COVID-19 Clinical Trials and Expanded Access

This is the first-in-human phase 1/2a trial of the inhaled administration of the SARS-CoV-2-neutralizing monoclonal antibody DZIF-10c in healthy volunteers and SARS-CoV-2-infected individuals. It will evaluate the safety, pharmacokinetic profile, immunogenicity, and antiviral activity of DZIF-10c.

Hypothesis: The apelin/APJ system is involved in the protection of the lung affected by the COVID-19 by interacting with the SARS-coV-2 entry door: the Angiotensin I Converting Enzyme 2 (ACE2) and the renin-angiotensin system (ras). Elevated systemic levels of apelins and ACE2 activity are associated to less critical forms of COVID-19 and characterized by less pulmonary hyperpermeability and inflammation. Goals: Main: In COVID-19+ patients, to establish the basic knowledge of 1) apelins and related systems (ras and degradation enzymes, of which ACE2) pheno-dynamic profile in bloodstream, 2) pulmonary hyperpermeability profile by biomarker's assessment i) comparison of SARS vs. lesser COVID-19 respiratory injury, and with non COVID-19 ARDS and non ARDS acute respiratory condition. Secondary: To set up links between basic and progressive clinical data (data collection system APEL-COVID).

PATIENTS WHO ARE ADMITTED TO HOSPITALIZATION IN HCOR AND WHO HAVE THE CONFIRMED DIAGNOSIS OF CORONA VIRUS, WILL BE ASKED TO CONSENT TO PARTICIPATE IN THIS STUDY THAT INTENDS TO STUDY THE EFFECTIVENESS OF THE REMOTE INTERCESSION PRAYER IN COMBATING THIS DISEASE.

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.

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.

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.

The study is a double-blind, randomized, placebo-controlled, multi-center, Phase 3 study to evaluate the efficacy and safety of fostamatinib in COVID-19 subjects.

The primary goal of the village-level intervention is to assess whether mask-wearing reduces community-level COVID-19 seroconversion. The individual experiment assess whether masks protect against COVID-19 seroconversion. It also assesses the efficacy of high-quality cloth vs. surgical masks.