COVID-19 Clinical Trials and Expanded Access

This study investigates a new diagnostic test in detecting SARS-CoV-2, the virus thatcauses the disease COVID-19. This may help to improve testing for COVID-19.

This is an open label randomized controlled clinical trial which was designed to confirmthe potential efficacy and safety of favipiravir in the management of patients with mildto moderate COVID-19 compared to best supportive care.

OBJECTIVE: The aim of the study is to demonstrate that the intracorporeal resection andanastomosis in left-sided colon cancer, sigma and upper rectum, is not inferior toextracoprporeal resection and anastomosis, in terms of anastomotic leakage.BACKGROUND: Due to the recent events of a pandemic respiratory disease secondary toinfection by SARS-CoV-2 virus or coronavirus 19 (COVID19), surgeons have been forced toadapt our surgical procedures in order to minimize exposure to the virus as much aspossible.Based on the recommendations in case of surgery in patients with highly contagious viraldiseases, the latest studies suggest minimally invasive accesses to minimize the risk ofcontagion. One of the proposed measures is the performance of intracorporeal anastomoses.Therefore, given the extensive experience of our center in minimally invasive surgery andstudies on the validation of intracorporeal anastomosis techniques in both laparoscopicsurgery of the right colon and rectum (TaTME), and the study of advantages that they canprovide to the patient, our intention is to apply it to surgery on the left colon, sigmaand upper rectum. Our hypothesis is that exteriorization of the colon through anaccessory incision increases the risk of tension at the mesocolon level, thus increasingthe risk of vascular deficit at the level of the staple area and it may increase the rateof anastomotic leakage. In this sense, studies that validate a standard technique ofintracorporeal anastomosis in left colon surgery and that demonstrate its benefit withrespect to extracorporeal anastomosis are lacking. We intend to describe a newintracorporeal anastomosis technique (ICA) that is feasible and safe for the patient andthat can be applied universally. Once the ICA technique is established, it will allow usto determine its non-inferiority compared to the standard technique performed up to nowwith extracorporeal anastomosis.METHODS: All consecutive patients with left-sided, sigma and upper rectum adenocarcinomawill be included into a prospective cohort and treated by laparoscopy with totallyintracorporeal resection and anastomosis. They will be compared with a retrospectivecohort of consecutive patients of identical characteristics treated by laparoscopy withextracorporeal resection and anastomosis, in the immediate chronological period.

Until now there is no vaccine or reliable treatment for the COVID-19 pandemic. Thefundamental mechanisms of non-invasive low-level laser in photobiomodulation (PBM) andphotodynamic therapy is to stimulate the mitochondrial respiratory chain where atransient release of non-cytotoxic levels of reactive oxygen species (ROS) will lead topositive modulation of the immune response. As previous studies mentioned that the mostimportant strategy for COVID-19 management is oxygenation and faster rehabilitation ofthe damaged tissue, antiviral effects, and, finally, reduction or controlling the cytokinestorm by reducing inflammatory agents. PBM may be used as adjuvant therapy or even analternative therapy in all these mechanisms without side effects and drug interactions.Objectives The objective of this clinical trial is to use the photobiomodulation therapy(PBMT), and photodynamic therapy as adjuvant therapy or even an alternative therapy forCovide-19.Patients and methods A randomized controlled study will be conducted on 60 patients ofpositive COVID 19. The patients will be divided into 3 equal groups. Group, I willreceive a low-level laser (diode laser 980nm) from laser watch for 30 minutes, 20 J for 3to 5 days, and laser acupuncture. Group 2 will be treated with photodynamic therapy byinjecting the methylene blue as a photosensitizer and irradiated with laser watch (diodelaser 670 nm). Group 3 will serve as a control. Evaluation methods will includelaboratory investigations and CT chest.

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.

Rationale In a very short time corona virus disease 2019 (COVID-19) has become a pandemicwith high morbidity and mortality. The main cause of death is respiratory failureincluding acute respiratory distress syndrome, however the exact mechanisms and otherunderlying pathology is currently not yet known. In the current setting of the COVID-19pandemic complete autopsies seem too risky due to the risk of SARS CoV-2 transmission.Yet, as so little is known, additional histopathological, microbiological and virologicstudy of tissue of deceased COVID-19 patients will provide important clinical andpathophysiological information. Minimal invasive autopsy combined with postmortem imagingseems therefore an optimal method combining safety on the one hand yet provingsignificant information on the other.This study aims to determine the cause of death and attributable conditions in deceasedCOVID-19 patients. This will be performed using post-mortem CT-scanning plus CT-guidedMIA to obtain tissue for further histological, microbiological and pathologicaldiagnostics. In addition, the pathophysiology of COVID-19 will be examined by furthertissue analysis.