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 410 of 750University Hospital, Montpellier
Our society is going through an unprecedented situation: the COVID 19 Pandemic is forcing many populations, worldwide, into confinement for their own protection. The very characteristics of this confinement and of the disease (isolation, potential severity of the illness, being psychologically unprepared for such a circumstance) have a significant impact on one's psyche, like emotional disorders -anxiety/depression-, difficulties when returning to normal life, vicarious traumas… Confinement is paradoxical in as although well-intended to protect the individual, it leads to the isolation of the individual. This paradox is destabilizing one's feelings, because when the investigators feel the need for protection and reassurance, the investigators are left alone and feel abandoned. The investigators therefore understand that this confinement framework is in essence a situation that might revive unresolved deprivation situations from the childhood. How to react in front of this upsurge in anxiety? Strategies used may include, among others, escape in the imaginary through numerical tools or others, and /or going to the actual characterized by deviant sexual behaviours. The investigators know in fact that certain moments, like anxiety, depression, boredom, psychological unrest are propicious for acting, for violent sexual offenders. The investigators therefore pay extra attention to our patients in such periods favoring these kinds of trouble. This study will enable us to understand if the confinement associated with COVID 19 has generated anxiety that lead sexual offenders or individuals with paraphilic disorders to engage into deviant fantasies or, potentially sexual activities.
Fundacion SEIMC-GESIDA
At present, no treatment has been approved for COVID-19. However, in light of the increased interest on using the anti-cytokine therapy targeting IL-6 tocilizumab in COVID-19 infected patients due to its potential benefit, the Spanish Agency for Medicine and Health Products (Agencia Española de Medicamentos y Productos Sanitarios, AEMPS) have initiated the controlled distribution of the drug. Tocilizumab is indeed proposed as a potential treatment for severe COVID-19 in Spain. Based on the positive results of tocilizumab in the treatment of COVID-19 patients and the experience of tocilizumab in inducing rapid reversal of CSS in other pathologies several clinical trials and observational studies are being conducted to assess the effectiveness and safety of tocilizumab in COVID-19 patients. Further studies with a large sample size are required to confirm the effectiveness of tocilizumab in patients with COVID-19 pneumonia. The need for the management of severe COVID-19 disease is imperative, and every effort should be made to collect relevant clinical outcomes. The aim of the present study is to evaluate the effectiveness of IV tocilizumab in treating patients with COVID-19 pneumonia who are currently hospitalized or admitted to ICU by describing improvement of respiratory function and mortality rate. This large real-world cohort therefore provides a unique opportunity to study this potential medicine during the current emergency situation, and support the findings from other ongoing clinical trials and observational studies, such as the Roche-sponsored Phase III study that is planned to start early April.
Yale University
This is a clinical trial to evaluate the efficacy of LAM-002A compared to placebo treatment in adults with a confirmed SARS-CoV-2 infection who are receiving standards supportive care in an outpatient setting.
University of Nebraska
This study will establish the safety and efficacy of using stellate ganglion blocks in patients with ARDS due to COVID-19 disease.
National University Hospital, Singapore
In December 2019, a novel coronavirus, now called COVID-19, emerged as a global health threat from Wuhan, China. Within weeks, the contagious virus spread within and between communities, causing a lower respiratory tract infection dominated by symptoms of fever, cough and sore throat. The incubation period was estimated at between 5 to 7 days, but could last as long as 14 days. Although COVID-19 causes a mostly mild and self-limiting disease, respiratory involvement has been reported in about 5% of the population, requiring supplemental oxygen and even ventilatory support to relieve hypoxia. Alveolar damage, fibrosis and consolidation have been reported in radiologic and post-mortem studies. Existing data suggest a mortality rate of COVID-19 is approximately 1-2%, higher among individuals with pre-existing comorbidities and in healthcare systems with suboptimal access to ventilatory support. Given its high transmissibility, COVID-19 has quickly spread across the globe within a short interval. By 27 April 2020, over 3 million people around the world have been diagnosed with COVID-19, and more 200,000 have succumbed to the disease. As a proportion of patients manifest mild or no symptoms, these numbers are likely an underestimate of the actual number of patients with COVID-19. More disconcertingly, patients are known to shed viruses despite mild or no symptoms, making it essential that a collective approach against COVID-19 incorporate active pharmacological treatment to prevent or mitigate virus pathogenesis prior to its potential evolution to cause respiratory distress. To date, clinical trials have focused on the treatment of hospitalised patients diagnosed with COVID-19; only few have examined the clinical benefits of pharmacological agents despite few compelling in vitro data. The relatively high transmission of COVID-19 in a closed dormitory environment of migrant workers in Singapore presents a real-life scenario where a prophylaxis treatment could reduce the impact of the disease. In Singapore, there are well grounded concerns an excess in cases could pose the possibility of strain in healthcare system and mentally drain her workers. The availability of an effective prophylaxis treatment is highly desirable to potentially reduce this burden. Data from the current study could also have implications on how future outbreaks in high-density areas should be managed, especially when residents are subjected to quarantine and isolation.
Hospital Regional de Alta Especialidad del Bajio
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection has been a world health issue during the last months, affecting mostly countries with a high metabolic risk, like Mexico. Patients with type 2 diabetes (T2D) have an increased risk of any kind of infection as well as an increased mortality risk. Hyperglycemia has been established as an important predictor of mortality in patients with T2D and SARS-CoV-2. The standard treatment of hyperglycemia in hospitalized patients has been basen on insulin schemes, but recently evidence suggest the utility of some other drugs, reducing the risk of hypoglucemia and increasing the probability of a proper metabolic control. The goal of this study is to compare the utility of dipeptidyl peptidase-4 inhibitor (DPP4i) as a combination with insulin on metabolic control and prognosis in hospitalized patients with SARS-CoV-2 and hyperglycemia.
Mereo BioPharma
The purpose of this study is to determine the safety, tolerability and pharmacokinetics (PK), and explore the mechanistic and clinical effect of alvelestat (an oral neutrophil elastase inhibitor) orally twice per day for 10 days added to standard of care in adult patients (≥18 years) with COVID-19 respiratory disease.
Gilead Sciences
The primary objective of this study is to characterize the impact of inhaled remdesivir (RDV) on severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral load in participants with early stage coronavirus disease 2019 (COVID-19).
UMC Utrecht
On March 11 2020 the World Health Organization (WHO) declared the coronavirus (SARS-CoV-2) outbreak a pandemic. Worldwide, the number of confirmed cases continues to rise, leading to significant morbidity and mortality. In the Netherlands, although the incidence is currently low due to social distancing measures, recurrence of infections is expected once measures are going to be lifted. Although individuals of any age can acquire SARS-CoV-2, adults of middle and older age are at highest risk for developing severe COVID-19 disease. Moreover, recent reports demonstrate that mortality rates rise significantly among patients 60 years and older. Therefore, strategies to prevent SARS-CoV-2 infection or to reduce its clinical consequences in vulnerable populations are urgently needed. Bacille Calmette-Guérin (BCG) vaccine not only protects against tuberculosis, but also induces protection against various respiratory infections, including those with a viral etiology. We hypothesize that BCG vaccination reduces clinically relevant respiratory tract infections requiring medical intervention, including COVID-19, in vulnerable elderly. The objective of this trial is to determine the impact of BCG vaccination on the incidence of clinically relevant respiratory infections or COVID-19 in vulnerable elderly. The trial is designed as an adaptive multi-center double-blind randomized placebo-controlled trial. The attempt is to include 5,200 to 7,000 vulnerable elderly, defined as ≥60 years of age being discharged from hospital in the last 6 weeks, or visiting a medical outpatient clinic, thrombosis care services, or chronic renal replacement departments. Patients with contraindications to BCG vaccination as stipulated in the Summary of Product Characteristics (SPC) and patients with a history of COVID-19 will be excluded. Participants will be randomized between intracutaneous administration of BCG vaccine (Danish strain 1331) or placebo (0.1ml 0.9% NaCl) in a 1:1 ratio.The trial has an adaptive primary endpoint. Based on accrual of the two endpoints, the primary endpoint will be either (a) COVID-19 or (b) clinically relevant respiratory tract infection requiring medical intervention, potentially including COVID-19 episodes. The other will be declared secondary endpoint. Other secondary endpoints include: all SARS-CoV-2 infections (including asymptomatic infections), influenza infection, acute respiratory infection (ARI; all infections regardless of medical intervention), ARI-related hospital admission, COVID-19 related hospital admission, pneumonia, mental, physical and social functioning, serious adverse events and adverse events, and death.
National Institute of Mental Health (NIMH)
Access to mental health care by essential workers and the unemployed during the COVID19 pandemic has been challenging. Usual access to mental health care is limited by social distancing, and for many now unemployed due to closures of businesses, insurance is insufficient to cover the costs of mental health care. For these individuals who are at risk for suicide (isolation, unemployment, financial crisis plus past suicide attempts, significant mental health challenges), access to care is crucial and many maybe turning to online and accessible interventions, such as mental health apps and other online resources. Indeed, organizations such as the VA have already created free access mobile applications for mental health in anticipation of this need. Using Psyberguide, the investigators will identify the top ten free apps that address mental health issues and conduct a nation-wide evaluation of these apps with participants who are essential workers and unemployed with risk for suicide. Participants will first be surveyed about which strategies they have used to manage mental health issues, what apps and online tools they have used, and what usability challenges they have faced. The investigators will then ask a random sample of participant to engage in a randomized trial of these top-rated apps for 4 weeks. Apps will be rated on usability, acceptability, feasibility and effectiveness. Results from this trial will be quickly disseminated through several avenues: (1) the UWAC website and ALACRITY Centers network; (2) through CREATIV Lab's partnership with Mental Health America; (3) through the UW Center for Suicide Prevention and Recovery (CSPAR) and partnerships with other suicide focused organizations including Forefront, the American Foundation for Suicide Prevention, that American Association of Suicidology, the Rocky Mountain MIRECC, and the Defense Suicide Prevention Office and (4) through local partnership with King County and WA state contact tracers.