COVID-19 Clinical Trials and Expanded Access

Low doses of radiation in the form of chest X-rays have been used to treat people withpneumonia. This treatment was found to be effective by reducing inflammation and withminimal side effects. However, it was an expensive treatment and was eventually replacedwith less costly treatments such as antibiotics. Radiation has also been shown in someanimal experiments to reduce some types of inflammation.Some patients diagnosed with COVID-19 pneumonia will experience worsening disease, whichcan become very serious, requiring the use of a ventilator. This is caused byinflammation in the lung from the virus and the immune system. For this study, the x-raygiven is called radiation therapy. Radiation therapy uses high-energy X-ray beams from alarge machine to target the lungs and reduce inflammation. Usually, it is given at muchhigher doses to treat cancers.The purpose of this study is to find out if adding a single treatment of low-dose x-raysto the lungs might reduce the amount of inflammation in the lungs from a COVID-19infection, which could help a patient to breathe without use of a ventilator.

Thymalfasin (thymosin alpha 1 or Ta1), the active pharmaceutical ingredient in ZADAXIN®injection, is a 28-amino acid synthetic peptide, identical to natural Ta1 produced by thethymus gland. Ta1 is a biological response modifier which activates various cells of theimmune system, and is therefore expected to have clinical benefits in disorders whereimmune responses are impaired or ineffective, including acute and chronic viral andbacterial infections, cancers, and vaccine non-responsiveness. Patients with end-stagerenal disease (ESRD) on hemodialysis, in addition to their intrinsic kidney disease andfrequent burden of comorbidities, also have increased risk of exposure to communicablediseases as they are treated several times each week at hemodialysis centers with severalother patients and clinic staff in attendance. The majority of patients are over 60 yearsof age and many are receiving immunosuppressive medications. Accordingly, ESRD patientsare particularly susceptible to COVID-19 infection. Ta1 has been shown to be safelyadministered to hemodialysis patients. It is our hypothesis that a course of Ta1administered to individuals with ESRD will reduce the rate and severity of infection withCOVID-19.

This is an observational study. The aim is to describe the natural history and clinicalevolution over time of hospitalized patients affected by Severe Acute RespiratorySyndrome-Coronavirus-2 (SARS-COV-2) infection, including the genetic pathology of thedisease and improve therapeutic procedures.

This is a prospective observational cohort study that will define the prevalence andincidence of CA-SARS-Cov2 infection using serological and PCR tests in a group ofsubjects during deconfinement. The team wishes to include approximately 1000 subjects inthis study.The health crisis through containment has also created unprecedented environmentalconditions with the very clear decrease in economic activities and a consequent decreasein exposure to the main air pollutants. The aim is therefore to carry out a case-controlstudy in which each subject will be his or her own control in unexposed condition (toPM2.5, PM10, NO...) then exposed (after the recovery of economic activity and the usuallevels of air pollutants) and to measure the impact of these pollutants on the immunesystem and epigenetic markers taking into account seasonality.The occurrence of infectious, cardiovascular, allergic and autoimmune events will then bemeasured according to the immunological profiles measured at inclusion.

The aim of this study is to apply serology testing methods for SARS-CoV2 antibodies insamples collected from HCWs in an acute hospital. This will enable the identification ofthose who are protected and non-infectious for SARS-CoV2 and those who are seronegativeand therefore potentially susceptible and infectious on patient contact. Prospectivetesting will provide data on the acquisition of SARS-CoV2 infections among HCWs andassociated risk factors for transmission during a pandemic at an acute care hospitalfacility in the capital region of Denmark.Hypothesis: Serial seroconversion measurements in hospital employees improve theorganization of the clinical treatment and care during the COVID-19 pandemic atNordsjællands Hospital and Nykøbing Falster County Hospital.

The aim of this preliminary study is to describe the potential decline in forcedexpiratory volume in 1 second (FEV1) or forced vital capacity (FVC) as measured by homespirometry in high-risk subjects infected with COVID-19. We hypothesize that themagnitude of such a decline in FEV1 and/or FVC may be associated with clinicaldeterioration and hospitalization. The study will ultimately inform a larger subsequentRCT that will evaluate the efficacy of home spirometry in the early detection (prerespiratory symptoms) of respiratory complications and therefore prompt early medicalattention which is a key for improving outcome.

Lower Respiratory Tract infections are a common cause of admission to the intensive careunit. Children routinely receive antibiotics until the tests confirm whether theinfection is bacterial or viral. The exclusion of bacterial infection may take 48 hoursor longer for culture tests on biological samples to be completed. In many cases, theresults may be inconclusive or negative if the patient has already received antibioticsprior to the sample being taken.A rapid assay to detect the most likely cause of infection could improve the speed withwhich antibiotic therapy is rationalised or curtailed.This study aims to assess whether a new genetic testing kit which can identify thepresence of bacteria and viruses within hours rather than days is a feasible tool inimproving antibiotic prescribing and rationalisation of therapy in critically illchildren with suspected lower respiratory tract infection.

This is a multicenter prospective study that aims to investigate the clinical impact ofSARS-CoV-2 infection in pregnant women, pregnancy outcomes and perinatal transmission.

Patients suffering lung failure, possibly from COVID-19 or hypoxic lung failure, willneed life-saving support from a breathing machine. Any patient needing this supportrequires drugs to keep them sleepy, or "sedated" to be comfortable on this machine.Sedation is made possible by using drugs given through a vein. Unfortunately, these drugsare in short supply worldwide due to the high number of COVID-19 patients needing thesemachines.Another way to provide sleep is by using gases that are breathed in. These are used everyday in operating rooms to perform surgery. These gases, also called "inhaled agents" canalso be used in intensive care units and may have several important benefits for patientsand the hospital. Research shows they may reduce swelling in the lung and increase oxygenlevels, which allows patients to recover faster and reduce the time spent on a breathingmachine. In turn, this allows the breathing machine to be used again for the next sickpatient. These drugs may also increase the number of patients who live through theirillness. Inhaled agents are widely available and their use could dramatically lesson thepressure on limited drug supplies.This research is a study being carried out in a number of hospitals that will compare howwell patients recover from these illnesses depending on which type of sedation drug theyreceive. The plan is to evaluate the number who survive, their time spent on a breathingmachine and time in the hospital. This study may show immediate benefits and may providea cost effective and practical solution to the current challenges caring for patients andthe hospital space, equipment and drugs to the greatest benefit. Furthermore, the studywill be investigating inflammatory profile and neuro-cognitive profiles in ventilatedpatients. Finally, this trial will be a team of experts in sedation drugs who care forpatients with proven or suspected COVID-19 who need lifesaving treatments.

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.