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 140 of 374Children's Hospital Colorado
The FDA has approved the CipherOx CRI T1 Tablet for use in subjects aged 19-36, and that this study aims to evaluate the device in subjects aged outside of this range and is being used off label. The FDA determined the Cipher OX CRI T1 Tablet to be a class II device in 2016, and additional research has been done since the FDA determination to further support the use of the device outside of its current labeling.
Alexandria University
This research is planned to illustrate the efficacy of Therapeutic Plasma Exchange (TPE) treatment in COVID-19 patients with resistant cytokine storm state.
University of California, Los Angeles
The purpose of this research is to conduct a cross-sectional survey to investigate how people's lifestyle decisions and social distancing choices are affected by the medical information they receive. The hypothesis is that a positive COVID-19 test result will lead to study participants having the greatest self-isolation intentions compared to those who are only clinically diagnosed for COVID-19 without a confirmatory diagnostic test result or those who receive a negative COVID-19 test result.
Rutgers, The State University of New Jersey
The purpose of this study is to evaluate the feasibility, acceptability and effectiveness of a brief, telehealth intervention (the Emotional Support Plan), intended to support autistic adults to cope with their negative emotions during and/or after the COVID-19 pandemic. The first objective is to develop and refine a brief telehealth-delivered treatment, the Emotional Support Plan (ESP), to help promote adults to cope during periods of acute distress, such as those experienced during the COVID-19 pandemic. The second objective is to assess the feasibility and effectiveness of the ESP to support autistic adults to implement emotion regulation strategies during periods of acute distress. The last objective is to yield preliminary data to apply for extramural grants to validate these methods to monitor and support mental health of autistic adults during key transitions (e.g., starting college).
Stony Brook University
The goal of this study is to test whether an online, self-administered SSI designed to strengthen perceived control over anxiety in the context of the COVID-19 pandemic (Contain COVID Anxiety) increases perceived control over anxiety more than a placebo, hand-washing-plan SSI (Remain COVID Free) in a weighted-probability sample of the United States (N = 500).
Karolinska Institutet
This research study is designed to investigate the effects of a remotely delivered simple cognitive task (a memory cue followed by playing the computer game "Tetris" with mental rotation instructions) on intrusive memories ("flashbacks") and other symptoms after a traumatic event(s). Hospital staff who experienced a work-related traumatic event(s) during the COVID-19 pandemic will be randomly allocated to either the simple cognitive task intervention or control. Randomization to assigned intervention occurs on Day 1, after completion of baseline measures (note: baseline measures are not used in randomization process). Baseline measures include questionnaires on Day 1 and an intrusive memory diary during the previous week (Week 0). Participants will be followed up at one week and one month, and where possible 3 and 6 months. It is predicted that participants given the simple cognitive task intervention will develop fewer intrusive memories, less severe related clinical symptoms, and will show higher functioning (e.g. at work) than those who are not. This will inform the future development of a simple technique to prevent distressing psychological symptoms after a traumatic event(s). Implementation and training aspects regarding remote recruitment and intervention delivery in a hospital context will also be explored. Participants use e.g. their smartphone for part of the intervention in the study.
University Health Network, Toronto
The vast majority of individuals with Covid19 have mild illness that can be managed in the outpatient setting. A small but significant number of these people will deteriorate and require hospitalization. Symptoms are a poor - and possibly late - indicator for deterioration. While people who have died, and/or been cared for in the ICU or hospital have been well characterized, there remains a dearth of information about the clinical course of people in the outpatient setting. Most notably, it is not known when to escalate to hospital care. The consequence of non-escalation when needed is significant patient morbidity and mortality, of escalation when not needed is unnecessarily overwhelmed hospitals. Technologies for clinical management and early diagnostics for severe Covid19 infection will address this challenge. The research goal of this study is to use real-time remote patient monitoring to detect which patients with Covid19 are at risk of deterioration to bring to hospital, while at the same ensuring the worried will receive reassurance so they stay at home. The clinical goal is to help clinicians provide excellent care using ubiquitous mobile phones.
University Hospital, Bordeaux
Although direct evidence is currently lacking, the high identity between SARS-CoV-1 and SARS-CoV-2 suggests, that the latter viral strain could also infect the Central Nervous System (CNS). Indeed, some cases of SARS-COV2 encephalitis begin to be described and CNS damages are increasingly highlighted in the literature, but still not objectified by imaging and do not allow to explain the entire clinical patterns. We hypothesise that these CNS damages are not always objectified by Magnetic Resonance Imaging (MRI) but could be indirectly observed by a physiological dysfunction of neural conduction in the brainstem. We will explore brainstem disruption through an electrophysiological approach.
Miltenyi Biomedicine GmbH
This is a prospective, epidemiological, cohort study to assess the feasibility of screening healthy asymptomatic workers for the presence of severe acute respiratory syndrome SARS-CoV-2 by pharyngeal swaps and serology at baseline, day 21 and day 40.
Dr. Alexander Supady
The prognosis of patients with severe COVID-19 disease, whose lungs are so severely diseased that they need to be supported by veno-venous ECMO (extracorporeal membrane oxygenation), is difficult to assess so far. Previously published data from studies, case reports and case series describe a very high mortality in this patient collective. The significance of established clinical prognostic cores in this patient population has not been systematically investigated. This is aggravated by the fact that even at very specialized centers only very few patients from this collective are (can be) treated, so that valid investigations are only possible in a multicenter patient collective. In this registry study, all patients diagnosed with COVID-19 and treated with vv-ECMO in the centers participating in the study should be retrospectively examined. The primary aim of the study is to investigate 30-day survival, secondary objectives include the analysis of different clinical scores at the time of ECMO implantation.