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 80 of 1415Centre Hospitalier Universitaire de Nīmes
Increased D-dimers at admission of COVID-19 infected patients entering hospital due to a severe disease is a risk factor for death. Understanding this acquired coagulopathy is a prerequisite before specific interventional studies. The study investigators aim to apply a normalized and automated thrombin generation test (TGT), developed for testing the thrombotic risk (triggered by 5 pM Tissue Factor, with a purified thrombomodulin (TM) challenge) and to study its association with survival.
Centre Hospitalier Intercommunal Villeneuve St Georges
This is a prospective multicenter cohort study. The question arises as to whether treatment with protease inhibitors (PIs) could have a preventive role for COVID-19 infection, especially since patients living with HIV (PLWHIV) have not been described as more at risk of developing COVID-19 infection. The aim of our study will therefore be to assess the impact of long-term protease inhibitors in PLWHIV on the incidence of COVID-19.
Medical Scientific Fund of the Mayor of Vienna
Inflammation and abnormalities in laboratory coagulation tests are inseparably tied. For example, coagulation abnormalities are nearly universal in septic patients. Coagulation disorders have also been reported in many patients with severe courses of Coronavirus disease 2019 (Covid-19). But it is difficult to assess these changes. Global coagulation tests have been shown to incorrectly assess in vivo coagulation in patients admitted to intensive care units. But other tests are available. Thrombin generation assay (TGA) is a laboratory test which allows the assessment of an individual's potential to generate thrombin. But also in conventional TGA the protein C system is hardly activated because of the absence of endothelial cells (containing natural thrombomodulin) in the plasma sample. Therefore the investigators add recombinant human thrombomodulin to a conventional TGA. Thereby the investigators hope to be able to depict in vivo coagulation more closely than global coagulation tests do.
Centre Hospitalier Universitaire de Nice
Study of the cellular immune response during the SARS-CoV-2 infection and identify cytokinic profiles in caregivers exposed to the virus with asymptomatic forms of COVID19, patients with an asymptomatic form followed in ambulatory care and patients hospitalized in the infectious disease department or in resuscitation at the CHU de Nice COVID-19 according to their clinical symptomatology and the kinetics of clinical aggravation using functional tests evaluating the Th1 type immune response. The project is divided into a clinical component comprising the study of the immune response in different populations and a cellular component focusing on the in vitro study of different immunomodulating treatments on their ability to induce an anti-viral Th1
Paracelsus Medical University
Context: On March 11, the World Health Organization (WHO) announced the current corona virus disease 2019 (COVID-19) outbreak as a pandemic. The first laboratory-confirmed case of COVID-19 in Austria was announced on February 27, 2020. Since then, the incidence of infection follows a gradual increase. Measurements taken by the Austrian government include travel restrictions, closing of national borders, social distancing, a mandatory use of facemasks in public, and closing of stores and restaurants. The underlying aim of those imposed restrictions is to contain the viral transmission and to slow spreading of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Objectives: The aims of this study are to determine i) how many employees in Austrian trauma hospitals and rehabilitation facilities have virus specific IgG and IgM antibodies against SARS-CoV-2, ii) how many are active virus carriers (symptomatic and asymptomatic), iii) how many employees are in their incubation period during the study period, and iv) to calculate the SARS-CoV-2 prevalence together with a specific occupation associated infection risk within the different specifications of health care workers. Study Design: Open uncontrolled observational cross-sectional study. Setting/Participants: A total of 4000 employees in 11 Austrian trauma hospitals and rehabilitation facilities of the Austrian Social Insurance for Occupational Risks (AUVA) will be invited to participate in the study. Study Interventions and Measures: An antibody test for SARS-CoV-2 specific IgG and IgM antibodies, and a RT-PCR test based on oropharyngeal swab samples, as well as laboratory-based antibody tests using ELISA, will be implemented to ensure protection and preservation of health in hospital staff and are not part of the study. The tests will be conducted twice, with approximately two weeks in between testing. The results of the tests will be used for statistical analysis in this study together with a questionnaire including questions related to personal health, traveling activities, living situation, as well as inquiries of symptoms and comorbidities.
Eurobio Scientific
Rationale : The emergence of the novel, pathogenic SARS-coronavirus 2 (SARS-CoV-2) threatens public health. To date, there are no effective drug option to prevent the infection, nor therapeutics for controlling the deadly COVID-19. However, the majority of patients infected with SARS-Cov-2 eliminate the virus by mounting a protective antiviral immune response, associated in particular with the production of neutralizing antibodies. Neutralizing antibodies could be of particular interest for therapeutic purposes, but also for preventive applications, to protect people who have never been in contact with the virus, or immunocompromised patients. The objectives of this study are : - To generate human monoclonal antibodies neutralizing SARS-Cov-2 from immortalized B cells of convalescent patients. - To compare the serological profiles between convalescent patients that develop mild or uncomplicated illness and convalescent patients that develop a more severe disease, that required hospitalization and oxygen support. - To compare for each patient the neutralizing efficiency of plasma to the neutralizing capacities of the monoclonal antibodies generated with immortalized B cells.
Froedtert Hospital
This is a Phase II study. This research study is being conducted to use convalescent donor plasma in seriously ill patients who have COVID-19.
Assistance Publique - Hôpitaux de Paris
The purpose of this study is to provide data on the proportion of seroconverted children and their immune status. It will also provide insight into the number of children currently infected at each time point including healthy carriers. Investigators will provide similar data on their parents in an ancillary study.
Stanford University
The overarching goal of this project is to confirm or refute the role of passive immunization as a safe and efficacious therapy in preventing the progression from mild to severe/critical COVID-19 illness and to understand the immunologic kinetics of anti-SARS-CoV-2 antibodies after passive immunization.The primary objective is to determine the efficacy and safety of a single dose of convalescent plasma (CP) for preventing the progression from mild to severe COVID-19 illness. The secondary objective is to characterize the immunologic response to CP administration. This study will enroll adults presenting to the emergency department (ED) with mild, symptomatic, laboratory-confirmed COVID-19 illness, who are at high risk for progression to severe/critical illness, but who are clinically stable for outpatient management at randomization.
Centre Hospitalier Universitaire de Nīmes
Loss of sense of smell and taste has been anecdotally reported during the covid-19 epidemic. The study investigators wanted to describe the prevalence of olfactory and gustatory dysfunction and assess the factors associated with positive SARS-CoV-2 infection.