COVID-19 Clinical Trials and Expanded Access

The study will follow COVID-19 patients who required intensive care after 3-6 months andone year after discharge from the ICU with functional level as well as organ function toassess recovery after COVID-19. Blood and urine will be collected for biobanking.

The purpose of this research study is 1) to conduct a prospective longitudinalsurveillance research trial, enrolling up to 200 CCHMC employees as they come back towork, and then following their clinical and laboratory parameters for up to 12 months;and 2) to support the ongoing development of diagnostic techniques for COVID-19. Theoverall goal is to investigate patterns of SARS-COV-2 infection, including immunologicalrecovery and genetic risk factors, among CCHMC employees to better understand how tosafely reintroduce the CCHMC work force back into their normal routines.

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.

This is a prospective, randomized, single-center, open-label controlled trial, designedto compare the efficacy of two ventilation strategies (Low Tidal Volume and positiveend-expiratory pressure (PEEP) based on the Acute Respiratory Distress Syndrome (ARDS)Network low PEEP-fraction of inspired oxygen inspired oxygen fraction (FIO2) Table versusLow Driving Pressure and PEEP guided by Electrical Impedance Tomography (EIT) in reducingdaily lung injury score in patients with acute respiratory distress syndrome caused byCOVID-19. The two strategies incorporate different prioritizations of clinical variables.The PEEP-FIO2 table strategy aims to reduce lung overdistension, even if it requirestolerating worse gas exchange. EIT-guided strategy prioritizes mechanical stressprotection, avoiding alveolar overdistension and collapse.

To respond to the COVID-19 pandemic, investigators will be deploying community healthworkers, equipped with mobile technology, and accompanied by youth to visit householdsdoor to door to screen for symptoms of COVID-19, isolate, test, and manage suspectedcases of COVID-19. The community health workers and youth will educate households aboutpreventive measures including frequent handwashing and home management of mild cases.Simultaneously, investigators will work with nurses, doctors, and clinical officers, totest and treat more severe cases of COVID-19 in health facilities. Our goals are: tovisit every household in Siaya county covering a population of close to 1 million, and totrain and support health workers working in 32 health facilities with oxygen capacity inSiaya to reduce the morbidity and mortality related to COVID19 and other conditions.

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.

This is a multi-center, observational study that will enroll 1) patients with severeCOVID-19 who have agreed to undergo therapy with Seraph® 100 under the existing EUA; 2)patients (medical record data) that have been previously treated with the Seraph® 100after the date of the EUA approval (17 April 2020), but before the date that the study isapproved at the study site, and 3) a convenience sample of patients (medical record data)in a historical control group who were admitted to the ICU at participating sites withsevere COVID-19 infection, meeting the EUA treatment criteria, but not treated withSeraph® 100 up to the time the PURIFY-OBS protocol is approved at the site

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.