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)

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.

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).

Plasma from patients who have recovered from coronavirus disease 2019 (COVID-19) isreferred to as COVID-19 convalescent plasma (CCP), and may contain antibodies againstSARS-CoV-2, the virus responsible for COVID-19. CCP infusion is being evaluated as atherapeutic or prophylactic approach in COVID-19 patients. The goal of this study is tohelp develop a bank of convalescent plasma in California, especially in medicallyunderserved communities particularly affected by the disease. In parallel, CCPadministered to COVID-19 patients will be collected and analyzed to determine whether theantibody profile correlates with clinical outcome. The purpose of this non-therapeuticstudy is to learn more about the CCP antibody profile and the effect it may have intreating COVID-19 infection.

The purpose of this study is to test whether Fisetin, a senolytic drug, can assist inpreventing an increase in the disease's progression and alleviate complications ofcoronavirus due to an excessive inflammatory reaction.

A prospective and retrospective cohort study. The objective will to determine thefrequency of COVID-19 in pregnant and postpartum women hospitalized with flu syndrome, toevaluate clinical and laboratory predictors of COVID-19 progression and to determine thefactors associated with adverse maternal and perinatal outcomes in healthcare centers intwo states of Northeast Brazil.The study will be conducted including pregnant andpostpartum women with clinical or laboratorial diagnosis of COVID-19, admitted in sixhealthcare centers in the Northeast of Brazil. All pregnant and postpartum women withclinical and/or diagnosis of COVID-19, attended in prenatal care, in emergency (maternitytriage), high-risk pregnancy ward, obstetric intensive care unit and rooming-in ward willbe included. The data will be collected in specific forms. The exams will be carried outby trained professionals within each institution.

Low doses of radiation in the form of chest x-rays has been in the past to treat peoplewith pneumonia. This treatment was thought to reduce inflammation and was found to beeffective without side effects. However, it was an expensive treatment and was eventuallyreplaced with less expensive treatment options like penicillin.The COVID-19 virus has emerged recently, causing high rates of pneumonia in people. Theauthors believe that giving a small dose of radiation to the lungs may reduceinflammation and neutralize the pneumonia caused by COVID-19. For this study, the x-raygiven is called radiation therapy. Radiation therapy uses high-energy X-ray beams from alarge machine to target the lungs and reduce inflammation. Usually, it is given at muchhigher doses to treat cancers.The purpose of this study is to find out if adding a single treatment of low-dose x-raysto the lungs might reduce the amount of inflammation in the lungs from COVID-19infection, which could reduce the need for a ventilator or breathing tube.

Trial Phase: Phase III: Interventional Trial: Virtual clinics to deliver universalinterventions to maintain and improve physical health, nutritional state andpsychological wellbeing in people with cancer who are following social distancingguidance: A COVID-19 targeted trial.Indication: Male or female participants, aged over 18 years old with suspicion orconfirmed diagnosis of cancer (does not require histological confirmation)Objective: To investigate the efficacy of remote multimodal universal interventionsdelivered via virtual clinics to improve physical function as measured by theEORTC-QLQ-C30.Secondary Objective:To investigate the efficacy of remote multimodal universal interventions delivered viavirtual clinics to improve emotional function, quality of life, participant activation(PAM), behaviour change and the effect it has on health economics (EQ-5D-5L).Exploratory Objective:Overall Survival and adherence to the intervention/advice using validated tools ordevelopment of a web-based toolkit.