COVID-19 Clinical Trials and Expanded Access

This is an open-label, randomized, multi-centre study where hospitalized subjects will berandomized in a 2:1 ratio to receive Isoquercetin (IQC-950AN) in addition to standard ofcare or standard of care only for 28 days following confirmation of a COVID-19 infection.

This study is an open-label, single-arm study to evaluate the safety and efficacy ofAstrostem-V, allogenic adipose tissue derived mesenchymal stem cells (AdMSC), in patientswith COVID-19 pneumonia. After each subject completes 12-Weeks visit (Visit 12) and thedata management team confirms all individual data have no issue, the individual databasewill be locked and the blinding will be open for the statistical analysis.

People living with HIV could have different susceptibility and outcome to the SARS CoV-2infection. The risk of SARS CoV-2 infection in this population could be no related to HIVinfection, immunodepression or antiretroviral therapy, but to the differentsusceptibility as measured by ACE2 or CD26 receptors. Also, patients with HIV-1 infectioncould have different cytokine profile and cellular immune response after SARS-CoV-2infection, leading to a differential outcome,

Covid-19 is an additional stressor Black women have to deal with that may interfere withhypertension self-care management. Social connectedness is a source of resilience forBlack women to promote mental and physical health. Unfortunately, in the face of theCovid-19 pandemic, social distancing is a challenge further isolating Black women fromtheir networks. How is social connectedness to manage stress and emotional well-being ina social-distancing society for Black women with hypertension? The research team proposeda synchronous web-based version of Enhanced Co-Created Health Education InterventioN(eCo-CHIN) that build the success and best practices derived from the originalintervention. A Covid-19 session will be included as a way of helping Black women tomaintain resilience and self-care during stressful times. The eCo-CHIN intervention isinnovative and timely because the research team are using a synchronous platformpreparing Black women on how to deal with Covid-19 while taking care of self. The primaryinvestigator for this pilot study (Dr. Wright) is a Black Early Stage Investigator andformer KL2 (career development) awardee. The interdisciplinary research team has theexpertise and resources to deliver this Enhanced Co-CHIN intervention.

In this study, clinically cured patients with severe COVID-19 were used to evaluate thetherapeutic effect of COVID-19 and the recovery and health status of patients over timewith highly sensitive PET/CT imaging technology. At the same time, PET/CT whole bodyscan, dynamic imaging and mathematical dynamic model were combined to evaluate thefunctions of the heart, lung, liver, kidney, brain and other important organs and theoutcome of inflammatory lesions in clinically cured COVID-19 patients.

Stress is underpinned by a biological reaction of the organism allowing the production ofenergy to respond to a change in the environment (or stressor). Stress reaction isexpressed in behavioural, cognitive, emotional and physiological terms. This biologicalresponse is non-specific because it is the same regardless of the stressor. Its evolutionover time has been conceptualised by Hans Selye (1956) in the General Adaptation Syndrome(GAS) which comprises three successive phases. (i) The first phase, known as the alarmphase, corresponds to the activation of all biological mechanisms according to a trendregulation, allowing a rapid response to the stressor. (ii) The second phase ofresistance which adjusts the stress response to the intensity of the perceived aggressionaccording to a constant regulation. (iii) When the aggression disappears, a recoveryphase dominated by the return of the parasympathetic brake allows a return to homeostasis(eustress).The "primum movens" of all pathologies is therefore the inability of the individual toadapt his stress response in duration and/or intensity to the course of the phases of theGAS (distress). The perception of not being in control of the situation contributes tothe perceived stress and constitutes a well-established risk of distress. It is a riskfactor for the emergence of burnout. It induces a biological cost called allostatic cost.Allostasis is a concept that characterizes the process of restoring homeostasis in thepresence of a physiological challenge. The term "allostasis" means "achieving stabilitythrough change", and refers in part to the process of increasing sympathetic activity andcorticotropic axis to promote adaptation and restore homeostasis. Allostasis works wellwhen allostasis systems are initiated when needed and turned off when they are no longerrequired. Restoring homeostasis involves effective functioning of the parasympatheticsystem. However, when the allostasis systems remain active, such as during chronicstress, they can cause tissue burnout and accelerate pathophysiological processes.The perception of uncontrollability depends on the stress situation, the psychologicaland physiological characteristics of the subject and his or her technical skills inresponding to the stressors of the situation. In particular, subjects with a high levelof mindfulness are more accepting of uncontrollability and less likely to activate thestress response.The COVID-19 pandemic situation is a situation characterized by many uncertainties aboutthe individual, family and work environment and the risk of COVID infection. Healthcareworkers, like the military, are high-risk occupations that are particularly exposed tothese uncertainties in the course of their work and continue to work in an uncertainsituation. These professionals are described as a population at risk ofoccupational/operational burnout that the level of burnout operationalises. Thisancillary study in a population of civilian and military non-healthcare workers willcomplement the study conducted among military health care workers. It will make itpossible to isolate the specificity of each profession (civilian or military, healthcarepersonnel or not) with regard to the risk of burnout in the COVID context.The objective of this project is to evaluate the impact of the perception of non-controlin the operational burnout of experts in their field of practice and to study thepsychological and physiological mechanisms mediating the relationship between thesubject's characteristics, perceived non-control and burnout.

North-east area of France was hit in February 2020 by the new coronavirus disease, moreseverely than other French regions. Factors affecting the evolution of the disease andits severity have been quickly identified, among them figuring different kinds of immunedeficiency. Even if nowadays HIV infection is usually well controlled by ARV drugs, thosepatients with uncontrolled viral load and/or low CD4 cell counts, remain at higher riskof severe COVID infection. In this context, the primary objective of our study is aimedat evaluating the prevalence of SARS-CoV-2 antibodies in a cohort of HIV-infectedpatients followed-up in an HIV-infection care center. Secondary objectives are:evaluating whether the antibodies are protective or not, the kinetic of these antibodies,and HIV associated factors with the presence of antibodies.

This study investigates a new diagnostic test in detecting SARS-CoV-2, the virus thatcauses the disease COVID-19. This may help to improve testing for COVID-19.

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.

Coronavirus Disease 2019 (COVID-19) has been widespread worldwide since December 2019. Itis highly contagious, and severe cases can lead to acute respiratory distress or multipleorgan failure. On 11 March 2020, the WHO made the assessment that COVID-19 can becharacterised as a pandemic. With the development of machine learning, deep learningbased artificial intelligence (AI) technology has demonstrated tremendous success in thefield of medical data analysis due to its capacity of extracting rich features fromimaging and complex clinical datasets. In this study, we aim to use clinical datacollected as part of routine clinical care (heart tracings, X-rays and CT scans) to trainartificial intelligence and machine learning algorithms, to accurately predict the courseof disease in patients with Covid-19 infection, using these datasets.