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 30 of 672Humanigen, Inc.
The primary objective of this study is to assess whether the use of lenzilumab in addition to current standard of care can alleviate the immune-mediated cytokine release syndrome (CRS) and improve ventilator-free survival in hospitalized subjects with severe or critical COVID-19 pneumonia.
Ain Shams University
Phase III Placebo-controlled adaptive multi-centre randomized controlled trial Interventional (Clinical Trial). The study will include nine hundred healthcare workers in the isolation hospitals for COVID-19 cases; they will be randomly assigned to receive either BCG vaccine or normal saline.
Università degli Studi dell'Insubria
The present Diagnostic Accuracy study aims at experimentally validating the use of a rapid salivary test to detect SARS-CoV-2 infection in both symptomatic and asymptomatic individuals as a preliminary approach to a mass screening program. The study is based on a consecutive recruitment of both patients showing symptoms probably associated with COVID-19 (i.e., cough, dyspnea, fever) and asymptomatic patients with a low risk phenotype. The expected number of recruited individuals is 100. The experimental test is a prototype of salivary test based on the Lateral Flow Immunoassay technique and is able to detect the presence of SARS-CoV-2 in saliva, especially the Spike protein (S). The comparison is represented by the nasopharyngeal swab, the gold standard of COVID-19 diagnosis. Patients will undergo both salivary immunoassay and nasopharyngeal swab, thus the outcome assessors are blinded, since the results of the rRT-PCR analysis require at least 6 hours before being available. The main outcomes are sensibility and specificity of the rapid salivary test, when compared with the gold standard (nasopharyngeal swab).
Laboratorios Clínicos de Puebla (Laboratorios Ruiz)
COVID-19 disease has become a very serious global health problem. Treatments for severe forms are urgently needed to lower mortality. Any procedure that improves these forms should be considered, especially those devoid of serious side effects.There is not enough published information on the use of allogeneic convalescent plasma (ACP) in the treatment of severe forms of COVID-19. The use of ACP can be combined with other treatments and has very few adverse effects. It takes 10-14 days for SARS-CoV2-infected patients to produce virus-neutralizing antibodies: within that time they can develop serious complications and die. Injecting PAC into patients with severe forms of COVID-19 shortens the period of risk while the patient produces the antibodies.
University of South Florida
The current available diagnostic methods used for the detection of COVID-19 takes up to 4 hours. In some cases, these diagnostics tests make take up to a couple of days. As it is highly contagious, people who are in close contact with the infected person are at high risk of being infected. COVID-19 is transmitted through respiratory droplets produced when an infected person coughs or sneezes. The desire for rapid detection of COVID-19 has become an immediate necessity. The purpose of Kaligia Biosciences' saliva monitoring device (RBA-2) is to detect the presence of the COVID-19 virus in human saliva. The RBA-2 uses Raman Spectros-copy to detect the coronavirus. Once the sample is scanned successfully, the spectra contains the response of the component present in human saliva and provide results in a matter of minutes, rather than hours or days.
Rigshospitalet, Denmark
Doctors, nurses and staff members of ear-nose and throat (ENT) departments are at high risk due to aerosol-inducing diagnostic procedures and surgery during the COVID-19 epidemic. Reports from China, Spain, Italy and England report of fatal cases among ENT specialists. With a concurrent lack of personal protection, it is of paramount importance to identify patients and healthcare workers at an early stage to prevent a COVID-19 outbreak in the department. A baseline study of all healthcare workers has been performed. Follow-up will be accomplished by interval testing, antibody measurements and REDcap Covid-19 questionnaires. All patients at risk of carrying SARS-CoV-2, or who are candidates for high-risk airway surgery will be tested. Infection control measures at the department will be implemented progressively according to the real-time surveillance results from both patients and healthcare workers.
Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
The present study will try to respond first in an initial phase, what is the minimum effective dose necessary of convalescent plasma for getting better in severly ill (not intubated) or very severely ill (intubated) patients. Once the dose will be determined by each type of patient group (severely ill vs. very severely ill) has been determined, phase 2 of the study will begin, where the safety and efficacy of the use of plasma will be evaluated based on clinical, imaging and laboratory criteria. So, our hypotheses are: 1. Is there a minimum effective dose to treat seriously ill patients with convalescent plasma with COVID-19? 2. the plasma dose with the minimum effective effect will improve the clinical, laboratory and clearance conditions of the presence of the virus in the severely ill patient?
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.
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.
The University of Hong Kong
Coronavirus Disease 2019 (COVID-19) emerged in December 2019, and in mere few months has resulted in a pandemic of viral pneumonia. Substantial proportion of patients with COVID-19 have biochemical evidence of myocardial injuries during the acute phase. Possible mechanisms including acute coronary events, cytokine storm, and COVID-19 related myocarditis, have been postulated for the cardiac involvement in COVID-19. It is uncertain whether COVID-19 survivors are at risk cardiac dysfunction including cardiac arrhythmia and heart failure. The prospective screening study aims to evaluate the possible latent effects from COVID-19 in COVID-19 survivors. COVID-19 survivors 4-6 weeks after hospital discharge will be recruited from the Infectious Disease clinic, Queen Mary Hospital with standard 12-lead electrocardiogram, serum troponin, NT-proBNP, and standard transthoracic echocardiogram. The outcome measures include (1) new onset cardiac arrhythmia, (2) N Terminal (NT)-proBNP elevation above the diagnostic range of heart failure, and (3) newly detected left ventricular dysfunction.