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 150 of 168Neurognos
The current coronavirus disease pandemic has posed a problem and a challenge for health systems globally. In the framework of a pandemic, a diagnosis is a key tool in containing and monitoring disease outbreaks. In this pandemic, the qPCR technique has become vitally important in virus detection, due to its wide detection and quantification range, and the high levels of sensitivity and specificity it presents. The methodology for diagnosing coronavirus by qPCR requires the prior extraction of viral genetic material, which is carried out using commercial kits created for this purpose. Currently, the high demand for supplies to carry out this technique has generated reagent shortage problems, including commercial kits for the extraction of viral genetic material. This research aims to evaluate a solution called AAA-Safe and its method, developed to optimize the diagnostic process, eliminating and replacing the viral RNA extraction stage. We hope that this alternative can be implemented in any molecular diagnostic laboratory, in order to speed up the delivery of a fast and safe diagnosis.
Johns Hopkins Aramco Healthcare
Healthcare workers play a critical role in fighting the pandemic, not only by managing the patients' health clinically, but also by implementing adequate measures for infection prevention and control in healthcare facilities. This puts healthcare workers at a greater risk of acquiring the disease. COVID-19 is caused by Severe Acute Respiratory Syndrome Coronavirus -2 (SARS-CoV-2) and many people can be infected with it asymptomatically and undetectably. Serology is an antibody test that provides additional information to polymerase chain-reaction (PCR) testing as it is the only way to reliably establish the fraction of the population that was infected . Seroconversion is the development of antibodies in the blood which can confirm suspected cases after the fact and reveal who was infected but asymptomatic and never realized it. Antibodies are specific proteins created as the body's response to the infection and this test is essential for detecting infected individuals with few or no symptoms at all.
Assiut University
Severe acute respiratory syndrome coronavirus 2 (COVID-19) poses substantial challenges for health care systems. With a vastly expanding amount of publications on COVID-19, clinicians need evidence synthesis to produce guidance for handling patients with COVID-19.
Assiut University
Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which first appeared in China, in December 2019 and is now spreading worldwide and poses a great threat to public health. In 12th July 2020, the total number of cases worldwide was about 13 million cases with case fatality rate of 4.4% and in Egypt the total cases was 81158 and case fatality rate was 4.6%. (1,2). In recent years, novel coronaviruses emerge periodically in different areas around the world. Severe acute respiratory syndrome coronavirus (SARS-CoV) occurred in 2002, which reportedly infected 8422 people with about 10% case fatality rate (3). Middle East respiratory syndrome coronavirus (MERS-CoV) was first identified in 2012 in Saudi Arabia, bringing a total of 1401 MERS-CoV infections, and about 35% case fatality rate (1). All the infection cases and recent epidemics show that coronaviruses impose a continuous threat to human beings and the economy as they emerge unexpectedly, spread easily, and lead to catastrophic consequences. As the number of recovered patients with COVID-19 continues to be increasing, the strength and duration of immunity after infection is an important point to be studied. Moreover, understanding this issue is a critical point for controlling this epidemic as they are the key for herd immunity and for informing decisions on how and when to ease physical distancing restrictions and to be ready for other waves of the infection. There is currently no evidence if the people who have recovered from COVID-19 have antibodies and protected from a second attack of infection or future wave of this pandemic or not. Therefore, we will carry out a longitudinal study of immunity in recovered patients to assess SARS-Cov2 patients' risk for future reinfection.
Kanuni Sultan Suleyman Training and Research Hospital
COVID-19 infected pregnant women is thought to have variable degrees of inflammatory response against the disease. Investigators of present study, suggested that fetuses are affected from the possible fetal inflammatory syndrome in case of maternal COVID-19. Therefore the aim of his study is to evaluate that if the cardiothymic index is affected by the maternal COVID-19 and to demonstrate any possible association of this measurement with neonatal morbidities.
Children's Hospital Medical Center, Cincinnati
As the global and pandemic spread of the novel coronavirus (SARS-CoV-2, COVID-19) continues, many knowledge gaps remain with regard to the epidemiology and transmission of infection, as well as the normal immunological responses after viral exposure. Cincinnati had its first confirmed case of COVID-19 on March 14, 2020, and despite extensive shelter-in-place and social distancing efforts, community spread continues at over 150-200 new cases per week. As new residents and fellows arrive in July 2020 to Cincinnati Children's Hospital Medical Center (CCHMC), many of whom come from metropolitan areas across the country, it is imperative that investigators determine the current prevalence of infection, measure the cumulative incidence of infection over the next 12-24 months, investigate the normal antibody patterns after infection, and help elucidate what constitutes a protective immunological response. The investigators have a unique but time-limited opportunity to optimally track the epidemiology and natural history of SARS-CoV-2 infection among trainees at CCHMC, including risk factors for transmission and immunological recovery. SCREEN will investigate epidemiological and immunological features of SARS-CoV-2 virus infection within the cohort of CCHMC residents and fellows who have patient contact. By collecting and analyzing weekly serial samples for SARS-CoV-2 (nasal swab for virus by PCR) and monthly serological exposure (serum antibodies by ELISA), the investigators will determine the prevalence and cumulative incidence of infection by SARS-CoV-2; the investigators will also document the antibody responses over time and identify cases of apparent viral recrudescence or re-infection.
University of Sao Paulo General Hospital
Infection with covid-19 is associated with respiratory failure, which when related to other etiologies can lead to reduced quality of life, physical, cognitive and mental dysfunction. There is no knowledge of the possible consequences of severe covid-19 infection. Our objective is to describe these repercussions, identifying risk factors and assessing the impact of physical training. At least 100 patients over 18 years of age who survive severe Covid-19 infection will be evaluated. Assessments after 1, 4, 6 and 12 months after hospital discharge. Quality of life, dyspnea, activity of daily living, muscle strength, mental and cognitive dysfunction will be evaluated, as well as pulmonary function test, cardiopulmonary stress test and chest tomography. Return to work, thromboembolic events and mortality up to 12 months will also be monitored. Hospitalization data will be used to identify factors related to quality of life, fatigue and respiratory dysfunction. Predefined risk factors will be evaluated: age, sex, smoking, previous comorbidities index, previous clinical frailty, serum C-reactive protein and leukocyte / lymphocyte ratio in the first 24 hours of hospitalization, time between onset of symptoms and hospitalization, ICU and mechanical ventilation, time on mechanical ventilation, compliance corrected by the ideal weight at the start of mechanical ventilation, driving pressure, tidal volume corrected by the ideal weight and PEEP (positive end expiratory pressure) after 24 hours of intubation in controlled ventilation, tidal volume corrected by the ideal weight after 24 hours of spontaneous ventilation, inspiratory muscle training and pulmonary rehabilitation after hospital discharge.
Ensemble Group Holdings, LLC
This study investigates the diagnostic performance of an AI algorithm in the detection of COVID-19 pneumonia on chest radiographs.
Centre Hospitalier Sud Essonne
The aim of this study is to evaluate the prevalence of COVID-19 among the workers of our hospital and the factors that are likely to influence this prevalence. It must be underlined that our hospital is settled in two towns and both hospital sites had different missions regarding the admissions of COVID-19-infected patients.
Klinikum Bayreuth GmbH
Recently published studies could demonstrate that detection of specific biomarkers in breath could be applied for the diagnosis of SARS-CoV-2.