Around the world, researchers are working extremely hard to develop new treatments and interventions for COVID-19 with new clinical trials opening nearly every day. This directory provides you with information, including enrollment detail, about these trials. In some cases, researchers are able to offer expanded access (sometimes called compassionate use) to an investigational drug when a patient cannot participate in a clinical trial.
The information provided here is drawn from ClinicalTrials.gov. If you do not find a satisfactory expanded access program here, please search in our COVID Company Directory. Some companies consider expanded access requests for single patients, even if they do not show an active expanded access listing in this database. Please contact the company directly to explore the possibility of expanded access.
Emergency INDs
To learn how to apply for expanded access, please visit our Guides designed to walk healthcare providers, patients and/or caregivers through the process of applying for expanded access. Please note that given the situation with COVID-19 and the need to move as fast as possible, many physicians are requesting expanded access for emergency use. In these cases, FDA will authorize treatment by telephone and treatment can start immediately. For more details, consult FDA guidance. Emergency IND is the common route that patients are receiving convalescent plasma.
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Displaying 210 of 438Ambry Genetics
This study aims to validate the use of human saliva as a substrate for an assay to detect SARS-CoV-2 and define accuracy, analytical sensitivity and specificity of the TaqPath RT-PCR test.
Direction Centrale du Service de Santé des Armées
Study of SARS-CoV2 Virus (COVID-19) Seroprevalence Among Lyon-Bron Military Health Schools Personnel
Emerging in China in December 2019, Covid-19, whose pathogen is SARS-Cov-2, was declared a global pandemic in March 2020. The clinical presentation is highly variable, ranging from asymptomatic forms to acute respiratory distress and even death. Transmission is by droplet route, with an R0 of approximately 3. Rapidly, population protection measures were put in place by governments, including the confinement of all persons whose functions were not considered essential and the closure of educational institutions. Health care institutions are places at risk of Covid-19 transmission and hospital staff are particularly exposed, either through direct contact with patients, contact with exposed persons or through the environment. In order to protect personnel, hygiene measures were immediately recalled and reinforced. During the period of containment, the majority of students from the Lyon-Bron Military Medical Schools were sent as reinforcement in Army Training Hospitals and in the Military Reanimation Unit (Mulhouse). Some students developed symptomatic forms of SARS-Cov-2 infection, documented by positive PCR, during Operation Resilience or on their return from the mission. The Lyon-Bron Military Medical Schools staff, exposed both to the initial phase of the epidemic and to national protection measures, represent an extremely interesting population for understanding the epidemiological dynamics of the virus.
Instituto Nacional de Enfermedades Respiratorias
Severe pneumoniae related to Coronavirus Disease (COVID-19), had a high in-hospital mortality; this condition are worst in subjects with acute kidney disease (AKI); conditioning increased mortality, days of assisted mechanical ventilation (AMV), increased nosocomial infections and high costs. We need many studies for determinated the risk factors for AKI in subjects with COVID-19. This study pretends identify the incidence of AKI in subjects with severe pneumoniae by COVID-19, describe the role of some biomarkers in the physiopathology of AKI-COVID-19; and determine the evolution of urinary biomarkers during hospitalization, like neutrophil gelatinase-associated lipocalin (NGAL), tissue inhibitor of metalloproteinases-2 (TIMP-2), insulin-like growth factor binding protein-7 (IGFBP7), and interleukin-6 (IL-6) and the progression of viruria of Severe Acute Respiratory Syndrome (SARS) related to CoronaVirus 2 (CoV2) in subjects with or without AKI.
Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida
Evaluating the rate of exposure to the virus in the close contact population who shared the home of a person infected with SARS-CoV-2 at the time of infection of the index case - adults or children - is a major factor in assessing the spread. virus in the family environment, assess the factors of circulation and determine whether immunity has been acquired. Screening for specific antibodies to SARS-CoV-2 will determine the exposure and protection acquired against this virus. Knowing the intra-family secondary transmission rate is essential for supporting the strategies for lifting the confinement envisaged and implementing a personalized approach. As of March 8, a platform for the home management of COVID + patients was set up when they, pauci or moderately symptomatic, do not require hospitalization. As of May 6, 2020, 881 patients have been registered in COVID and followed, constituting the active COVIDOM / PSL file. Of the 512 patients included between March 1 and 31, 45% have a household consisting of 3 people. All patients had weekly clinical follow-up by telephone for the duration of the disease with a maximum of 4 weeks having been achieved. If the recommendations of barrier gestures, isolation in an apartment were made during the symptomatic phase, the absence of masks available to all did not allow, in practice, to achieve the isolation and quarantine recommended ideally. to break the transmission of the virus. The FAMI-CoV study proposes to assess the rate of exposure to the virus in contacts sharing the same focus of index cases. A sub-study will assess the proportion of antibodies that have been neutralizing.
University of Oxford
The C-MORE study is prospective observational holistic longitudinal study which will characterise the prevalence of multi-organ injury among COVID-19 survivors post hospital discharge and assess its effects on quality of life, exercise tolerance and mental health.
Centre Leon Berard
Evaluation of the ddPCR ability to detect the SARS-CoV-2 in nasopharyngeal samples of symptomatic patients with suspected COVID-19 infection using an IgG serological assay (EUROIMMUN Anti-SARS-Cov2 ELISA Ig) as gold/reference standard (FDA validated commercial serologic test).
Owlstone Ltd
The primary aim of this study is to investigate the performance of Breath Biopsy RD for the detection of SARS-CoV-2 in both a clinical and at home setting.
Luigi Sacco University Hospital
In recent months, a new coronavirus, SARS-CoV-2, has been identified as the cause of a serious lung infection named COVID-19 by the World Health Organization. This virus has spread rapidly among the nations of the world and it is the cause of a pandemic and a global health emergency. There is still very little scientific evidence on the virus, however epidemiological data suggest that one of the most frequent comorbidities is diabetes, along with hypertension and heart disease. There is no scientific evidence on the possible effects of this infection on the function of the β cell and on glycemic control. Clinical evidence seems to suggest that COVID-19 infection mostly affects the respiratory system, and an acute worsening of glycemic compensation is not described as generally observed in bacterial pneumonia. However, previous work on acute respiratory syndromes (SARS) caused by similar coronaviruses, had described that the infection has multi-organ involvement related to the expression of the SARS coronavirus receptor, the angiotensin 2 converting enzyme, in different organs, especially at the level of endocrine pancreatic tissue. In the population of this previous work, glucose intolerance and fasting hyperglycaemia have been described and in 37 of 39 diabetic patients examined, a remission of diabetes was observed three years after the infection. It is possible that the coronaviruses responsible for SARS may enter the pancreatic islets using the angiotensin 2 converting enzyme receptor, expressed at the level of the endocrine pancreas, thus causing diabetes. Additionally, previous literature on coronavirus infections (SARS and MERS or Middle-East Respiratory Syndrome) suggested that diabetes could worsen the evolution of the disease. In particular, in case of Middle-East Respiratory Syndrome-CoV infection, diabetic mice had a more prolonged serious illness and a delay in recovery regardless of the viremic titer. This could probably be due to a dysregulation of the immune response, which results in more serious and prolonged lung disease. There are currently no data on pancreatic beta cell function in patients with COVID-19.
Hanane EL KENZ
When the COVID-19 virus infects a person, it enters the lung epithelial cells of its host and uses its genetic material to replicate. The pulmonary epithelial cells of a part of the population, known as "secretors", are capable of expressing the antigens of the "ABO" system on their surface. This secretory status can be established by determining the antigens of the Lewis blood group system. When the virus replicates in an "secreting" individual, the antigens of the "ABO" system of the infected individual will be present on the surface of the viruses formed in his/her lungs. It was shown in 2003 that the response of a given individual to the transmission of a virus depends on his/her blood group and on the antigens of the "ABO" system carried by the virus. A patient of group "O" would thus defend himself much better against a virus carrying antigens of blood group "A", the natural antibodies "anti-A" of the patient reducing the ability of the virus to bind to its specific receptor on pulmonary epithelial cells, to penetrate them to replicate itself. The first data collected in Wuhan (China) seems to confirm this hypothesis. A COVID-19 virus transmission model can therefore be established on the basis of blood groups. In order to reduce the spread of the virus among nursing staff, it is possible to establish a preferential algorithm for patient management based on the "ABO" and "Lewis" blood groups of patients and "ABO" of nursing staff in health care units, if operational and human conditions allow.
GCS Ramsay Santé pour l'Enseignement et la Recherche
The objective of this study is to look for the presence of SARS-CoV-2 in the semen of patients diagnosed with COVID+ based on RT-PCR analysis of nasopharyngeal swabs.