COVID-19 Clinical Trials and Expanded Access

This will be a prospective observational study of lactating mothers who are planning to,have scheduled or have received vaccination against SARS-COV-2 (COVID-19 vaccine).Mothers may have delivered at Mount Sinai Hospital or may be from the general publicrecruited by social media or word of mouth. As the study participants will be lactatingmothers, they will not be under the care of the investigators. Due to lack ofinformation, we are unsure of an appropriate sample size but envision we will recruit atleast 10 women each immunized with the approved mRNA vaccines (e.g. Pfizer-BioNTech andModerna COVID-19 vaccines) and in the future at least two other vaccines (e.g.Oxford-AstraZeneca) as they are approved and become available. Milk samples will beanalyzed for the presence of antibody to SARS-CoV-2 using the Anti-SARS-CoV-2 ELISA (IgGand IgA). These analyses will be conducted in the Department of Microbiology at SinaiHealth following validation of the procedures in human milk.

This study is a longitudinal cohort study which investigates the effect of COVID-19 inambulatory care. This study aims to assess the effect of COVID-19 beyond the acute phase,i.e. on long-term symptoms, respiratory and cardiovascular health, use of healthservices, and quality of life.

Investigating the potential role of Aerosolized retinoic acid, a potent Vitamin Ametabolite for treating COVID-19 Anosmia and retinoic acid insufficiency .A novelapproach for regaining Sense of Smell.Mahmoud ELkazzaz(1),Tamer Haydara(2), Abedelaziz Elsayed(3) ,Yousry Abo-amer(4), HeshamAttia(5), Quan Liu(6) and Amr Ahmed(7) 1. Department of chemistry and biochemistry, Faculty of Science, Damietta University, Egypt. 2. Department of Internal Medicine, Faculty of Medicine, Kafrelsheikh University, Egypt 3. Department of Pharmaceutical Biotechnology, Faculty of Pharmacy, Tanta University, Egypt. 4. Hepatology,Gastroenterology and Infectious Diseases Department, Mahala Hepatology Teaching Hospital, Egypt 5. Department of Immunology and Parasitology, Faculty of Science, Cairo University, Egypt. 6. School of Life Sciences and Engineering, Foshan University, Laboratory of Emerging Infectious Disease, Institute of Translational Medicine, The First Hospital of Jilin University, Changchun, China. 7. Director of tuberculosis program Ghubera, public health department ,First health cluster ,Ministry of health ,Saudia Arabia. - Very important Note: This clinical study is the first clinical study in literature (First posted August 12, 2021) which demonstrated depending on molecular findings that Vitamin A /Retinoic Acid will treat smell loss resulted by COVID-19Recent rapidly accumulating evidences and reports indicate that partial loss of the senseof smell or even total anosmia are early markers of SARS-CoV-2 infection and frequentlyreported symptoms associated with the COVID-19 pandemic (Lechien J. R et al., 2020)However, the cellular mechanisms of this phenomenon are unknown. The rates of insomniaand depression were 26.45% and 9.92% in the COVID-19 patients after recovery. Therefore,finding an effective treatment for COVID-19 Anosmia is a critical point. Although, ACE2has been identified as the principal host cell receptor of 2019-nCoV, and it is thoughtto play a critical role in the virus's entrance into the cell and subsequent infection,many cells can be infected by COVID-19 while also expressing little or no ACE2. Eventhough the COVID-19 entry receptor, angiotensin-converting enzyme 2 (ACE2), is notexpressed in the receptor of olfactory neurons, or its synthesis is limited to to a minorfraction of these neurons.of these neurons, COVID-19 infection causes a loss of smell(anosmia) (Katarzyna Bilinska et al.,2021). Our recent findings showed that COVID-19binds directly to STRA6 receptors of retinol leading to retinol depletion and retinoicacid insufficiency (M Elkazzaz et al,. 2021) . Retinoic acid insufficiency in theolfactory epithelium, both in mouse and chick models, causes progenitor cell maintenancefailure and, consequently, olfactory neurons differentiation is not maintained . Anexplant system, showed that renewal of olfactory neurons is inhibited if retinoic acidsynthesis was failed in the olfactory epithelium (Paschaki M et al., 2013) . It's worthnoting that vitamin A shortage also causes olfactory and taste problems, In a study byGarrett-Laster et al., (1984), the patients had vitamin A deficiency because ofmalnutrition and alcoholic liver cirrhosis; they lost their sense of smell after thatdisorder. LaMantia and Rawson et al.,( 2007) reported that administration of retinoidacid after the damage of olfactory system motivates an immune response and produces amore quick recovery of olfactoryguided behavior. It was showed that Isotretinoin improvedthe significantly performance of patients in the olfactory test(Demet Kartal et al.,2017)Moreover, there is increasing evidence that retinoic acid (atRA) influences geneexpression of components of renin-angiotensin system (RAS), which plays a pivotal role inthe pathophysiology of essential hypertension. Retinoic acid induced ACE2 expression indifferent animal models. Moreover, a study suggests that topical retinoids may haveapplicability in promoting sinus regeneration and wound healing. In a study comparingtreated and untreated nasal mucosa ,untreated regenerated mucosa showed expected changesof submucosal gland loss, basal lamina and lamina propria fibrosis and loss of cilia.Reinoic acid treatment appeared to result in better mucosal regeneration marked by lesscellular atypia and fibrosis(Mendy S. Maccabee et al,. 2003).. Aerosolized retinoic acidwill have an effective role in treating post COVID-19 anosmia (loss of smell) viaupregulating ACE2, STRA 6 and regenerating of olfactory receptors and olfactory sensorycells and neurons.

Participants were assigned randomly into two groups, aerobic exercise and resistanceexercise groups. All participants in both groups followed the WHO guidelines ofquarantine and used standardized medications given by the physician according to theTurkish Ministry of Health guidelines, including the Hydroxyclorocin Sulphate 200 Mg FilmTablet (Plaquenil 200 Mg Film Tablet). The dose was 2 times/ day, 200Mg/time, for 5 days.Besides, the aerobic exercise group performed moderate-intensity aerobic exercises for 40min/ 3 sessions/week, 40 minute/session, and the resistance exercise groups 40 min/ 3sessions/week, 40 minute/session.

On 30 January 2020, WHO declared the SARS-CoV-2 outbreak as a public health emergency ofinternational concern. Compared to SARS-CoV, which caused an outbreak of SARS in 2003,SARS-CoV-2 has a higher transmission capacity. Although the clinical manifestations ofSARS-CoV-2 are dominated by respiratory symptoms, some patients have severecardiovascular damage. In addition, patients with underlying cardiovascular disease maybe at increased risk of death. Therefore, understanding the impairments caused bySARS-CoV-2 to the cardiovascular system and the underlying mechanisms is of the utmostimportance.Circulating endothelial cells (CECs) are generally considered markers of lesions and maybe non-invasive markers of pulmonary vascular dysfunction during SARS-CoV-2 infection.Another marker of endothelial activation could be circulating extracellular vesicles.They could also be involved in the spread of the virus. Thus this project proposes tostudy different aspects of the diagnosis and pathophysiology of SARS-CoV-2. We propose tofully study activation state of coagulation and endothelium on a plasma and cellular sidein patients diagnosed with SARS-CoV-2/COVID19. The different forms of the disease will beincluded: without lung disease, with a more or less severe lung disease, i.e. havingevolved or not towards acute respiratory distress syndrome (ARDS). Extensive research ofbiomarkers will be compared to the detection of the virus in the respiratory tract aswell as in the blood. This work will contribute to a better description of diseasepathophysiology and should allow us to identify a patient profile in whom preventive orcurative anticoagulant therapy could be considered.

Bone and soft tissue sarcomas represent about 7-12% of all pediatric cancer and are aheterogeneous group of tumors arising in connective tissues embryologically derived fromthe mesenchyme. For some of these tumors relapse and mortality rates are stillsignificantly high. Therefore, further studies are needed to better understandpathogenetic processes underlying sarcomas to offer new and more effective treatments.Next generation sequencing (NGS) has opened new frontiers for cancer research allowing toidentify somatic or constitutional mutations known or yet unknown with the aim to betterunderstand carcinogenesis. The establishment of the genomic profile of the tumor couldalso help clinicians to personalize patients treatment based on their genetic andmolecular alterations.

The physical inactivity promoted by the patient's hospitalization, including thoseinfected with the coronavirus, can lead to an important health impairment, includingatrophy and loss of muscle function. Thus, a prospective study will be conducted toassess the effect of a home-based exercise training program on health outcomes andquality of life in COVID-19 survivors.

A double-blind, randomized, controlled, clinical trial to evaluate the efficacy andsafety of MSC (mesenchymal stromal cells) intravenous administration in patients withCOVID-induced ARDS compared to a control arm.

The principal objective is to determine the impact of phenelzine on the activationphenotype of T cells and myeloid cells during SARS-CoV2 infection

The recent and unexpected occurrence of patients with the development of skin lesions onthe hands and/ or feet has been described recently. As these cases occurredcontemporaneously with the Coronavirus Disease 2019 (COVID-19) and as it was the mostoften occurrence of de novo frostbites, the question raised of whether there is a directlink between the occurrence of these lesions and infection of the severe acuterespiratory syndrome coronavirus 2 (SARS-CoV-2) the responsible for CoVID-19. Indeed,mechanisms of these lesions and the precise correlation with Sars-CoV-2 remains poorlyunderstood. Therefore, this study aim to: 1. Determine the possible link with this virus, 2. Understand the mechanisms involved in the pathogenesis of these lesions.