COVID-19 Clinical Trials and Expanded Access

This Phase 2/3 study is a multi-portion design to confirm that the chosen formulation anddosing regimen of CoVLP has an acceptable immunogenicity and safety profile.The Phase 3 portion is an event-driven, randomized, observer blinded, placebo-controlleddesign that will evaluate the efficacy and safety of the CoVLP formulation compared toplacebo.Subjects will be followed for safety and immunogenicity for a period of 12 months afterthe last vaccination.

This phase I trial evaluates the side effects and best dose of GEO-CM04S1 (previouslydesignated as COH04S1), a synthetic modified vaccinia Ankara (MVA)-based SARS-CoV-2vaccine, for the prevention of COVID-19 infection. COVID-19 infection is caused by theSARS-CoV-2 virus. SARS-CoV-2 has demonstrated the capability to spread rapidly, leadingto significant impacts on healthcare systems and causing societal disruption. GEO-CM04S1was created by placing small pieces of SARS-CoV-2 DNA (the chemical form of genes) intosynthetic MVA, which may be able to induce immunity (the ability to recognize and fightagainst an infection) to SARS-CoV-2. The purpose of the Phase 1 study is to determine thesafety and the optimal dose of the GEO-CM04S1 vaccine.The Phase 2 study is designed as a multi-center, double-blind, randomized, parallel,study to evaluate the safety profile of 2 dose levels of GEO-CM04S1 as a single boostershot to assess the immune response measured by the fold-increase in antibody againstSARS-CoV-2 Spike protein at day 28 post-injection among healthy adult volunteers.

Through SARS-CoV-2 IgG testing of PCR positive and negative cases the study will followthe COVID-19 immune response by monitoring the SARS-CoV-2 IgG antibody levels over aperiod of two years. Further, risk factors will be identified by the use of thetest-negative design including population controls, allowing comparison of participantswith positive and negative tests, and with population controls (triangulation). Specialemphasis will be on high risk groups in general and on different occupational,environmental and socio-economic groups in particular. Finally, severity of illness,deaths and the use of health care during will be assessed using national register datafrom Telemark and Agder.

To evaluate pulmonary changes and the results of a cardiopulmonary rehabilitationprotocol (CPRP) in patients after SARS-VOC-2 infection. Clinical trial type study to beconducted between 2020 and 2024 involving clinical-functional cardiopulmonary imaging andblood transcriptome profile: before CPRP (T1), 2 months after CPRP (T2) and 1 year later(T3). Expected results: a) clinical, image and transcriptome changes; b)clinical-functional improvement after CPRP.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the cause of atypicalemerging pneumonia. The clinical spectrum varies from an asymptomatic or mild illness toa serious illness with a high risk of mortality. The most severely affected patients (5%)present an acute respiratory distress syndrome (ARDS), requiring assistance withmechanical ventilation in intensive care.In 2003, persistent lung damage was observed in a third of patients in a Singaporeancohort one year after SARS-CoV infection. A Chinese study showed that 27.3% of theirSARS-CoV patients presented a decreased carbon monoxide diffusion (DLCO) and 21.5% ofpulmonary fibrosis lesions.Due to the very recent emergence of SARS-CoV-2, no data is currently available oflong-term outcome of these patients. However, recent publications including short-term CTmonitoring suggest the genesis of fibrotic pulmonary parenchymal sequelae.In view of these data, the investigators can fear the occurrence of pulmonary sequelae inpatients infected with SARS-CoV-2. It is therefore essential to evaluate the evolution ofthe respiratory status of the most severe patients who have had a stay in intensive carewith respiratory assistance.

Coronavirus-2019 disease (COVID-19) and community-acquired pneumonia are significantproblems of modern medicine. Pneumonia is the most common severe complication ofCOVID-19. But at the same time, COVID-19 is not the only cause of community-acquiredpneumonia. Moreover, pneumonia is only one of the numerous possible severe complicationsof COVID-19. Medical centers specialized for the hospital treatment of patients withsevere COVID-19 and community-acquired pneumonia were organized in different regions ofRussia during coronavirus pandemic-2020. The indications for hospitalization to one ofthese centers based in the National Medical and Surgical Center (NMSC) are: confirmed orsuspected severe COVID-19 or community-acquired pneumonia.A prospective medical registry of such patients hospitalized to NMSC, is intended toanalyze and compare their clinical and instrumental data, co-morbidity, treatment,short-term and long-term outcomes in real clinical practice.Stage 1. Hospital treatment in NMSCDuration of this stage: from the date of admission to the hospital up to the date ofdischarge from the hospital / or up to the date of death during the referencehospitalization. The date of admission to the hospital will be the date of enrollment tothe study.Evaluation of electronic health record data using the Medical Information System (MIS).Assessment of the outcomes of the hospital phase (discharge from the hospital, death) andsignificant events (acute respiratory and pulmonary failure, requiring mechanicalventilation; cardiovascular events - myocardial infarction, cerebral stroke, acute heartfailure, paroxysmal heart rhythm disturbances, bleedings, thrombosis of large vessels andthromboembolic complications). A survey of patients to clarify data on risk factors,somatic diseases, and drug therapy before hospitalization.COVID-19 was diagnosed when severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)infection was confirmed by Polymerase chain reaction (PCR). Pneumonia was confirmedaccording to computerized tomography (CT) data.Stage 2. Prospective outpatient follow-up for 24 monthsDuration of this stage: 24 months after discharge from the hospital This work will bedelivered by investigators from the National Medical Research Center for Therapy andPreventive Medicine.Evaluation of long-term outcomes and events among residents of Moscow and the MoscowRegion according to a patient survey (contact by phone for 30-60 days, 6 months, 12 and24 months after discharge from the hospital) and medical records.

The COVID-19 (coronavirus) pandemic has had a huge impact on healthcare resources andstaff in the UK. Understanding the key risk factors associated with infection amongsthealthcare workers is essential for future pandemic response plans.Currently there are scarce data relating to the infection rates and associated factorsamongst healthcare workers in the United Kingdom (UK). Studies of infection rates inhealthcare workers have largely relied on the real-time reverse transcriptase-polymerasechain reaction (RT-PCR) test to date and it appears that Healthcare workers are twice aslikely to succumb to Coronavirus infection, when compared to the general population andthose from Black and minority ethnic (BAME) backgrounds appear to be particularly atrisk.Currently there is no evidence that the presence of SARS-CoV-2 (severe acute respiratorysyndrome coronavirus 2) antibodies provides seasonal or long term immunity to futureinfection.Therefore, this study aims to understand the current level of SARS-CoV-2 antibodypositivity and try to determine the likely risk to healthcare workers in the UK toCOVID-19 infection. This study hopes to find out whether certain individualcharacteristics will have an impact on likelihood of infection susceptibility andantibody response and determine the impact of the presence of antibodies on thelikelihood of future clinical infection over a 12 month period.The study involves an initial online survey and linkage to the recent antibody test, thena further online survey in 6 and 12 months' time. The data obtained will be linked todata that the Human Resources Department (HR) holds.Participants also have the option to partake in another antibody test at 6 and 12 months'time and linked to the data collected.

The primary objective of this study is to provide expanded access of S-nitrosylationtherapy for the treatment of severe acute respiratory syndrome coronavirus (SARS-CoV2)infection.

Timing of of corticosteroids administration is very important in COVID19 cases for therecovery and decrease the mortality.

A randomized, open-label, 2 arm, pilot trial of Lambda 180 mcg administeredsubcutaneously once weekly, for up to two weeks (2 injections at most), in addition tostandard supportive care, compared to standard supportive care alone, in a population ofCOVID-19 infected patients.patients will be randomized according to 1:1 ratio to one of the 2 trial arms: Lambda 180mcg S.C + standard care (intervention arm) or standard care only (control arm).