COVID-19 Clinical Trials and Expanded Access

Uganda hosts 1.4 million refugees, making it Sub-Saharan Africa's largest refugee host community and the third largest globally. Adolescents and young people (AYP) comprise half of the world's 70.8 million forcibly displaced persons, yet they are understudied in pandemics, including in COVID-19. Poverty, overcrowded living conditions, and poor sanitation likely elevate forcibly displaced persons' COVID-19 risks by limiting their ability to practice mitigation strategies. There continue to be significant knowledge gaps regarding the implementation and effectiveness of behaviour change interventions on improving COVID-19 prevention practices (i.e. hand and respiratory hygiene, physical distancing). mHealth (healthcare delivered by mobile phones) is cost-effective, aligned with how youth learn and socialize, vital for physical distancing, and has been used for COVID-19 messaging in other low- and middle-income countries. Nested within an ongoing HIV self-testing cluster-randomized trial, this study aims to develop, implement, and evaluate the effectiveness of an mHealth intervention in increasing COVID-19 prevention practices with displaced/refugee AYP aged 16-24 in Kampala, Uganda. Participants will be enrolled in a 8-week mHealth social group intervention program that is informed by the RANAS (Risks, Attitudes, Norms, Abilities, and Self-Regulation) approach to Water, Sanitation, and Hygiene. Using a pre-test/post-test design, this study will assess changes in participants' self-efficacy (e.g. ability, confidence, adherence) in COVID-19 prevention practices.

The current COVID-19 epidemic threatens to overwhelm the capacity of many countries to meet their populations' health care needs. Although several vaccines specific for SARS-CoV-2 have been or are being developed, these require testing in animal and human safety studies and they are unlikely to be available during the expected peak periods of the growing epidemic. Two groups at especially high risk of infection and disease are front line health care workers working directly with COVID-19 patients and elderly residents of group homes or facilities that provide skilled nursing care to this frail population. Interim measures to protect these groups while we await a high efficacy vaccine are desperately needed. Based on the capacity of BCG to (1) reduce the incidence of respiratory tract infections in children and adults; (2) exert antiviral effects in experimental models; and (3) reduce viremia in an experimental human model of viral infection, we hypothesize that BCG vaccination may induce (partial) protection against susceptibility to and/or severity of SARS-CoV-2 infection. This study will evaluate the efficacy of BCG to reduce risk of infection by SARS-CoV-2 and mitigate COVID-19 disease severity in at risk health care providers. A phase III randomized controlled trial provides the highest validity to answer this research question. Given the immediate threat of the SARS-CoV-2 epidemic the trial has been designed as a pragmatic study with a highly feasible primary endpoint, which can be continuously measured. This allows for the most rapid identification of a beneficial outcome that would allow other at-risk individuals, including the control population, to also benefit from the intervention if and as soon as it has demonstrated efficacy and safety.

To develop an International registry on head and neck cancer patients infected with COVID-19

An early stage trial to check how safe and tolerable, as well as how the body handles continuous daily use of Active IMP over 28 days in healthy volunteers.

This study evaluates and rehabilitates the cognitive functions of attention, memory, visual perception, language, and executive by the mentalPlus® digital game of COVID-19 surviving patients after remission of symptoms.

It is becoming increasingly evident that sleep plays an essential role for human health, and it represents an important biophysiological variable for athletes' well-being and recovery. The International Olympic Committee recently highlighted the importance of obtaining sufficient sleep volume and quality among athletes, but acute sleep deprivation is not unusual. Several factors, both endogenous and exogenous, are able to negatively influence sleep in athletes: body temperature, altitude, chronotype, training volume, anxiety, westward and eastward travels, and many others. Since December 2019, when a new coronavirus (SARS-CoV-2) was originally revealed by an ophthalmologist in Wuhan (Hubei province, China), a related severe acute respiratory syndrome - namely COVID-19 - has been spreading at a pandemic rate, putting global health systems under unprecedent pressure. Italy, as the first Western country tremendously hit by this disease outbreak, has become the iconic resilient outpost under international policymakers' attention. When initial clusters were identified, restrictive actions to curb isolated upsurges of infection were taken by the health region system of Lombardy, thereafter, were extended to all northern Italy and to the entire country. From February 21, when the first Italian COVID-19 case was diagnosed in southern Lombardy, to March 22, when Italian's government restrictions to contain the pandemic were extended, prohibiting all non-essential business activities and banning all movements of people nationwide, the country faced an unchartered scenario, from several standpoints, along with the psychosocial one. Inevitably, the Covid-19 outbreak has largely influenced the daily life of athletes too. Therefore, the primary aim of this study was to examine the differences in athletes' sleep quality, quantity and training volumes during the social confinement due to the virus outbreak. For this purpose, a survey will be used. This variables will be evaluated in 3 different time frames: 1) May 2020; 2) September 2020; 3) January 2021.

A pragmatic superiority randomized controlled trial comparing Telepsychoeducation plus personalized videos vs. Telepsychoeducation without personalized videos for the prevention of future emotional distress in professionals and students from essential services with low to moderate levels of emotional distress in Brazil. Note: This study was approved by the Ethics and Research Committee of the Hospital de Clínicas de Porto Alegre and is originally registered at Plataforma Brasil, a Brazilian study registration platform (under CAAE: 30608420.5.0000.5327). Recruitment began in May 28th 2020.

Medical personnel working in the Intensive Care Unit will be examined by means of tests. Their aim is to check how work-related stress in a potentially lethal threat affects the occurrence of depression, stress, anxiety and sleep disorders. We also want to check whether people working in such extremely difficult conditions show no greater interest in death.

This single blind, randomized, controlled trial (RCT) evaluates, a nonpharmacological intervention, TM (Transcendental Meditation) for improving burnout (, as measured by self-reporting (survey), physiologic, and neuro-functional imaging studies in health care providers (HCPs) when practiced over 3 months' time. The investigators define HCPs as any physician, physician trainee, nurse, physician assistant, nurse practitioner or respiratory therapist. HCPs will be screened by a single-item stress scale and Columbia Suicide Severity Rating Scale (CSSRS) to understand their stress level and exclusion criteria respectively. The Global Severity Index of the Brief Symptom Inventory (BSI)-18 Global Severity score will be used as the primary outcome for pre- and post-TM training (baseline, 1 vs. 3 months). In addition, the investigators will evaluate physiological markers of stress and cardiovascular resiliency such as 1) changes (pre/post-treatment) in heart rate variability (HRV) through wearables, 2) Galvanic Skin Response (GSR) - changes in sweat gland activity that result from changes in an emotional state. fMRI will be performed by the Duke Brain Imaging and Analysis Center (BIAC) on a subset of participants to evaluate changes A specifically developed mobile app will aid data collection as well as reminders for providers to aid compliance for meditation

Evaluation of awake prone position on ventilation inhomogeneity in COVID-19 associated respiratory failure.