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 a phase 2 multi-center, double-blind, randomized, placebo-control clinical trialwith 200 subjects who have never been infected by COVID-19 (SARS-Cov-2 virus screen testnegative, no blood SARS-Cov-2 IgM and IgG antibodies detected during enrollment) followedby a pilot study of 5 subjects to demonstrate the safety of proposed three-dose regimenof autologous AdMSCs infusions. The 100 study subjects who have previously banked theirAdMSCs with Celltex, will receive three doses of autologous AdMSCs (approximately 200million cells) intravenous infusion every three days. The 100 subjects in the controlgroup who have previously banked their AdMSCs with Celltex will not receive any Celltex'sAdMSC therapy but placebo treatments. All subjects are monitored for safety (adverseevents/severe adverse events), COVID-19 symptoms, SARS-Cov-2 virus test, blood SARS-Cov-2IgM and IgG antibodies tests, blood cytokine and inflammatory (CRP, IL_6, IL-10, TNFα)tests and disease severity evaluation for 6 months after the last dose of AdMSC infusionfor the study group and 6 months after the enrollment for the control group.

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.

Purpose: The emergence of a new coronavirus SARS-CoV-2 causing a novel infection in thehuman race resulting in a world-spanning pandemic came as a surprise and at a tremendouscost both for individual human lives as well as for the society and the health caresector. The knowledge on how this new infection affects both the mother and the unbornchild as well as the outcomes for the mother and the child in the long run are unknown.What is known is based on case-reports and small case-series solely. Both thecoronaviruses causing Middle East Respiratory Syndrome (MERS) and Severe AcuteRespiratory Syndrome (SARS) can cause a threat to pregnant women and their offspring,which leads to the question whether this could be the case also for SARS-CoV-2.Aims: To establish a biobank of biological material from infected as well as non-infectedpregnant women and their offspring. To combine this biobank with Swedish quality andhealth care registers, computerized patient charts and questionnaire data, enabling bothshort-term follow up, such as obstetric outcomes, as well as long-term outcomes both formother and child. To study how the pandemic situation affects both the mother and herpartner in their experience of pregnancy, childbirth, and early parenthood.Design: A national Swedish multicentre study. Women are included when they have apositive test for SARS-CoV-2 or a clinical suspicion of coronavirus disease 2019(COVID-19) (COVID-19 group). Pregnant women without COVID-19 symptoms will be included attheir routine visits (Screening group). Blood samples and other biological material willbe collected at different time-points. Additional predictors and outcomes are collectedfrom the Swedish Pregnancy Register as well as obligatory Swedish health registers. Thebiobank and its linkage to health registers through the Swedish personal identificationnumber will enable future research. Child development will be followed during the firstyear of life by questionnaires to the parents. Womens' and their partners' experience ofchildbirth and parenthood will be studied in form of questionnaires as well as in form ofinterviews.Conclusion: This project will help obstetricians and neonatologists better recognizeclinical manifestations of the virus, identify possible risk factors during pregnancy andtailor therapies alongside providing right level of surveillance and management duringpregnancy, delivery, and child health care.

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.

This phase III trial compares low dose whole lung radiation therapy to best supportivecare plus physicians choice in treating patients with COVID-19 infection. Low dose wholelung radiation therapy may work better than the current best supportive care andphysician's choice in improving patients' clinical status, the radiographic appearance oftheir lungs, or their laboratory blood tests.

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.

The purpose of this study is to find out if immunization with IMM-101 will reduce theincidence of severe respiratory and COVID-19 infections in cancer patients.