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 40 of 63Dr. Alexander Supady
In December 2019 in the city of Wuhan in China, a series of patients with unclear pneumonia was noticed, some of whom have died of it. In virological analyses of samples from the patients' deep respiratory tract, a novel coronavirus was isolated (SARS-CoV-2). The disease spread rapidly in the city of Wuhan at the beginning of 2020 and soon beyond in China and, in the coming weeks, around the world. Initial studies described numerous severe courses, particularly those associated with increased patient age and previous cardiovascular, metabolic and respiratory diseases. A small number of the particularly severely ill patients required not only highly invasive ventilation therapy but also extracorporeal membrane oxygenation (vv-ECMO) to supply the patient's blood with sufficient oxygen. Even under maximum intensive care treatment, a very high mortality rate of approximately 80-100% was observed in this patient group. In addition, high levels of interleukin-6 (IL-6) could be detected in the blood of these severely ill patients, which in turn were associated with poor outcome. From experience in the therapy of severely ill patients with severe infections and respiratory failure, we know that treatment with a CytoSorb® adsorber can lead to a reduction of the circulating pro- and anti-inflammatory cytokines and thus improve the course of the disease and the outcome of the patients. The aim of the study is to investigate the influence of extracorporeal cytokine adsorption on interleukin-6-levels and time to successful ECMO explantation under controlled conditions in patients with particularly severe COVID-19 disease requiring extracorporeal membrane oxygenation.
Washington University School of Medicine
This is a small scale pilot study to evaluate if core warming improves respiratory physiology of mechanically ventilated patients with COVID-19, allowing earlier weaning from ventilation, and greater overall survival. This prospective, randomized study will include 20 patients diagnosed with COVID-19, and undergoing mechanical ventilation for the treatment of respiratory failure. Patients will be randomized in a 1:1 fashion with 10 patients (Group A) randomized to undergo core warming, and the other 10 patients (Group B) serving as the control group who will not have the ensoETM device used. Patients randomized to Group A will have core warming initiated in the ICU or other clinical environment in which they are being treated after enrollment and provision of informed consent from appropriate surrogate or legally authorized representative.
Nordsjaellands Hospital
Prone position ventilation is frequently used in the ICU to treat severe hypoxemia in patients with COVID-19 associated acute respiratory distress syndrome (ARDS). The aim of the PROVENT-COVID study is to assess whether applying prone position ventilation immediately after intubation reduces the duration of mechanical ventilation compared to prone position ventilation according to standard criteria for prone position.
University of Alabama at Birmingham
This is a pilot study designed to demonstrate the feasibility of conducting a larger study of standard plasma therapy in COVID-19 patients.
West China Hospital
This is a phase Ⅱb, single-center, randomized, double-blind, placebo-controlled study, to evaluate the immunogenicity and safety of the recombinant COVID-19 vaccine (Sf9 cells) in the subjects from healthy adults and elderly adults aged 18 years and above (aged 18-59 and 60-85 years) with immunization procedures 0, 21, 42 days and doses 40μg.
University of Massachusetts, Worcester
The objective of this study is to better understand public attitudes towards coronavirus disease 2019 (COVID-19) vaccination. This understanding will inform the development of community engagement strategies to be used in future interventions and studies aimed at addressing factors that impact the disproportionate burden of COVID-19 in under-served and vulnerable communities.
Sinovac Research and Development Co., Ltd.
This study is a randomized and controlled phase Ⅳ clinical trial of the COVID-19 vaccine (Vero cell), Inactivated manufactured by Sinovac Research & Development Co., Ltd. The purpose of this study is to evaluate the immunogenicity and safety of COVID-19 vaccine (Vero cell), Inactivated co-administration with EV71 vaccine
Charles Drew University of Medicine and Science
African Americans (AA)/People of Color (POC) are disproportionately impacted by COVID-19 to an extent not observed in other racial/ethnic subgroups. People of color are uniquely affected because keeping diabetes under control - the best defense against COVID-19 - has become more difficult as the pandemic has disrupted medical care, exercise and healthy eating routines which are already well-known challenges for the African American community. Diabetes Self-Management Education and Support (DSMS/S) facilitates the knowledge, skills, and ability necessary for diabetes self-care as well as activities that assist a person in implementing and sustaining the behaviors needed to manage their condition on an ongoing basis. Now, given the implications of COVID-19 on the AA/POC diabetes community, it is imperative to enhance DSME/S with education about protection and prevention of COVID-19. To begin to solve this problem we will adapt and implement the "emPOWERed to Change" DSME/S program to provide enhanced type 2 diabetes mellitus (T2DM) education with an additional emphasis on COVID-19 protection and prevention. This study will employ Community Based Participatory Research methods and will be conducted virtually in the community setting. The proposed hypothesis, based on the Health Belief Model (HBM) and the Theory of Planned Behavior (TPB), is: African Americans (AA)/People of Color (POC) in Los Angeles County with type 2 diabetes mellitus (T2DM) randomized to participate in the "emPOWERed to Change" program (N=48) are more likely to demonstrate sustained glycemic control, increase in knowledge and skills related behaviors, and risk factors associated with T2DM and SARS-CoV-2 (COVID-19) and increased compliance with prevention, and vaccination as compared to those who are randomized to usual care (N=48) in this 12 week program. We propose a randomized control study design among 96 participants with 48 assigned to an intervention group and 48 assigned to a control group. This study will also explore the experience of the participants' appraisal of knowledge and skills acquisition for DSME/S to maintain T2DM control, reduce complications, and SARS-CoV-2 (COVID-19) prevention and protection. The ultimate goal is to design prospective larger behavioral studies (SuRe first or R21) with a multi-centered intervention with other RTRN institutions to demonstrate the applicability of this approach specifically focusing on the AA/POC community.
Diagnósticos da América S/A (DASA)
This is a Phase 2/3, randomized, multicenter, double-blind, dose-response study to evaluate the safety, immunogenicity, and efficacy of UB 612 in 2 age groups, adults 18 to 59 and ≥60 years of age with or without comorbidities.
Emanuela Keller
In neurocritical care, besides the standard intensive care monitoring, even more data are obtained from the very complex pathophysiological changes in brain disease. Medical staff for decision-making cannot integrate the huge amount of clinical data generated every second and visualized on different monitors, anymore. Lack of data integration and usability is a major reason that only few of the knowledge physicians use in this field is evidence based. Early warning systems, powered by predictive algorithms that detect critical states before they happen would allow the staff to intervene early and mitigate or even prevent such a critical state.