State of Oxygen Metabolism, Cardiovascular and Respiratory System Reserve Capacity in Patients Who...
Covid19COVID19 InfectionThis clinical study will create an evidence base for rehabilitation approach, which will be used for restoration of pulmonary ventilation and gas exchange, increase of tolerance to physical load reduced in patients who underwent COVID-19. The aim of the present clinical study is to evaluate the effectiveness of medical rehabilitation of COVID-19 patients based on the study of individual physiological parameters of oxygen metabolism and reserve capabilities of the cardiovascular and respiratory systems.
Two-year Efficacy of Three Exercise Rehabilitation Strategies on Dyspnea in Patients Who Presented...
DyspneaCOVID-19Dyspnea is defined by a subjective sensation of respiratory discomfort, the intensity of which varies according to the terrain, the anamnesis and the cause. Resuscitation is associated with many causes of dyspnea, including initial distress, mechanical ventilation, or after-effects following the pathology and its management. Respiratory distress is the most severe form of impaired lung function. It is the first cause of hospitalization in intensive care. This distress, indicative of the failure of the respiratory system, is always severe and potentially fatal. It therefore constitutes an absolute therapeutic emergency. Dyspnea is often the revealing symptom of the condition and the urgency surrounding its management is an additional factor of concern for the patient. As a result, dyspnea is a pejorative element associated with severity or even death. In patients surviving the initial condition, dyspnea persists and can be found months or even years later, despite the initial rehabilitation. It is strongly associated with anxiety or even the fear of dying and contributes to the occurrence of post-traumatic stress syndromes. This persistent sensation of respiratory discomfort, limiting the patient's autonomy in his activities of daily living, seems to be able to reduce his quality of life. In addition, the perpetuation of this dyspnea could favor a spiral of deconditioning causing a progressive deterioration of the cardio-respiratory system justifying new hospitalizations. In patients with chronic respiratory failure, exercise rehabilitation supervised by hysiotherapists allows, in addition to improving autonomy, a significant reduction in dyspnoea, thus increasing the quality of life of these patients. The main objective of this study is to evaluate the effect at 2 years of 3 modes of management of dyspnea: exercise rehabilitation, standard physiotherapy and "usual care" on post-resuscitation dyspnea in patients with presented with severe COVID-19.
Randomized, Single-blinded, Multicenter Trial Comparing the Immune Response to a 2nd Booster Dose...
COVID-19 VaccinesThe effectiveness of COVID-19 vaccines in reducing the risk of severe COVID-19 is currently demonstrated. In France, since the beginning of the vaccination campaign, 54,266,859 people have received at least one injection (ie. 80.5% of the total population), 53,354,698 people now have a complete vaccination schedule (ie. 79.1% of the total population) and since the beginning of the booster campaign, 39,558,416 people have received a 1st booster dose. However, the data currently available on the persistence of immunity on the one hand, and the appearance of viral variants with reduced sensitivity to vaccine immunity on the other, suggest the need to administer booster doses at variable intervals depending on age and comorbidities. Real-life efficacy data from France and around the World confirm that people who have received a booster dose are better protected than those who have only received a primary vaccination schedule (HAS). In this context, the Ministry of Health, has pronounced on the possibility of administering a second booster dose for people aged 60 and over. Moreover, the recommendations for the Haute Autorité de Santé for the 2nd booster dose in general population should be available in June 2022. Three vaccines, mRNA BNT162b2 vaccine, Sanofi/GSK monovalent D614 and B.1.351 formulations were administered as 1st booster in the CoviBOOST trial. All three vaccines boosted antibodies and neutralizing response after a BNT162b2 initial course. Heterologous boosting with the Sanofi/GSK SARS-CoV-2 recombinant adjuvanted protein vaccine B.1.351 (Beta formulation) provided higher rates of neutralizing antibodies against variants, including Omicron BA.1, compared with the mRNA BNT162b2 vaccine. Due to the start of the study after the beginning of booster vaccination campaign in elderly, the enrollment of participants over 65 years of age was difficult so, only 8 subjects aged 60 years and over were enrolled. As vaccine immunogenicity is lower in older populations and is waning more rapidly, it is important to evaluate the adjuvanted vaccine in this population. The objective of this ancillary study is to compare, in participants aged of 60 years and older and previously vaccinated with 3 doses of mRNA vaccine (2 doses of Pfizer BioNTech) and a 3rd dose of Pfizer BioNTech or Moderna, the immunogenicity of a second booster dose of the B.1.351 strain recombinant protein- based subunit vaccine to BNT162b2 (mRNA Pfizer BioNTech Vaccine).These results will provide important information for booster vaccination recommendations in this age group.
Efficacy, Safety and Immunogenicity Study of the Recombinant Two-component COVID-19 Vaccine (CHO...
COVID-19This is a multicenter designed Phase III clinical trial. About 10000 participants plan to be enrolled.The objectives of this study are to evaluate the efficacy, safety and immunogenicity of the recombinant two-component COVID-19 vaccine (CHO cell) in adults
Impact of COVID-19 Vaccination on Serum 25-hydroxyvitamin D Level
Acne VulgarisVitamin D Deficiency1 moreVitamin D plays a pivotal but still not well understood role in the immune response to coronavirus disease (COVID-19) infection and vaccination. Many studies also showed a high negative correlation between the severity of inflammatory disease and serum 25-hydroxyvitamin D levels. Patients with acne vulgaris often had deteriorated skin condition after COVID-19 vaccination. Therefore, this study aimed to investigate the relationship of COVID-19 vaccination with serum 25-hydroxyvitamin D level and severity of acne vulgaris.
Olfactory Training in COVID-19 Associated Loss of Smell
COVID-19HyposmiaOlfactory dysfunction (OD) like hyposmia or anosmia has been realized as a common symptom or even cardinal sign of the disease and can be persisting after recovering. There are two different hypotheses on the pathogenesis of OD in past COVID-19: The central hypothesis, which speculates on neurotrophic abilities on olfactory receptors in the neuroepithelium, and the peripheral hypothesis, which speculates on damage of the sensory olfactory epithelium. Potential treatment strategies aim for the unique neural plasticity of the olfactory system and its potential for recovery. Clinical studies and case reports have shown a promising effect of olfactory training (OT) by frequent sniffing and/or exposure to odors 2-4 times a day for several weeks. The main objective of the study is to assess the effects of olfactory training in patients with COVID-19 related OD on: objective olfactory testing with the Sniffin' sticks test (identification and discrimination) (primary endpoint), subjective OD and its impact on the daily life (key secondary endpoint), other clinical scales and questionnaires referring to OD-related mood and quality of life (other secondary endpoint), gender differences in COVID-19 related OD (exploratory endpoint). Approach / methods OT will be performed twice a day with a 4-odor training set for 12 weeks. Effects of OT on COVID-19 related OD will be measured with objective and subjective efficacy variables. The sense of smell is an important function for social relationships and is therefore a challenging clinical problem with few proven therapeutic options. With this new approach, we want to investigate a possible simple treatment for an impedimental symptom of COVID-19, but also learn more about the pathomechanism of post-infectious OD. To our knowledge, this will be the first study comparing patients with COVID-19 associated OD with and without OT in clinical outcomes.
CU-COMMITS: COVID-Care in Black and Latino Communities and Households. Clinical and Molecular Outcomes...
COVID-19SARS CoV 2 InfectionThe purpose of this study is to describe the long-term health effects of COVID-19 in a population of mostly Black and Latinx individuals and their households who were diagnosed with COVID-19 at Columbia University Irving Medical Center. In New York, the upper Manhattan and south Bronx communities neighboring Columbia University Irving Medical Center (CUIMC) have been two of the most impacted communities of the COVID-19 pandemic. These neighborhoods are predominantly non-Hispanic black or African American and Latinx. This study will invite people who tested positive for COVID-19 and/or were treated at Columbia University Irving Medical Center to: 1) take a survey to ask about current symptoms and any health problems and 2) ask permission to review COVID-related health history including COVID-19 testing results (from the medical record) since infection to learn about health effects after COVID-19 infection; 3) invite anyone in their household to take a survey; and 4) for up to 500 patients who were hospitalized for COVID, give the option of doing a nasal swab to test for SARS-CoV-2 virus and blood test to check for antibody up to 12 months after diagnosis, to compare how results are different 12 months after infection. The goal is to learn about how the severity of person's infection in 2020 influences long term health effects and how others in their household are impacted by COVID-19.
Beta-glucans for Hospitalised Patients With COVID-19
COVID-19This randomised trial aims to assess the role of beta1-3 glucan supplementation in improving clinical symptoms and other outcomes amongst hospitalised patients with COVID-19.
Incidence and Predictors of Acute and Chronic Complications in Patients With Diabetes and Severe...
Covid19Diabetes MellitusAll surviving patients of the Michigan Medicine COVID-19 Cohort (M2C2, PI: Hayek) that were admitted to the University of Michigan for severe COVID-19 disease are eligible for this study. Investigators had prior approval from the Institutional Review Board (IRB) to collect the baseline blood and urine samples of these participants. Initial analysis on those samples are ongoing. In preliminary analysis of these patients a significantly higher risk for severe acute complications in patients with diabetes compared to those without diabetes was observed. The study will also enroll people following documented COVID-19 infection, regardless of whether or not they were hospitalized. The goal of the study is to understand what drives the increased risk of severe acute COVID-19 complications as well as to understand the long term sequelae of COVID-19 infection in patients with diabetes. The objectives of this study are to invite surviving M2C2 participants as well as others who have survived COVID-19 infection for an in-person visit, to measure biomarkers of inflammation and kidney, nerves, heart and blood vessels damage. participants will also be comprehensively phenotyped for diabetic complications outcomes, diabetes kidney disease, diabetes neuropathy and cardiovascular disease. Participants will be asked to fill out questionnaires to assess psychosocial metrics. The rationale is that correlating markers of acute hyperinflammation (cytokine storm syndrome) at admission in diabetes patients can inform vigilance and care for long term complications in survivors. Completing these studies will generate evidence-based guidelines for mitigating sequelae in diabetes COVID-19 survivors and identify critical psychosocial factors to mitigate psychological harm.
Correlation Analysis of Covid-19 IgG Antibody Level in Seminal Plasma and Semen Index
Covid-19IgG Antibody1 moreSince December 2019, more and more cases of unexplained pneumonia appeared after exposure to the South China Seafood Market in Wuhan City, Hubei Province. Later, the disease were confirmed to be acute respiratory infectious diseases caused by the 2019 new coronavirus infection. Even though we have had great victories in the war against this pandemic, there is still a very large number of deaths early on. As research progresses, vaccines for this infectious disease are already being developed. There are currently two vaccines in widespread use worldwide: mRNA vaccines and inactivated vaccines. In China, inactivated vaccines are more commonly used. At present, some studies believe that mRNA vaccine does not affect the pregnancy rate and abortion rate of women, but the study sample size is small, and the conclusions are limited. The effects of inactivated vaccines on fertility are still in the blank. We now hope to conduct prospective studies, mainly to study the effect of inactivated vaccine injection on male semen, and whether it has an effect on the quality of embryos in IVF patients