COVID-19 Clinical Trials and Expanded Access

The goal of the research is to assess candidate COVID-19 rapid diagnostic tests (e.g.immunodiagnostic antibody tests, like Cellex qSARS-CoV-2 IgG/IgM Rapid Test, or antigentests, like Turklab Test-It COVID-19 Home Test, AllBio Science Inc. and ArtronLaboratories Inc. rapid COVID-19 antigen tests in order to judge their clinical accuracycompared to Centers for Disease Control (CDC)-recommended molecular genetic testing andclinical diagnosis. Second, it is our goal to determine if self-testing assisted byCOVIDscanDX mobile device camera acquisition software platform and telemedicineclinical/technical support (virtual point-of-care) improves the ease of use and immediateinterpretation of the tests, thus making self-testing comparable in accuracy and safetyto testing in a clinical setting. Third, we are testing antibodies to SARS-CoV-2 afterdiagnosis with COVID-19 or following vaccination to measure the onset and time course ofdetectable antibodies from finger-stick blood drops and rapid antibody lateral flowtests. The overall purpose of the study is to dramatically increase the capacity ofCOVID-19 testing by establishing the safety, ease-of-use and validity of self-testingassisted by mobile device imaging and telemedicine remote support and provide evidence ofantibody time-course response to vaccination.

In absence of vaccine and medications specifically designed to treat SARS-CoV-2 disease,identifying treatment options is critical at this time to control the disease outbreak.For this, we have designed a phase II trial of efficacy and safety with 3 branches ofdifferent combinations of treatment to identify which is the best early treatment optionfor patients with pneumonia due to SARS-CoV-2 (Covid-19) Identifying treatment options asearly as possible is critical to the SARS-CoV-2 outbreak response. Currently, there is noapproved vaccine for the disease and the treatments being used are not specificallydesigned for the SARS-CoV-2 virus, but are different groups of drugs used for otherpathologies with mechanisms of action that justify their use because they inhibit entryof the virus into virus cells or proteases.The study aims to compare Imatinib 400mg, Baricitinib 4mg or supportive treatment,administered for 7 days in the setting of SARS-CoV-2 pneumonia treatment.Patients who meet inclusion criteria and do not have any exclusion criteria will berandomized to receive open treatment 1:1:1

The infection caused by COVID19 worldwide makes it necessary to monitor drugsadministered for the treatment of patients hospitalized with SARS-CoV-2. In order to knowmore about the efficacy and safety of the treatments used, researchers from theCantabrian health service have developed an observational study, in the form of anambispective registry, in which clinical data from patients treated with the differentdrugs currently recommended by the Spanish Agency of Medicines and Health Products(SAMHP) and the Ministry of Health, or others that may arise, are collected and analyzed.Although the conduct of clinical trials is a priority at this time, we cannot lose theclinical experience that is currently being generated, which may allow us to improve thetherapeutic strategies for future patients.

The purpose of this study is to assess the safety and efficacy of leronlimab (PRO 140)administered as weekly subcutaneous injection in subjects with severe or criticalCOVID-19 disease.

The aim of the project is to better understand the Covid-19 inpatient course of thedisease and to quickly identify the positive experiences in the treatment in order toupdate guidelines for the treatment and use of medication.

Several patients with hypoxaemic SARS-CoV2 pneumonia were able to benefit from hyperbaricoxygen treatment (HBOT) in China. In a clinical case published in the Chinese journal ofhyperbaric medicine, treatment with repeated HBO sessions prevented admission tointensive care unit with mechanical ventilation in a patient aged 69 who presented withsigns of respiratory decompensation. HBOT is the most powerful oxygenation modality inthe body today. HBOT can dramatically increase the amount of dissolved oxygen in theblood. HBOT not only promotes blood transport but also its tissue delivery. Furthermore,HBOT has specific immunomodulatory properties, both humoral and cellular, making itpossible, for example, to reduce the intensity of the inflammatory response and tostimulate antioxidant defenses by repeating sessions. A virucidal capacity of HBOT mightalso be involved. HBOT is generally regarded as safe with very few adverse events.Following this feedback, it is proposed in the context of crisis management related toSARS-CoV2 to assess the value of HBO treatment of patients with CoV2 pneumonia. Indeed,it seems essential to propose therapeutic strategies to limit the risk of respiratorydecompensation requiring admission to intensive care unit for patients with SARS-CoV2pneumonia.

A novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) disease (COVID-19)emerged at December 2019 in Wuhan, China, and soon caused a large global outbreak. Thedelayed treatment for many chronic diseases, due to the concern of SARS-CoV-2 infection,is an increasing serious problem. Here the investigators investigate the safety ofchemotherapy for patients with gynecological malignancy in Wuhan, the center of high-riskregions of COVID-19.

Evaluate HACOR socre utility and efficacy in predicting NIV and/or CPAP failure inpatients with COVID-19 associated respiratory failure.Propose adaptations to HACOR score based on the "state of art" of COVID-19

Pakistan is a resource restraint country, it's not possible to carry out coronavirustesting at mass scale. Simple cost effective intervention against the present pandemic ishighly desirable.For patients: Identifying an antiviral gargle that could substantially reduce thecolonies of COVID-19 residing in mouth and oro-naso-pharynx is likely to reduce the viralload. Such reduction in the viral load through surface debridement could aid theeffective immune response in improving the overall symptoms of the patients.For dentists: This study is important because the nature of the dental professioninvolves aerosol production, carrying out dental work on asymptomatic patients carryingcoronavirus puts the entire dental team at a great risk of not only acquiring theinfection but also transmitting it to the others. Antiviral gargles could be used bydentist and their auxiliaries as prophylaxis.For physicians and nurses: The risk of morbidity and mortality is high among physiciansand nurses involved in the screening and management of Covid-19 patients. Globally, over215 physicians and surgeons have died while taking care of Covid-19 patients. The causeof death is attributed to high exposure of viral load. The antiviral gargles and nasallavage can decrease the fatalities among doctors and nurses.Thus, patients, physicians, nurses and dentists, all could be benefited with thisfindings of this study.

In December 2019, viral pneumonia caused by a novel beta-coronavirus (Covid-19) broke outin Wuhan, China. Some patients rapidly progressed and suffered severe acute respiratoryfailure and died, making it imperative to develop a safe and effective vaccine to treatand prevent severe Covid-19 pneumonia. Based on detailed analysis of the viral genome andsearch for potential immunogenic targets, a synthetic minigene has been engineered basedon conserved domains of the viral structural proteins and a polyprotein protease. Theinfection of Covid-19 is mediated through binding of the Spike protein to the ACEIIreceptor, and the viral replication depends on molecular mechanisms of all of these viralproteins. This trial proposes to develop and test innovative Covid-19 minigenesengineered based on multiple viral genes, using an efficient lentiviral vector system(NHP/TYF) to express viral proteins and immune modulatory genes to modify dendritic cells(DCs) and to activate T cells. In this study, the safety and efficacy of this LV vaccine(LV-SMENP) will be investigated.