COVID-19 Clinical Trials and Expanded Access

Background:People who get COVID-19 have a wide range of symptoms. They also recover from COVID-19 indifferent ways. In this study, researchers will use survey data to describe the differentways people experience and recover from COVID-19. They will also use the data to helpcreate future studies to understand why some people do not fully recover.Objective:To learn more about the range and timing of symptoms that people have before, during, andafter COVID-19 infection.Eligibility:People ages 18 and older who can give documentation of a positive COVID-19 or antibodytest.Design:Participants will be screened with a telephone interview. It will take 15 minutes. Theywill provide their COVID-19 test results and medical records.Participants will complete a second telephone interview. It will take 30 60 minutes. Theywill also take online surveys every 3 months for 3 years.The interview and surveys will ask participants about their health before they gotCOVID-19, what happened while they had COVID-19, and what their recovery has been like.Participants will get log-in data to take the online surveys. Completing all of thesurveys the first time may take up to 3 hours. Follow-up surveys will take up to 30minutes. Participants do not have to complete the surveys in one sitting. They will beable to save their progress and finish the surveys later.Participants may be contacted to take part in other research studies.

In this study, providing access to physiotherapy applications by telerehabilitationmethod and the effectiveness of this application will be examined for patients who haveundergone lung surgery in the early postoperative period during the pandemic process inwhich social isolation continues.

This is a phase I trial followed by a phase II randomized trial. The purpose of phase Istudy is the feasibility of treating patients with acute respiratory distress syndrome(ARDS) related to COVID-19 infection (COVID-19) with cord blood-derived mesenchymal stemcells (MSC). The purpose of the phase II trial is to compare the effect of MSC withstandard of care in these patients. MSCs are a type of stem cells that can be taken fromumbilical cord blood and grown into many different cell types that can be used to treatcancer and other diseases. The MSCs being used for infusion in this trial are collectedfrom healthy, unrelated donors and are stored and grown in a laboratory. Giving MSCinfusions may help control the symptoms of COVID-19 related ARDS.

The primary objective is to assess the ability of COVID-19 IgG and IgM assays to detectan immune response in COVID-19 patients in the Henry Ford Health System (HFHS), bothduring hospitalization and over the following 12 months.

Background:Mitochondrial disease is a rare disorder. It can cause poor growth, developmental delays,muscle weakness, and other symptoms. The disease is usually inherited. It can be presentat birth or develop later in life. Infection is a major cause of disease and death inpeople with this disease. Researchers want to learn more about these infections and thedeclining health of people who have this disease. To do this, researchers will study theDNA of people who become ill. Their DNA will be compared to the DNA of theirhousehold/family members.Objective:To learn more about how genes affect people with mitochondrial disease.Eligibility:People age 2 months and older with mitochondrial disease and their household/familymembers. .Design:Participants will complete a questionnaire about their health history. Their medicalrecords may be reviewed. They will give a blood sample.If the participant becomes ill, they may have a videoconference with a doctor or nurse atthe NIH to perform a physical exam. They may be contacted after their illness to giveupdates on their health. They may be asked to give extra blood samples or complete extraquestionnaires.Participants genetic data will be put into a database. The data will be labeled with acode and not their name. The data will be shared with other researchers.Participation lasts about 1 year. This may be extended if the participant is very ill.

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.

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.

Background:COVID-19 is an acute respiratory syndrome. One symptom of COVID-19 is a reduction in thenumber of cells called lymphocytes in the blood. Lymphocytes are a type of white bloodcell that fights infections. With fewer lymphocytes, the body cannot effectively fightback against SARS CoV-2, the virus that causes COVID-19. Researchers want to betterunderstand how SARS-CoV-2 affects these blood cells. This information may give them ideasfor new treatments.Objective:To learn more about how SARS-CoV-2 affects lymphocytes, the immune, and the bloodclotting system.Eligibility:Adults age 18 and older who either currently have COVID-19 or have recently recoveredfrom itDesign:Participants will give a blood sample. For this, a needle is used to collect blood froman arm vein. For participants who have a central line, blood will be collected throughthat instead.Participants medical records related to COVID-19 will be reviewed.Participants who have recovered from COVID-19 will be asked to undergo leukapheresis tocollect white blood cells. For this, blood is taken from a needle placed in one arm. Amachine separates out the white blood cells. The rest of the blood is returned to theparticipant through a needle placed in the other arm. This takes about 2-3 hours.Recovered participants may have material collected from inside the nostrils and/orrectum. This is done by gently rubbing the area with a sterile cotton swab.Recovered participants may have an echocardiogram to look at their heart. For this, asmall probe is held against the chest to get pictures of the heart from different angles.This takes less than 30 minutes.Participation lasts 1-2 days on most cases and may be split in a few visits for recoveredpatients if leukapheresis and echocardiogram are done....

Many of the patients hospitalized for a severe form of SARSCoV-2 respiratory impairmentrequire prolonged intensive care that can be complicated in the short term, In the mediumand long term, physical and psychological sequelae can affect patients' quality of lifeand prevent a return to normal working life.To date, there is little data on the fate of patients treated in Resuscitation for asevere form of COVID-19, both in terms of respiratory sequelae, as well as in terms ofpsychological sequelae and their quality of life. The objective of this study is to beable to describe and evaluate the possible physical and psychological sequelae andquality of life of patients hospitalized in Resuscitation for a severe form of COVID-19in the short (3 and 6 months), medium (1 year) and long (5 years) End of their stay inICU. To do this, we want to carry out a prospective, observational and monocentric studyin the consultation department of the Nice CHU. All patients admitted to Resuscitationfor a severe form of COVID-19 who have accepted the longitudinal medical follow-upproposed by the Nice CHU will be included in the study and data from the computerizedmedical record will be analyzed.

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.