COVID-19 Clinical Trials and Expanded Access

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.

COVID-19 is associated with acute pulmonary and cardiac injury. To better understand thedegree and severity of cardiopulmonary injury as well as short and long-term sequelae ofCOVID-19 infection, this study will perform longitudinal study in patients who had recentknown diagnosis of COVID-19.

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).

Coronavirus has caused containment of more than a third of the world's population. Somecountries have used a major screening strategy. Screening procedures, such as waiting (orresulting) for the test, can be stressful and can attract the most stressed people.However, there is currently no data on the relationship between stress and screening forSARS-CoV2

The primary objective of this study is to evaluate the effect of additional estradiolestrogen therapy on clinical response and mortality in non-severe COVID-19 patients

Currently, there is no approved treatment for COVID-19 in France, either for the acutephase, nor for the late chronic phase. the investigator suggest that nintedanib has thepotential to block the development of lung fibrosis when initiated early enough toinhibit the activation of mesenchymal cells and the progression of virus-inducedpulmonary fibrosis. Computerized Tomography (CT) manifestations of fibrosis or fibrousstripes are described in COVID-19 (Ye, Eur Radiol 2020). Pan et al observed fibrousstripes in 17% patients in the early phase of the disease (Pan, Eur Radiol 2020). Ye etal observed bronchiectasis in 2 patients (15.4%) and evidence of pulmonary fibrosis in 3patients (23.7%) at HRCT performed at 4 weeks (Ye, Eur Radiol 2020). Long term data arestill lacking in patients with COVID-19 and the investigators do not know how manypatients will have fibrotic sequelae from the acute illness.