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.
Search Tips
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 70 of 183Cartesian Therapeutics
Emergency study to test the safety of Descartes-30 cells in patients with moderate-to-severe acute respiratory distress syndrome (ARDS) AND COVID-19
Daxor Corporation
In patients with SARS-CoV-2 or bacterial infection admitted to the intensive care unit (ICU), the state of the intravascular volume, the characteristics of the blood volume components, and the development of a vascular leak is currently unknown. The relationship of these parameters with parameters of cardiac performance, lung edema and sublingual microcirculatory perfusion parameters have never been studied.
Amazon Web Services (AWS) Canada
The VOICE-COVID study will evaluate the concordance of screening for symptoms of COVID-19 using a voice based device (Amazon Alexa) compared to manual screening by a study coordinator for individuals entering the Cardiology/Heart Failure clinic at the McGill University Health Centre.
Västmanland County Council, Sweden
This research study is designed to investigate the effects of a brief psychological intervention for improving depressed mood in older individuals (65 years and older) in isolation during the Coronavirus (COVID-19) pandemic. The treatment is delivered by telephone and consists of four weekly individual sessions. Two therapeutic methods are used in combination during this intervention: Behavioral activation (BA) and Mental Imagery (MI). BA involves identifying and scheduling enjoyable and meaningful activities to improve mood and reduce social isolation. To enhance BA efficacy and adherence, MI is paired with BA as MI is known to activate emotion and motivation. The MI intervention in this study involves having participants imagine, in vivid sensory detail, engaging in some of the activities that are scheduled during BA. Approximately 154 individuals will participate in the study. Half of the participants will be randomised to start the intervention immediately, while the other half of the participants will be randomized to a control group receiving the intervention after 4 weeks. This procedure makes it possible to evaluate the effects of the treatment while not disadvantaging participants randomized to the control group. Participants will be asked to fill in questionnaires before, during (at the end of each intervention week), and after treatment (or waiting period for the control group). Questionnaires will also be sent 1-, 3- and 6 months after treatment to follow up on the results. A smaller group of participants (10-15) will be asked to participate in a more detailed interview about how they experienced the treatment.
Children'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.
United States Department of Defense
- This is a phase II randomized study of convalescent plasma for the treatment of non-immune individuals with COVID-19 infection at high risk of complications. - Subjects will be considered as having completed the study after 2 months (+/- 5) days, unless consent withdrawal or death occurs first. - Subjects will be randomized to receiving convalescent plasma or best supportive care. - Patients randomized to best supportive care may receive plasma should they require hospitalization for progression of COVID-19 disease. - The final analysis will be conducted once the last subject completes the 2-month visit or withdraws from the study.
Johns Hopkins University
The investigators aim to deliver a tele-wellness supported app to Baltimore City's Family Child Care Home (FCCH) providers who are caring for children of Essential Personnel. Once a pre-survey is conducted, login information will be assigned to 30 Family Child Care Home providers and parents the FCCH serve. Providers and Parents will receive self-care and parenting/parent engagement support through the app and through a tele-wellness service, Ask a Nurse, provided by community health nurses at the Johns Hopkins School of Nursing. Children will have access to gamified learning materials in early literacy, math, social-emotional learning, and nutrition.
Baylx Inc.
This is a phase 1/2a study including 2 parts, phase 1 and phase 2a. The phase 1 part is an open-label, single-arm, dose-escalating study to evaluate the safety and explore the dose limiting toxicity and maximum tolerated dose of a human umbilical cord derived mesenchymal stem cell product (BX-U001) in severe COVID-19 pneumonia patients with acute respiratory distress syndrome (ARDS). Qualified subjects after the screening will be divided into low, medium, or high dose groups to receive a single intravenous infusion of BX-U001 at the dose of 0.5×10^6, 1.0×10^6, or 1.5×10^6 cells/kg of body weight, respectively. The Phase 2a part is a randomized, placebo-controlled, double-blind clinical trial examining the safety and biological effects of BX-U001 at the appropriate dose selected from phase 1 for severe COVID-19 pneumonia patients with the same inclusion/exclusion criteria as the phase 1 part.
University of Michigan
This clinical trial is a sub-study to treat participants that were not eligible in the main study (HUM00152509/NCT03874793) to receive MBCT or MRT in hard hit COVID-19 areas with trauma history and current COVID-related distress. The purpose of this treatment-only sub-study is to see how eligible participants with life history of any trauma and are currently experiencing elevated COVID-related stress are affected by two different PTSD therapies involving Mind-Body practices; Mindfulness based Cognitive Therapy (MBCT) and Muscle Relaxation Therapy. The targeted individuals will reside in areas (Washtenaw, Wayne, and Oakland counties in Michigan, etc.) that have been affected by COVID-19. Participants will have assessments before and after 8 weeks of therapy (remote MBCT or MRT).
VISIBLE PATIENT, E-MEDIA
Automated quantification of the pulmonary volume impaired during acute respiratory failure could be helpful to assess patient severity during COVID-19 infection or perioperative medicine, for example. This study aim at assessing the correlation between the amount of radiologic pulmonary alteration and the clinical severity in two clinical situation : 1. SARS-CoV-2 infections 2. Postoperative hypoxemic acute respiratory failure