COVID-19 Clinical Trials and Expanded Access

Gazelle COVID-19 is a fluorescent lateral flow immunoassay and accompanying Readerintended for the qualitative detection of nucleocapsid antigen from SARS-CoV-2 in nasalswab specimens from individuals who are suspected of COVID-19 by their healthcareprovider within 5 days of symptom onset. The study will be conducted To obtain data tomeasure the positive percent agreement and negative percent agreement of the GazelleCOVID-19 Test compared to Reverse Transcriptase Polymerase Chain Reaction (RT-PCR).Thestudy will assess Gazelle COVID-19 Test performance using dual mid-turbinate nasal swabsamples. This study will primarily assess Gazelle COVID-19 Test performance onsymptomatic subjects (within five days of onset of symptoms) at point of care (POC). Asubset of asymptomatic subjects will be enrolled after the symptomatic subject enrollmentis complete.

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.

The study hypothesis is that low-dose computed tomography (LDCT) coupled with artificialintelligence by deep learning would generate imaging biomarkers linked to the patient'sshort- and medium-term prognosis.The purpose of this study is to rapidly make available an early decision-making tool(from the first hospital consultation of the patient with symptoms related to SARS-CoV-2)based on the integration of several biomarkers (clinical, biological, imaging by thoracicscanner) allowing both personalized medicine and better anticipation of the patient'sevolution in terms of care organization.

The aim of this study is to analyze the impact of video dance class and unsupervisedphysical activity on clinical-functional parameters, self-isolation and non-motorssymptoms in people with Parkinson's disease during the Covid-19 pandemic.

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.

This is a pivotal phase III study to evaluate the efficacy of nitazoxanide 600 mg BIDcompared to placebo to treat hospitalized patients with non-critical COVID-19.

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 VIGIL study was set up at the beginning of the pandemic, in the spring of 2020, at atime when diagnostic testing for SARS-CoV-2 had to be performed according to specificclinical criteria (even if no clinical picture suggestive of COVID had been clearlyidentified). The management of sick young children (with respiratory tract infection thatcould be attributed to COVID) by pediatricians (infectious diseases specialists,emergency physicians, general practitioners, and outpatients) was facilitated by analgorithm whose objective was to help define the indications for SARS-CoV-2 PCR andsubsequently for antigenic testing. The current technique of deep nasopharyngeal swabbing(for PCR or antigenic testing) is delicate and difficult in children, and is therefore aserious handicap for community-based screening, especially since infectious episodes arefrequent in children. Since then, nasal self-tests that can be easily used in childrenhave been commercialized and have facilitated screening.Because of the similarity between the clinical signs of respiratory tract infections inchildren, it is often impossible to distinguish between different viral respiratoryinfections and epidemics may overlap in time. However, the identification of the pathogenis the key to improve management of these infectious diseases. The VIGIL study istherefore continuing, still facilitated by the existence of an active pediatric networkexisting for 20 years. ACTIV AFPA and GPIP have created networks of hospital andambulatory pediatricians who actively participate in various observatorieshttps://www.jpeds.com/article/S0022-3476(17)31606-2/fulltext To date, these observatorieshave resulted in the publication of more than 80 articles in international journals(https://www.activ-france.com/fr/publications).

The aim of the study is to clinically use bovine Lf as a safe antiviral adjuvant fortreatment and to assess the potential in reducing mortality and morbidity rates inCOVID-19 patients. The study was approved by the ethical committee of the Egyptian Centerfor Research and Regenerative Medicine in 11-5-2020.