A Pilot Study of the Use of Oscillation and Lung Expansion (OLE) Therapy in PatientsHospitalized with COVID-19

Primary Objective:Primary population (former smokers cohort): - Evaluate the efficacy of itepekimab compared with placebo on the annualized rate of acute moderate-or-severe COPD exacerbations in former smokers with moderate-to-severe COPDSecondary Objectives:Primary population (former smokers cohort): - 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 COPDSecondary population (current smokers cohort) - Estimate the efficacy of itepekimab compared with placebo on the annualized rate of acute moderate or severe COPD exacerbations in current smokers with moderate-to-severe COPD - Estimate the efficacy of itepekimab compared with placebo on pulmonary function in current smokers with moderate-to-severe COPD - Estimate the safety and tolerability of itepekimab in current smokers with moderate-to-severe COPD - Estimate the PK profile of itepekimab in current smokers with moderate to severe COPD - Estimate immunogenicity to itepekimab in current smokers with moderate-to-severe COPD

This is a first-in-human, Phase I/II, randomized, placebo-controlled, observer-blinded,age-escalating study to assess the safety, reactogenicity and immunogenicity of a SKSARS-CoV-2 recombinant protein nanoparticle vaccine (GBP510) adjuvanted with or withoutAS03 in healthy younger and older adults.

In order to prevent reinfection, it is needed to detect the cellular-mediated immuneresponse to the Sars-CoV-2 infection. The first goal of this study will be to detect thecellular-mediated immune response in patients affected by COVID-19 (with or withoutvaccination) and healthy subjects who undergone vaccination program. The second goal ofthis study will be to identify the genetic and epigenetic biomarkers that influenceindividual immunological response and clinical evolution to the severe manifestations ofthe COVID-19.

The COVID-19 pandemic is causing many deaths around the world, putting a strain on healthservices. Patients with pre-existing chronic conditions are most affected by theSARS-COV2 infection. Infectious complications are a common cause of mortality and one ofthe main causes of morbidity in all these diseases. The main objective of this project isthe assessment of patients with thalassemia, drepanocytosis, other haemoglobinopathiesand rares inherited anemias suffering from SARS-COV-2 to: 1. Obtain clinical and epidemiological data that can provide information on a possible increased vulnerability of these patients to SARS-COV-2 infection; 2. Sharing therapeutic approaches considering the lack of information about the treatment.

Determination of both the degree and duration of the immunity provided after receivingthe BNT162b2 vaccine against SARS-Cov-2.

This is a prospective, multi-center, observational study that will enroll patientsreceiving dialysis (hemodialysis or peritoneal dialysis) or patients with kidneytransplantation who will be vaccinated against COVID-19.

Strengthening outpatient low respiratory tract infection surveillance to document theburden of Respiratory Syncytial Virus (RSV)

The proposed study will investigate respiratory aerosols in SARS-CoV-2 (Severe AcuteRespiratory Syndrome Corona Virus 2) positive and negative children and adults with theResp-Aer-Meter (Palas GmbH). For this purpose, first, the measurement of respiratoryaerosols (particle sizes and concentration) with the Resp-Aer-Meter will be established.Thereafter, a comparison between polymerase chain reaction (PCR) SARS-CoV-2 positive andnegative participants (children and adults) will be conducted. In addition to themeasurement of aerosols, the clinical symptoms, lung function (FEV1) and laboratoryinflammatory markers will be analyzed.

The Hearts of Athletes study is being conducted to determine the heart involvement withCOVID-19 in athletes. This study aims to enroll any Adult (18 years of age or greater)• Athlete is defined as NCAA Collegiate Athlete, Professional Athlete, Military, orOlympic Athlete will be eligible for the study.With COVID-19• COVID-19 diagnosed via an RT-PCR (nasal or throat swab test) prior to enrollmentOr without COVID-19• Identified as a local Control participant (similar sport) to a participant withCOVID-19, who is willing to undergo a standard cardiovascular evaluationParticipants with and without COVID-19 will use their mobile devices to provide healthinformation, like symptoms, by answering survey questions daily for 30 days. Also,participants will allow their de-identified cardiac images to be sent to the Duke HeartCenter for blinded analysis.No physical risks are associated with this study. One possible risk, although minimal, isloss of confidentiality.