COVID-19 Clinical Trials and Expanded Access

This is a pilot phase, open label, non-randomized study for the treatment of ARDS inpatients infected with COVID-19. Subjects will be enrolled and treated with one dose ofmesenchymal stem cells and follow-up will occur 90 days post-treatment.

This is a phase 1/2a study including 2 parts, phase 1 and phase 2a. The phase 1 part isan open-label, single-arm, dose-escalating study to evaluate the safety and explore thedose limiting toxicity and maximum tolerated dose of a human umbilical cord derivedmesenchymal stem cell product (BX-U001) in severe COVID-19 pneumonia patients with acuterespiratory distress syndrome (ARDS). Qualified subjects after the screening will bedivided into low, medium, or high dose groups to receive a single intravenous infusion ofBX-U001 at the dose of 0.5×10^6, 1.0×10^6, or 1.5×10^6 cells/kg of body weight,respectively. The Phase 2a part is a randomized, placebo-controlled, double-blindclinical trial examining the safety and biological effects of BX-U001 at the appropriatedose selected from phase 1 for severe COVID-19 pneumonia patients with the sameinclusion/exclusion criteria as the phase 1 part.

This study uses questionnaires to gain an understanding of how experiences during theCOVID-19 pandemic, regardless of COVID-19 status, may have impacted health-relatedquality of life (HRQOL) and other areas such as COVID-19-specific psychological distress,disruptions to health care, finances and social interactions in cancer patients. Thecoronavirus disease 2019 (COVID-19) is an infectious disease that is caused by the severeacute respiratory syndrome coronavirus 2 (SARS-CoV-2). The information learned from thisstudy will guide the development of psychosocial programs to improve patient care andoutcomes in cancer patients and survivors in the context of facing a global pandemic.

This is an open label, dose escalating safety study of the advanced therapyinvestigational medicinal product (ATIMP) KI-MSC-PL-205, where patients diagnosed withSARS-CoV-2-induced severe acute respiratory distress syndrome (ARDS), according to theBerlin Definition, and who are on respirator/ventilator (used synonymously in thisprotocol) support due to respiratory insufficiency with or without concomitantcirculatory problems, will be included and treated with a single dose of KI-MSC-PL-205.

The COVID-19 crisis began in China in December 2019 and was declared a pandemic by theWorld Health Organisation on March 11th 2020. The pandemic has changed the way thatclinicians interact with and treat patients overnight. Staff within the NHS will be underhigh levels of stress due to the increased needs and worse outcomes of work as they areshielding or self-isolating and may feel helpless and guilty. The psychological impact ofthe pandemic will be prolonged and varied. It is vital that Investigators increaseunderstanding as much as possible to support NHS staff.The aim of this survey is to examine the possible mental health burden on NHS staff as aresult of the COVID-19 pandemic and how these change as the pandemic progresses. Byunderstanding these effects, it will allow researchers to identify recommendations toallow support mechanisms to be put in place for NHS staff, to better manage this andfuture pandemics and similar crises.Investigators are aiming to sample several cohorts of NHS staff including a subset ofstaff who are shielding. Staff will be asked to complete a series of online surveys atmultiple timepoint: on study initiation, 1 month later and then 3 months after thepandemic has ceased in the UK. Additional timepoints may be added depending on the lengthand severity of the pandemic.The main outcomes will be tracking changes in mental health measurements at thepre-defined timepoints. This work will allow Investigators to produce recommendationsabout the increased mental health support that NHS staff will need. If a need isdemonstrated then an interventional research project will be designed and implemented.

The purpose of this study is to analyze in depth the relationship of myeloid cellsubpopulations during infection by Severe acute respiratory syndrome coronavirus 2(SARS-Cov2), the virus mediating Covid-19. Myeloid cells include neutrophils, monocytesand dendritic cells, each divided into subpopulations with different functions in immunedefense and immune pathologies.The study is based on the following hypotheses: - Infection and the interferon response to infection may induce hyperactive or immunosuppressive differentiation of myeloid cells, that may be treated by specific inhibitors. - Some myeloid cell subpopulations currently identified in our laboratories might be markers for Covid-19 prognosis. - Alternative receptors may be present on myeloid cells, inducing the cytokine storm, a target for therapy. - The expression of Interferon (IFN) receptor and IFN responding genes on myeloid cells and on respiratory epithelial cells may correlate with prognosis and indicate potential treatment targets. - Interferon responses are known to be skewed during Covid-19, but some IFN subtype polymorphisms may correlate with prognosis and these subtypes migt be supplemented or inhibited for therapy.

Background:People who are recovering from COVID-19 may continue to have problems that affect theirdaily life. For instance, they might feel overly tired. Researchers want to learn ifexercise can help people recover after COVID-19 infection.Objective:To study if participation in a rehabilitation exercise program can help people recoveringfrom COVID-19.Eligibility:Adults ages 18-80 with a lab-confirmed SARS-CoV2 infection (the virus that causesCOVID-19), and are still having some symptoms.Design:Participants will have a medical history and physical exam. They will give blood andurine samples. They will have tests to measure heart and lung function. Their bloodvessels will be assessed.Participants will have a computed tomography scan of the body. They will have anultrasound of the muscles in their arms, legs, and chest.Participants will take a 6-minute walk test. They will take other balance and movementtests.Participants will walk on a treadmill while hooked up to a monitor. Then they will beinterviewed. It will be audio-recorded.Participants will complete surveys about their symptoms and daily activities.Participants will take a smell test. For this, they will identify different smells. Theywill also have memory, attention, and mental functioning tests.Participants will wear an activity monitor on their wrist 24 hours a day. They willexercise 3 times a week for 10 weeks by moving vigorously on a track or treadmill for 30minutes. They will attend education classes once a week for 10 weeks.Participants will be contacted by phone or email every 3 months for 1 year after theycomplete the exercise part of the study. They will wear an activity monitor for up to 2weeks.

Evaluation of the agreement between fingerstick samples, venous blood, serum and plasmasamples when using the LumiraDx SARS-CoV-2 Ab Test against the reference method, usingstandard qualitative comparison techniques.

Older adults and those with chronic underlying health conditions are the most susceptibleto COVID-19 and its complications. Although there has been a rapid response to studyingthe effects of COVID-19 in the acute stages, little is known about recovery over thelonger-term. Older adults who survive the diseases are at risk of developing persistentmobility limitations due to extensive bed rest during hospitalization. For older patientsand those with underlying frailty recovering from COVID-19, this could rapidly lead tosignificant physical deconditioning and rapid declines in mobility. Understanding thetrajectory of functional recovery of older hospitalised patients with COVID-19 in theshort- and long-term is critical to improving patient outcomes and informing health andrehabilitative interventions for survivors.

The Innovative Support for Patients with SARS COV-2 Infections Registry (INSPIRE) studyis a CDC-funded COVID-19 project to understand the long-term health outcomes in recentlytested adults, both negative and positive, who have suspected COVID symptoms at the timeof their test. Participants will complete short online surveys every 3 months for 18months, share information about their health using a secure web-based platform, and arecompensated for their time.