COVID-19 Clinical Trials and Expanded Access

Coronavirus Disease 2019 (COVID-19) is a newly emerged disease, caused by severe acuterespiratory syndrome coronavirus 2 (SARS-CoV-2). The COVID-19 pandemic is having a largeimpact on the mental and physical health of patients, yet data on the quality of life ofpost-COVID-19 patients is lacking. There are currently no post-COVID-19 specific measuresfor quality of life, particularly none which include the views of post-COVID-19 patientsthemselves. This observational study will recruit participants to contribute theirpreferences to the creation of a post-COVID-19 specific patient-reported measure onpost-COVID-19 quality of life. Participants will be split into three groups: those whowere not hospitalised; those who were hospitalised but not in intensive care units; andthose who were hospitalised and in intensive care units. The creation of this measurewill form phase 1 of the study, with 30-60 participants (10-20 in each group above)recruited to complete online surveys to find out their preferences of areas of life toinclude in such a measure. This will involve 3 online surveys, 1) to ask which areas oflife they feel are impacted and how; 2) to find consensus about the areas to be included;3) to weight the relevance of these areas in relation to each other. In phase 2recruitment will open to additional participants and all participants will be asked tocomplete the finalised post-COVID-19 quality of life measure once a month for 12 months,aiming for a minimum of 100 participants at this stage. All participants will also beasked to complete a demographic questionnaire to inform the analysis of the data.

This is a longitudinal study of the long-term impact of COVID-19 on the lungs.Participants will be followed over a period of up to 4 years and impacts of COVID-19 onthe lungs will be measured with magnetic resonance imaging (MRI) using hyperpolarizedxenon-129, pulmonary function tests, exercise capacity, computed tomography imaging andquestionnaires.

To assess blood levels of vasoactive mediators that may regulate pulmonary endothelialpermeability and contribute to multi-organ injury in patients with COVID-19 disease andto correlate the levels of these mediators with disease outcomes such as ICU admission,length of ventilatory support, respiratory failure, kidney failure, heart failure, anddeath.

Several publications document the occurrence of symptoms that persist or occur late.The identification of the observed clinical manifestations and their clinical andparaclinical description are essential to better understand the natural evolution ofCOVID-19, to clarify the pathophysiological mechanism of these possible latemanifestations, and to identify potential management options for patients.Since this type of event is infrequent, a large-scale national multicenter cohort studyfocusing on symptomatic patients is needed.

This clinical trial will evaluate the safety, tolerability and efficacy of GLS-1027 inthe prevention of severe pneumonitis caused by SARS-CoV-2 infection

The purpose of this double-blind, randomized, controlled study is to assess safety,reactogenicity, and preliminary immunogenicity of 202-CoV at multiple dose levels,administered as 2 injections (i.m) at 28 days apart in adult subjects 18 years of age andabove.

The COVID-19 pandemic is caused by the severe acute respiratory syndrome coronavirus 2(SARS CoV-2), an emerging coronavirus, which has already infected 192 million people witha case fatality rate close to 2%. About 5% of patients infected with SARS CoV-2 have acritical form with organ failure. Among critical patients admitted to intensive care,about 70% of them will require ventilatory assistance by invasive mechanical ventilation(MV) with a mortality rate of 35% and a median MV duration of 12 days. The most severelung damage resulting from SARS CoV-2 infection is the acute respiratory distresssyndrome (ARDS). The virus infects alveolar epithelial cells and capillary endothelialcells leading to an activation of endothelium, hypercoagulability and thrombosis ofpulmonary capillaries. This results in abnormal ventilation / perfusion ratios andprofound hypoxemia. To date, the therapeutic management of severe SARS CoV-2 pneumonialay on the early use of corticosteroids and Interleukin-6 (IL-6) receptor antagonist,which both reduce the need of MV and mortality. The risk factors of death in IntensiveCare Unit (ICU) are: advanced age, severe obesity, coronary heart disease, active cancer,severe hypoxemia, and hepatic and renal failure on admission. Among MV patients, thedeath rate is doubled in those with both reduced thoracopulmonary compliance and elevatedD-dimer levels. Patients with severe alveolar damage are at risk of progressing towardsirreversible pulmonary fibrosis, the incidence of which still remain unknown. Thediagnosis of pulmonary fibrosis is based on histology but there are some non-invasivealternative methods (serum or bronchoalveolar biomarkers, chest CT scan). We aim toassess the incidence of pulmonary fibrosis in patients with severe SARS CoV-2 relatedpneumonia. We will investigate the prognostic impact of fibrosis on mortality and thenumber of days alive free from MV at Day 90. Finally, we aim to identify risk factors offibrosis.

The purpose of this double-blind, randomized, controlled study is to assessimmunogenicity and safety of 202-CoV at multiple dose levels, administered as 2injections (i.m) at 28 days apart in adult subjects 18 years of age and above.

Decentralized clinical study designed to collect further cough sounds, self-reportedsymptoms, and medical treatment questionnaires from participants enrolled on theCOVID-Cough Study ("Study 1").The aim of this further data collection study ("Study 2") is to: 1. develop an understanding of changes in cough sounds associated with COVID-19 and how they alter during the disease; 2. develop an understanding of other causes of COVID-19-like symptoms and their associated cough sound patterns; and 3. gain a broader understanding of the clinical outcomes of individuals who present for COVID-19 testing.

Coronavirus disease 2019 (COVID-19) which is caused by the virus SARS-CoV-2 has resultedin an ongoing global pandemic. It is unclear whether the relatively low number ofreported cases of COVID-19 in people with CF (pwCF) is due to enhanced infectionprevention practices or whether pwCF have protective genetic/immune factors. This studyaims to prospectively assess the proportion of pwCF, including both adults and childrenwith CF who have evidence of SARS-CoV-2 antibodies over a two-year period. This studywill also examine whether pwCF who have antibodies for SARS-CoV-2 have a differentclinical presentation and what impact this has on their CF disease. The proposed studywill recruit pwCF from paediatric and adult CF centres in Europe. Serological testing todetect antibodies will be performed on blood samples taken at month 0, 6, 12, 18 and 24with additional time-points if bloodwork is available via normal clinical care. Clinicaldata on, lung function, CF-related medical history, pulmonary exacerbations, antibioticuse, and microbiology and vaccination receipt, will be collected during routine clinicalassessments.Associations will be examined between socio-demographic and clinical variables andserologic testing. We will also examine the effects of SARS-CoV-2 infection on clinicaloutcomes and analyse end-points to explore any age-related or gender-based differences,as well as subgroup analysis of outcomes in lung-transplant recipients and pwCF receivingCFTR modulator therapies. As pwCF receive COVID-19 vaccination we will perform acomparison of the development and progression of anti-SARS-CoV-2 antibodies in pwCFfollowing natural infection and vaccination SARS-CoV-2 over time.