COVID-19 Clinical Trials and Expanded Access

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.

Coronavirus disease 2019 (COVID-19) which is caused by the virus Severe Acute RespiratorySyndrome Coronavirus-2 (SARS-CoV-2) has resulted in an ongoing global pandemic. It isunclear whether the relatively low number of reported cases of COVID-19 in people with CF(pwCF) is due to enhanced infection prevention practices or whether pwCF have protectivegenetic/immune factors. This study aims to prospectively assess the proportion of pwCF,including both adults and children with CF who have evidence of SARS-CoV-2 antibodiesover a two-year period. This study will also examine whether pwCF who have antibodies forSARS-CoV-2 have a different clinical presentation and what impact this has on their CFdisease. The proposed study will recruit pwCF from paediatric and adult CF centresthroughout the United Kingdom. Serological testing to detect antibodies will be performedon blood samples taken at month 0, 6, 12, 18 and 24 with additional time-points ifbloodwork is available via normal clinical care. Clinical data on, lung function,CF-related medical history, pulmonary exacerbations, antibiotic use, and microbiology andvaccination receipt, will be collected during routine clinical assessments.Associations will be examined between socio-demographic and clinical variables andserologic testing. The investigators will also examine the effects of SARS-CoV-2infection on clinical outcomes and analyse end-points to explore any age-related orgender-based differences, as well as subgroup analysis of outcomes in lung-transplantrecipients and pwCF receiving cystic fibrosis transmembrane conductance regulator (CFTR)modulator therapies. As pwCF receive COVID-19 vaccination the investigators will performa comparison of the development and progression of anti-SARS-CoV-2 antibodies in pwCFfollowing natural infection and vaccination SARS-CoV-2 over time.

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)

A Phase 1, Randomized, First-in-human, Open-label Study to Evaluate the Safety andImmunogenicity of eOD-GT8 60mer mRNA Vaccine (mRNA-1644) and Core-g28v2 60mer mRNAVaccine (mRNA-1644v2-Core) in HIV-1 Uninfected Adults in Good General Health

It is expected that large numbers of healthcare workers will experience a broad range ofpsychological reactions and symptoms including anxiety, depression, moral distress, andtrauma symptoms that will cause both significant suffering as well as occupational andsocial impairment. The purpose of this study is to find interventions which are helpfulin treating psychological distress in healthcare workers caring for COVID-19 patients.There are two phases of the study. All participants will take part in Phase I, whichconsists of 4 sessions over a two-week period of either a narrative writing interventionor a medical music intervention. Participants will be randomly assigned to the narrativewriting intervention or medical music intervention.After Phase I, participants will be re-assessed. Healthcare workers who meet criteria forPTSD will be given the option to participate in Phase II of the study, in which they willbe offered a choice between one of two evidence-based treatments for PTSD: InterpersonalTherapy (IPT) or Exposure Therapy (ET). Both treatments are comprised of ten 75-minutesessions scheduled twice weekly. Participants will be allowed to choose a preferredtreatment in Phase II. After Phase II participants will complete a final assessmentconcluding the study. All interventions will be offered using distance technology.

Although recognized as an autoimmune disease the etiology of type 1 diabetes remainsunknown. Virus infections has been suggested as a possible agent triggering theautoimmune reaction finally resulting in beta-cell destruction and fate of insulinsecretion. SARS Cov-2 virus enters the infected cells by binding to the ACE-2 receptor,which is abundant in many tissues including the pancreas. Accordingly, SARS Covid-19infection may trigger the development of type 1 diabetes either by an activation of theimmune system or directly via beta-cell infection and destruction.Our aim is to study the impact of the Covid-19 epidemic on the development of type 1diabetes. This will be done in two ways: a clinical study and an epidemiological followup. During the next two years, adult patients with newly diagnosed type 1 diabetes willbe asked to participate. Type 1 diabetes will be diagnosed by usual means and a mixedmeal tolerance test will be performed at time of diagnosis and after one year to evaluatebeta-cell function. People with type 1 diabetes and serologically documented previousSARS Covid-19 will be compared with people with no previous infection regarding beta-cellfunction and fate of insulin secretion. In addition, we will estimate the number of newdiagnosed type 1 diabetes patients compared to previous years.

The Coronavirus has caused containment of more than a third of the world's population.Containment can drastically change lifestyle habits, including eating habits such as thenumber of meals, meal times or their composition. However, there is currently no data onthe influence of confinement on eating habits.

Bone and soft tissue sarcomas represent about 7-12% of all pediatric cancer and are aheterogeneous group of tumors arising in connective tissues embryologically derived fromthe mesenchyme. For some of these tumors relapse and mortality rates are stillsignificantly high. Therefore, further studies are needed to better understandpathogenetic processes underlying sarcomas to offer new and more effective treatments.Next generation sequencing (NGS) has opened new frontiers for cancer research allowing toidentify somatic or constitutional mutations known or yet unknown with the aim to betterunderstand carcinogenesis. The establishment of the genomic profile of the tumor couldalso help clinicians to personalize patients treatment based on their genetic andmolecular alterations.

Coronavirus has caused containment of more than half of the world's population and amajor and rapid reorganization of clinical and support services. The spread ofcoronavirus (COVID-19) has posed significant challenges for occupational health services.However, there is currently no data on the influence of this epidemic on the practice andfeelings of dental surgeons and associates

(a) Objectives 1. To assess the full lung function, exercise capacity, quality of life in patients with COVID-19 over 2 years. 2. To assess the longevity of the serology response to SARS-CoV2. 3. To investigate the association of the neutralization titer in plasma from different vaccinated cohorts to its protection of infection using in vivo model 4. To investigate the SARS-CoV-2 specific cellular and humoral immunities as well as their determinant factors from community subjects who have received different types of COVID-19 vaccines. 5. To assess the third booster dose for subjects who have poor antibody response despite having received two doses of CoronaVac (Sinovac)