COVID-19 Clinical Trials and Expanded Access

(a) Objectives 1. To assess the full lung function, exercise capacity, quality of life in patients with COVID-19 over 2 years. 2. To assess the longevity of the serology response to SARS-CoV2. 3. To investigate the association of the neutralization titer in plasma from different vaccinated cohorts to its protection of infection using in vivo model 4. To investigate the SARS-CoV-2 specific cellular and humoral immunities as well as their determinant factors from community subjects who have received different types of COVID-19 vaccines. 5. To assess the third booster dose for subjects who have poor antibody response despite having received two doses of CoronaVac (Sinovac)

The CVP-COVID19 registry is both a retrospective and prospective study design in order toidentify predictors of cardiovascular disease progression and mortality for COVID-19. Theregistry enrolls consecutive patients with positive microbiological tests for SARS-CoV-2admitted to an academic hospital in northern Italy for worsening of COVID-19 symptoms.The study does not test any new diagnostic or therapeutic approach. Patients are treatedaccording to good clinical practice. Patients characteristics, including medical history(with particular attention to cardiovascular and pneumological risk factors), features ofphysical examination, results laboratory and radiological tests and treatments (pre- andin-hospital) are related with patient outcome. Logistic analysis (univariate,multivariate and propensity) are performed in order to identify factors associated withdisease progression. Primary endpoint: mortality.

The COVID-PCD is a participatory research project that aims to study how COVID-19 affectspeople with primary ciliary dyskinesia (PCD). The study is advertised through patientsupport groups and participants register online and answer a baseline questionnaire withdetails on PCD diagnosis, habitual symptoms, and COVID-19 episodes occurring before studyentry. A short weekly follow-up questionnaire includes questions on incident SARS-CoV-2infections, current symptoms, social contact behaviour, and physical activity.Occasionally, participants receive extra questionnaires focused on special topics. Thestudy is hosted at the University of Bern and recruitment started on May 30th, 2020.

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.

NAPKON-HAP is the deep phenotyping platform of the National Pandemic Cohort Network(NAPKON) in Germany. NAPKON is a data and biospecimen collection of patients withCOVID-19 and is part of the University Medicine Network (NUM) in Germany. The primaryobjective of the study is to provide a comprehensive collection of data and biosamplesfor researchers from national consortia and for participation in international researchcollaborations for studying COVID-19 and future pandemics.Data is collected from patients with COVID-19 three times per week during theirhospitalization and at follow-up visits after hospital discharge 3, 6, 12, 24, and 36months after symptom onset. Data include epidemiological and demographic parameters,medical history and potential risk factors, documentation of routine medical procedures,and clinical course, including different patterns of organ involvement, quality of care,morbidity, and quality of life. Moreover, extensive serial high-quality bio samplingconsisting of various sample types is performed to allow deep molecular, immunological,and virological phenotyping.Patients not requiring Intensive Care Unit (ICU)/ Intermediate Care (IMC) treatment willreceive 7 and patients requiring ICU/IMC treatment will receive 16 full-phenotypingvisits including sampling for biobanking. During hospitalisation the planned bloodsampling rate in total is 35 ml at each visit. The total amounts and/or sampling datesmay differ according to the ethics committee's regulations for different study centers.At follow-up visits, the clinical assessment includes an update of the medical historyand recent medical events from which additional clinical data is collected (i.e.outpatient CT-scans, echocardiography, external laboratory data). Clinical symptoms arerecorded and a physical examination will be performed. Vital signs are recorded androutine blood testing and biosampling is continued. Quality of life is measured withpatient-reported outcome questionnaires.Follow-up visits at months 3 and 12 are "deep phenotyping" visits with a comprehensiveand detailed set of examinations. In the following visits at months 24 and 36, onlyexaminations with pathologic results from the last deep phenotyping visit at month 12will be performed.A shorter follow-up visit to record quality of life, recent medical events and with areduced number of examinations focusing on cardiorespiratory performance will take placeat month 6.In case of relevant medical events, new medical information or changes in theparticipant´s health status, an unscheduled visit can take place anytime within theentire study period.Data collection during follow up includes standardized quality of life assessmentincluding PROMIS® (Patient-Reported Outcomes Measurement Information System). Thepulmonary characterization will include body plethysmography, diffusion capacity,respiratory muscles strength measurement, spiroergometry, capillary blood gas analysisand lung imaging studies (low-dose Computed Tomography (CT), Magnetic Resonance Imaging(MRI) of the lung). Cardiological phenotyping includes echocardiography,electrocardiogram (ECG), 24h-ECG, 24h-blood pressure monitoring, stress cardiac MRI andpulse wave analysis. Neurocognitive testing includes brain MRI, electroencephalogram(EEG), somatosensory testing, refractometry (Visit 3 and 12 months), physical activitytest, neurocognitive tests, somatosensory phenotyping, taste- and smell-test.Endocrinological phenotyping will incorporate Advanced Glycation Endproducts (AGE)reader, continuous glucose monitoring for 14 days, Air Displacement Plethysmography (ADP)or bioelectrical impedance analysis (BIA).

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.

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.

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 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.

The overall purpose of this project is to better understand the epidemiology of COVID-19in patients with hematological malignancies (including hematopoietic stem cell transplantrecipients) in the different European Countries. The results obtained will allow us tobetter know the prevalence of this complication in the different categories of patientswith hematological malignancies (HMs). In order to attain the objectives previouslydescribed we will develop a multicentre, international, observational, retrospective andprospective study of consecutive cases of COVID-19 among HMs. There will be a clinicalfollow-up of the patients included in this study to observe the survival rate. Datacollected form this study will be evaluated with a descriptive analysis.