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 1010 of 1321Rockefeller University
This is a first-in-human, open label, single dose, dose-escalation phase 1 study to evaluate the safety and pharmacokinetics of a combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein in healthy volunteers.
University of Chile
Deep sedation in patients with COVID-19 may be challenging in many aspects. The use of an EEG-based protocol to guide deep sedation may be useful in this particular population, considering their unusually high sedation requirements. In the present trial, we aim to evaluate an EEG-based protocol to guide deep sedation in patients with COVID19, using to EEG derived parameters that are displayed in the BIS monitor: Suppression Rate and Spectral Edge Frequency. The protocol is designed to both minimize the suppression rate along with maintaining a spectral edge frequency over 10 Hz. The use of this protocol may reduce the amount of sedatives administered and, therefore, diminish the time needed for the weaning process.
St. Luke's Health System, Boise, Idaho
The Mental Health Among Patients, Providers, and Staff (MHAPPS) Study is designed to study how the COVID-19 pandemic has affected mental health and wellbeing, and how to support mental health while minimizing the burden on the healthcare system. The study will enroll adults and adolescents who have had a primary care visit in the last 12 months, as well as healthcare providers and staff from a large health system in Idaho. The study will include: Aim 1: a cross sectional survey to measure the prevalence of various measures of mental distress and how they are associated with COVID-19-related factors; and Aim 2: a randomized controlled trial comparing the effectiveness of two versions of a Caring Contacts intervention to reduce loneliness and mental distress.
Medigen Vaccine Biologics Corp.
The purpose of this study is to assess the safety and immunogenicity of MVC-COV1901 vaccine compared to placebo in participants who are generally healthy or with stable pre-existing health conditions.
Izmir Bakircay University
The pathogenesis of COVID-19, which is caused by the coronavirus species, which has become a global health problem affecting the lives of billions of people worldwide and is a member of the Betacoronavirus genus, is not fully understood. Although its pathogenesis is thought to be multifactorial, it results in a systemic hyperinflammatory response and associated thromboembolic complications in severe cases. It is thought that some vitamins and nutrients may be beneficial for COVID-19 infected patients due to their anti-inflammatory and antioxidant properties. Vitamins such as A, B, C, D, E and folate; trace elements such as iron, zinc, magnesium, selenium and copper play important roles in supporting both innate and adaptive immune systems, and studies have shown that the trace elements investigated have important roles in COVID-19. For this reason, it is important to investigate the levels of trace elements. In addition, while the disease spreads all over the world, individuals are required to stay at home for a long time against the risk of contamination. Due to these isolation and limitations, physical activity levels decrease in individuals. As reductions in the level of physical activity may cause possible secondary symptoms, another parameter is to determine the physical activity level in order to prevent the potential harmful effects of these protective lifestyle regulations related to COVID-19 and to prevent the restrictions from causing physical inactivity. This study is planning to conduct between January and February 2021 in order to compare the trace element levels in blood samples and physical activity levels of patients with COVID-19 (SARS CoV-2) who applied to Izmir Bakircay University Cigli Training and Research Hospital (Cigli Regional Training Hospital) and hospitalized in the COVID-19 service. It was planned as a prospective, randomized controlled trial. Research data will be obtained from blood samples taken from participants. In addition, data on physical activity levels will be collected through a questionnaire. After analyzing the data obtained from the research with appropriate statistical methods, the data will be evaluated.
Rush University Medical Center
The proposed study will be conducted to investigate the mechanism of patients' responses to prone positioning with coronavirus disease 2019 (COVID-19) acute respiratory distress syndrome (ARDS) and non-COVID-19 ARDS utilizing lung ultrasound.
National Agency for Scientific and Technological Promotion, Argentina
The COVID-19 pandemic together with the strategies that are applied to control it are generating high morbidity and mortality worldwide. Its impact on health systems is worrisome, affecting all the population, even those who are not infected or at risk. The indirect impact of the COVID-19 pandemic on the access to the medical care of patients on the waiting list for organ transplantation might be multifactorial, including the need to relocate health-related resources (medical personnel, supplies, critical care unit beds, etc), the risk of COVID-19 transmission among donors or patients on the waiting list, and also after transplantation. Additionally, the pandemic reduces significantly the donor pool. We consider that it is important to assess the impact that the pandemic has in particular individual populations, such as in patients requiring a liver transplant. Along with the lockdown, the rate of organ donation has dropped, and liver transplant programs across the world have reduced or suspended their activity. Unfortunately, this is invariably associated with an increase in mortality on the waiting list. Knowing the impact of the pandemic on patients who require a liver transplant will provide tools to understand and plan the health resources related to the care of these patients, not only at present but also in the following years.
Hospital Israelita Albert Einstein
COVID-19, an acute respiratory disease caused by coronavirus-2 (SARS-CoV-2), and in most cases, causes mild to moderate symptoms of fever, cough and dyspnea. However, a not insignificant portion, given the total number of people affected, will present symptoms of severe acute respiratory failure and multiple organ failure, requiring hospitalization under intensive care, use of mechanical ventilation, prolonged period of immobilization and, consequently, physical, cognitive and psychological damage, which may affect survivors for a long period after hospitalization. All of these factors are known to have an impact on various areas of life: personal, social and economic, which makes the need for continued specific care after hospital discharge relevant. In this context, the role of rehabilitation programs is fundamental, aiming not only at a safer dehospitalization, but also at the continuity of care with the objective of restoring the biopsychosocial skills of these individuals, allowing functional independence for activities of daily life and a shorter return physical and social activities performed before the disease. However, the big challenge for the health system is how to offer this on a large scale. Therefore, knowing the clinical and functional profile of these patients at discharge and verifying the viability of a digital platform for rehabilitation and monitoring of these patients is the first step to allow the creation of a new form of continuity of care and access to affected patients with serious diseases such as COVID-19 and other syndromes capable of generate functional impairment. Therefore,the investigators objective is to characterize and monitor the functional profile and exercise capacity of patients affected by COVID-19 at the hospital discharge, as well as to verify the viability and compliance of patients to the use of a digital platform for the application of a distance rehabilitation program.
Azienda Ospedaliera San Gerardo di Monza
The outbreak of the SARS-CoV-2 pandemic may be considered a traumatic phenomenon. In a sample of subjects suffering from different psychiatric disorders, psychopathological status and Post-Traumatic Stress Disorder (PTSD) symptoms over time are assessed using specific psychometric scales. In a sample of healthy controls PTSD symptoms are evaluated by Impact of Event Scale Revised (IES-R) and compared to patients' scores. We hypothesize that a significant number of psychiatric outpatients have experienced a clinical psychopathological worsening and a greater prevalence of PTSD symptoms compared to the general population. The study of the potential psychopathological changes could represent a useful contribution to deepen the understanding of psychological consequences of the pandemic.
Research Institute for Biological Safety Problems
Multicenter, randomized, blind, placebo-controlled clinical study of III phases on the assessment of preventive efficiency, safety and immunogenicity QazCovid-in®-vaccine against COVID-19 in healthy adult volunteers