COVID-19 Clinical Trials and Expanded Access

The purpose of this study is to advance the scientific understanding of how a prenatalCOVID-19 infection and associated psychological distress influences infantneurodevelopment. This project will aim to shed light on how families and childdevelopment are impacted by the current COVID-19 pandemic and will work to better supportthese families and children as they grow.

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.

Primary Objective:Evaluate the efficacy of itepekimab compared with placebo on the annualized rate of acutemoderate-or-severe COPD exacerbations in former smokers with moderate-to-severe COPDSecondary Objectives: - Evaluate the efficacy of itepekimab compared with placebo on pulmonary function in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on occurrence of acute exacerbation of COPD (AECOPD) in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on severe AECOPD in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on corticosteroid-treated AECOPD in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on respiratory symptoms in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on Forced Expiratory Volume in 1 second (FEV1) slope in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on health-related quality of life (HRQoL) as assessed by St. George's Respiratory Questionnaire (SGRQ) in former smokers with moderate-to-severe COPD - Evaluate the safety and tolerability of itepekimab in former smokers with moderate-to-severe COPD - Evaluate the pharmacokinetic (PK) profile of itepekimab in former smokers with moderate-to-severe COPD - Evaluate immunogenicity to itepekimab in former smokers with moderate-to-severe COPD

This is a Phase 1, open-label, multicenter, dose-escalation, safety, tolerability,pharmacokinetic and pharmacodynamic study with cohort expansion at the RP2D to evaluatesafety and anti- tumor activity of Q702 administered orally.

The purpose of this umbrella study is to evaluate isatuximab when combined with novelagents with or without dexamethasone in participants with relapsed or refractory myeloma.Substudy 01 is the control Substudy. Substudies 02, 03, and 06 are controlledexperimental substudies. Substudies 04 and 05 are independent experimental substudies.

This is a first-in-human study, Phase 1, randomized, placebo-controlled, double blindedstudy that will be conducted in 2 parts.

Initially, it was suspected that Covid-19 would primarily affect the airways, but severalstudies have now shown that it is a disease with multisystem manifestations. Covid-19 hasthe potential to affect physical, cognitive, and psychological functions in multipleways. It has been clear that a significant proportion of patients with Covid-19 developlong-term symptoms. The term post-acute Covid-19 syndrome (PACS) is now used to describethe wide range of prolonged symptoms following the infection. Patients who have been inhospital for Covid-19 for a long time may need specialized rehabilitation, however, alsonon-hospitalized patients with mild symptoms may need specific rehabilitation to be ableto meet the complex symptoms and problems that may arise. Previous studies on therecovery and rehabilitation after other coronavirus shows the importance to developtailored interventions so that these patients receive appropriate rehabilitationThe aim of this study is to evaluate the effects of inspiratory muscle training on adultpatients with PACS and decreased respiratory muscle strength.A randomized controlled trial will be used. A total of 90 adult patients with PACS and 80% or less of predicted value in inspiratory muscle strength (maximal inspiratorypressure) will be eligible for enrollment. Patients will be randomized either to anintervention group or a control group. The intervention will consist of inspiratorymuscle training performed twice daily for 8 weeks. This will be combined with an 8-weekphysical exercise training program. The control group will perform the same physicalexercise training according to standard care. All measurements will be performed atbaseline and after 8 weeks.Primary outcome is maximal inspiratory pressure. Secondary outcomes are: Maximalexpiratory pressure, pulmonary function, physical capacity, physical activity,respiratory status and symptoms, health-related quality of life, work ability, fatigue,self-reported outcome measure of physical function and voice function.Covid-19 has the potential to affect physical, cognitive, and psychological functions inmultiple ways and lead to a negative impact on quality of life in the long-termperspective. Therefore, development of a rehabilitation program with specific tailoredinterventions will be necessary to improve physical and psychological function, as wellas health-related quality of life and work ability.

This study investigates the changes in practice by pulmonary procedural programs acrossthe United States as they faced the coronavirus pandemic. Information gathered from thisstudy may help guide pulmonary programs on a wider scale and improve their practice. Thestudy may also help researchers understand where they should focus research efforts tobetter respond to a pandemic in the future.

Viruses are a major health problem for the general public and at risk populations.Normally, detection of antibody titers is the gold standard for determining theeffectiveness of the immune system following natural or vaccine caused immunization.However, determining the effectiveness of other parts of the immune system are lesscommon due to the difficulties with testing. Furthermore, there is a critical need toaddress other therapies in case vaccination is not successful in immuncompromisedpopulations. Exercise has been shown to increase the strength of the immune systemagainst many types of viruses and therefore could be simple way to improve immunityagainst the COVID-19 virus. The aim of this research is to determine the effects ofexercise on anti-viral immunity against many types of common viruses before and aftervaccination. We hypothesize that exercise will enhance the anti-viral immunity before andafter vaccination.Up to 30 healthy volunteers (age 18-44 years) will be recruited to participate in thisstudy. For completion of Aim 1, three visits are needed totaling around 7 hours of thepatient's time and for Aim 2, three visits are needed totaling around 4.5 hours of thepatient's time. The initial visit will be for pre-screening and if deemed healthy enoughto participate, an exercise test to determine the VO2 max of the participant will beconducted. The following visits will require a trained phlebotomist to insert anin-dwelling catheter and participants will undergo a 20-minute incremental exercisetrial. Approximately 50mL of blood will be collected at four different timepoints: atrest, 60% VO2 max, 80% VO2 max, and 1-hr post-exercise. All four collected blood sampleswill be used to expand viral specific T-cells and compare IFN-γ rele

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has caused pandemic sinceoutbreak in 2020.Patients with chronic liver disease (CLD) are at higher risk ofmortality and morbidity due to COVID-19. Despite there is a large number of clinicaltrials of COVID-19 vaccines, only a few participants with chronic liver diseases wereincluded.