COVID-19 Clinical Trials and Expanded Access

Background:The higher death rate from COVID-19 in the older population is associated with low CD8 Tcell counts in the blood. Researchers want to learn the status of CD8 T cells specific toSARS-CoV-2 and their changes with aging and in COVID-19. This may help to identify whyCOVID-19 is particularly lethal in the elderly and help to create an effective vaccineagainst SARS-CoV-2 in the elderly.Objective:To identify SARS-CoV-2 specific CD8 T cells in humans, and to determine their quantityand quality in people who have recovered from COVID-19.Eligibility:Maryland residents age 18 and older who have tested positive for and recovered fromCOVID-19.Design:Participants will be screened by phone. They must be able to provide a copy of theirpositive COVID-19 test result.Participants will visit the NIA/Clinical Research Unit. The visit will take about 1 hour.Laboratory tests showing a positive COVID-19 result will be verified.Participants vital signs will be checked. This will include blood pressure, temperature,pulse, and respiration. Height and weight will be measured.Participants will have a medical history and medicine review. They will complete aCOVID-19 questionnaire.Participants will have blood drawn. They will give a urine sample.Participants will give a saliva sample. They will rinse their mouth with water. Afterabout 3 minutes, they will let saliva pool in the base of their mouth and then spit intoa sterile container.Participants may be asked if they would be willing to return for optional visits at about4 months and 1 year later. They will repeat the same laboratory sampling performed at thefirst visit....

This is a multicenter, non-interventional, retrospective study using data captured in theEHRs (Electronic Health Records) of the participating hospital sites to determine factorsthat predict disease prognosis and outcomes in COVID-19 patients, specifically:Hospitalization/Off-site monitoring, transfer to ICU and/or need for medical mechanicalventilation (both invasive and non- invasive), length of ICU stay, and outcome (cure/hospital discharge, in-hospital death)

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.

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.

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.

The study is a randomized, double-blind, placebo-controlled, dose escalation,multi-center clinical trial (RCT) of SPI-1005 in adult subjects with positive PCR testfor novel SARS-CoV-2 (nCoV2) and moderate symptoms of COVID-19 disease.

This is a a randomized double blind placebo controlled Phase 2 trial with a 12 patientlead-in to evaluate safety, prior to full enrollment to an additional 28 patients (for atotal of 40 patients) to assess efficacy of decitabine in the treatment of critically illpatients with COVID-ARDS. The patients will be randomized in a 1:1 ratio to receivestandard of care plus Decitabine or standard of care plus saline based placebo. Theprimary objective is to determine safety and efficacy of decitabine for COVID-19 ARDSbased on clinical improvement on a 6-point clinical scale.

An International Multi-Centre Randomised Adaptive Platform Clinical Trial to Assess theClinical, Virological and Immunological Outcomes in Patients with SARS-CoV-2 Infection(COVID-19).