COVID-19 Clinical Trials and Expanded Access

Novel coronavirus 2019 (COVID-19) has emerged as a major international public healthconcern. While much of the morbidity and mortality associated with COVID-19 has beenattributed to acute respiratory distress syndrome (ARDS) or end-organ failure, emergingdata suggest that disorders of coagulation, in particular hypercoagulability and venousthromboembolism (VTE), may represent an additional major, and possibly preventable,complication (Wu C, et al. JAMA Intern Med. 2020 Mar 13. [Epub ahead of print] and TangN, et al. Thromb. Haemost. 2020 Feb 19. [EPub Ahead of Print]). Abnormal coagulationtesting results, especially markedly elevated D-dimer and FDP, have been associated witha poor prognosis in COVID-19 infection. We propose the following Electronic Health Record(EHR)-guided 10000-patient, retrospective observational cohort study to assess VTEincidence, risk factors, prevention and management patterns, and thrombotic outcomes inpatients with COVID-19 infection. In order to gain the valuable perspective of otherregional and national centers providing care for large populations of COVID-19, we havestarted a collaborative network with 5 additional sites which will provide us withde-identified data from 1000 patients each. These 5000 patients in addition to the5000-patient cohort we are enrolling within the Mass General Brigham Network willcomprise this study population.

This study will assess whether the promotion of emotional exchange between mother andinfant during the first four months of life improves primarily mother-child earlyrelational health (ERH) and secondarily child neurodevelopmental and maternal mentalhealth outcomes. In prior research on preterm infants, a similar interventiondemonstrated increased quality of maternal caregiving behaviors and significantimprovements in premature infants' neurodevelopment across multiple domains, includingsocial-relatedness and attention problems. The goal of the emotional exchangeintervention is to help mothers provide appropriate stimulation crucial for social,emotional, and neurobehavioral development, by helping the mother and child becomeattuned, or 'in sync', with each other. Measures of ERH, such as bonding, maternalsensitivity, and mother-child emotional connection will be compared between two groups:one receiving newborn parenting education and the other undergoing facilitated emotionalexchange. Assessments will involve videos of mother-infant interactions during eachintervention session and follow-up surveys conducted as part of a linked InstitutionalReview Board-approved study. Data collected in this study will contribute tounderstanding the underlying mechanisms of mother-infant interactions and their role inshaping optimal neurodevelopmental trajectories for infants and maternal mental health.

Time to recover of Anosmia and / or ageusia and early corticosteroid use

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,

This project covers several research aims. In a cohort study, the investigators aim tocompare confirmed COVID-19 patients with non-COVID-19 patients who undergo surgicaltreatment and study factors associated with good or bad outcomes.

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.