COVID-19 Clinical Trials and Expanded Access

Administration of systemic corticosteroids for patients with severe forms of severe acuterespiratory syndrome(SARS-Co-2) infection are recommended by several guidelines. In thevery beginning of SARS-Co-2 pandemic the early recommendation by professionalorganization was against routine use of corticosteroids for patients with coronavirusdisease 2019 (COVID-19) acute respiratory distress syndrome (ARDS), despite previous dataand clinical practice for patients with refractory or severe form of ARDS.

The purpose of this umbrella study is to evaluate isatuximab when combined with novelagents with or without dexamethasone in participants with relapsed or refractory myeloma.Substudy 01 is the control Substudy. Substudies 02, 03, and 06 are controlledexperimental substudies. Substudies 04 and 05 are independent experimental substudies.

This is a first-in-human study, Phase 1, randomized, placebo-controlled, double blindedstudy that will be conducted in 2 parts.

Several publications document the occurrence of symptoms that persist or occur late.The identification of the observed clinical manifestations and their clinical andparaclinical description are essential to better understand the natural evolution ofCOVID-19, to clarify the pathophysiological mechanism of these possible latemanifestations, and to identify potential management options for patients.Since this type of event is infrequent, a large-scale national multicenter cohort studyfocusing on symptomatic patients is needed.

To assess blood levels of vasoactive mediators that may regulate pulmonary endothelialpermeability and contribute to multi-organ injury in patients with COVID-19 disease andto correlate the levels of these mediators with disease outcomes such as ICU admission,length of ventilatory support, respiratory failure, kidney failure, heart failure, anddeath.

Coronavirus Disease 2019 (COVID-19) is a newly emerged disease, caused by severe acuterespiratory syndrome coronavirus 2 (SARS-CoV-2). The COVID-19 pandemic is having a largeimpact on the mental and physical health of patients, yet data on the quality of life ofpost-COVID-19 patients is lacking. There are currently no post-COVID-19 specific measuresfor quality of life, particularly none which include the views of post-COVID-19 patientsthemselves. This observational study will recruit participants to contribute theirpreferences to the creation of a post-COVID-19 specific patient-reported measure onpost-COVID-19 quality of life. Participants will be split into three groups: those whowere not hospitalised; those who were hospitalised but not in intensive care units; andthose who were hospitalised and in intensive care units. The creation of this measurewill form phase 1 of the study, with 30-60 participants (10-20 in each group above)recruited to complete online surveys to find out their preferences of areas of life toinclude in such a measure. This will involve 3 online surveys, 1) to ask which areas oflife they feel are impacted and how; 2) to find consensus about the areas to be included;3) to weight the relevance of these areas in relation to each other. In phase 2recruitment will open to additional participants and all participants will be asked tocomplete the finalised post-COVID-19 quality of life measure once a month for 12 months,aiming for a minimum of 100 participants at this stage. All participants will also beasked to complete a demographic questionnaire to inform the analysis of the data.

Background:Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes coronavirus disease2019 (COVID-19). The global outbreak of COVID-19 is a major public health problem.COVID-19 causes a wide range of symptoms. These symptoms range from mild breathingproblems to life-threatening problems or death. Some people have no symptoms. This studyaims to learn how acute and late immune responses to COVID-19 lead to different outcomes.The immune system is the body s defense against germs, including viruses, that invade thebody.Objective:To characterize the immune responses during and after SARS-CoV-2 infection and determineif there is any relationship to clinical course and outcome.Eligibility:People ages 0 99 who have confirmed or suspected SARS-CoV-2 infection, people who are notinfected despite heavy exposure, and relatives of enrolled participants.Design:This is a sample collection protocol to receive send-in biological specimens forexploratory studies, including gene testing. Participants will not be seen at the NIH forstudy visits.Study staff will talk with participants health care providers to screen them for thestudy. Participants enrolled into the protocol will send samples and clinical informationat least once and more often if the participant has COVID-19. All participants willprovide blood samples and possibly stool. We may also ask for left over specimens fromany medical procedures completed as part of medical care. The study staff will alsorequest participants health care providers to complete a survey to collect demographicand medical data. Some of this information may need to be provided directly by theparticipant.Pregnant individuals are invited to participate and may be asked to give cord bloodsamples after delivery. Study findings that affect participants health may be shared withtheir health care provider. Depending on findings, participants may be contacted to takepart in other NIH studies.

Patients reactions towards their diagnosis as having COVID-19. The effect of patients'reaction toward their prospect management. How this can make many hazards. Also, obstacleand barrier to better management.

Automated quantification of the pulmonary volume impaired during acute respiratoryfailure could be helpful to assess patient severity during COVID-19 infection orperioperative medicine, for example.This study aim at assessing the correlation between the amount of radiologic pulmonaryalteration and the clinical severity in two clinical situation : 1. SARS-CoV-2 infections 2. Postoperative hypoxemic acute respiratory failure

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.