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.

This phase I trial investigates breathing techniques and meditation for health careworkers during COVID-19 pandemic. Breathing techniques and medication may help managestress and improve lung health. The goal of this trial is to learn if breathingtechniques and meditation may help to reduce stress and improve lung health in healthcare workers during the COVID-19 pandemic.

The proposed study is designed to investigate if and how pregnant women infected withCoronavirus Disease-19 (COVID-19) infection go on to develop long-term immunity. InDecember 2019, a group of people in Wuhan, China presented with symptoms of a pneumoniaof an unknown cause that led to the discovery of a new coronavirus called COVID-19.COVID-19 has caused a global pandemic with 7,140,000 confirmed cases and 418,000 deathsas of 13th June 2020. In the United Kingdom (UK), there have been 294,000 cases and41,662 deaths as of 13th June 2020. In humans, this infection primarily involves theupper part of the lungs, but it can also affect other organs. It causes mild symptoms inthe majority of people affected but some people can have severe infections, with someeven requiring critical care in hospital. During Severe acute respiratory syndrome(SARS), a previous coronavirus epidemic, pregnant women were disproportionately affectedwith severe illness. Understanding how the immune system responds long-term to thisinfection may hold the key to developing better vaccines and efficient treatment plans.Specialised immunity develops when individuals are infected by this and other viruses.The investigators of this study propose that, in pregnancy, this specialised immunity maynot behave effectively. This may affect their ability to develop long lasting immunityand make them more vulnerable to re-infection. In this study, the investigators aim torecruit patients across 6 groups including COVID-19 newly infected pregnant women, andpeople with differing illness severity, mild to moderate, severe/critical, no infection(controls), as well as pregnant women with influenza and those receiving influenzavaccine. The study team will compare COVID-19 in pregnancy with non-pregnant infected andwith influenza infected and vaccinated pregnant women. The study team will consentpatients in all of these groups to provide a series of blood samples at different timepoints in a 12-month period.

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.

Plasma from patients who have recovered from coronavirus disease 2019 (COVID-19) isreferred to as COVID-19 convalescent plasma (CCP), and may contain antibodies againstSARS-CoV-2, the virus responsible for COVID-19. CCP infusion is being evaluated as atherapeutic or prophylactic approach in COVID-19 patients. The goal of this study is tohelp develop a bank of convalescent plasma in California, especially in medicallyunderserved communities particularly affected by the disease. In parallel, CCPadministered to COVID-19 patients will be collected and analyzed to determine whether theantibody profile correlates with clinical outcome. The purpose of this non-therapeuticstudy is to learn more about the CCP antibody profile and the effect it may have intreating COVID-19 infection.

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.

This study collects blood samples, medical information, and medical images from patientswho are being treated for cancer and have a positive test for SARS CoV-2, the newcoronavirus that causes the disease called COVID-19. Collecting blood samples, medicalinformation, and medical images may help researchers determine how COVID-19 affects theoutcomes of patients undergoing cancer treatment and how having cancer affects COVID-19.

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 project aims to clarify how immunity to SARS-CoV2 develops in humans and toinvestigate the possibility of finding patients with a particularly effective,neutralizing antibody response for future treatment. The project also aims to detail thevirus's damage mechanisms in tissue.