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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To search this directory, simply type a drug name, condition, company name, location, or other term of your choice into the search bar and click SEARCH. For broadest results, type the terms without quotation marks; to narrow your search to an exact match, put your terms in quotation marks (e.g., “acute respiratory distress syndrome” or “ARDS”). You may opt to further streamline your search by using the Status of the study and Intervention Type options. Simply click one or more of those boxes to refine your search.
Displaying 120 of 370ExThera Medical Corporation
Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) has caused a global pandemic and is associated with significant morbidity and mortality. The mortality rate for COVID-19 patients admitted to an intensive care unit (ICU) who require mechanical intubation is approximately 75%. While the pathophysiology of severe COVID-19 has yet to be fully understood, it is possible that a combination of high viral loads and an overactive dysregulated inflammatory response may contribute. Therefore, the clearance of SARS-CoV-2 virus and cytokines could provide a more opportunistic environment for the innate immune system to clear the virus and establish lasting immunity. The Seraph®-100 Microbind® Affinity Blood Filter (Seraph®-100) is an extracorporeal broad-spectrum sorbent hemoperfusion filter for removing virus and cytokines from the blood. The FDA authorized an Emergency Use Authorization (EUA) for treatment of severe COVID-19 with the Seraph®-100. As part of the EUA, this registry study will collect de-identified data to assess safety and efficacy on the use of Seraph®-100 Microbind® Affinity Blood Filter in the treatment of COVID-19 patients.
Northwell Health
The FDA has provided an emergency waiver for the use of non-invasive continuous glucose monitors (CGM) in hospitals, so frontline health care providers (in hospitals) can remotely monitor patients with diabetes thus reducing patient's discomfort, limiting exposure to COVID-19 and preserving critical personal protective equipment (PPE). The FreeStyle Libre 14-day system is a continuous glucose monitoring system consisting of a handheld reader (smart phone may be used) and a sensor applied with adhesive to back of the upper arm. In order to evaluate the reliability of the Freestyle Libre CGM for in-patient use, we propose a study which will examine the correlation between the libre CGM data and capillary blood glucose test - the current standard of care taken by the Accuchek Inform II platform.
University of Texas at Austin
The primary aim of this study is to examine the efficacy of a one-session, hour-long HIPAA-compliant video platform-based mindfulness + compassion telehealth intervention on reducing feelings of loneliness during COVID-19 quarantine. Participants (n=120) currently isolating due to COVID-19 will be randomized to one of three interventions: (a) mindfulness + compassion (MC); (b) mindfulness alone (MO); and (c) waitlist control (WL). The investigators predict that participants in the active intervention groups (mindfulness or mindfulness + compassion) will show a significantly greater reduction in subjective feelings of loneliness at one week follow-up compared to those in the waitlist control group. Additionally, investigators predict that participants in the active intervention groups will show a significantly greater reduction in stress at one week follow-up compared to those in the waitlist control group. Last, investigators predict that participants in the mindfulness + compassion group will show a significantly greater reduction in subjective feelings of loneliness at the 2-week follow-up follow-up relative to those in the mindfulness only group.
Cedars-Sinai Medical Center
The COVID-19 pandemic has undoubtedly elevated levels of stress to people all over the globe, but none more than to the providers on the front-line. The purpose of the study is to first, assess the effects of the pandemic on burnout, team cohesion, and resiliency among healthcare providers battling COVID-19 together in a medical ICU (MICU). Secondly, the investigators hope to then assess the effects of simple positive feedback on transforming culture and attitudes during times of major stress.
Promundo, United States
This proposed study will assess how COVID-19 and the associated 'stay at home' orders are affecting low-income Rwandan couples' relationships and family dynamics. The study builds on an existing randomized controlled trial of the Bandebereho fathers/couples intervention (NCT02694627), which will allow us to assess not only the current conditions in households, but also whether or how the significant impacts of the intervention are sustained under extreme stress.
Assistance Publique - Hôpitaux de Paris
The purpose of this study is to define seroprevalence of anti-SARS-CoV2 among children of Hospital Workers in APHP, particularly exposed population, according to parents' SARS-CoV2 serological status.
European Institute of Oncology
In COVID-19 pandemic, it is of critical importance to identify a rapid and simple diagnostic method to be used in clinical settings to timely inform and refine strategies that can prevent, control, and stop the spread of SARS-CoV-2. The 2019-nCoV IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a qualitative, membrane-based immunoassay for the detection of immunoglobulin G (IgG) and Immunoglobulin M (IgM) antibodies to SARS-CoV-2 in whole blood, serum or plasma specimen. Clinical specimens from patients who were suspected of being infected with 2019-nCoV will be used to evaluate the performance of the assay.
Yale University
The purpose of this study is to evaluate the performance of a non-invasive olfactory device as a rapid indicator of COVID-19 in positive subjects.
University Hospital Southampton NHS Foundation Trust
Trial Phase: Phase III: Interventional Trial: Virtual clinics to deliver universal interventions to maintain and improve physical health, nutritional state and psychological wellbeing in people with cancer who are following social distancing guidance: A COVID-19 targeted trial. Indication: Male or female participants, aged over 18 years old with suspicion or confirmed diagnosis of cancer (does not require histological confirmation) Objective: To investigate the efficacy of remote multimodal universal interventions delivered via virtual clinics to improve physical function as measured by the EORTC-QLQ-C30. Secondary Objective: To investigate the efficacy of remote multimodal universal interventions delivered via virtual clinics to improve emotional function, quality of life, participant activation (PAM), behaviour change and the effect it has on health economics (EQ-5D-5L). Exploratory Objective: Overall Survival and adherence to the intervention/advice using validated tools or development of a web-based toolkit.
Cambridge University Hospitals NHS Foundation Trust
This study aims to evaluate several of Owlstone Medical's Breath Biopsy aerosol respiratory droplet capture techniques for the detection of nCOVID-19. These are single use disposable breath capture devices with removable filters and fitted PVA strip that directly sample exhaled breath aerosols and therefore, directly sample the primary transmission route for the virus. They can be used independently and shipped for analysis for the presence of nCOVID-19 using established existing assays available in any reference lab. The trial is a non-inferiority trial comparing diagnostic accuracy of collection via face mask vs. available diagnostic procedures in standard care and will also asses the feasibility of patient use of the equipment. Subjects will be recruited at the Addenbrookes Hospital, Cambridge. Minimal patient characteristics (e.g. age, sex) are collected. Between 20 and 100 subjects with with a positive nCOVID-19 diagnosis will be sampled to obtain to address the primary study hypothesis. Due to the pre-test probability of patients being positive for nCOVID-19 is unknown we will monitor the number of sampled subjects with a positive diagnosis on a weekly basis. The clinical diagnosis of the subject based on a combination of imaging, viral diagnostics and clinical assessment will be used as the reference standard. When this number hits 100 the study will be discontinued. In total no more than 500 subjects shall be sampled in this trial.