COVID-19 Clinical Trials and Expanded Access

GEN-COVID multicenter study aims to identify the genetic variants of the host genomeresponsible for the clinical variability of patients with COVID-19. This variability todate is only partially related to the age and comorbidities of patients. The primaryobjective of the study is therefore to identify genetic variants associated with theseverity of the disease, while the secondary objective consists in the identification ofvariants associated with longitudinal disease trajectories.This is a laboratory study that involves the conduct of genetic investigations, includingwhole exome sequencing and genome wide association studies, on human biological materialfrom patients affected by COVID-19.Clinical information useful to describe the level of disease severity will be alsocollected for each enrolled patient.A total of at least 2,000 COVID-19 patients is expected to be included.

Convalescent Plasma for COVID-19 Research (CONCOR-Donor) study, is a national, naturalhistory study of plasma donors recovered from COVID-19. CONCOR-Donor study will addressimmune response, duration of protective immunity, and clinical factors and host geneticscontributing to the variability of immune response. We will also study long-term outcomesfrom COVID-19 infection. Results from the study will help define therapeutic strategiesfor COVID-19.

The primary objective is to assess the ability of COVID-19 IgG and IgM assays to detectan immune response in COVID-19 patients in the Henry Ford Health System (HFHS), bothduring hospitalization and over the following 12 months.

Background:People who get COVID-19 have a wide range of symptoms. They also recover from COVID-19 indifferent ways. In this study, researchers will use survey data to describe the differentways people experience and recover from COVID-19. They will also use the data to helpcreate future studies to understand why some people do not fully recover.Objective:To learn more about the range and timing of symptoms that people have before, during, andafter COVID-19 infection.Eligibility:People ages 18 and older who can give documentation of a positive COVID-19 or antibodytest.Design:Participants will be screened with a telephone interview. It will take 15 minutes. Theywill provide their COVID-19 test results and medical records.Participants will complete a second telephone interview. It will take 30 60 minutes. Theywill also take online surveys every 3 months for 3 years.The interview and surveys will ask participants about their health before they gotCOVID-19, what happened while they had COVID-19, and what their recovery has been like.Participants will get log-in data to take the online surveys. Completing all of thesurveys the first time may take up to 3 hours. Follow-up surveys will take up to 30minutes. Participants do not have to complete the surveys in one sitting. They will beable to save their progress and finish the surveys later.Participants may be contacted to take part in other research studies.

The health crisis imposed by COVID-19 is forcing major worldwide social reorganizationthat will have profound consequences on our society. Currently, one-third of the world'spopulation (~3 billion individuals) is living under some kind of isolation or quarantinemeasures, causing an unprecedented and rapidly evolving psychosocial crisis.The psychosocial consequences of this health crisis will persist long after restrictionmeasures are lifted and the pandemic is over. This impact will be significant forindividuals facing unique contexts or challenges (e.g., older adults, individuals livingwith a disability, underprivileged families) and will most likely exacerbate existingsocial and gender inequalities in health and human development.There is an urgent need for information on the evolution of the psychosocial dimensionsof health and coping strategies used by our population and our health and social servicesstructures. Thus, this study is designed to accelerate the availability of high-quality,real-time evidence within health and social services structures to address, support andminimize psychosocial consequences of the COVID-19 pandemic. Through constantly evolvingresearch questions responsive to the course of the pandemic evolution, the rapid systemtransformations and adaptation of services, and knowledge users (KUs) needs, MAVIPAN aimsto address, document, monitor, and evaluate the following: 1. Individuals and families' adjustments and mitigation strategies, especially for those considered vulnerable and in high-risk contexts. 2. Healthcare and social services workers and managers' adjustments and mitigation strategies. 3. The organization of service structures. 4. The social and economic response.To achieve these objectives, we use a mixed methods study design that combinesquantitative questionnaires and qualitative interviews to deepen our understanding ofelements such as the coping strategies used during the pandemic. A first measure wastaken during lock-down as well as a follow-up at 3 months. Another follow-up will be madeat 7 months. At least one per year follow-up will be made over the course of the study (5years). Additional measures may be taken depending on the evolution of the pandemic andthe sanitary measures put in place by the authorities.

COVID-19 has become a global problem. There is an urgent need to improve the diagnosisand screening of patients and healthcare workers for COVID-19 in the UK. Mask basedsampling is a method of detecting SARS-COV-2 (the virus responsible for COVID-19) in thebreath of suspected COVID-19 patients or healthcare workers in the mask that they wouldwear in hospital. The investigators have previously demonstrated the utility of thismethod in other respiratory infections, such as tuberculosis.This project aims to investigate the utility of mask-based sampling is a tool for thediagnosis and quantification of COVID-19 in breath and the implications in a healthcaresetting using three cohorts of participants. Initially we will compare the amount ofCOVID-19 detected by mask sampling compared with standard nasopharyngeal swab, which isthe current gold standard test, in patients who present to hospital with COVID-19symptoms.We will address the length of time COVID-19 is breathed out by people affected by thevirus and the how infectious the virus is over time in a cohort of symptomatic healthcareworkers who are isolating at home. This will allow us to understand how long someonestays infectious for and may have the potential to inform public health measures, forinstance when healthcare workers can return to work or duration of isolation. Finally wewill investigate asymptomatic carriage of COVID-19 by different healthcare workers indifferent areas of the hospital during a screening study. This will allow us tounderstand the extent of infection amongst healthcare workers and allow us to addresshospital acquired transmission.

The goal of this project is to rapidly screen promising agents, in the setting of anadaptive platform trial, for treatment of critically ill COVID-19 patients. In this phase2 platform design, agents will be identified with a signal suggesting a big impact onreducing mortality and the need for, as well as duration, of mechanical ventilation.

A global study for a better understanding of the cardiovascular conditions that increasethe risk of developing severe COVID-19, and a better characterization of cardiovascularcomplications in hospitalized patients with COVID-19.

This is a prospective cohort observational registry study that will include data on allpatients who are treated at MHS facilities for COVID-19.

COVID-19 is a community acquired pneumonia caused by infection with a novel coronavirus,SARS CoV2 and is a serious condition with high mortality in hospitalised patients, forwhich there is no currently approved treatment other than supportive care. Urgentinvestigation of potential treatments for this condition is required.This protocol describes an overarching and adaptive trial designed to provide safety,pharmacokinetic (PK)/ pharmacodynamic (PD) information and exploratory biologicalsurrogates of efficacy which may support further development and deployment of candidatetherapies in larger scale trials of COVID-19 positive patients receiving normal standardof care.Given the spectrum of clinical disease, community based infected patients or hospitalisedpatients can be included. Products requiring parenteral administration will only beinvestigated in hospitalised patients. Patients will be divided into cohorts, a)community b) hospitalised patients with new changes on a chest x-ray (CXR) or a computedtomography (CT) scan or requiring supplemental oxygen and c) hospitalised requiringassisted ventilation. Participants may be recruited from all three of these cohorts,depending on the experimental therapy, its route of administration and mechanism ofaction. The relevant cohort(s) for any given therapy will be detailed in thetherapy-specific appendix.Candidate therapies can be added to the protocol and previous candidates removed fromfurther investigation as evidence emerges. The trial will be monitored by an independentData Monitoring Committee (DMC) to ensure patient safety.Each candidate cohort will include a small cohort of patients randomised to candidatetherapy or existing standard of care management dependent on disease stage at entry.Cohort numbers will be defined in the protocol appendices.This is a Phase IIa experimental medicine trial and as such formal sample sizecalculations are not appropriate.