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 1530 of 1839Gadjah Mada University
Virgin Coconut Oil (VCO) contains multiple compounds which have antibacterial, antiviral, and immunomodulatory properties. The role of VCO as an antivirus to treat COVID-19 requires further studies. A previous study has investigated the used of 30 ml of VCO to healthy volunteers for a month and reported no side effect. Here the investigators conduct a pilot trial to investigate the effect of VCO towards the clinical outcomes of COVID-19 patients in Indonesia.
University of Aarhus
SARS-CoV-2, one of a family of human coronaviruses, was initially identified in December 2019 in Wuhan city. This new coronavirus causes a disease that has now been named COVID-19. The virus has subsequently spread throughout the world and was declared a pandemic by the World Health Organisation on 11th March 2020. As of April 1, 2020, there are 874.081 numbers of confirmed cases with 43.290 fatalities. There is no approved therapy for COVID-19 and the current standard of care is supportive treatment. Key markers implying a fatal outcome are acute respiratory distress syndrome (ARDS)-like disease with pronounced dyspnea, hypoxia and radiological changes in the lung. Senicapoc improves oxygenation and reduces fluid retention, inflammation, and bleeding in the lungs of mice with ARDS-like disease. In cells, there is an antiviral effect of senicapoc.
Daniel Benjamin
ACTIV-1 IM is a master protocol designed to evaluate multiple investigational agents for the treatment of moderately or severely ill patients infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The research objectives are to evaluate each agent with respect to speed of recovery, mortality, illness severity, and hospital resource utilization. Each agent will be evaluated as add-on therapy to the standard of care (SoC) in use at the local clinics, including remdesivir (provided). The SoC may change during the course of the study based on other research findings. Comparisons of the agents among themselves is not a research objective. The study population corresponds to moderately and severely ill patients infected with the coronavirus disease 2019 (COVID-19) virus. Recruitment will target patients already hospitalized for treatment of COVID-19 infection as well as patients being treated for COVID-19 infection in Emergency Departments while waiting to be admitted to the hospital. Patients both in and out of the ICU are included in the study population.
Spring Research Foundation
This clinical trial evaluates the safety, efficacy, and biomarker levels of FDA-approved drug disulfiram in the treatment of adult subjects hospitalized with moderate COVID-19. Disulfiram may limit the hyperinflammatory response associated with COVID-19 and reduce the risk of progression to severe illness. Subjects will be screened and randomized to receive either daily administration of oral disulfiram or placebo for 14 days. Subjects will be followed up on Day 28.
ANNA FALANGA
Coronavirus disease-2019 (COVID-19), a viral respiratory illness caused by the severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2), has been associated with the occurrence of cardiovascular adverse events including acute myocardial injury, acute heart failure, cardiac arrhythmias, and thromboembolic disease. These complications represent an important issue in COVID-19 patients accounting for the increased morbidity and mortality of this syndrome. According to a scoping review, venous thromboembolism and stroke occurred in approximately 20% and 3% of patients, respectively, with higher frequency observed in severely ill patients admitted to intensive care units. Despite the use of pharmacological thromboprophylaxis, the thrombotic risk still remained elevated in severe COVID-19 patients, and the optimal doses and timing of anticoagulation are not yet defined. The pathogenesis of COVID-19 associated thrombosis recognizes a prominent role of endothelial damage induced by both direct viral injury and an excessive and aberrant hyper-inflammatory host immune response associated to an increase in infection-related cytokines and chemokines. The occurrence of a hypercoagulable state in COVID-19 patients associated to a profound endothelial cell activation/dysfunction can result in the pathological phenomenon of immunothrombosis. In this study, in a prospective cohort of consecutive COVID-19 hospitalized patients, an extensive characterization of the hemostatic alterations were performed, in order to: 1) clarify mechanisms underlying the coagulopathy in these patients; 2) how and to what extent the concomitant infection with SARS-CoV-2 affect this coagulopathy; and 3) identify biomarkers potentially predictive of disease outcome (i.e. any thrombotic recurrence and death).
Hamad Medical Corporation
The purpose of this study is to assess the effectiveness of a telemental health intervention on the mental health of pregnant women during the COVID-19 crisis in Qatar.
Jewish General Hospital
Social isolation is defined as the objective and/or subjective reduction of number and quality of interpersonal contacts leading to a loss of an individual's social role and stigmatization. It is a major problem in Canadian society with a high prevalence in the older population (30% in individuals aged 65 and over, representing 1.5 million individuals). Social isolation is associated with a wide range of mental and physical health problems that leads to an increase in the use of health and social services. This issue increased with the coronavirus disease (COVID-19) pandemic which attacking your society at its core. Social distancing and in particular home confinement exacerbated social isolation of frailer groups like the elderly people. In 2016, the International Federation on Ageing reported that "the main new problem facing seniors in Canada is maintaining their social contacts and activities". This highlights the need for efficient and effective interventions to improve the social inclusion of older adults experiencing social isolation. Research suggests that art-based activities carried out at museums have significant benefits for older adults experiencing social isolation, and may foster social inclusion, well-being, quality of life and mitigate frailty. Yet few studies have examined empirically the effects of museum art-based activities in older adults experiencing social isolation. In 2019, the principal investigator of this research conducted an experimental pilot study based on a pre-post intervention (i.e., 3-month cycle of weekly guided tours carried out at the Montreal Museum of Fine Arts (MMFA)), single arm, prospective and longitudinal follow-up named "Effects of Montreal Museum of Fine Arts visits and older community dwellers with a precarious state: An experimental study", which indicated the potential of museum tours to improve social inclusion, well-being, the quality of life and frailty in older community members experiencing social isolation. However, these studies were performed before the COVID-19 crisis and were in-site activities. The principal investigator hypothesizes that a 3-month cycle of virtual weekly MMFA tours may induce changes in well-being, quality of life and health condition in older community dwellers participating like the 'Beautiful Thursday' cycle, and that this activity can prevent the worsening of vulnerability and social isolation due to social distancing.
Coalition for Epidemic Preparedness Innovations
The purpose of this Phase 2a, randomized, blinded, placebo-controlled, multi-center study is to evaluate the safety, tolerability and immunogenicity of INO-4700 administered by intradermal (ID) injection followed by electroporation (EP) using the CELLECTRA™ 2000 device in healthy adult volunteers for Middle East Respiratory Syndrome Coronavirus (MERS-CoV) infection. This study is divided into 2 parts: Part 1- dose finding stage and Part 2- dose expansion stage.
National Institute of Allergy and Infectious Diseases (NIAID)
The primary objectives of this study are: - To determine the proportion of children with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) related death, rehospitalization or major complications after infection with SARS-CoV-2 and/or Multisystem Inflammatory Syndrome in Children (MIS-C), and - To determine immunologic mechanisms and immune signatures associated with disease spectrum and subsequent clinical course during the year of follow-up.
Pfizer
This is a Phase 1/2, randomized, placebo-controlled, and observer-blind study in healthy Japanese adults. The study will evaluate the safety, tolerability, and immunogenicity of the SARS-CoV-2 RNA vaccine candidate against COVID-19: - As 2 doses, separated by 21 days - At a single dose level - In adults 20 to 85 years of age