COVID-19 Clinical Trials and Expanded Access

This is an observer-blind, randomized study which aims to assess the immune response andthe safety of two different approved vaccines for first and second dose in healthyadults.

This study will test the COVID-19 vaccine candidate AZD1222 to investigate its safety,tolerability and capability of boosting immune responses both in the blood and the lungwhen administered to the respiratory tract, in volunteers previously vaccinated byintramuscular COVID-19 vaccination. Using standardised methods, we will measure immuneresponses in the blood, nose and lower airway and compare with data from ongoing clinicaltrials of intramuscular vaccination. Thus, we will show the effect of the delivery methodand provide the critical information required to begin further clinical trials to showthe efficacy of this needle-free vaccination strategy for booster vaccination.

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.

We hypothesize that the intake of Omni-Biotic® 10 AAD can reduce intestinal inflammationand improves dysbiosis in Covid-19 disease. We further hypothesize that Omni-Biotic® 10AAD can reduce the duration of diarrhea, stool frequency, improve stool consistency,improve other gastrointestinal symptoms of Covid-19, reduce disease duration andseverity.The investigators aim to perform a randomized, double blind, placebo-controlled studyusing telemedicine in patients with Covid-19 disease.

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.

Primary Objective:To determine the maximum tolerated dose (MTD) of SAR442257 administered as a single agentin patients with relapsed and refractory multiple myeloma (RRMM) and relapsed andrefractory non-Hodgkin lymphoma (RR-NHL), and determine the recommended Phase 2 dose(RP2D)Secondary Objectives: - To characterize the safety profile of SAR442257 - To characterize the pharmacokinetics (PK) profile of SAR442257 - To assess preliminary evidence of antitumor activity

Background:COVID-19 is a disease caused by the SARS-CoV-2 virus. It infects the respiratory tract.Some people who get COVID-19 have only mild symptoms. But for others, infection leads topneumonia, respiratory failure, and, in some cases, death. Researchers want to learn moreabout any effects that may persist after people recover from COVID-19.Objective:To learn about any long-term medical problems that people who have recovered fromCOVID-19 might have, and whether they develop an immune response to SARS-CoV-2 thatprovides protection against reinfection.Eligibility:People age 18 and older who have recovered from documented COVID-19 or were in closecontact with someone who had COVID-19 but did not get the infectionDesign:Participants will be screened over 2 visits. During visit 1, they will answer questionsabout any symptoms they are having and will be tested for SARS-CoV-2 infection which willinvolve a nasal swab sample or other FDA approved test. If the test is negative, theywill proceed to the second visit, which will include:Physical examinationMedical historyMental health interview (which may be recorded if the participant agrees)Chest x-ray (for recovered COVID-19 participants only)Blood and urine testsPregnancy test (if needed)Lung function test (for recovered COVID-19 participants only)6-minute walk test (for recovered COVID-19 participants only)Questionnaires about their general and mental healthLeukapheresis to collect white blood cells (optional).Participants will be put into 1 of 2 groups: the COVID-19 group or the close contactgroup.Participants will have study visits every 6 months for 3 years. They will repeat some ofthe screening tests. Participants in the COVID-19 group may have visits more often ifthey develop symptoms that suggest re-infection with SARS-CoV-2.

The current project is a prospective, multicentric cohort study aiming at amultidisciplinary assessment (pulmonary, cardiometabolic, sleep and mental health) of theconsequences of infection by SARS-CoV-2, 3 months after the diagnosis in order to bettercharacterize these complications. 400 patients with a positive diagnosis of SARS-CoV-2will be included in the study 3 months after their diagnosis: They will be followed at 6months, 1 year, 3 years, and 5 years, as function of their after-effects discovered at 3months and their evolution.