COVID-19 Clinical Trials and Expanded Access

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.

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.

The purpose of this study is to evaluate pulmonary function of patients recovering frommild, moderate, and severe COVID-19 disease using hyperpolarized 129Xe MRI.

The purpose of this study is to collect information that will help the reasearchers learnmore about COVID-19 infections in cancer patients, and to find out about the effects ofthese infections on cancer treatment and outcomes. The research study involves askingpeople to complete a series of online questionnaires that include questions about theirmedical history, lifestyle, and risk factors related to the COVID-19 infection. The studywill enroll both MSK patients and their household family members.

The overall objective of this study is to evaluate the clinical efficacy of oralfamotidine in symptomatic non-hospitalized patients with confirmed COVID-19. This studyis expected to enroll up to 84 patients with mild to moderate symptoms divided into eachof the two study arms. Clinical outcomes of the two treatment arms will be compared. Thisstudy will be conducted virtually/remotely.

This is a prospective single-center study for the follow-up of SARS-CoV-2 positivepatients in the district of Konstanz (LKN). As part of the coronavirus pandemic, patientswith SARS-CoV-2 infection are currently being treated in the clinics of the LKN's healthnetwork at the Singen (Hegau-Bodensee Clinic) and Konstanz (Konstanz Clinic) locations.So far, there is little data on the long-term effects of SARS-CoV-2 infection. As part ofthis study, the disease progression of these patients will be monitored. Study objective:Prospective, controlled follow-up observation of SARS-CoV-2 positive patients regardingtheir secondary diseases and quality of life.

The AGILE platform master protocol allows incorporation of a range of identified andyet-to-be-identified candidates as potential treatments for adults with COVID-19 into thetrial. Candidates will be added into the trial via candidate-specific trial (CST)protocols of this master protocol as appendices. Having one master protocol ensuresdifferent candidates are evaluated in the same consistent manor and opening up new trialsfor new candidates is more efficient. Inclusion of new candidates will be based onpre-clinical data, evidence in the clinical setting and GMP capabilities.

None of the vaccines approved, or in clinical trials, have so far been tested ontransplanted patients. If they produce an immune response to the Spike protein ofSARS-CoV-2 it is unknown how long the protective immunity will last.Not all immune responses are equal. The investigators will quantify immune cell subsetswith flow and mass cytometry analyses to describe the phenotype of responding immunecells, including specific T cells. If not already established, patient human Leukocyteantigen (HLA) genotypes will be typed.In order to compare the immune responses with healthy individuals a control group ofhospital employees will be included and sampled before and after vaccination according tothe same time schedules as the kidney transplanted patients.