COVID-19 Clinical Trials and Expanded Access

The COVID-19 pandemic has been characterized by high morbidity and mortality, especiallyin certain subgroups of patients. To date, no treatment has been shown to be effective inpatients with early-onset disease and mild symptoms. Experimental studies havedemonstrated a potential anti-inflammatory role of Fluvoxamine, Fluoxetine, Budesonideand Spirulin Platensis in SARS-CoV-2 infections and observational studies have suggesteda reduced complications in patients with COVID-19 disease.

The purpose of the study is to describe disability following hospitalization in people ofworking-age surviving COVID-19.

The NanoCOAT study is a multi-center, prospective, non-randomized, feasibility,observational, non-significant risk study. The NanoCOAT study will enroll a minimum of 10and a maximum of 100 subjects in a potential for a multi-site in order to collect dataand analyze physiological and biometric trends due to Covid-19.

The main overarching aim of this study is to build a research clinic, as part of theNoRCoRP platform covering Nottingham and Nottinghamshire to facilitate learning andresearch in the whole population of patients who have had COVID-19.

There is an unmet need to evaluate the impact of sub-clinical/mild COVID19 disease in theoutpatient setting on prevalent and incident renal injury, as this data is currentlyunavailable. To capture the diversity of race/ethnic risk and COVID19 related municipalshelter-in-place guidance, the investigators will enroll COVID19-negative andCOVID19-positive samples balanced by race/ethnicity from 3 different states, California,Michigan, and Illinois. Study endpoints will be assayed from urine samples mailed to thestudy team at 2, 6, and 12 months after their date of PCR test, with no requirement forthese individuals to leave their homes to participate.

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.

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.

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.

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.

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