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.

Prospective, multi-centre, randomized, double-blind trial to assess efficacy and safety of ivermectin for the treatment of initial infection with SARS-CoV2 infection. Study arms: A) placebo B) ivermectin 600 μg/kg daily for 5 consecutive days (I_600) + placebo. C) ivermectin 1200 μg/kg daily at empty stomach with water for 5 consecutive days (I_1200). Patients will be randomized at emergency room of hospitals as well as at outpatient ambulatory care as well as at home, according to routine procedures of recruiting centres. In arm A and B, the number of placebo tablets to be administered will be calculated by the study dedicated pharmacist considering the number of tablets that should be taken in case a patient with the same weight is assigned to arm C.

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.

The aim is to demonstrate a decrease in complications among ambulatory patients who are diagnosed with mild COVID-19 by treating them with nitazoxanide for 7 to 14 days on top of standard care compared to patients who receive standard care and placebo only.

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

More cases of COVID-19 pandemic are being reported daily around the world. It is highly infectious and, over 7 million people have been infected and more than 400,000 people have died globally till this date. Countries around the world are struggling to avoid the spread of this pandemic. Center for Disease Control and Prevention (CDC) confirmed that there are no approved drugs for COVID-19 treatment. Researchers around the globe, however, are researching different medications for COVID-19 patients, including the drug Hydroxychloroquine (HCQ), which is mainly used for Rheumatoid Arthritis and Malaria. Not enough data was obtained yet to know how well all of these medications are functioning. Therefore, aim to perform a randomized placebo-controlled trial to assess the impact of these medications on COVID -19 healthcare workers exposed while treating COVID 19 patients in Qatar to avoid causality and comorbidities in healthcare workers. It is considered as a weak base. Many viruses enter the host cells via endocytosis, as a result of which they are initially taken up into an intracellular compartment that is "typically fairly acidic" whereas; Hydroxychloroquine would alter the acidity of this compartment, which can interfere with the ability of viruses to escape into the host cell and start replicating. Another hypothesis on the rationale of the Antiviral activity of HCQ, is that HCQ may also alter the ability of the virus to bind to the outside of a host cell in the first place. An interventional, double-blind, placebo-controlled randomized trial that will include participants who will be healthcare workers at risks of exposure to COVID-19 while managing patients with confirmed infection. Study will compare the safety, efficacy and effectiveness of Post Exposure Prophylaxis (PEP) use of HCQ in healthcare workers at risk of exposure to COVID-19 patients, in comparison to Placebo in Qatar.

- This clinical trial proposal is based on the FDA protocol for emergency use of convalescent plasma for treatment of COVID-19 cases, and on the WHO guidelines for use of convalescent plasma in other infectious diseases. - This Clinical trial is to be applied in Cairo University quarantine hospital. The collection, testing and storage of convalescent plasma will be done inside CUH main blood bank. The concept of this clinical trial is built on the collection of convalescent plasma from individuals who had recovered from documented infection with SARS-CoV-2, to be used for patients with- or at high risk of progression to- severe/life-threatening clinical conditions due to SARS-CoV-2 infection. An informed consent is required to join this clinical trial; patients will be transfused with one or two units of ABO compatible convalescent plasma. Those patients will be followed up and the clinical and laboratory data will be compiled, including adverse events related to the administration of convalescent plasma (CP). Other data to be collected retrospectively will include patient demographics, acute care facility resource utilization (total length of stay, days in ICU, days intubated, and survival till discharge from an acute care facility).

Residents in homeless shelters will be randomized to 4 different COVID-19 screening strategies with the primary outcome being COVID-19 detection rate.

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.