COVID-19 Clinical Trials and Expanded Access

A randomized, double-blind, placebo-controlled international multicenter clinical trialdesign will be adopted. A total of 29,000 subjects aged 18 years and above are planned tobe recruited, including 750 subjects aged 18-59 years and 250 subjects aged 60 years andabove in China; 21,000 subjects aged 18-59 years and 7,000 subjects aged 60 years andabove will be recruited outside China. Safety and immunogenicity will be evaluated amongthe Chinese subjects, and efficacy, immunogenicity and safety will be evaluated among thesubjects outside China. Among them, 750 subjects aged 18-59 and 250 subjects aged 60 andabove from outside China and all subjects from China will be selected as theimmunogenicity subgroup for immunogenicity bridging study. The IgG levels of SARS-COV-2neutralizing antibody and RBD protein binding antibody will be detected by blood samplingbefore vaccination, 14 days and 6 months after full course of vaccination to evaluate theimmunogenicity and immune persistence.

Multicenter observational study of diagnostic test validation (Research Involving theHuman Person, type 3) In addition to the diagnosis by the reference method(nasopharyngeal swab), the patient will be asked to provide a saliva sample via asalivary spit. The clinical circumstances of the diagnosis, the age of the patient, theassociated terrain (diabetes, immunodepression, pregnancy) will be noted. Thenasopharyngeal and saliva samples will be analyzed in Cayenne and the remaining sampleswill be frozen and stored at the CRB before being sent to the University Hospital of Caenfor analysis and concordance verification.The expected benefits are:Possibility of repeating tests in the same person more easily due to the absence of painand thus reduce the barriers to diagnosis and screening.Possibility of self-sampling, which could simply be sent to the laboratory, which wouldrelieve the diagnostic sites that mobilize staff and require a fairly heavy organization.Avoid long waiting lines that can be an obstacle and lead to a renunciation of thediagnosis.

The investigators wish to set up a pharmaco-epidemiological cohort within the HospitalTerritorial Groups of the Cévennes-Gard Camargue, East-Hérault and Haute-Garonne and WestTarn on a specific population, patients undergoing immunotherapy for cancer, as currentlythere is no data available under "real life" conditions following anti-COVIDvaccination19. The hypothesis is that patients undergoing immunotherapy will not developmore vaccine-related adverse events than those observed in the efficacy and safetyvalidation studies of the BNT162b2 mRNA Covid-19, mRNA-1273 SARS CoV-2,Oxford/AstraZeneca and Ad26COV2.S, JMJ Vaccine or J & J COVID-19 Vaccine.

This is a phase III randomized, double blinded, placebo-controlled multi-center study toassess the efficacy and safety of aerosolized Novaferon for the treatment of asymptomaticor mildly patients infected with SARS-CoV-2.

Coronavirus disease 2019 (COVID-19) is a serious respiratory disease that results frominfection with a newly discovered coronavirus (SARS-COV-2). Unfortunately, COVID-19 isnot only a short-term infection. Patients (pts) recovering from SARS-COV2 infectioncomplain of persisting symptoms including: fatigue, diffuse myalgia and weakness, whichmay lead to chronic fatigue syndrome and as well as many other complications.The vast majority of COVID-19 patients remaining in isolation/quarantine, due to the mildcourse of the disease, do not require hospitalization. In this group of patients, thecourse of COVID-19 is very different - from asymptomatic patients to very severe and longlasting symptoms also with a decrease in saturation.There are many studies describing the course and complications of patients hospitalizeddue to COVID-19. There is little published data on how non-hospitalized patients get sickand what are the early and late complications of SARS-CoV-2 infection. In addition, manypatients remain ill even many months after COVID-19, entering what is known asLONG-COVID.Therefore, the STOP-COVID Registry was established. The purpose of the Registry is toassess the course of COVID-19 infection, early and late cardiovascular complications ofCOVID-19 in patients with and without hospitalization. In addition, the purpose of theSTOP-COVID Registry is to assess the incidence of LONG-COVID with all other complicationsand to identify predictive factors.

The purpose of this study is to examine the effect of Andrographis Extract, BoesenbergiaExtract compared to standard treatment in asymptomatic COVID patients.

Hypoxemic acute respiratory failure is one of the main COVID-19 patients complicationthat lead to in intensive care hospitalization.This complication determines a variable mortality from 25 to 30%. To correct hypoxemia(often severe) is often needed non-invasive or invasive mechanical ventilation.Mechanical ventilation is not a therapeutic strategy, but it allows to extend thetime-to-recovery necessary to solve COVID-19 respiratory failure cause.Calibration of ventilatory support is essential to ensure adequate time-to-recoverywithout contributing to onset lung and / or diaphragmatic damage.Basal diaphragmatic activity assessment, device for administering the oxygenation supportchoice and setting ventilatory support parameters are decisive.Ultrasound is the best method for measuring diaphragmatic work. The aim of this study isto evaluate the diaphragmatic thickening fraction in COVID-19 patients admitted toIntensive Care Unit (ICU) for acute respiratory failure and to record its function onweaning.

Long-term neurocognitive and psychiatric consequences of COVID-19 remain mostly unknownto date. It has been reported that coronaviruses cause direct central nervous systeminfection (Needham et al. 2020). Besides that, new or worsening cognitive impairmentcommonly occurs and persists in survivors of intensive care unit (ICU) stay (Hosey &Needham. 2020). The purpose of our study is to search and describe the cognitive andpsychiatric long-term consequences of COVID-19 on patients who have been discharged fromcritical care units. This is an ambidirectional cohort study, that attempts to followadults discharged from critical Care Units Adults due to COVID-19 up to 12 months afterdischarge, to evaluate the presence of cognitive impairment, linguistic and phonationfunction, depression, fatigue, functional gastroenterological symptoms, anxiety, or posttraumatic disorder, and performance in activities of daily living and physical responseto exercise as well.

The coronavirus (COVID-19) pandemic is a significant psychological stressor thatthreatens the onset of a mental health crisis in the US. Fear and anxiety about COVID-19and its economic impact, as well as loneliness due to the required social isolation, aredriving the mental health impacts of COVID-19; in a recent Kaiser Family Foundation poll,45% of respondents reported that the coronavirus has had a negative impact on theirmental health. This is reflected in Southeastern Ohio. In data that the investigatorscollected from 317 Ohio University faculty, staff, and students from late May to earlyJune, 39% reported moderate-to-severe levels of anxiety, 41% reported moderate-to-severelevels of depression and 57% reported the COVID-19 outbreak was impacting their sense ofsocial connection much or very much. Despite the significant community need foraccessible and affordable care, there are currently no evidence-based interventions forindividuals coping poorly with coronavirus-related distress. The investigators havedeveloped a virtual group-based intervention targeting cognitive biases that amplify theexperience of stress and anxiety (i.e., amplifying cognitions; Coping withCoronavirus-Related Emotion and Worry [COPING CREW]). The next step in developing thisintervention in a scientifically rigorous manner is to refine the manual and proceduresand conduct a pilot test of the intervention.

Evaluation of the efficacy of the AstrazenicaCovid 19 vaccine to develop IgG antibody andits level based on th12 weeks program. Also to follow the changes of markers ofcoagulation (D-dimer) after vaccination compared to the basic level. A cardiologyconsultant will follow D-Dimer results to be managed properly if there is a need. As itis expected to receive Sinopharm vaccine there will be comparison between results of thetwo types of vaccine. To our knowledge this will be the first study done on Egyptianpopulation.