COVID-19 Clinical Trials and Expanded Access

The objective of the COVID-19 International Drug Pregnancy Registry (COVID-PR) is toevaluate obstetric, neonatal, and infant outcomes among women treated with monoclonalantibodies or antiviral drugs indicated for mild, moderate, or severe COVID-19 from thefirst day of the last menstrual period (LMP) to end of pregnancy. For monoclonalantibodies, the exposure period also includes 90 days prior to the first day of the LMP.

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.

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.

Richmond Research Institute (RRI) is applying existing and new COVID-19 PCR and antibodytests to help develop methodologies which provide fast and accurate results. Infectionwith coronavirus (SARS-CoV-2) is currently a worldwide pandemic and reliable testing forCOVID-19 is crucial to understand who is infected and therefore a risk to others byspreading the infection. RRI are currently carrying out the following tests:A. Using a membrane-based immunoassay to detect IgG and IgM antibodies to SARS-CoV-2 inwhole blood, serum or plasma specimens helps to assess whether an individual haspreviously had the virus and is potentially immuneB. Polymerase Chain Reaction (PCR) testing using an established method to check foractive SARS-CoV-2 infections.C. Quantification of anti-SARS-CoV-2 IgG and IgM antibodies in whole blood samples.The above tests are being used by RRI to follow infections (PCR) and immunity (IgG) intheir workforce, as well as their families (including children) and visitors to theirsite.Collecting this data allows the gathering of epidemiological data on SARS-CoV-2 includingincidence, prevalence, information on asymptomatic carriers and efficacy of vaccination.Furthermore, identifying individuals that are infected with SARS-CoV-2 has greatpotential to improve health outcomes by allowing infected individuals to seek the correctmedical treatment as well as self-isolate and reduce transmission.

In the United Kingdom, there are currently 138,000 confirmed patients with coronavirus,causing 18,738 deaths. Whilst the disease may be mild in the majority of patients, asignificant proportion of patients require intensive care therapy and a ventilator due tolung injury. In addition to lung injury/failure (acute respiratory distress syndrome(ARDS)), around 50% of patients admitted to intensive care develop acute kidney injury(AKI) (requiring advanced support via haemofiltration) and multi-organ failure.It is unclear why patients suffering from COVID-19 develop such severe lung injury(requiring life support or ventilation) or indeed why patients develop other organdysfunction such as kidney injury. The investigators hypothesis that this may due to anover-reaction of the immune system particularly in the lungs. This then results in therelease of various mediators and biological messengers which can be pushed into the bloodbloodstream (exacerbated by positive pressure generated by the ventilator). Thesemediators then travel, via the blood, to other organs such as the kidney where they causeinflammation and injury of cells, resulting in organ failure.The investigators would like to apply their well-established laboratory methods tofurther the scientific community's knowledge of this severe and deadly viral conditionand we hope that this would lead to the development of medication that would treat thisdeadly virus.

Background:The SARS-CoV-2 virus has caused a pandemic infection called COVID-19. It is a globalthreat to people, communities, and health systems. Researchers are concerned about themental health effects of the pandemic. They want to learn more about how it is affectingpeople s alcohol use and problems, and how it may continue to affect them over time.Objective:To study the impact of the COVID-19 pandemic on alcohol use and consequences inindividuals across the spectrum of alcohol use and those with alcohol use disorder.Eligibility:Participants who have been screened under the NIAAA Screening, Assessment and ManagementProtocol (14-AA-0181)Design:Participants will complete a baseline survey by phone. It will ask about alcohol use,alcohol dependence, and stress. It covers 2 time periods: the 12 months before thepandemic started and the time since it started.Participants will get an ID code and a link to an online survey. They will complete theonline survey within a week of the phone survey.Participants will complete a series of online surveys over 24 months. For the first year,surveys will be completed weekly for the first 4 weeks, then biweekly for the next 8weeks, and then every 1-2 months for the rest of the year. For the second year, surveyswill be completed every 6 months. Surveys will cover the following topics: - Alcohol use and its consequences - Other substance use - Stress - Impact of the COVID-19 pandemic - Pain - Physical health - Sleep - Quality of life.Because the course of the pandemic may change, the frequency of the surveys may change.Participation lasts 2 years.

Researchers are creating a real time COVID-19 registry of current ICU/hospital carepatterns to allow evaluations of safety and observational effectiveness of COVID-19practices and to determine the variations in practice across hospitals.

The COntAGIouS trial (COvid-19 Advanced Genetic and Immunologic Sampling; an in-depthcharacterization of the dynamic host immune response to coronavirus SARS-CoV-2) proposesa transdisciplinary approach to identify host factors resulting in hyper-susceptibilityto SARS-CoV-2 infection, which is urgently needed for directed medical interventions.

The purpose of this study is to understand the impact of COVID-19 on patients with cancerthrough a survey.