COVID-19 Clinical Trials and Expanded Access

The study is a multicenter, adaptive, randomized, double-blinded and placebo-controlledPhase II/III clinical trial. It will be conducted at selected investigational sitesglobally. The study is comprised of 2 parts.

To evaluate if omalizumab is effective in decreasing mortality in severe hospitalizedCOVID-19 cases.

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

Sample Size: n=570Accrual Ceiling: n=627Study Population: Patients age 18 to 100 yearsThe study duration includes 51 months to recruit patients and 24 months of totalfollow-up time counted from the first day of COVID-19 symptoms or date of confirmedCOVID-19 diagnosis.Study Design: This is a prospective, observational cohort study to evaluate the short-and long-term end-organ complications of COVID-19 and to establish a COVID-19 biobank.Participant Cohorts: 1. Individuals who had previous asymptomatic or mild COVID-19 (mild=never required supplemental oxygen during the acute phase of the infection) 2. Individuals who had previous moderate or severe COVID-19 (moderate=required supplemental oxygen by nasal cannula during the acute phase of the infection; severe=required supplemental oxygen by either high-flow nasal cannula, non-invasive positive pressure ventilation or intubation) 3. Individuals who had COVID-19 but did not have signs or symptoms related to COVID-19 lasting beyond 4 weeks from the date of COVID-19 symptom-onset or diagnosis 4. Individuals who have not had COVID-19 (i.e. individuals who tested negative for COVID-19 and who never had symptoms consistent with COVID-19)

The COVID-19 can cause important sequels in the respiratory system by bilateral pneumoniaand frequently presents loss of strength, dyspnea, polyneuropathies and multi-organicaffectation. Long COVID-19 has been defined as the condition occurring in individualswith a history of probable or confirmed SARS-CoV-2 infection, with related symptomslasting at least 2 months and not explainable by an alternative diagnosis. The practiceof digital physiotherapy presents itself as a promising complementary treatment method tostandard physiotherapy, playing a key role in the recovery of function in subjects whohave passed the disease and who maintain some symptomatology over time. The aims of thisresearch are to explore the effect of a digital physiotherapy intervention on functionalrecovery in patients diagnosed with Long COVID-19 and to identify the level of adherenceto the treatment carried out. Physiotherapy interventions acquires a fundamental role inthe recovery of the functions and the quality of life. As secondary objectives, the aimis to identify the satisfaction and perception of patients with the intervention and thepresence of barriers to its implementation (throught a qualitative research), as well asto evaluate the cost-effectiveness from the perspective of the health system. Aquasi-experimental pre-post study assessed initially and at the end of the 4-weekintervention the functional capacity (1-min STS and SPPB) and the adherence (software).The hypothesis of this research is that the implementation of a TR program presentspositive results. If hypothesis is confirmed, that would be an opportunity to define newpolicies and interventions to address this disease and its consequences.

COVID-19 (Coronavirus disease 2019) is a new infectious disease caused by a virus namedas SARS-CoV2 (Severe Acute Respiratory Syndrome Coronavirus-2). Although it can have adevastating effect on many organs, the respiratory tract is particularly affected. In thecourse of the disease, a wide clinical spectrum is observed, from flu-like illness tolung failure. Some of the patients who survived the disease continue to have problemssuch as shortness of breath, fatigue, decrease in walking distance, decrease inparticipation in daily life activities. These problems suggest that the effects onrespiratory and cardiac functions continue even after the disease ends. This study wasdesigned to demonstrate the effects and extent of COVID-19 on cardiopulmonary capacity.

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.

The purpose of this study is to describe post-intensive care syndrome (PICS) of patientssurviving to coronavirus disease 2019 (COVID19) and their rehabilitation and recoveryprocess from hospital to home return

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.