COVID-19 Clinical Trials and Expanded Access

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.

Collection and analysis of demographic, clinical, radiographic and laboratorycharacteristics of CoViD-19 patients to identify predictors of disease severity,mortality and treatment response, and to identify subgroup of patients that might benefitfrom specific therapeutic interventions

The study aims to investigate organ dysfunction and biomarkers in patients with suspectedor verified COVID-19 during intensive care at Uppsala University Hospital.