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 960 of 1236National 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.
Liverpool University Hospitals NHS Foundation Trust
The aim of this study is to explore the acceptability and feasibility of a novel medical device system for autonomously monitoring of breath and heart sounds in Covid-19 (detecting and monitoring the progression of Covid-19 pneumonitis, by evaluating sounds captured through a wearable device (Senti)). As a first-in-man study, the investigators will investigate the safety of the Senti device, the usability and acceptability of the device; and ensure technical and practical feasibility of the device in a real-world clinical setting. Healthcare resources have been stretched substantially by Covid-19. Devices which enable patients to be monitored at home and direct these precious resources to those who require them are needed more than ever. 10 patients will be recruited (the study participants) in two tranches (6 and 4) who are being discharged from A&E into the community, with Covid-19. These patients will wear the Senti device. The first tranche will use the device over a single session lasting 20 minutes only. The second tranche (which will include patients from tranche one, and which will only proceed if no adverse events are detected in tranche one), participants will wear the device at their discretion (particularly encouraged to wear overnight) over the course of 5 days. The investigators will survey the study participants to answer three key questions: What is the feasibility of the Senti data-capture device? Is this device usable in clinical practice? What are the requirements to train patients to use the device? The investigators will also consider: Does the device function technically and practically, in real-world clinical scenarios? What are the key expected and unexpected safety issues related to using the device (with a particular emphasis on whether the device is likely to cause pressure sores)? These questions will establish the feasibility of using the Senti data capture device as part of a novel medical device system for the autonomous evaluation and monitoring of bioacoustic signals for Covid-19.
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
University of Bologna
The coronavirus disease 2019 (COVID-19) initially developed at the beginning of December 2019 in Whuan, Hubei province of China has spread all over the world. Beside the most common symptoms at onset of illness including fever, fatigue, dry cough, myalgia and dyspnoea, there are less common symptoms such as headache abdominal pain, diarrhoea, nausea and vomiting. The proportion of patients complaining gastrointestinal symptoms is variable between 3,4% and 17,0%. Interestingly, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) RNA has been reported to be detectable in 50% of patients' stool samples and in these patients around the 50% had diarrhoea. SARS-CoV2 transmission has been reported to be through droplets. However, mounting evidence indicates that SARS-CoV2 has a tropism for the gastrointestinal tract and is excreted with faeces. Accordingly, a faecal-oral route of transmission of the virus has been recently postulated. Indeed, SARS-CoV2 binds to host ACE 2 receptors (ACE2) to entry into cells which are abundantly expressed by intestinal epithelial cells and regulate intestinal inflammation. Taken together, this evidence could provide a rational basis for the development of gastrointestinal symptoms reported by COVID19 infected patients. Primary aim: to evaluate the prevalence and prognosis of gastrointestinal symptoms in patients admitted to hospital for COVID19 disease Secondary aims 1. to evaluate long term consequences of COVID-19 on gastrointestinal symptoms 2. to evaluate long term consequences of COVID-19 on the development of post-infection irritable bowel syndrome (PI-IBS) 3. to evaluate long term consequences of COVID-19 on the development of post-infection dyspepsia 4. to assess the clinical and laboratory predictors (risk factors) of post-infection gastrointestinal symptom development
TC Erciyes University
The objective is to determine the safety and immunogenicity of two different strengths (3 µg and 6 µg) of an inactivated COVID 19 Vaccine compared to placebo so that to demonstrate the safety and efficacy in prophylaxis of COVID-19.
National Institutes of Health Clinical Center (CC)
A retrospective cohort study will be conducted using a large administrative database of U.S. hospitals to understand the volume-outcome relationship among patients hospitalized with COVID-19.
NOWDiagnostics, Inc.
This study is designed to compare the performance of the NOWDx COVID-19 Test to an emergency use authorized PCR test result. The intent is to show the rapid test device is comparable to a currently marketed device. The NOWDx COVID-19 Test is an in vitro lateral flow immunoassay intended for qualitative detection of total antibodies to SARS-CoV-2 in human whole blood (venous and fingerstick).
Aivita Biomedical, Inc.
This is an adaptive Phase I trial of a vaccine consisting of autologous dendritic cells previously loaded ex vivo with SARS-CoV-2 spike protein, with or without GM-CSF, to prevent COVID-19 in adults.