COVID-19 Clinical Trials and Expanded Access

A total of 300 healthy volunteers between the ages of 18 and 80 with no previous historyof COVID-19 will be entered into the study and will receive IPV by injection on Day 1.Blood specimens collected pre-inoculation will be tested for cross-reactivity topoliovirus and SARS-CoV-2 by Western blot. An additional specimen will be collected onDay 28 post-inoculation and, likewise tested for cross-reactivity to poliovirus andSARS-CoV-2.The number of subjects with an immune response to SARS-CoV-2 antigens followinginoculation with IPV will be summarized.

Despite enormous progress in understanding COVID-19, there is little evidence that asolution, therapeutic or preventive, is close to being achieved. Repurposing of wellknown, widely available drugs represent an attractive approach to speed up availabilityof active treatments. Such substances as i.e. hydroxychloroquine and others, are alreadyunder investigation and in widespread off label use. For many reasons Methylene blue(MB), the oldest synthetic substance in medicine (1876 synthesized by BASF) is such apromising candidate for an active treatment against SARS-CoV-2 infected people and forCOVID-19 patients.

This is a phase I, randomized, placebo-controlled, double-blind study, to evaluate safetyand immunogenicity of a recombinant SARS-CoV-2 vaccine (CHO cell) in Chinese healthypopulation aged 18 years and older. After randomization, the trial for each subject willlast for approximately 13 months. Screening period is 1 week prior to randomization (Day-7 to Day -1), and each dose of either SARS-CoV-2 vaccine (CHO Cell) or placebo will begiven intramuscularly (IM) on Day 0 and Day 14 for a two-dose regimen, or on Day 0, Day14, and Day 28 for a three-dose regimen. Subjects who are ≥18 years old and ≤ 59 yearsold will be enrolled in adult group, and healthy elderly population who are >59 years oldwill be enrolled in elderly group. After adult group completes the follow-up 7 days afterfirst vaccination, elderly group will be recruited.

COVID-19 infection was shown to cause endothelial dysfunction .At the level of the endothelium the pathophysiological mechanisms have been hypothesizedand were divided into pro-coagulant, pro-inflammatory, anti-fibrinolytics, impairedbarrier function, vasoconstrictor and pro-oxidant. So far, the pro-coagulant andpro-inflammatory pathways have been studied and as a result dexamethasone andanticoagulation became part of the standard therapies for the disease. However, so far,no RCT has been evaluated on targeting the vasoconstrictive and antioxidant pathways withan aim of revealing clinical benefit.So, with this trial we intend to provide a regiment composed of several medications wehypothesize will act on several downstream pathways that would improve endothelialfunction primarily via the increase in NO production and release.At the time of this proposal there has been no randomized trials evaluating or testingthe use of cardiovascular drugs targeting endothelial dysfunction in COVID-19 patients.As previously noted there has been a call to study these drugs and their effect after astrong research regarding their theorized effectiveness. For evidence, there was arecently published meta-analysis evaluating the role of statins in COVID-19 withpreliminary findings suggested a reduction in fatal or severe disease by 30% anddiscredited the suggestion of harm, that emphasized on the need of well-designedrandomized controlled trial to confirm the role of statins in COVID-19 patients.Our study would help determine the potential therapeutic effect of the endothelialprotocol as adjunct to mainstream management. This study seeks to further our knowledgein treating COVID-19 to ultimately improve clinical outcomes and reduce complications.

To develop an International registry on head and neck cancer patients infected withCOVID-19

This is study is comprised of three approaches. First, the investigators will conduct aretrospective cohort study to determine factors associated with COVID-19 severity andcomplications and understand COVID-19 outcomes, including all-cause mortality,post-discharge events, and impacts of rehabilitation services (third aim). The second aimis a mixed-method study and follows COVID-19 patients with repeated surveys to determinepatient-reported functional outcomes, health recovery, and rehabilitation needs afterCOVID-19. The investigators will recruit patients and their informal caregivers forinterviews to assess their function and rehabilitation needs.

To compare myocardial injury in COVID 19 patients presented with myocardial infarctionand non COVID Patients presented with myocardial infarction evaluated with CMR

The purpose of this study is to test the effectiveness of prophylactic mouth rinses inreducing the amount of viruses, specifically SARS-CoV-2 in the oral cavity. This researchwill guide dental and medical providers on best practices to be performed prior to dentaland medical procedures involving the oral cavity.

Small molecule inhibitors have previously been investigated in different studies aspossible therapeutics in the treatment of SARS-CoV-2. In the current drug repurposingstudy, the investigators identified the leukotriene (D4) receptor antagonist Montelukastas a novel agent that simultaneously targets two important drug targets of SARS-CoV-2.The investigators initially demonstrated the dual inhibition (main protease andSpike/ACE2) profile of Montelukast through multiscale molecular modeling studies. Next,the investigators characterized its effect on both targets by different in vitroexperiments including the Fluorescent Resonance Energy Transfer (FRET)-based mainprotease enzyme inhibition assay, surface plasmon resonance (SPR) spectroscopy,pseudovirus neutralization on HEK293T / hACE2, and virus neutralization assay usingxCELLigence MP real time cell analyzer.

The study assesses the efficacy of early administration of hyperimmune plasma in covid-19patients who are on CPAP or intubated. Efficacy is measured as a 2 point decrease in theWHO scale