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 50 of 585University of Pittsburgh
Since the novel coronavirus, SARS-CoV-2, was first reported in the Hubei province of China in December 2019, the US has become an epicenter for the pandemic, accounting for more than 220,000 cases and 4,800 deaths (CDC). The rapid spread of the associated disease, COVID-19, has overwhelmed healthcare systems in spite of unprecedented measures to reduce contagion. The resulting uncertainty with regard to the duration and magnitude of the pandemic and limited availability of resources and treatment have been detrimental to the mental health of frontline healthcare providers (NIH). Preserving the psychological wellbeing of these individuals is paramount to mitigating the effect of COVID-19 and delivering optimal patient care. Of particularly grave concern is how professional and personal distress caused by the COVID-19 pandemic will affect provider burnout (Lai et al. JAMA Network Open 2020). Professional burnout, characterized by emotional exhaustion, career de-prioritization, and loss of self-efficacy, represents a significant threat to the US healthcare system (Shanafelt et al. Ann Surg 2010; Han et al. Annals of Internal Medicine 2019). While burnout has been described as a reaction to chronic work-related stress (Melamed et al. Psychol. Bull. 2006), individual factors such as anxiety increase susceptibility to burnout (Sun et al. J Occup Health 2012). Although data suggests that occupational stress might amplify risk of anxiety (DiGiacomo and Adamson J Allied Health 2001), we have yet to understand how intensified anxiety among frontline providers during global health crises contributes to burnout. Similarly, it is unknown whether factors such as perceived organizational support (POS), a key driver of job satisfaction and performance (Muse and Stamper, J Managerial Issues 2007), modify anxiety and burnout under these circumstances. We hypothesize that diminished POS in response to the COVID-19 pandemic is associated with burnout and that this relationship is mediated by an increase in providers' anxiety. Delineating this relationship is a critical first step in developing interventions that ease the mental health burden of this pandemic and future crises for healthcare providers.
Guangzhou Blood Center
The fight against the spread of the 2019-nCoV epidemic has achieved some success in China, but the epidemic is far from over. A key factor making the epidemic under control in China is the government's call for social distance, which has led to few people going out for donation. As a result, the number of blood donors on the streets has been continuing to decline. Urgent recruitment of blood donors is therefore planned during the period from 30 April to 10 May via emergency recruitment SMS . This study has been designed to compare which information extraction frameworks would be more sensitive to blood donors in emergency situations.
National Institute of Allergy and Infectious Diseases (NIAID)
This surveillance study will collect detailed clinical, laboratory, and radiographic data in coordination with biologic sampling of blood and respiratory secretions and viral shedding in nasal secretions in order to identify immunophenotypic and genomic features of COVID-19 -related susceptibility and/or progression. The aim: for the results obtained from this study to assist in generating hypotheses for effective host-directed therapeutic interventions, to help to prioritize proposals for such interventions, and/or optimize timing for administration of host-response directed therapeutics.
TASK Applied Science
A novel betacoronavirus, SARS-CoV-2, is spreading rapidly throughout the world. A large epidemic in South Africa may overwhelm available hospital capacity and healthcare resources which would be worsened by absenteeism of healthcare workers and other frontline staff (HCW). Strategies to prevent morbidity and mortality of HCW are desperately needed to safeguard continuous patient care. Bacillus Calmette-Guérin (BCG) is a vaccine against tuberculosis (TB), with protective non-specific effects against other respiratory tract infections in in vitro and in vivo studies, with reported morbidity and mortality reductions as high as 70%. We hypothesize that a BCG vaccination may reduce the morbidity and mortality of healthcare workers during the COVID-19 outbreak in South Africa.
Fundació Institut Germans Trias i Pujol
It has been shown in previous important outbreaks of infectious diseases that they have a huge impact on individuals and communities. The psychological effects of the illness itself and the traumatic experiences of loved ones are experienced by individuals and complete health systems. Added to this, the social ecosystem and family finances are also severely affected. After several months of the outbreak start and several weeks of quarantine and self-isolation, the emotional burden on the community has increased. Added to this, many of the confirmed cases are healthcare workers. In addition to the risk of infection, these front-line staff are exposed to high levels of stress and anxiety. This gets worse as the pressure on the health system increases, forcing them to deal with significant ethical issues. To respond to all these issues, the research group led by Dr. Cris Vilaplana at the Germans Trias i Pujol Research Institute (IGTP), have launched a questionnaire to ask the public, including health professionals, how are they being affected by the pandemic, not only in relation to their health but in terms of their emotional wellbeing and their family finances. The project is an initiative of the SMA-TB consortium (IGTP and Anaxomics) to fight against COVID-19. The Fundació Lluita contra la SIDA is also collaborating in the project. The survey is based on questions related to depression, anxiety, stress, and post-traumatic stress disorder, which have already been used in other epidemic outbreaks and in disaster situations, but it also includes questions adapted to the current situation. The survey (now available in 4 languages) has been designed to be shared using a snowball strategy, making possible for everybody to participate and collaborate. The results obtained will initially help us to better understand the impact of the outbreak of COVID-19 on the general wellbeing of the population and health workers so that we can go on to develop strategies in coordination those in charge of administrations in order to adapt policies to people's real needs. The results of the study will be published in a scientific article and will be publicly available.
Columbia University
Stress and anxiety can have an adverse impact on health, and the experience of many around the 2020 outbreak of COVID-19 is affecting health and well-being. Individuals with chronic disease such as multiple sclerosis may be particularly vulnerable in some ways, but also particularly resilient in others. This study evaluates the effects of belonging to online support groups that meet weekly for 12 weeks to address the stress and anxiety felt by individuals with Multiple Sclerosis (MS). This study will also measure and explore the effects of online support groups.
University of Miami
The purpose of this research study is to learn more about how mindfulness training may influence thinking and feeling.
GlaxoSmithKline
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 [
Orbiteratec (funding)
Novel Coronavirus is defined to be the cause of COVID-19, recently. It's known that COVID-19 goes with excessive immune reaction of human body in severe cases. The investigators hypothesize that quercetin, as a strong scavenger and anti-inflammatory agent, can be effective on both prophylaxis and treatment of COVID-19 cases. Therefore, the aim of this study to evaluate the possible role of quercetin on prophylaxis and treatment of COVID-19.
Centre Hospitalier Universitaire, Amiens
Covid-19 (English acronym meaning coronavirus disease 2019) is an emerging infectious disease caused by a strain of coronavirus called SARS-CoV-2. The current pandemic has resulted in a significant number of admissions in the emergency room (ER) due to suspicion of COVID-19 infection. Use of lung ultrasound is standard practice to diagnose acute respiratory failure in ER. Recently, typical lung ultrasonographic characteristics of COVID-19 disease has been described. During the COVID-19 pandemic, the use of this tool could be of interest in order to allow an early, simple and reliable triage in patients with suspected COVID-19 infection admitted in ER. In addition, the visualization of early signs in specific areas could be a predictive marker of the severity of the disease. The objective of this project will be to study the association between the signs on lung ultrasound and the result of RT-PCR in patients with suspected COVID-19 infection in the ER.