral: Intermittent prone positioning instructions
2. Behavioral: Usual care positioning with no instructions

MeSH:Respiratory Insufficiency

This is a compassionate use, proof of concept, phase IIb, prospective, interventional, pilot study in which the investigators will evaluate the effects of compassionate-use treatment with IV tirofiban 25 mcg/kg, associated with acetylsalicylic acid IV, clopidogrel PO and fondaparinux 2.5 mg s/c, in patients affected by severe respiratory failure in Covid-19 associated pneumonia who underwent treatment with continuous positive airway pressure (CPAP).

NCT04368377

Conditions

1. Pneumonia, Viral
2. Corona Virus Infection
3. Respiratory Failure
4. Embolism and Thrombosis

Interventions

1. Drug: Tirofiban Injection
2. Drug: Clopidogrel
3. Drug: Acetylsalicylic acid
4. Drug: Fondaparinux

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Pneumonia Respiratory Insufficiency Thrombosis Embolism Embolism and Thrombosis

HPO:Pneumonia Thromboembolism

Patients with the acute respiratory distress syndrome (ARDS) have markedly varied clinical presentations. Main characteristics of mechanically ventilated ARDS caused by COVID-19, and adherence to lung-protective ventilation strategies are not well known.

NCT04368975

Conditions

1. Acute Respiratory Failure With Hypoxia

MeSH:Respiratory Insufficiency Hypoxia

HPO:Hypoxemia

The COVID-19 pandemic has led to a potential shortage of life-saving mechanical ventilators. The purpose of this study is to determine whether a novel simpler to device, the automated bag-valve-mask (BVM) compressor, can be used to provide assisted ventilation temporarily to patients in need. This includes patients with COVID-19 lung infection and respiratory failure. If successful, this would increase the pool of total available ventilator hours to alleviate any shortage.

NCT04369274

Conditions

1. Respiratory Failure

Interventions

1. Device: Mechanical ventilation with the automated BVM compressor

MeSH:Respiratory Insufficiency