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Covid19 clinical trials

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NCT ID: NCT04412382 Recruiting - Covid-19 Clinical Trials

Covid-19: Possible Role of Neutrophil Extracellular Traps

NETSINCOVID
Start date: June 1, 2020
Phase:
Study type: Observational [Patient Registry]

The process by which neutrophils expel DNA together with various proteins to the outside, forming a network structure called Neutrophil Extracellular Traps (NETs) constitutes a particular cell death that involves the destruction of the nuclear membrane before the plasmatic one. This process is called NETosis and differs from other known forms of cell death, such as necrosis and apoptosis. This process, however, if exaggerated, brings local or systemic damage. Viruses are known for their ability to evade the body's immune response. Only recently has it been seen that they can act as triggers for NETosis process. In fact, many viruses can stimulate neutrophils to produce NETs. Virus-induced NETs can begin to circulate in an uncontrolled manner, leading to an extreme systemic response of the body with the production of immunocomplexes, cytokines, Interferon I etc. To date, there are no data in the literature on the role of NETs in Covid-19 infection, a viral infection that leads to highly lethal interstitial pneumonia and for which there is currently no vaccine or specific therapy. Advanced forms of Covid-19 are often characterized by hyperinflammation ("cytokine storm") with the development of an ARDS-like condition. Furthermore, reports of micro and macro thrombotic phenomena such as microangiopathy, pulmonary embolism (which has led to a careful evaluation procedure for antithrombotic prophylaxis and/or coagulation in Covid-19 patients) are increasingly frequent. The primary objective of the study is to understand if NETs can be implicated in the response to Covid-19 and by which mechanisms. Concrete therapeutic proposals could derive from the knowledge and enhancement of this form of innate immunity. To do this, it will be necessary to evaluate the activity of NETosis in Covid-19 patients and evaluate whether the clinical course of the disease (worsening vs healing) determines the degree of NETosis activity. Therefore, the association between mortality from Covid-19/survival and NETs activity will be studied. Secondary objectives concern the possibility of studying the associations among NETosis markers and blood inflammation markers and among NETosis markers and the onset of peripheral or deep vein thrombosis. Finally, the possibility that the plasma deriving from Covid-19 patients could trigger the NETosis process in vitro will be evaluated.

NCT ID: NCT04412369 Active, not recruiting - Clinical trials for Cardiovascular Diseases

Multi-modality Imaging & Immunophenotyping of COVID-19 Related Myocardial Injury

MIIC-MI
Start date: July 1, 2020
Phase:
Study type: Observational

Cardiovascular involvement in coronavirus disease-2019 (COVID-19) encompasses a wide range of vascular and myocardial pathologies, including both acute and long-term sequelae. The MIIC-MI study aims to investigate mechanisms of cardiac injury in COVID-19 using multi-modality imaging and immunophenotyping to better understand the link with adverse patient outcomes.

NCT ID: NCT04412356 Completed - Covid-19 Clinical Trials

Timing of Tracheotomy in Covid-19 Patients

TTCOV19
Start date: June 6, 2020
Phase: N/A
Study type: Interventional

Critically ill covid-19 patients may require respiratory support including mechanical ventilation. After an initial period with an endotracheal tube, a tracheotomy is performed in order to reduce potential airway complications, reduce the need of sedation and facilitate the monitoring and recovery. The optimal timing of this surgical procedure is, however, still unknown. The aim of this randomized, controlled trial is to compare the outcome of early (within 7 days after intubation) vs late (at least 10 days after intubation) tracheotomy in covid-19 patients. The need for mechanical ventilation, sedation, additional oxygen support, frequency of complications, duration at the ICU and mortality through the ICU stay will be evaluated and compared.

NCT ID: NCT04412330 Completed - Covid-19 Clinical Trials

Optimizing Outcomes With Physical Therapy Treatment for IndividuALs Surviving an ICU Admission for Covid-19

OPTIMAL
Start date: May 1, 2020
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT04412317 Recruiting - Covid-19 Clinical Trials

Use of PCR-Sars-CoV-2 in Children

VIGIL
Start date: June 3, 2020
Phase:
Study type: Observational [Patient Registry]

The VIGIL study was set up at the beginning of the pandemic, in the spring of 2020, at a time when diagnostic testing for SARS-CoV-2 had to be performed according to specific clinical criteria (even if no clinical picture suggestive of COVID had been clearly identified). The management of sick young children (with respiratory tract infection that could be attributed to COVID) by pediatricians (infectious diseases specialists, emergency physicians, general practitioners, and outpatients) was facilitated by an algorithm whose objective was to help define the indications for SARS-CoV-2 PCR and subsequently for antigenic testing. The current technique of deep nasopharyngeal swabbing (for PCR or antigenic testing) is delicate and difficult in children, and is therefore a serious handicap for community-based screening, especially since infectious episodes are frequent in children. Since then, nasal self-tests that can be easily used in children have been commercialized and have facilitated screening. Because of the similarity between the clinical signs of respiratory tract infections in children, it is often impossible to distinguish between different viral respiratory infections and epidemics may overlap in time. However, the identification of the pathogen is the key to improve management of these infectious diseases. The VIGIL study is therefore continuing, still facilitated by the existence of an active pediatric network existing for 20 years. ACTIV AFPA and GPIP have created networks of hospital and ambulatory pediatricians who actively participate in various observatories https://www.jpeds.com/article/S0022-3476(17)31606-2/fulltext To date, these observatories have resulted in the publication of more than 80 articles in international journals (https://www.activ-france.com/fr/publications).

NCT ID: NCT04412304 Completed - Covid-19 Clinical Trials

Anticoagulant Therapy and 28-days Mortality in Critically Ill COVID-19 Patients

Start date: March 6, 2020
Phase:
Study type: Observational

The aims of the study are to to associate anticoagulation (AC) regime with outcome in critically ill patients with Covid-19. This will be done by describe baseline characteristics and comorbidities before hospital admission, level of organ support and dose of AC treatment and associate this with 28 days survival, survival outside ICU, thromboembolic event and bleeding complications.

NCT ID: NCT04412291 Recruiting - Covid-19 Clinical Trials

A Study in Patients With COVID-19 and Respiratory Distress Not Requiring Mechanical Ventilation, to Compare Standard-of-care With Anakinra and Tocilizumab Treatment The Immunomodulation-CoV Assessment (ImmCoVA) Study

Start date: June 11, 2020
Phase: Phase 2
Study type: Interventional

The study is designed as a randomized, controlled, multi-center open-label trial to compare standard-of-care (SOC) treatment with SOC + anakinra or SOC + tocilizumab treatment in hospitalized adult subjects who are diagnosed with severe COVID 19. Arm A: Standard-of-care Treatment (SOC) Arm B: Anakinra + SOC Arm C: Tocilizumab + SOC. All subjects will be treated with standard-of-care treatment. Arms B and C will also receive broad spectrum antibiotics initiated before or latest 24 hours after initiation of treatment with study drug. The primary follow-up period of the study is 29 days.

NCT ID: NCT04412278 Completed - COVID Clinical Trials

Impact of COVID-19 Pandemic on Perceived Exercise Benefits and Barriers

Start date: June 1, 2020
Phase:
Study type: Observational

It is aimed to determine the physical activity level and exercise benefits and barriers caused by Covid-19 pandemic and reveal the relationship between them.

NCT ID: NCT04412265 Completed - Covid19 Clinical Trials

Frailty in Elderly Patients With COVID-19

FRA-COVID
Start date: April 16, 2020
Phase:
Study type: Observational

This is a multicentric retro-prospective observational study that wants to evaluate the relation between frailty and clinical outcomes in elderly patients with COVID-19.

NCT ID: NCT04412252 Withdrawn - COVID-19 Clinical Trials

Safety and Efficacy of Tofacitinib in Hospitalized Participants With COVID-19 Pneumonia Who Are Receiving Standard of Care Therapy

Start date: July 6, 2020
Phase: Phase 2
Study type: Interventional

The study is designed as a multicenter, randomized, double-blind, placebo-controlled, parallel group study of the safety and efficacy of tofacitinib in hospitalized adult participants with COVID-19 pneumonia who are receiving SoC therapy and who are not on HFNC, noninvasive ventilation, invasive mechanical ventilation, or ECMO on Day 1 at the time of randomization. Participants with laboratory confirmed SARS-CoV-2 infection as determined by a positive PCR or other commercially available or public health assay, who have agreed to participate will be screened within 48 hours after hospitalization to determine eligibility. This should be completed within 48 hours prior to Day 1. Eligible participants will be randomized on Day 1 in a 1:1 ratio to the tofacitinib treatment group or the placebo treatment group and will receive treatment for up to 14 days, or until discharge from the hospital, whichever is earlier. If a participant requires intubation prior to the end of the 14-day treatment period, they will continue to receive tofacitinib or matching placebo until Day 14 (or until discharge from the hospital, if earlier than Day 14), if clinically appropriate. Participants will be assessed daily (up to Day 28) while hospitalized for clinical, safety, and laboratory parameters. Follow-up visits will occur on Day 28, 28 to 35 days after the ET/ED/EOT visit, and on Day 60. An independent, external DSMB will be convened to oversee the safety of participants and make recommendations regarding the conduct of the trial in accordance with the Charter.