COVID-19 Clinical Trials and Expanded Access

In the context of the COVID19 pandemic and containment, chest CT is currently frequently performed on admission, looking for suggestive signs and basic abnormalities of COVID19 compatible viral pneumonitis pending confirmation of identification of viral RNA by reverse-transcription polymerase chain reaction(PCR), with a reported sensitivity of 56-88% in the first few days, slightly higher than PCR (60%) (1). Nevertheless, currently established radiological abnormalities are not specific for COVID19 and the specificity of the chest CT is ~25% when PCR is used as a reference (1). Deconfinement and its consequences will complicate the triage of COVID patients and the role of the scanner, with the expected impact of a decrease in the prevalence of infection in the emergency department and an increase in the number of "all-round" patients, including patients with non-COVID viral infiltrates or pneumopathies. In addition, there are currently no imaging criteria to complement the clinical and biological data that can predict the progression of lung disease from the initial data.

A multicenter randomized clinical trial aiming to assess the efficacy of hydroxychloroquine associated to Zinc compared to hydroxychloroquine, in the prevention of Military Health Professionals Exposed to SARS CoV2 in Tunisia

The investigators are conducting a national COVID-19 prevalence survey on a sample of 3,000 inhabitants that were randomly selected from the Slovenian population. The sample is representative in age, gender, and geographical distribution. The main objective is to assess how many people in Slovenia have COVID-19 in April/May 2020 and how many were infected with SARS-CoV-2 previously. The investigators are using a direct detection of SARS-CoV-2 RNA in nasopharyngeal samples with validated two-target PCR-based commercial assay. For a serological response to the etiological agent, IgG and IgA anti-SARS-CoV-2 antibodies are measured in plasma samples using a validated commercial assay.

The Coronavirus disease 2019 (COVID-19) is causing a global pandemic with high morbidity and mortality among adults and mainly the elderly. Children seem to be little or not affected by this infection. It is estimated that children could be asymptomatic or pauci-symptomatic carriers and thus be vectors of the disease. This is why measures to close schools and confine populations have been decreed in a large number of countries, including France. However, there are only a few data on the prevalence of COVID19 disease in children. The deconfinement strategy depends on data on the prevalence of the disease, especially in children. Investigators propose to evaluate the incidence of Covid-19 in preschool and elementary schools children in the city of Nice (South of France) during the pandemic period using a local prospective study of 914 children

The present study aims to assess the determinants of health-related quality of life and long-term outcomes among survivors of hospitalization for Covid-19 in Brazil. The investigators will conduct a multicenter prospective cohort study nested in randomized clinical trials (coalition Covid-19 Brazil initiative) originally designed to assess the effects of specific Covid-19 treatments. Adult survivors of hospitalization due to proven or suspected SARS-CoV-2 infection will be followed up for a period of one year by means of structured telephone interviews. The primary outcome is one-year health-related quality of life assessed by the EQ-5D-3L. Secondary outcomes include all-cause mortality, rehospitalizations, return to work or study, physical functional status assessed by the Lawton & Brody Instrumental Activities of Daily Living Scale, dyspnea assessed by the modified medical research council dyspnea scale, need of long-term ventilatory support, symptoms of anxiety and depression assessed by the Hospital Anxiety and Depression Scale, and symptoms of posttraumatic stress disorder assessed by the Impact of Event Scale-revised.

Acute respiratory distress syndrome (ARDS) is a syndromic definition of an acute lung injury with alteration of biomechanics (lower respiratory system compliance) mostly associated with increased lesional edema. Increase in Pulmonary Vascular Permeability Index (PVPI) accompanied with accumulation of excess Extravascular Lung Water (EVLW) is the hallmark of ARDS. In routine clinical practice, the investigators measure the EVLW and PVPI in ARDS patients, as suggested by expert's recommendations, using a transpulmonary thermodilution (TPTD) technique. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a newly recognized illness that has spread rapidly throughout Wuhan (Hubei province) to other provinces in China and around the world. Most critically ill patients with SARS-CoV-2 will present the criteria for the definition of ARDS. However, many of these patients have a particular form of ARDS with severe hypoxemia often associated with near normal respiratory system compliance. This combination is almost never seen in severe ARDS. Thus other mechanisms (including probably vascular mechanisms), that are still poorly described, have to be involved in SARS-CoV-2. EVLW and PVPI have never been assessed in SARS-CoV-2 mechanically ventilated patients. The aim of this study is to evaluate these two parameters in order to best characterize and understand the mechanisms related to SARS-CoV-2. Based on observation of several cases in intensive care units (ICU), the investigators hypothesize that there are following different SARS-CoV-2 patterns: 1. Nearly normal compliance, low lung recruitability, normal EVLW and low PVPI. 2. Low compliance due to increased edema, high lung recruitability, high EVLW and high PVPI.

OSCAR (Otilimab in Severe COVID-19 Related Disease) is a multi-center, double-blind, randomized, placebo-controlled trial to assess the efficacy and safety of otilimab for the treatment of severe pulmonary COVID-19 related disease. The study is being conducted in 2 parts (Part 1 and Part 2). Otilimab is a human monoclonal anti-granulocyte macrophage colony stimulating factor (GM-CSF) antibody that has not previously been tested in participants with severe pulmonary COVID-19 related disease in Part 1. The aim of this study is to evaluate the benefit-risk of a single infusion of otilimab in the treatment of hospitalized participants with severe COVID-19 related pulmonary disease with new onset hypoxia requiring significant oxygen support or requiring early invasive mechanical ventilation (less than or equal to [

To evaluate the safety, toxicity and immunological effects of infusion of allogeneic bone marrow-derived human mesenchymal stem (stromal) cells (MSCs) and whether this therapy has an influence on the resolution processes in ARDS patients infected with Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

The objective of this investigation is to determine the incidence of the use of the low flow nasal cannula in suspected or confirmed cases with Covid-19

. Coronavirus (SARS-CoV2) appeared first in China late 2019 and caused an acute respiratory disease referred to as Coronavirus disease 2019 (COVID-19). SARS-CoV2 is considered by the World Health Organization (WHO) as pandemic and affected nations worldwide, leading to close borders and major economical struggle. The ongoing viral threat due to the lack of effective therapies and vaccination might prolonged this economical challenge and many businesses will face huge financial constraints leading to laying off labors, an increase in the unemployment rate, and major companies' bankruptcies. However, returning to normal business operations should be done with a safety focus and not be at the cost of global health and wellbeing. Immunity against COVID-19 is going to be a major determinant for a future safe work environment and will reduce the viral infection risk. Therefore, PI is suggesting that if an employee has antibodies against SARS-CoV-2 confirmed by serological testing, he or she could go back to work safely with taking the necessary precautions.