COVID-19 Clinical Trials and Expanded Access

The aim of this study is to apply serology testing methods for SARS-CoV2 antibodies insamples collected from HCWs in an acute hospital. This will enable the identification ofthose who are protected and non-infectious for SARS-CoV2 and those who are seronegativeand therefore potentially susceptible and infectious on patient contact. Prospectivetesting will provide data on the acquisition of SARS-CoV2 infections among HCWs andassociated risk factors for transmission during a pandemic at an acute care hospitalfacility in the capital region of Denmark.Hypothesis: Serial seroconversion measurements in hospital employees improve theorganization of the clinical treatment and care during the COVID-19 pandemic atNordsjællands Hospital and Nykøbing Falster County Hospital.

Lower Respiratory Tract infections are a common cause of admission to the intensive careunit. Children routinely receive antibiotics until the tests confirm whether theinfection is bacterial or viral. The exclusion of bacterial infection may take 48 hoursor longer for culture tests on biological samples to be completed. In many cases, theresults may be inconclusive or negative if the patient has already received antibioticsprior to the sample being taken.A rapid assay to detect the most likely cause of infection could improve the speed withwhich antibiotic therapy is rationalised or curtailed.This study aims to assess whether a new genetic testing kit which can identify thepresence of bacteria and viruses within hours rather than days is a feasible tool inimproving antibiotic prescribing and rationalisation of therapy in critically illchildren with suspected lower respiratory tract infection.

Patients suffering lung failure, possibly from COVID-19 or hypoxic lung failure, willneed life-saving support from a breathing machine. Any patient needing this supportrequires drugs to keep them sleepy, or "sedated" to be comfortable on this machine.Sedation is made possible by using drugs given through a vein. Unfortunately, these drugsare in short supply worldwide due to the high number of COVID-19 patients needing thesemachines.Another way to provide sleep is by using gases that are breathed in. These are used everyday in operating rooms to perform surgery. These gases, also called "inhaled agents" canalso be used in intensive care units and may have several important benefits for patientsand the hospital. Research shows they may reduce swelling in the lung and increase oxygenlevels, which allows patients to recover faster and reduce the time spent on a breathingmachine. In turn, this allows the breathing machine to be used again for the next sickpatient. These drugs may also increase the number of patients who live through theirillness. Inhaled agents are widely available and their use could dramatically lesson thepressure on limited drug supplies.This research is a study being carried out in a number of hospitals that will compare howwell patients recover from these illnesses depending on which type of sedation drug theyreceive. The plan is to evaluate the number who survive, their time spent on a breathingmachine and time in the hospital. This study may show immediate benefits and may providea cost effective and practical solution to the current challenges caring for patients andthe hospital space, equipment and drugs to the greatest benefit. Furthermore, the studywill be investigating inflammatory profile and neuro-cognitive profiles in ventilatedpatients. Finally, this trial will be a team of experts in sedation drugs who care forpatients with proven or suspected COVID-19 who need lifesaving treatments.

Background: Fatigue is among the most common symptoms of the long-term effects ofcoronavirus (long COVID). This study aims to compare the effectiveness of osteopathicmanipulative treatment (OMT) combined with physiotherapy treatment (PT) compared to PTalone on fatigue and functional limitations after two months post randomization in adultswith long COVID.Methods: This is a study protocol for a two-arm, assessor-blinded, pragmatic randomizedcontrolled superiority trial. Seventy-six participants will be randomly allocated toOMT+PT or PT. The PT includes usual care interventions including motor and respiratoryexercises targeting cardiorespiratory and skeletal muscle functions. The OMT entailsdirect, indirect, visceral, and cranial techniques. Patients will be evaluated before andafter a 2-month intervention program, and at 3-month follow-up session. Primaryobjectives comprise fatigue and functional limitations at 2-month post randomization asassessed by the fatigue severity scale and the Post-COVID Functional State scale.Secondary objectives comprise fatigue and functional limitations at 3 months, and theperceived change post-treatment as assessed by the Perceived Change Scale (PCS-patient).

Administration of systemic corticosteroids for patients with severe forms of severe acuterespiratory syndrome(SARS-Co-2) infection are recommended by several guidelines. In thevery beginning of SARS-Co-2 pandemic the early recommendation by professionalorganization was against routine use of corticosteroids for patients with coronavirusdisease 2019 (COVID-19) acute respiratory distress syndrome (ARDS), despite previous dataand clinical practice for patients with refractory or severe form of ARDS.

Researchers are creating real-time epidemiology registry to evaluate the efficacy ofCOVID-19 subject risk assessment scores based on recording of symptoms, biomarkers,chronic illness and mental health assessments with digital technology using wearables andmobile app tools. Researchers aim to study in Phase 1, epidemiological variations inCOVID-19 presentation in both PCR positive and negative subjects in the registry.Assessment of variables, predictive modeling of variables that impact severity ofCOVID-19 positive and negative subjects and assessment of predictors for post COVID-19complications. In Phase 2, 2700 subjects with COVID-19 positive test will be studied inthe intervention group comparing ECL-19 vs placebo with primary end point of hospitaladmission assessment. Treatment strategy for PCR positive COVID-19 subjects in theregistry who are in Stage I of the disease process with ECL-19 drug compared to placeboin reducing hospital admissions

COVID-19 is a novel disease caused by SARS-CoV-2 that primarily affects the lungs butalso various other organs of the body already in early stages of the disease. Due to themultiple organ involvements in the acute phase, it is conceivable that - in a significantproportion of patients - longterm sequels in various organ systems might occur, therebyimpacting the individual's health status and quality of life; and posing a relevantburden to the resources of the health care systemAssessment of SARS-CoV-2-longterm morbidity and sequels on the population level:In order to identify and treat these sequels in a timely fashion and to get a sense ofthe prevalence of such SARS-CoV-2 sequels on the population level, it is important tocollect follow-up data and to comprehensively re-examine a population-representativesample of SARS-CoV-2 infected individuals.Within the COVIDOM study we will conduct deep clinical and biochemical phenotyping inpopulation-representative samples in Germany. This will allow novel insights into diseasepathogenesis and chronicity of virus infections.

Background:Viral infections such as COVID-19 may lead to flare-ups in people with systemicautoimmune diseases (SAD). These infections may also change the function of their immunesystem and/or cause problems with their blood vessels. Researchers want to learn howpeople with SAD respond to treatments or vaccines for COVID-19.Objective:To understand how COVID-19 affects inflammation, the immune system, and blood vessels inadults and children with autoimmune diseases.Eligibility:People ages 15 and older who have been diagnosed with an autoimmune disease or are ahealthy volunteerDesign:Participants will have a screening visit. This will include:Medical history and physical examEKGChest x-rayCOVID-19 test. A swab will be put in the participant s nose or the back of their mouth.Blood and urine testsParticipants will be placed into 1 of 4 groups: 1. Those with previously documented COVID-19 infection or COVID vaccination 2. Those with a recently known COVID-19 exposure or vaccination 3. Those with no known COVID-19 exposure or vaccination 4. Those who developed an acute COVID-19 infectionDepending on their group, participants will have 1 to 5 more visits. These will occurover 12 to 18 months. Visits may include:FDG PET/CT scan. Participants will lie in a doughnut-shaped machine. The machine createspictures of the body. For the scan, they will have a radioactive substance injected intotheir arm through an IV.Kidney function testsNon-invasive vascular studies test. These tests are similar to what it feels like to haveblood pressure checked.

The objective of the COVID-19 Vaccines International Pregnancy Exposure Registry(C-VIPER) is to evaluate obstetric, neonatal, and infant outcomes among women vaccinatedduring pregnancy with a COVID-19 vaccine.Specifically, the C-VIPER will estimate the risk of obstetric outcomes (spontaneousabortion, antenatal bleeding, gestational diabetes, gestational hypertension,intrauterine growth restriction, postpartum hemorrhage, fetal distress, uterine rupture,placenta previa, chorioamnionitis, Caesarean delivery, COVID-19), neonatal outcomes(major congenital malformations, low birth weight, neonatal death, neonatalencephalopathy, neonatal infections, neonatal acute kidney injury, preterm birth,respiratory distress in the newborn, small for gestational age, stillbirth, COVID-19),and infant outcomes (developmental milestones [motor, cognitive, language,social-emotional, and mental health skills], height, weight, failure to thrive, medicalconditions during the first 12 months of life, COVID-19) among pregnant women exposed tosingle (homologous) or mixed (heterologous) COVID-19 vaccine brand series from 30 daysprior to the first day of the last menstrual period to end of pregnancy and theiroffspring relative to a matched reference group who received no COVID-19 vaccines duringpregnancy.

The ongoing Coronavirus Disease 2019 (COVID-19) pandemic has been intensified by nopopulation-based immunity to the severe acute respiratory disease coronavirus 2(SARS-CoV2) and initially lack of effective treatments or vaccines available to mitigatethe pandemic. Currently, two COVID-19 vaccines are available for vaccination in Europethrough conditional marketing authorisation granted by the European Medicines Agency andfurther vaccine will be licensed. These vaccines have shown good vaccine efficacy inphase 3 vaccine trials. We will recruit subjects who will be prioritised for vaccinationwith the primary aim of comparing the immune responses after COVID-19 vaccination andnatural SARS-CoV-2 infection. In Western Norway we have recruited cohorts of health careworkers and patients infected with SARS-CoV-2 and will extend to COVID-19 vaccinees.Demographic, clinical data and repeated blood samples will be collected to evaluate thecomplications and kinetics, duration and breadth of the immune responses comparingnatural infection to vaccination.