COVID-19 Clinical Trials and Expanded Access

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.

Safe and effective severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccinesmay reduce the transmission of and achieve population immunity against the COVID-19pandemic, which accounted for more than 3.75million deaths worldwide. With World HealthOrganization's (WHO) effort on ensuring equitable access to COVID-19 vaccines,vaccination rate may increase in the near future.On the other hand, vaccination hesitancy has emerged as a major hindrance on the globalvaccination campaigns in certain areas due to safety concerns, social factors, and publichealth policies. For instance, a recent survey conducted in Hong Kong showed a lowvaccine acceptance rate of 37%. Long-term safety concerns and post-vaccination eventsrelayed by the social media maybe reasons for vaccination hesitancy. Among which,cerebrovascular accidents (CVA) after vaccination were one of the most frequentlyreported post-vaccination events. These reports ranged from ischemic strokes in elderlypatients with multiple cardiovascular co-morbidities, to hemorrhage strokes in otherwise"young-and-fit" adults. While many of these events were investigated by the COVID-19immunization expert committee, an important premise to address the apprehension of CVAafter vaccination is the provision of evidence-based information of the impact ofCOVID-19 vaccines on brain health.In this prospective, longitudinal, observational study, we aim to elucidate therelationship between COVID-19 vaccines and cerebrovascular health in healthy citizens ina population-based cohort.

This study, which has a randomized controlled experimental design, was planned todetermine the effect of music therapy on the anxiety level of family health personnelworking in primary health care centers during the COVID-19 pandemic. The study will becarried out between 4 August and 31 December with nurses, midwives and other familyhealth personnel working in family health centers. Participants will be randomized intotwo groups, a control and an intervention group. Individuals in the intervention groupwill receive 15 minutes of music therapy once a day for 5 days. No intervention will bemade in the control group. Data Descriptive Question and State-Trait Anxiety Inventoryonline design; It will be collected on the Google Forms platform.. Data analysis will bedone using SPSS 20 program.

This is a prospective study in which a process of identifying and improving a reductionof functional capacity in COVID-19 survivors >50 years old.The overall goal of this study to identify the feasibility and value of risk-guidedmedical therapy and exercise intervention in COVID-19 survivors.

Background:Inequalities in COVID-19 infection, hospitalization, and death in under-studied,under-represented, and under-reported groups of people are severe. A growing number ofstudies have assessed the impact of individual risk factors. But few studies haveassessed which factors are the greatest drivers of COVID-19 disparities from a widerperspective.Objective:To understand the long-term impacts of COVID-19 on minority women and their families toassist in developing community-based programs to help in recovery.Eligibility:Healthy people aged 18 and older who reside in North Carolina.Design:Participants will take a 45-minute online survey. The survey will cover theirdemographics, community, health, lifestyle, household, and environment.Participants may choose to have tests. They may visit the Clinical Research Unit. Theymay also have a home visit for these tests. In some cases, they may mail samples to thestudy team in prepaid envelopes.Participants may take an optional 15 minute survey about their reproductive history.Participants may give a blood sample.Participants may give a urine sample. They will fill out a log and return with theirsample.Participants may give saliva samples.Participants may give toenail samples from each toe.Participants may give dust samples. They will be given 8 alcohol swabs. Two will be fortesting. They will be asked to swipe a total of 3 door frames. Each door frame should bein a different room of the house.Participants may be given silicone wristbands to wear for 1 week. This is to measuretheir exposure to air pollutants.Participants may be contacted in the future for follow-up. They may be contacted byphone, email, or letter.

Repetitive transcranial magnetic stimulation (rTMS) is a FDA-approved treatment fordepression and Obsessive Compulsive Disorder (OCD). The goal of the study is to learn howto optimize the treatment to improve symptoms of depression and OCD. This researchproject will test a new accelerated 5-day accelerated rTMS protocol for treating symptomsof depression and OCD.A second goal of this study is to identify biomarkers of depression and OCD in the brainusing functional magnetic resonance imaging (fMRI). This approach will predict who willbenefit from TMS, determine the optimal treatment target, and improve treatment outcomes.Subjects will receive a clinical assessment of symptoms and an fMRI brain scan before andafter each treatment course to measure the effect of treatment on symptom severity and onfMRI measures of functional connectivity.Participants will be randomized to receive rTMS targeting either the lateral prefrontalcortex (LPFC) or the dorsomedial prefrontal cortex (DMPFC). Participants will complete a5-day course of rTMS delivered hourly for 10 hours per day. Participants who show apartial response to treatment but not a full response will then receive a second 5-daycourse. Treatment non-responders will be crossed over to receive rTMS targeting theopposite brain area.The primary hypothesis is that accelerated rTMS treatment will yield rapid improvement insymptoms for patients with depression and OCD in just 5 days, and that response rates canbe further improved by adding a second 5-day treatment course.

This phase 2 trial studies the immune response to GEO-CM04S1 (previously designated asCOH04S1) compared to standard of care (SOC) mRNA SARS-COV-2 vaccine in patients withblood cancer who have received stem cell transplant or cellular therapy.GEO-CM04S1 belongs to a category called modified vaccinia Ankara (MVA) vaccines, createdfrom a new version of MVA, called synthetic MVA. GEO-CM04S1 works by inducing immunity(the ability to recognize and fight against an infection) to SARS-CoV-2. The immunesystem is stimulated to produce antibodies against SARS-CoV-2 that would block the virusfrom entering healthy cells. The immune system also grows new disease fighting T cellsthat can recognize and destroy infected cells. Giving GEO-CM04S1 after cellular therapymay work better in reducing the chances of contracting coronavirus disease 2019(COVID-19) or developing a severe form of COVID-19 disease in patients with blood cancercompared to SOC mRNA SARS-CoV-2 vaccine.

Background: There are no proven therapies specific for pulmonary dysfunction in patientswith acute hypoxemic respiratory failure (AHRF) caused by infections (includingCovid-19). The full spectrum of AHRF ranges from mild respiratory tract illness to severepneumonia, acute respiratory distress syndrome (ARDS), multiorgan failure, and death. Theefficacy of corticosteroids in AHRF and ARDS caused by infections remains controversial.Methods: This is a multicenter, randomized, controlled, open-label clinical trial testingdexamethasone in mechanically ventilated adult patients with established AHRF (includingARDS) caused by confirmed pulmonary or systemic infections, admitted in a network ofSpanish ICUs. Eligible patients will be randomly assigned to receive dexamethasone:either 6 mg/d x 10 days or 20 mg/d x 5 days followed by 10 mg/d x 5 days. The primaryoutcome is 60-day mortality. The secondary outcome is the number of ventilator-free daysat 28 days. All analyses will be done according to the intention-to-treat principle.

Automated quantification of the pulmonary volume impaired during acute respiratoryfailure could be helpful to assess patient severity during COVID-19 infection orperioperative medicine, for example.This study aim at assessing the correlation between the amount of radiologic pulmonaryalteration and the clinical severity in two clinical situation : 1. SARS-CoV-2 infections 2. Postoperative hypoxemic acute respiratory failure

Novel coronavirus 2019 (COVID-19) has emerged as a major international public healthconcern. While much of the morbidity and mortality associated with COVID-19 has beenattributed to acute respiratory distress syndrome (ARDS) or end-organ failure, emergingdata suggest that disorders of coagulation, in particular hypercoagulability and venousthromboembolism (VTE), may represent an additional major, and possibly preventable,complication (Wu C, et al. JAMA Intern Med. 2020 Mar 13. [Epub ahead of print] and TangN, et al. Thromb. Haemost. 2020 Feb 19. [EPub Ahead of Print]). Abnormal coagulationtesting results, especially markedly elevated D-dimer and FDP, have been associated witha poor prognosis in COVID-19 infection. We propose the following Electronic Health Record(EHR)-guided 10000-patient, retrospective observational cohort study to assess VTEincidence, risk factors, prevention and management patterns, and thrombotic outcomes inpatients with COVID-19 infection. In order to gain the valuable perspective of otherregional and national centers providing care for large populations of COVID-19, we havestarted a collaborative network with 5 additional sites which will provide us withde-identified data from 1000 patients each. These 5000 patients in addition to the5000-patient cohort we are enrolling within the Mass General Brigham Network willcomprise this study population.