COVID-19 Clinical Trials and Expanded Access

The proposed trial will obtain preliminary data on the feasibility of studying RTB101 ascompared to placebo for COVID-19 post-exposure prophylaxis in adults age ≥ 65 years toinform the design of a subsequent pivotal trial.

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.

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.

This is an observer-blind, randomized study which aims to assess the immune response andthe safety of two different approved vaccines for first and second dose in healthyadults.

This study will test the COVID-19 vaccine candidate AZD1222 to investigate its safety,tolerability and capability of boosting immune responses both in the blood and the lungwhen administered to the respiratory tract, in volunteers previously vaccinated byintramuscular COVID-19 vaccination. Using standardised methods, we will measure immuneresponses in the blood, nose and lower airway and compare with data from ongoing clinicaltrials of intramuscular vaccination. Thus, we will show the effect of the delivery methodand provide the critical information required to begin further clinical trials to showthe efficacy of this needle-free vaccination strategy for booster vaccination.