COVID-19 Clinical Trials and Expanded Access

A new virus to humans, first identified in December 2019, is causing a global pandemic with over 1 million infections and many thousands of deaths. The virus, SARS-CoV2, leads to coronavirus disease 2019 (COVID-19), which mainly affects the breathing system. Around 1 in every 5 people with COVID-19 have more severe infection needing treatment in hospital. Up to half of them require help with breathing in an intensive care unit. Information we have so far about COVID-19 suggests that people with underlying conditions, such as high blood pressure and heart disease, or older people are at higher risk of having severe illness. Scientists do not yet understand why but think it may be related to the immune system. SARS-CoV2 activates the immune system causing inflammation in the lungs, which is also seen in circulating immune cells in the blood. Preliminary reports show that the response of the immune system can be inappropriate, both overactive and also poorly responsive (exhausted). Changes in the type and function of immune cells have been linked to increased risk of severe disease or death from COVID-19. In this study, the investigators will look for markers of immune function when a person first attends hospital, which can be used to predict whether they will go on to have a more severe infection. This will help treat patients more effectively, for example, by moving high risk patients to an intensive care setting at an early stage. The team will investigate the immune system in detail in 200 patients with COVID-19 attending University Hospitals Plymouth. The investigators will look for changes in the number, type and function of circulating immune cells and measure whether these changes are linked to severity of the infection or death. The investigators will use established techniques to measure immune function that could be rapidly put into routine hospital care to help guide treatment for individual patients.

This study will provide investigational convalescent plasma for patients infected with the SARS-CoV-2 with mild to moderate symptoms who meet inclusion criteria as judged by physician evaluation.

Study to assess the safety and efficacy of STI-5656 (Abivertinib Maleate) plus SOC versus SOC in subjects hospitalized with COVID-19

The purpose of the study is to assess safety, tolerability and immunogenicity of the drug "Gam-COVID-Vac ", a solution for intramuscular administration, with the participation of healthy volunteers Study objectives A safety and tolerability assessment of the drug "Gam-COVID-Vac ", solution for intramuscular administration, using single dose of each component (Stage 1). A safety and tolerability assessment of the drug "Gam-COVID-Vac ", solution for intramuscular administration, using prime-boost immunization according to the proposed scheme (Stage 2). Post-vaccination immunity assessment at different time points after vaccination by: - Determination of antigen-specific antibody titer in blood serum by ELISA by comparison with baseline values before the vaccine administration and at days 14, 21, 28, and 42 after vaccination (hereinafter, the countdown comes from the first time of the vaccine administration); - Determination of virus neutralizing antibody titer before and at days 14, 28, and 42 after vaccination; - Determination of antigen-specific cellular immunity (specific T-cell immunity) before the vaccine administration and at days 14 and 28 after vaccination.

The onset of Coronavirus Disease 2019 (COVID-19) in the first months of 2020 had a huge impact on Italian population and Healthcare System, with more than 150.000 total confirmed cases1. SARS-CoV-2 is a highly contagious new virus, causing an influenza like illness and respiratory tract infection demonstrating fever (89%), cough (68%), fatigue (38%), sputum production (34%) and/or shortness of breath (19%). The aim of this observational study is to detect symptoms, disabilities, participation and the lived experience of the disease in individuals affected by COVID-19 two months after the hospital discharge.

Aim of the study is to investigate whether the Covid-19 is found in the vaginal swab samples of female patients diagnosed with covid-19, to evaluate the presence of Covid-19 and the risk of transmission of Covid-19 by intercourse or vaginal delivery.

Hospital mortality attributed to SARS-CoV-2 in France increased daily by 28% in the week before confinement. The week following this decision, the daily increase was 30%. During the week of the second week of confinement, it started a decline of 19% estimated over the last 5 days, reaching the cumulative number of 2606 deaths on 29/3 (site https://www.eficiens.com/coronavirus- personal statistics / and calculation). The diagnosis of viral carriage by RT-PCR is reserved for symptomatic cases among caregivers, due to the shortage of available tests and the cumbersome implementation. The carrier diagnosis is the benchmark, on which are implemented the therapeutic strategies and established the national statistics. It can present false negatives, linked to a research too early or too late in relation to the infection, or to a technical defect of the nasal swab sample. Caregivers on the front line in patient care, in hospitals or in the city, have only partial access to this diagnostic test, depending on the existence of symptoms. The implementation of a systematic serological screening, planned by the government and which cannot be based only on the search for the virus, will make it possible to inform the caregivers presenting symptoms or not, of their serological status, and therefore of their degree immunity or, on the contrary, susceptibility to infectious contacts. It should therefore be very voluntarily requested. On the occasion of this screening, the constitution of the COVID-3S cohort will make it possible to verify the degree of contamination in an asymptomatic population, information which is sorely lacking for the estimation of the immune coverage of the population. The implementation of the Covid-3S study will be based on the work of the National Reference Center of Pr B Lina, from the COVID-SER cohort, for the selection of the most efficient test (s). It seems useful to initiate the constitution of this cohort as soon as possible in relation to the evolution of the epidemic. Pending receipt of official recommendations, the lack of knowledge of the performance of serological tests means that it should be applied first to health professionals, better able to appreciate its limits, for the initial period before determining a validated serological screening strategy. Once the strategy has been specified, the gradual expansion of screening to the patient population will provide a more representative basis for the construction of epidemiological models for evaluating strategies.

An observational study of consecutive patients testing positive for COVID-19 who require admission to hospital to determine the degree of myocardial injury through biomarkers and echocardiography and the impact of this on cardiovascular outcomes. The COVID-19 disease and CARdiac Events study (COVICARE).

COVID-19 is a new emerging disease caused by infection with the SARS-CoV-2 coronavirus, with no specific therapeutic options. Since the end of February 2020, the Strasbourg University Hospital (HUS) had faced a sudden increase of patients with COVID-19 resulted from a SARS-CoV-2 superspreading event (religious meeting). Infected individuals went to regional hospitals, and this led to a cluster of infected healthcare workers at the Strasbourg University Hospitals from the first week of March. To date, several hundred Strasbourg hospital workers have presented a SARS-CoV-2 infection confirmed by the RT-PCR test from a nasopharyngeal sample. Most of them developed a mild form of COVID-19. It is important to understand how far the infection has spread in the hospital staff, and to which extent the individuals who have been infected develop antibodies against SARS-CoV-2.

The purpose of this study is to define seroprevalence of anti-SARS-CoV2 among children of Hospital Workers in APHP, particularly exposed population, according to parents' SARS-CoV2 serological status.