COVID-19 Clinical Trials and Expanded Access

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.

Purpose: The emergence of a new coronavirus SARS-CoV-2 causing a novel infection in thehuman race resulting in a world-spanning pandemic came as a surprise and at a tremendouscost both for individual human lives as well as for the society and the health caresector. The knowledge on how this new infection affects both the mother and the unbornchild as well as the outcomes for the mother and the child in the long run are unknown.What is known is based on case-reports and small case-series solely. Both thecoronaviruses causing Middle East Respiratory Syndrome (MERS) and Severe AcuteRespiratory Syndrome (SARS) can cause a threat to pregnant women and their offspring,which leads to the question whether this could be the case also for SARS-CoV-2.Aims: To establish a biobank of biological material from infected as well as non-infectedpregnant women and their offspring. To combine this biobank with Swedish quality andhealth care registers, computerized patient charts and questionnaire data, enabling bothshort-term follow up, such as obstetric outcomes, as well as long-term outcomes both formother and child. To study how the pandemic situation affects both the mother and herpartner in their experience of pregnancy, childbirth, and early parenthood.Design: A national Swedish multicentre study. Women are included when they have apositive test for SARS-CoV-2 or a clinical suspicion of coronavirus disease 2019(COVID-19) (COVID-19 group). Pregnant women without COVID-19 symptoms will be included attheir routine visits (Screening group). Blood samples and other biological material willbe collected at different time-points. Additional predictors and outcomes are collectedfrom the Swedish Pregnancy Register as well as obligatory Swedish health registers. Thebiobank and its linkage to health registers through the Swedish personal identificationnumber will enable future research. Child development will be followed during the firstyear of life by questionnaires to the parents. Womens' and their partners' experience ofchildbirth and parenthood will be studied in form of questionnaires as well as in form ofinterviews.Conclusion: This project will help obstetricians and neonatologists better recognizeclinical manifestations of the virus, identify possible risk factors during pregnancy andtailor therapies alongside providing right level of surveillance and management duringpregnancy, delivery, and child health care.

This phase III trial compares low dose whole lung radiation therapy to best supportivecare plus physicians choice in treating patients with COVID-19 infection. Low dose wholelung radiation therapy may work better than the current best supportive care andphysician's choice in improving patients' clinical status, the radiographic appearance oftheir lungs, or their laboratory blood tests.

The purpose of this study is to find out if immunization with IMM-101 will reduce theincidence of severe respiratory and COVID-19 infections in cancer patients.

During the current pandemic, in Italy the majority of asymptomatic or pauci-symptomaticCOVID-19 cases were not identified nor diagnosed and this fact caused a decrease in theeffectiveness of the various containment measures implemented. Therefore, in a futurescenario where a new viral swarm is expected, the early identification of all infectedcases becomes essential to plan and activate a containment strategy for the spread of thevirus, given the current absence of vaccines.The typical radiological finding of COVID-19 is an interstitial pneumonia, which can beresponsible, in a significant portion of patients, of an acute respiratory distresssyndrome (ARDS).Low-dose chest CT and simple blood tests could identify sub-solid pulmonary nodules(SSNs) indicative of COVID-19 infection in asymptomatic subjects.Objectives of this observational study are the early detection of COVID-19 markersindicative of prior exposure or persisting viral infection in asymptomatic subjects andthe assessment of the frequency and outcome of COVID-19-related SSNs in asymptomaticsubjects by time, domicile, and other individual risk factors.SMILE lung CT screening program cohort has been considered, based on 960 subjects at highlung cancer risk for tobacco smoking (≥20 pack/year) and age (50-75 years), together withinflammatory and respiratory profile. SMILE utilizes a top technology dual-source CTscanner (Somatom Force) with the lowest radiation dose ever applied to lung screening.All chest CT images from screening subjects will be re-evaluated by two additional CADprograms, specifically designed for the analysis of SSNs and quantification of the totalvolume of lung parenchyma showing an increased density. This re-evaluation will improvethe sensitivity and specificity of radiomic assessment.This study cohort, enriched by the already established longitudinal biobank of frozenplasma samples, represent an ideal opportunity to assess the frequency of SSNs inasymptomatic subjects, due to the effect of COVID-19, particularly among subjects livingin areas at high risk of viral exposure. It will also be possible to evaluate ifCOVID-19-related SSNs are associated with chronic co-morbidity, other individual riskfactors, inflammatory (CRP) / immunomodulatory (25(OH)D) blood profile, and/or can betraced by immune markers such as IgM/IgG and other cytokines.Clinical data will be integrated with an analysis of the IgG-IgM profile specific forcovid-19, on the plasma samples taken at the time of the CT scan, or subsequently, incollaboration with University of Milan, Luigi Devoto Work Clinic.The lasting collaboration with the Radiological Science Department of the University ofParma in lung screening also offers the opportunity to validate the results obtained inthis cohort on chest CT performed at the University Parma Hospital during the last twomonths in symptomatic subjects for suspected covid-19 pneumonia.In collaboration with University of Milano Bicocca, Machine Learning (ML) tools will beapplied to predict the clinical relevance, severity and ultimate outcome of SSNs, basedon radiomic CT features, epidemiologic risk, co-morbidity and inflammatory/immune bloodbiomarkers. ML analysis will generate a predictive algorithm for clinical outcome ofSSNs, and specifically the risk of COV-I9 infection and unfavorable disease prognosis.

In March 2020, the World Health Organization (WHO) declared the novel coronavirus(COVID-19) a global pandemic. Ontario has confirmed more than 547,000 cases of COVID-19since testing began. For many of these patients, symptoms resolve within 4 weeks ofonset. However, it is becoming apparent that a significant number of individuals areexperiencing symptoms that persist long after the acute infection, known as Long COVID.These individuals have a wide constellation of presenting symptoms, often varying frominitial presentation. For this study, we will be enrolling individuals receiving care atThe Ottawa Hospital for Long COVID. This study aims to determine the following fourthings: 1) will adding electronic case management improve quality of life three monthsafter coming to hospital with Long COVID; 2) is the electronic case management platformcost effective; 3) is there any factors that predict outcomes at 3 months; 4) todetermine how a personalized rehabilitation program supported by a digital platform couldbe implemented for individuals with Long COVID. We will enroll individuals from TheOttawa Hospital who will then be randomly assigned to receive either usual care or usualcare plus electronic case management, through a platform called NexJ Connected Wellness.Participants will also complete questionnaires every 4 weeks for 3 months. We will belooking at quality of life, mental and physical health, cognitive symptoms, fatigue andpain.