COVID-19 Clinical Trials and Expanded Access

Currently, there is no approved treatment for COVID-19 in France, either for the acutephase, nor for the late chronic phase. the investigator suggest that nintedanib has thepotential to block the development of lung fibrosis when initiated early enough toinhibit the activation of mesenchymal cells and the progression of virus-inducedpulmonary fibrosis. Computerized Tomography (CT) manifestations of fibrosis or fibrousstripes are described in COVID-19 (Ye, Eur Radiol 2020). Pan et al observed fibrousstripes in 17% patients in the early phase of the disease (Pan, Eur Radiol 2020). Ye etal observed bronchiectasis in 2 patients (15.4%) and evidence of pulmonary fibrosis in 3patients (23.7%) at HRCT performed at 4 weeks (Ye, Eur Radiol 2020). Long term data arestill lacking in patients with COVID-19 and the investigators do not know how manypatients will have fibrotic sequelae from the acute illness.

Coronavirus has caused containment of more than a third of the world's population. Somecountries have used a major screening strategy. Screening procedures, such as waiting (orresulting) for the test, can be stressful and can attract the most stressed people.However, there is currently no data on the relationship between stress and screening forSARS-CoV2

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.

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.

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.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has caused pandemic sinceoutbreak in 2020. Patients with cancers may be at higher risk than those without cancerfor coronavirus disease 2019 (COVID-19). At present, limited data are available on thesafety and immunogenicity of COVID-19 vaccination for patients with cancer.

Background: Fatigue is among the most common symptoms of the long-term effects ofcoronavirus (long COVID). This study aims to compare the effectiveness of osteopathicmanipulative treatment (OMT) combined with physiotherapy treatment (PT) compared to PTalone on fatigue and functional limitations after two months post randomization in adultswith long COVID.Methods: This is a study protocol for a two-arm, assessor-blinded, pragmatic randomizedcontrolled superiority trial. Seventy-six participants will be randomly allocated toOMT+PT or PT. The PT includes usual care interventions including motor and respiratoryexercises targeting cardiorespiratory and skeletal muscle functions. The OMT entailsdirect, indirect, visceral, and cranial techniques. Patients will be evaluated before andafter a 2-month intervention program, and at 3-month follow-up session. Primaryobjectives comprise fatigue and functional limitations at 2-month post randomization asassessed by the fatigue severity scale and the Post-COVID Functional State scale.Secondary objectives comprise fatigue and functional limitations at 3 months, and theperceived change post-treatment as assessed by the Perceived Change Scale (PCS-patient).

The objective of the COVID-19 International Drug Pregnancy Registry (COVID-PR) is toevaluate obstetric, neonatal, and infant outcomes among women treated with monoclonalantibodies or antiviral drugs indicated for mild, moderate, or severe COVID-19 from thefirst day of the last menstrual period (LMP) to end of pregnancy. For monoclonalantibodies, the exposure period also includes 90 days prior to the first day of the LMP.

Aim of the study is to investigate possible predictors and factors that may be associatedwith the development and maintenance of mental and physical health constrains includingdepression and anxiety symptomatology as well as loneliness in hospitalized post-COVIDpatients and non-COVID patients in Germany. Furthermore, it will be investigated whetherpsychological interventions have an effect on anxiety and depression symptomatology, onloneliness values, self-efficacy and perceived social support values. Specifically, theresearch aim is to examine the relationships between loneliness, self-efficacy, andsocial support and to address the question of what factors increase the risk of postcovid depression/anxiety, and to test the buffering effect of physical and socialactivities. For this purpose an experimental group comparison will be applied, in whichtwo interventions will be performed on post-COVID patients and non-COVID patients in theunit of Physical Medicine and Geriatrics in Medical Rehabilitation. (PhD Project byAnnika Roskoschinski, M.Sc., Psychology, Principal Investigator)

For caregivers in the Bronx, the pandemic has caused unprecedented psychologicaldistress; in addition to combating social determinants of health (SDOH), these familiesnow face greater financial insecurity and challenges related to their school-agedchildren. Furthermore, social distancing requirements and limited telehealth resourcesfor Bronx families have posed greater barriers to healthcare. Such parental distresscontributes to heightened risk of transgenerational cycles of psychological stress,trauma and maltreatment. The social and economic impacts of the COVID-19 pandemic havehad significant consequences for family well-being, putting parents at higher risk ofexperiencing distress and potentially impairing their ability to provide supportive careto their children. Although children may be less susceptible to the most damagingphysical consequences of COVID-19, there are growing concerns regarding the short-andlong-term impacts of pandemic-related stressors on children. The marked upheaval offamily life over an extended period may make children vulnerable to mental healthconsequences associated with the public health crisis and infection mitigation efforts.School and childcare closures, unstable financial circumstances, social isolation andlack of support have a disproportionate, cumulative impact on parents and may underminetheir capacities to provide support for their children. Importantly, a large body ofevidence suggests that parental stress during times of disasters inducespsychopathologies in family members including children. Further, high anxiety anddepressive symptoms in parents during the pandemic have been associated with higher childabuse potential, whereas greater parental support was associated with lower perceivedstress and child abuse potential. In addition to psychological impacts, stress associatedwith caregiving can interfere with parents' ability to maintain their own health. Thismultimodal study addresses key strategies to mitigate the psychological and health impactof COVID-19 in parents.