COVID-19 Clinical Trials and Expanded Access

To perform comprehensive cardiac and thoracic non invasive imaging assessment by MRIand/or CT scan including cardiac functional evaluation and myocardial tissuecharacterization of COVID_19 related disease in pediatric patients with cardiacinvolvement.

The objectives of this proposal are to: 1) determine the rate of SARS-CoV-2seroconversion in unselected pregnant women in Hong Kong; 2) determine the rate ofSARS-CoV-2 infection in women presenting with miscarriage and stillbirth; 3) follow thepregnancy course and perinatal outcome of confirmed COVID-19-infected pregnant cases; 4)determine the risk and characteristics of vertical transmission; and 5) evaluate theplacental barrier, immune response and fetal damage in vertical transmission ofSARS-CoV-2. A series of longitudinal and cross-sectional observational studies, and alaboratory-based study will be conducted to fulfil the 5 objectives.

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.

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 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.

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.

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.

Background: Fatigue is among the most common symptoms of the long-term effects ofcoronavirus (long COVID). This study aims to compare the effectiveness of osteopathicmanipulative treatment (OMT) combined with physiotherapy treatment (PT) compared to PTalone on fatigue and functional limitations after two months post randomization in adultswith long COVID.Methods: This is a study protocol for a two-arm, assessor-blinded, pragmatic randomizedcontrolled superiority trial. Seventy-six participants will be randomly allocated toOMT+PT or PT. The PT includes usual care interventions including motor and respiratoryexercises targeting cardiorespiratory and skeletal muscle functions. The OMT entailsdirect, indirect, visceral, and cranial techniques. Patients will be evaluated before andafter a 2-month intervention program, and at 3-month follow-up session. Primaryobjectives comprise fatigue and functional limitations at 2-month post randomization asassessed by the fatigue severity scale and the Post-COVID Functional State scale.Secondary objectives comprise fatigue and functional limitations at 3 months, and theperceived change post-treatment as assessed by the Perceived Change Scale (PCS-patient).

This is a phase Ⅰ/Ⅱ, single-center, randomized, double-blind, placebo-controlled study,to evaluate the safety, tolerability and immunogenicity of the recombinant COVID-19vaccine (Sf9 cells) in the subjects from healthy aged 6-17 years with immunizationprocedures 0, 21, 42 days and doses (10μg/20μg/40μg).