COVID-19 Clinical Trials and Expanded Access

The NanoCOAT study is a multi-center, prospective, non-randomized, feasibility,observational, non-significant risk study. The NanoCOAT study will enroll a minimum of 10and a maximum of 100 subjects in a potential for a multi-site in order to collect dataand analyze physiological and biometric trends due to Covid-19.

1. Develop a wearable sensor package to gather data on COVID-19-like signs and symptoms such as elevated body temperature, respiratory parameters, heart rate ,cough and gait. 2. Create algorithms to monitor and track changes to COVID19-like signs and symptoms for developing a better care and isolation strategies for COVID-19 pandemic.

COVID-19 Viral Global Pandemic resulting in post-infection pulmonary damage, includingFibrotic Lung Disease due to inflammatory and reactive protein secretions damagingpulmonary alveolar structure and functionality. A short review includes: - Early December, 2019 - A pneumonia of unknown cause was detected in Wuhan, China, and was reported to the World Health Organization (WHO) Country Office. - January 30th, 2020 - The outbreak was declared a Public Health Emergency of International Concern. - February 7th, 2020 - 34-year-old Ophthalmologist who first identified a SARS-like coronavirus) dies from the same virus. - February 11th, 2020 - WHO announces a name for the new coronavirus disease: COVID-19. - February 19th, 2020 - The U.S. has its first outbreak in a Seattle nursing home which were complicated with loss of lives.. - March 11th, 2020 - WHO declares the virus a pandemic and in less than three months, from the time when this virus was first detected, the virus has spread across the entire planet with cases identified in every country including Greenland. - March 21st, 2020 - Emerging Infectious Disease estimates the risk for death in Wuhan reached values as high as 12% in the epicenter of the epidemic and ≈1% in other, more mildly affected areas. The elevated death risk estimates are probably associated with a breakdown of the healthcare system, indicating that enhanced public health interventions, including social distancing and movement restrictions, should be implemented to bring the COVID-19 epidemic under control." March 21st 2020 -Much of the United States is currently under some form of self- or mandatory quarantine as testing abilities ramp up..March 24th, 2020 - Hot spots are evolving and identified, particularly in the areas ofNew York-New Jersey, Washington, and California.Immediate attention is turned to testing, diagnosis, epidemiological containment,clinical trials for drug testing started, and work on a long-term vaccine started.The recovering patients are presenting with mild to severe lung impairment as a result ofthe viral attack on the alveolar and lung tissues. Clinically significant impairment ofpulmonary function appears to be a permanent finding as a direct result of theinterstitial lung damage and inflammatory changes that accompanied.This Phase 0, first-in-kind for humans, is use of autologous, cellular stromal vascularfraction (cSVF) deployed intravenously to examine the anti-inflammatory and structuralpotential to improve the residual, permanent damaged alveolar tissues of the lungs.

The purpose of this pilot study is to measure the impact of non-invasive pneumaticmanipulation of transthoracic pressure on oxygenation in patients with Acute RespiratoryDistress Syndrome (ARDS) due to Coronavirus Disease 2019 (COVID 19) who are on mechanicalventilator support. This will be achieved by a pneumatic Vest placed around the chestwall of consenting patients who meet inclusion criteria. The Vest is essentially anon-invasive segmental device placed upon the anterior and posterior right and leftaspects of the chest wall. The researchers have the ability to inflate and deflate thechambers of the Vest to achieve preset pressures as determined by the protocol andobserve the patient's physiological response. Participants will have up to four hours ofintervention with the study intervention, followed by 1 hour of post-interventionobservation.

The etiological agent of the current pandemic is a (+)ssRNA virus. SARS-CoV-2 isinfecting thousands of people in the world with a fatality rate that varies from 0.1 to5% in affected countries, thereby causing enormous economic losses. Few antibiotics haveshown any efficacy in their combat, but have not yet proven adequate to stop the spreadof the disease, nor are there any approved vaccines at the moment. From experiments inplants ongoing infections by RNA viruses, using thermotherapy, which is the applicationof heat at a temperature between 35-43 °C, the investigators know that raising thetemperature affects the transcription of viral proteins due to the formation of small RNAmolecules that interrupt the replication process by grouping in specific regions of theRNA molecule, preventing and inhibiting transcription. These small molecules are calledsmall interfering RNAs (siRNAs). This feature has been used through thermotherapy inhumans to combat the rapid replication of cells (i.e. cancer cells), attack cellsinfected by RNA viruses, and in the treatment of some parasitic infections.There arevarious commercially available devices for thermotherapy use in humans; they are mainlybeing used to ease muscle pain. They work by increasing the temperature in the rangerecommended for thermotherapy in humans 39-43 ° C. Therefore, the investigators considerthis treatment modality can be used to aid in the elimination of SARS-CoV-2 from thehuman body, decreasing viral load, which could allow the immune system time for itscontrol and elimination.

The study aims to investigate the efficacy of extracorporeal CO2 removal for correctionof hypercapnia in coronavirus disease 19 (COVID-19)-associated acute respiratory distresssyndrome