COVID-19 Clinical Trials and Expanded Access

Initially, it was suspected that Covid-19 would primarily affect the airways, but severalstudies have now shown that it is a disease with multisystem manifestations. Covid-19 hasthe potential to affect physical, cognitive, and psychological functions in multipleways. It has been clear that a significant proportion of patients with Covid-19 developlong-term symptoms. The term post-acute Covid-19 syndrome (PACS) is now used to describethe wide range of prolonged symptoms following the infection. Patients who have been inhospital for Covid-19 for a long time may need specialized rehabilitation, however, alsonon-hospitalized patients with mild symptoms may need specific rehabilitation to be ableto meet the complex symptoms and problems that may arise. Previous studies on therecovery and rehabilitation after other coronavirus shows the importance to developtailored interventions so that these patients receive appropriate rehabilitationThe aim of this study is to evaluate the effects of inspiratory muscle training on adultpatients with PACS and decreased respiratory muscle strength.A randomized controlled trial will be used. A total of 90 adult patients with PACS and 80% or less of predicted value in inspiratory muscle strength (maximal inspiratorypressure) will be eligible for enrollment. Patients will be randomized either to anintervention group or a control group. The intervention will consist of inspiratorymuscle training performed twice daily for 8 weeks. This will be combined with an 8-weekphysical exercise training program. The control group will perform the same physicalexercise training according to standard care. All measurements will be performed atbaseline and after 8 weeks.Primary outcome is maximal inspiratory pressure. Secondary outcomes are: Maximalexpiratory pressure, pulmonary function, physical capacity, physical activity,respiratory status and symptoms, health-related quality of life, work ability, fatigue,self-reported outcome measure of physical function and voice function.Covid-19 has the potential to affect physical, cognitive, and psychological functions inmultiple ways and lead to a negative impact on quality of life in the long-termperspective. Therefore, development of a rehabilitation program with specific tailoredinterventions will be necessary to improve physical and psychological function, as wellas health-related quality of life and work ability.

The investigators wish to set up a pharmaco-epidemiological cohort within the HospitalTerritorial Groups of the Cévennes-Gard Camargue, East-Hérault and Haute-Garonne and WestTarn on a specific population, patients undergoing immunotherapy for cancer, as currentlythere is no data available under "real life" conditions following anti-COVIDvaccination19. The hypothesis is that patients undergoing immunotherapy will not developmore vaccine-related adverse events than those observed in the efficacy and safetyvalidation studies of the BNT162b2 mRNA Covid-19, mRNA-1273 SARS CoV-2,Oxford/AstraZeneca and Ad26COV2.S, JMJ Vaccine or J & J COVID-19 Vaccine.

This study investigates the changes in practice by pulmonary procedural programs acrossthe United States as they faced the coronavirus pandemic. Information gathered from thisstudy may help guide pulmonary programs on a wider scale and improve their practice. Thestudy may also help researchers understand where they should focus research efforts tobetter respond to a pandemic in the future.

This is a phase III randomized, double blinded, placebo-controlled multi-center study toassess the efficacy and safety of aerosolized Novaferon for the treatment of asymptomaticor mildly patients infected with SARS-CoV-2.

Coronavirus disease 2019 (COVID-19) is a serious respiratory disease that results frominfection with a newly discovered coronavirus (SARS-COV-2). Unfortunately, COVID-19 isnot only a short-term infection. Patients (pts) recovering from SARS-COV2 infectioncomplain of persisting symptoms including: fatigue, diffuse myalgia and weakness, whichmay lead to chronic fatigue syndrome and as well as many other complications.The vast majority of COVID-19 patients remaining in isolation/quarantine, due to the mildcourse of the disease, do not require hospitalization. In this group of patients, thecourse of COVID-19 is very different - from asymptomatic patients to very severe and longlasting symptoms also with a decrease in saturation.There are many studies describing the course and complications of patients hospitalizeddue to COVID-19. There is little published data on how non-hospitalized patients get sickand what are the early and late complications of SARS-CoV-2 infection. In addition, manypatients remain ill even many months after COVID-19, entering what is known asLONG-COVID.Therefore, the STOP-COVID Registry was established. The purpose of the Registry is toassess the course of COVID-19 infection, early and late cardiovascular complications ofCOVID-19 in patients with and without hospitalization. In addition, the purpose of theSTOP-COVID Registry is to assess the incidence of LONG-COVID with all other complicationsand to identify predictive factors.

The purpose of this study is to examine the effect of Andrographis Extract, BoesenbergiaExtract compared to standard treatment in asymptomatic COVID patients.

Hypoxemic acute respiratory failure is one of the main COVID-19 patients complicationthat lead to in intensive care hospitalization.This complication determines a variable mortality from 25 to 30%. To correct hypoxemia(often severe) is often needed non-invasive or invasive mechanical ventilation.Mechanical ventilation is not a therapeutic strategy, but it allows to extend thetime-to-recovery necessary to solve COVID-19 respiratory failure cause.Calibration of ventilatory support is essential to ensure adequate time-to-recoverywithout contributing to onset lung and / or diaphragmatic damage.Basal diaphragmatic activity assessment, device for administering the oxygenation supportchoice and setting ventilatory support parameters are decisive.Ultrasound is the best method for measuring diaphragmatic work. The aim of this study isto evaluate the diaphragmatic thickening fraction in COVID-19 patients admitted toIntensive Care Unit (ICU) for acute respiratory failure and to record its function onweaning.

Long-term neurocognitive and psychiatric consequences of COVID-19 remain mostly unknownto date. It has been reported that coronaviruses cause direct central nervous systeminfection (Needham et al. 2020). Besides that, new or worsening cognitive impairmentcommonly occurs and persists in survivors of intensive care unit (ICU) stay (Hosey &Needham. 2020). The purpose of our study is to search and describe the cognitive andpsychiatric long-term consequences of COVID-19 on patients who have been discharged fromcritical care units. This is an ambidirectional cohort study, that attempts to followadults discharged from critical Care Units Adults due to COVID-19 up to 12 months afterdischarge, to evaluate the presence of cognitive impairment, linguistic and phonationfunction, depression, fatigue, functional gastroenterological symptoms, anxiety, or posttraumatic disorder, and performance in activities of daily living and physical responseto exercise as well.

Viruses are a major health problem for the general public and at risk populations.Normally, detection of antibody titers is the gold standard for determining theeffectiveness of the immune system following natural or vaccine caused immunization.However, determining the effectiveness of other parts of the immune system are lesscommon due to the difficulties with testing. Furthermore, there is a critical need toaddress other therapies in case vaccination is not successful in immuncompromisedpopulations. Exercise has been shown to increase the strength of the immune systemagainst many types of viruses and therefore could be simple way to improve immunityagainst the COVID-19 virus. The aim of this research is to determine the effects ofexercise on anti-viral immunity against many types of common viruses before and aftervaccination. We hypothesize that exercise will enhance the anti-viral immunity before andafter vaccination.Up to 30 healthy volunteers (age 18-44 years) will be recruited to participate in thisstudy. For completion of Aim 1, three visits are needed totaling around 7 hours of thepatient's time and for Aim 2, three visits are needed totaling around 4.5 hours of thepatient's time. The initial visit will be for pre-screening and if deemed healthy enoughto participate, an exercise test to determine the VO2 max of the participant will beconducted. The following visits will require a trained phlebotomist to insert anin-dwelling catheter and participants will undergo a 20-minute incremental exercisetrial. Approximately 50mL of blood will be collected at four different timepoints: atrest, 60% VO2 max, 80% VO2 max, and 1-hr post-exercise. All four collected blood sampleswill be used to expand viral specific T-cells and compare IFN-γ rele

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has caused pandemic sinceoutbreak in 2020.Patients with chronic liver disease (CLD) are at higher risk ofmortality and morbidity due to COVID-19. Despite there is a large number of clinicaltrials of COVID-19 vaccines, only a few participants with chronic liver diseases wereincluded.