COVID-19 Clinical Trials and Expanded Access

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.

Multicenter retrospective and prospective observational study based on the collection ofsequential anonymized data from principal Italian ITP centers, to describe the clinicalcourse of ITP patients becoming infected by SARS-CoV-2 and of COVID-19 patientsdeveloping de novo ITP.

SUMMARY Rationale: Allied health professionals (i.e., dietitians, exercise therapists,physical therapists, occupational therapists and speech and language therapists) mightplay an important role in the recovery of patients with COVID-19 who experiencelimitations in daily physical functioning and participation. However, the evidence basefor allied healthcare in patients with COVID-19 has yet to be established. To facilitatecare for people recovering from COVID-19 and to establish this evidence base, the Dutchministry has created a temporary regulation for primary care allied healthcarespecifically for patients with COVID-19.Objective: This study is setup alongside the temporary regulation and aims to evaluatethe longitudinal recovery trajectories and related costs of patients who visited aprimary care allied healthcare professional for the management of severe symptoms andactivity limitations and/or participation restrictions related to COVID-19.Study design: Prospective cohort study. Study population: 1,315 adult patients recoveringfrom COVID-19 with severe symptoms and activity limitations and/or participationrestrictions, and who are referred to a primary care allied health professional by ageneral practitioner or medical specialist within four months of the start of the diseasewill be eligible for this study.Intervention (if applicable): Although the nature of this study is non-experimental, theallied healthcare intervention can be considered experimental due to the novelty of thedisease.Main study parameters/endpoints: The primary outcome domain of this study isparticipation measured with the Utrechtse Schaal voor Revalidatie - Participatie(USER-P). The primary endpoint is set at 6 months. A 5 point difference will beconsidered clinically relevant for patients with COVID-19.Nature and extent of the burden and risks associated with participation, benefit andgroup relatedness: There are no specific risks involved with participation in this study,as it entails the completion of questionnaires over the timeframe of one year (at thestart of the treatment, the end of the treatment, 3 months, 6 months, 9 months and 12months). The load of the survey will be highest at months 3, 6 and 12 with a total of 74survey items. Input from patient representatives suggested that this number of items wasfeasible, especially because participants are allowed to complete the survey over anumber of days. Finally, none of the items in the survey are considered emotionallydistressing. The prescribed interventions are conform the recommendations of the bestavailable evidence and are in line with usual allied healthcare interventions. Therefore,risks are likely to be negligible conform usual allied healthcare.

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.

Investigating the role of 13cis retinoic acid in the treatment of COVID-19 andenhancement of Its spike protein based vaccine efficacy and safety.

The coronavirus disease 2019 (COVID-19) caused by the infection of severe acuterespiratory syndrome coronavirus 2 (SARS-CoV-2)，resulting in more than 82 millionconfirmed cases and caused around 1.8 million deaths, as of 2 January 2021. The ongoingpandemic still poses unprecedented global threat to public health system worldwide. OnDecember 31, 2020, the joint prevention and control agency of China Council announcedthat Sinopharm SARS-CoV-2 inactivated vaccine had been conditionally approved by NationalMedical Products Administration, and the protection rate was 79.34%. So far, more than198 vaccines were currently in preclinical or clinical development. The investigatorsaimed to initiate an observational cohort of healthy individuals injected with SARS-CoV-2Vaccine, which will perform a longitudinal, comprehensive analysis of the SARS-CoV-2vaccine Induced adaptive immune responses.

A Study of the relation of COVID-19 infection and its severity to upper and lower airwaynitric oxide, upper airway viral load and lung function.

Myocardial infarction (MI), as one of the many complications of COVID-19, is one of thecontributing patients of patients' death. This study attempts on developing anintervention of MI by regenerating damaged cardiomyocytes due to insufficiency of oxygenin cardiac muscles, triggered by an occlusion of coronary artery (MI). Heart patchdeveloped from amnion bilayer seeded with amnion epithelial stem cells and patient'sautologous cardiomyocytes is used as a therapy. Patients who undergo bypass (CABG)surgery are given heart patch, and then patients condition are observed by ECG, Echo,blood test, and radiology (technetium-99m)

The purpose of this study is to examine how patients with multiple myeloma (MM) have beenimpacted by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic.The study will use a questionnaire to further understand how patients are being affectedand gather information in order to track the long-term effects of the coronavirus.The scope of the questionnaire will include, COVID-19 diagnosis and treatment, changes inmyeloma treatment and care, clinical trial familiarity, health and fitness, and qualityof life.This questionnaire is a follow-on to the "MM and COVID-19" questionnaire.

Sex and gender matter to health equity, especially in a pandemic. Sex (a biologicalattribute) and gender (a social construct) may influence an individual's susceptibility,vulnerability and exposure to infectious disease. In previous coronavirus epidemics (SARSand MERS), male sex was associated with worse outcomes. Both immune and the hemostaticresponse display ample sexual dimorphism.The primary aim of the study is to determine whether sex differences in biomarkers ofplatelet and immune function, gut microbiome, clinical characteristics, therapy, clinicalcost sensitive outcomes (i.e. in-hospital transition of care, case severity, andmortality due to COVID-19) exist in patients affected by COVID-19.