When to Apply to Which Patient in MSC?
COVID-19 Acute Respiratory Distress SyndromeMesenchymal stem cell (MSC) therapy is among the promising treatments for acute respiratory distress syndrome (ARDS). Our study aimed to investigate the clinical efficacy of MSC treatment in COVID-19 patients, to determine when this treatment can be applied to which patient, and to evaluate its contribution to prognosis.
Impact of Post-ARDS Covid-19 Sedation on Persistent Neuroinflammation
Severe COVID-19ICU Patients admitted after ARDS due to COVID infection should be weaned from invasive mechanical ventilation as quickly as possible. 60% of ARDS patient after COVID infection admitted in ICU developp a delirium during mechanical ventilation weaning, serious event that can lead to death or acute and late complications since 30% of patients who had a delirium in ICU develop cognitive sequelae. Based on epidemiological arguments and mouse models, severe neuroinflammation is considered to be one of the physiopathological mechanisms causing delirium during ventilatory weaning. In addition to its sedative properties, dexmedetomidine exhibits neuroprotective effects. In experimental models, dexmedetomidine reduces brain inflammation acting directly on the microglial phenotype. The role of this chronic neuroinflammatory condition on cognitive abilities and reserve begins to emerge in the literature no matter the initial stress is (surgery, head trauma, or Alzheimer's type dementia) and is therefore able to influence quality of life. The evaluation of this neuroinflammation by non-invasive tools appears essential in the management and follow-up of post-COVID cerebrolesed patients, as well as the potentially neuroprotective evaluation of dexmedetomidine.
Safety and Immunogenicity of Recombinant Protein RBD Fusion Dimer Vaccine Against the Virus That...
COVID-19SARS-CoV-2 Acute Respiratory DiseaseThis is a Phase IIb, randomized, controlled, observer-blinded, clinical trial to evaluate safety and immunogenicity of COVID-19 Vaccine HIPRA in adult healthy volunteers in Vietnam
Immunogenicity and Safety of a Booster Vaccination With a Recombinant Protein RBD Candidate Vaccine...
COVID-19SARS-CoV-2 Acute Respiratory DiseaseThis Phase IIb clinical study aims to compare the immunogenicity and safety of a booster dose of recombinant protein RBD fusion dimer vaccine as a heterologous booster (to subjects who have received the second dose of the Pfizer-BioNTech (Comirnaty) COVID-19 vaccine at least 182 days prior to the booster dose in this study) versus a homologous booster (subjects who received the second dose of the Comirnaty COVID-19 vaccine at least 182 days prior to the booster dose in this study) will receive a third dose of the Comirnaty vaccine). The extension part of the study aims to compare the immunogenicity and safety of a fourth dose of PHH-1V in subjects with a primovaccination with Pfizer-BioNTech (Comirnaty) COVID-19 vaccine plus either a booster dose of Comirnaty or PHH-1V versus those with three vaccinations of Comirnaty.
National Vaccine Adverse Event Reporting Survey and Etiology
COVID-19Vaccine Adverse Reaction12 moreIf your serious vaccine-induced adverse event has been entered in the CDC Vaccine Adverse Event Reporting System (VAERS) we are interested in enrolling you for this study in order to log your symptoms. The primary goal of this study is to create a national database and gather vaccine-associated serious adverse events/injury data from newly vaccinated individuals in the US in order to identify the possible underlying causal relationships and plausible underlying biological mechanisms. The project aims to identify the genetic determinants of vaccine-induced adverse response by studying host genetics. We plan to use whole genome sequencing to identify single nucleotide polymorphisms associated with cardiovascular, neurological, gastrointestinal, musculoskeletal and immunological symptoms induced by vaccine administration. The secondary goal is to establish criteria that enable classification of vaccine-induced adverse events/injuries compare data from our database with the official Vaccine Injury Table National Vaccine Injury Compensation Program on or after March 21, 2017. The tertiary goal is to establish a database to gather detailed long-term adverse reaction data from subjects enrolled in FDA Emergency Use Authorized vaccine clinical trials.
Ventilator Strategies in ICU Patients With COVID-19 - a National-wide Retrospective Observational...
ARDS Due to COVID-19Mechanical ventilation is likely lifesaving in patients with coronavirus disease 2019 (COVID-19) but may also result in adverse events. Only few studies describe the strategies used and adverse effect of mechanical ventilation in an unselected population of ICU patients with COVID-19. This study is designed to be a retrospective study focusing on all mechanical ventilated ICU patients with COVID-19 included in the national Danish COVID ICU database between 10.03.2020 - 02.04.2021 i.e. a total of 1,193 patients. The investigators will register the use of the core interventions around mechanical ventilation and its potential adverse event, including barotrauma and prolonged ventilation. This study will provide important data on the ventilation strategies used and its potential adverse events in unselected ICU patients with COVID-19 and thereby inform clinicians, patients, policy-makers, and future research in this area.
Nitric Oxide Nasal Spray (NONS) as Prevention for Treatment of Individuals at Risk of Exposure to...
SARS-CoV-2 InfectionA multicenter, randomized, double-blinded, placebo-controlled, phase 3 clinical efficacy study evaluating nitric oxide nasal spray (NONS) as prevention for treatment of individuals at risk of exposure to COVID-19 infection.
Musculoskeletal Problems and Endurance in Healthcare Professionals With and Without COVID-19
COVID-19 Respiratory InfectionThe effects of frequency and severity of physical complaints and symptoms on general well-being, sleep and quality of life are known. However, in the COVID-19 process, the disease has very different effects, both physical and psychological, and some symptoms persist even if the disease is overcome; In addition to these, the fact that the measures taken throughout the country prompt individuals to take measures to protect themselves from the disease and make it compulsory under some conditions intertwine many different dimensions of the disease on human health and significantly affect daily life. In this context, our first aim in this study is to compare factors such as musculoskeletal problems, physical activity level, endurance and quality of life in healthcare workers with and without COVID-19. Seconder aim is to examine the relationships between factors such as musculoskeletal problems, physical activity level, endurance and quality of life, and to examine the effect levels of the parameters by performing regression analyzes depending on the result.
Safety and Immunogenicity of 9-valent Human Papillomavirus (9vHPV) Vaccine Coadministered With Messenger...
Papillomavirus InfectionsCoronavirus Disease (COVID-19)The purpose of this study to evaluate the safety and immunogenicity of a 2-dose regimen of 9vHPV vaccine, where the first dose is administered concomitantly with a first dose of a 2-dose regimen of mRNA-1273 vaccine versus nonconcomitant administration of 9vHPV and mRNA-1273 vaccines in boys and girls 9 to 11 years of age.
Immunogenicity and Reactogenicity Following a Booster Dose of COVID-19 mRNA Vaccine (Pfizer-BioNtech)...
COVID-19Vaccine ReactionThe vaccination campaign in France began in early 2021 and was declared mandatory for all French people in July 2021. The efficacy of COVID-19 vaccines has since been widely demonstrated, as well as their safety, and now 60% of the adult population in France has received a first dose, most of them with Pfizer-BioNTech's mRNA vaccine. However, despite the increasing coverage, new data highlight the need for a booster dose for the most vulnerable people, including patients with immune deficiency. This makes it likely that a booster dose will also be needed in the general population, especially among healthcare workers, due to the active circulation of new variants since the beginning of summer 2021 and evidence of reduced protection against them. On the other hand, in addition to evaluating the potential benefit of a booster vaccination, it appears interesting to also evaluate a heterologous vaccination regimen, i.e. a booster with a different vaccine than the one used for the primary vaccination. Some studies have already evaluated a two-dose heterologous regimen and the results have shown stronger protection against SARS-CoV-2. In addition, this alternative could provide a real benefit in terms of accessibility, cost, and acceptability. The vaccine developed by Sanofi-Pasteur is based on a traditional recombinant protein approach using GSK's AS03 adjuvant. Two formulations of this vaccine are currently under development, the first targeting the S protein of the D614 strain (Wuhan strain), the second targeting the B.1.351 variant. Their value as a booster needs to be evaluated. The objective of this trial is therefore to evaluate the immunological response and safety induced by a homologous vaccine booster (Pfizer-BioNTech vaccine booster) and a heterologous vaccine booster (one of the two experimental Sanofi/GSK vaccines booster), on the D614 (Wuhan) strain and on the SARS-CoV-2 variants.