COVID-19 Clinical Trials and Expanded Access

Since initial reports of a novel coronavirus emerged from Hubei province, China, theworld has been engulfed by a pandemic with over 3 million cases and 225,000 deaths by30th April 2020. Health care systems around the world have struggled to cope with thenumber of patients presenting with COVID-19 (the disease caused by the SARS-CoV-2 virus).Although the majority of people infected with the virus have a mild disease, around 20%experience a more severe illness leading to hospital admission and sometimes requiretreatment in intensive care. People that survive severe COVID-19 are likely to havepersistent health problems that would benefit from rehabilitation.Pulmonary rehabilitation (PR) is a multidisciplinary program which is designed to improvephysical and social performance and is typically provided for people with chronic lungconditions. PR courses typically last 6-12 weeks with patients attending classes once ortwice weekly and consist of exercise and education components. PR is known to improvesymptoms (e.g. breathlessness), quality of life and ability to exercise in those withlung conditions. Breathlessness is a very common symptom reported by people presenting tohospital with COVID-19 and loss of physical fitness will be very common. Using existingpulmonary rehabilitation programmes as a model, we have developed a tele-rehabilitationprogramme (a programme that will be delivered using video link to overcome the challengesfaced by social distancing and shielding advice) for people that have been critically illwith COVID-19. In order to prove whether people benefit from this tele-rehabilitationprogramme after being admitted to hospital following COVID-19 we would need to perform alarge clinical trial. However, before doing this it is important for us to answer somekey questions: - How many people that have been admitted to hospital and needed intensive care treatment for COVID-19 still report breathlessness, fatigue, cough and limitation of activities after being discharged from hospital? - Is it possible to recruit these people to a trial of tele-rehabilitation after hospital discharge? - Are people willing and able to perform tele-rehabilitation in their own home using video-link to connect with their therapist? - Are there other rehabilitation needs that are commonly encountered by people requiring intensive care treatment for COVID-19 that could be addressed by tele-rehabilitation that the programme doesn't currently address? Investigators will perform a small study called a feasibility trial to answer these questions and gather some early information about possible benefits of tele-rehabilitation. Based on our understanding of other similar diseases, doctors and therapists think that people will benefit from rehabilitation after COVID-19. The investigators therefore want to test a trial design that makes sure that everyone gets the treatment. This type of trial is called a feasibility, wait-list design randomised controlled trial. People with breathlessness and some limitation of activities will be selected at random to receive tele-rehabilitation within 2 weeks or to wait 6-8 weeks before starting. how many people were eligible to take part, how many agreed to take part and the symptoms and rehabilitation needs that they have will be assessed. Investigators will then monitor symptoms and ability to exercise at the start and end of the trial and before and after tele-rehabilitation.

A Phase I, double- blinded, randomized, placebo- controlled study to test the safety ofLomecel-B in Adults suffering from mild to severe acute respiratory distress syndrome(ARDS) due to COVID-19 resultant from 2019-nCoV coronavirus infection, or resultant frominfluenza virus infection.

The purpose of this study is to advance the scientific understanding of how a prenatalCOVID-19 infection and associated psychological distress influences infantneurodevelopment. This project will aim to shed light on how families and childdevelopment are impacted by the current COVID-19 pandemic and will work to better supportthese families and children as they grow.

This phase I trial investigates breathing techniques and meditation for health careworkers during COVID-19 pandemic. Breathing techniques and medication may help managestress and improve lung health. The goal of this trial is to learn if breathingtechniques and meditation may help to reduce stress and improve lung health in healthcare workers during the COVID-19 pandemic.

Recent studies have shown that some individuals may be asymptomatic but continue to shedthe COVID-19 virus. These individuals may represent a population that can unknowinglytransmit the virus. Healthcare workers (HCW) may acquire COVID-19 from the community orfrom possibly infected patients. It is important to gather data with respect to this tofurther understand the prevalence of asymptomatic carriage in individuals who work inresearch facilities, offices and clinical areas of hospitals and researchfacilities/institutes since this has important implications for infection control, aswell as staff and patient safety. The purpose of this study is to test whether aproportion of these individuals may be asymptomatic shedders of the COVID-19 virus.

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.

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.

To evaluate pulmonary changes and the results of a cardiopulmonary rehabilitationprotocol (CPRP) in patients after SARS-VOC-2 infection. Clinical trial type study to beconducted between 2020 and 2024 involving clinical-functional cardiopulmonary imaging andblood transcriptome profile: before CPRP (T1), 2 months after CPRP (T2) and 1 year later(T3). Expected results: a) clinical, image and transcriptome changes; b)clinical-functional improvement after CPRP.

The COVID-19 (coronavirus) pandemic has had a huge impact on healthcare resources andstaff in the UK. Understanding the key risk factors associated with infection amongsthealthcare workers is essential for future pandemic response plans.Currently there are scarce data relating to the infection rates and associated factorsamongst healthcare workers in the United Kingdom (UK). Studies of infection rates inhealthcare workers have largely relied on the real-time reverse transcriptase-polymerasechain reaction (RT-PCR) test to date and it appears that Healthcare workers are twice aslikely to succumb to Coronavirus infection, when compared to the general population andthose from Black and minority ethnic (BAME) backgrounds appear to be particularly atrisk.Currently there is no evidence that the presence of SARS-CoV-2 (severe acute respiratorysyndrome coronavirus 2) antibodies provides seasonal or long term immunity to futureinfection.Therefore, this study aims to understand the current level of SARS-CoV-2 antibodypositivity and try to determine the likely risk to healthcare workers in the UK toCOVID-19 infection. This study hopes to find out whether certain individualcharacteristics will have an impact on likelihood of infection susceptibility andantibody response and determine the impact of the presence of antibodies on thelikelihood of future clinical infection over a 12 month period.The study involves an initial online survey and linkage to the recent antibody test, thena further online survey in 6 and 12 months' time. The data obtained will be linked todata that the Human Resources Department (HR) holds.Participants also have the option to partake in another antibody test at 6 and 12 months'time and linked to the data collected.

Tocilizumab is an effective treatment for severe coronavirus disease 2019 (Covid-19)pneumonia and related inflammation. Given limited global supplies, clarification of theoptimal tocilizumab dose is critical. We conducted an open-label, randomized, controlledtrial evaluating two different dose levels of tocilizumab in Covid-19 (40mg and 120mg).Randomization was stratified on remdesivir and corticosteroid at enrollment. The primaryoutcome was the time to recovery. The key secondary outcome was 28-day mortality.