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 180 of 468Hackensack Meridian Health
This expanded access program will provide access to investigational convalescent plasma for patients at Hackensack University Medical Center infected with SARS-CoV-2 who have severe or life-threatening COVID-19, or who are judged by a healthcare provider to be at high risk of progression to severe or life-threatening disease.
KBio Inc
This is an First In Human (FIH), observer-blinded, randomized, placebo-controlled, parallel group study to evaluate the safety and immunogenicity of KBP-COVID-19 plus CPG adjuvant vaccine in healthy adult subjects in 2 age groups, Part A (18-49 years) and Part B (50-85 years).
Cellenkos, Inc.
To assess the safety and efficacy of CK0802 in treatment of patients with COVID-19 induced moderate-to-severe PNA-ARDS.
Spartan Bioscience Inc.
This study will evaluate the efficacy of various sample collection methods for use with the Spartan COVID-19 System. It will compare the results from the Spartan COVID-19 System with results that are obtained using a predicate lab-based COVID-19 test that uses a nasopharyngeal swab sample. The goal is to determine which sample collection methods are most effective in capturing SARS-CoV-2 virus.
SAb Biotherapeutics, Inc.
Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). SAB Biotherapeutics has developed SAB-185, an Anti-SARS-CoV-2 Human Immunoglobulin Intravenous (transchromosomic [Tc] bovine-derived), as a potential therapeutic to treat COVID-19. This study will evaluate the safety, immunogenicity, and pharmacokinetics of SAB-185 in healthy participants.
Escola de Saúde Pública do Ceará
The number of COVID-19 cases has been growing exponentially, so that the industrialized economies are facing a significant shortage in the number of ventilators available to meet the demands imposed by the disease. Noninvasive ventilatory support can be valuable for certain patients, avoiding tracheal intubation and its complications. However, non-invasive techniques have a high potential to generate aerosols during their implementation, especially when masks are used in which it is virtually impossible to completely prevent air leakage and the dispersion of aerosols with viral particles. In this context, a helmet-like interface system with complete sealing and respiratory isolation of the patient's head can allow the application of ventilatory support without intubation and with safety and comfort for healthcare professionals and patients. This type of device is not accessible in Brazil, nor is it available for immediate import, requiring the development of a national product. Meanwhile, a task force under the coordination of the School of Public Health (ESP) and Fundação Cearense de Apoio à Pesquisa (FUNCAP), with support from SENAI / FIEC and the Federal Universities of Ceará (UFC) and the University of Fortaleza (UNIFOR) advanced in the development of a prototype and accessory system capable of providing airway pressurization through a helmet-type interface, which was called the Elmo System.
Janssen Vaccines & Prevention B.V.
The study will evaluate the efficacy of Ad26.COV2.S in the prevention of molecularly confirmed moderate to severe/critical COVID-19, as compared to placebo, in adult participants.
Radboud University Medical Center
Patients who receive intensive care are known to be at high risk for physical, psychological, and cognitive impairments, a constellation known as PICS. COVID-19 patients are expected to have high chances of suffering from PICS (PICS-COV) as they frequently require several weeks of intensive care and traditional PICS preventive measures are virtually impossible due to infection control precautions, prone positioning, and deprivation of social contact. To prevent PICS after ICU discharge in COVID-19 patients, physical therapy is recommended. From recent but limited experience it appears that even patients with COVID-19 who have not been admitted to the ICU can suffer from impairments in the same domains and sometimes to a similar degree of severity. Also for these patient group rehabilitation seems warranted. Yet, the resources needed to provide rehabilitation treatment to COVID-19 patients are inadequate because healthcare systems faced a shortage of high-quality treatment for these impairments already before the COVID-19 crisis emerged. Virtual Reality (VR) provides potential to healthcare practitioners to administer fast, temporary, and tailor-made rehabilitation services at a distance, and offers a solution to address the impending surge of demand for rehabilitation after COVID-19 infection. VR consists of a head mounted display (HMD) that can bring the user by computer-generated visuals into an immersive, realistic multi-sensory environment. Current VR technology is accessible, easy in use for a large audience, and safe in use. There already exist multiple VR applications for providing physical, psychological, and cognitive rehabilitation. These applications have been brought together in a VR suite for rehabilitation after COVID-19. Patients visiting a physiotherapist for rehabilitation from COVID-19 will be asked to participate in this study. They receive a VR HMD for training purposes. This study aims to understand the usability, feasibility, and tolerability of VR for rehabilitation after COVID-19, and to pilot the effectiveness of VR improving the physical ability, mental and cognitive status of patients.
Fundación Neumologica Colombiana
The objective of this study is to evaluate the efficacy and safety of the Unisabana-Herons invasive mechanical ventilator designed to provide the basic ventilatory support necessary to preserve the life of patients with respiratory failure and indication of mechanical ventilation, especially for those who suffer from acute respiratory distress syndrome (ARDS) when conventional commercial invasive ventilators are not available in the context of the health emergency due to the COVID-19 epidemic. The Unisabana-Herons ventilator allows to precisely configure the respiratory rate, tidal volume (or inspired air volume), inspiratory time, the inspiration: expiration ratio, the positive pressure at the end of expiration (PEEP), the inspired fraction of oxygen and inspiratory air flow, parameters that allow managing the respiratory failure associated with COVID-19. The ventilator also monitors peak inspiratory pressures (PIP), mean, PEEP, plateau, and graphs in real time the pressure-time, volume-time, flow-time curves, which allows detecting when one of these is at levels dangerous to induce ventilator trauma (barotrauma and volutrauma) and thus ensure effective and safe ventilation, so as to avoid ventilator-induced lung injury.
University of Utah
The purpose of this study is to explore the effectiveness of processed human amniotic fluid as a treatment for COVID-19.