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 60 of 135Kaohsiung Kai-Suan Psychiatric Hospital
The Coronavirus disease 2019 (COVID-19) had its outbreak in late 2019 in China and is considered a biological disaster. With medical organizations and staff on the frontline, the investigators should conduct assessments, for the different tiers of medical staff, patients, and community residents, on the short- term psychological and mental disabilities or danger factors that they might have faced. As such, the investigators can design and establish a set of evaluative indicators of the risks of biological disasters, and strategies to manage guide and cope, and internal/ external testing strategies. These work in guaranteeing quality and performance, and as such, establishing "Digital Platform for Integrated Research of Coronavirus disease 2019 (COVID-19)".
National Cancer Institute (NCI)
This study collects blood samples, medical information, and medical images from patients who are being treated for cancer and have a positive test for SARS CoV-2, the new coronavirus that causes the disease called COVID-19. Collecting blood samples, medical information, and medical images may help researchers determine how COVID-19 affects the outcomes of patients undergoing cancer treatment and how having cancer affects COVID-19.
Egyptian Military Medical Services
The aim of the study is to clinically use bovine Lf as a safe antiviral adjuvant for treatment and to assess the potential in reducing mortality and morbidity rates in COVID-19 patients. The study was approved by the ethical committee of the Egyptian Center for Research and Regenerative Medicine in 11-5-2020.
Rigshospitalet, Denmark
The experience of a loved one's stay in a COVID-19 intensive care unit (ICU), either intubated or on respiratory support, forces family caregivers (hereafter 'caregivers') to face core existential fears, such as uncertainty and death. It also poses a serious threat to basic human needs for autonomy, competence, and relatedness, as family caregivers have no control over the illness, and limited prior competence in dealing with critical illness. COVID-19 likely aggravates this experience, as social distancing cuts caregivers off from visiting patients in the ICU, from using their usual social supportive network and the threat of infection extends to caregivers themselves, their children and family. Combined, these extreme circumstances put caregivers in emotional turmoil and in need of psychological support and assistance in managing difficult emotions. ICU caregivers are at risk of developing clinically relevant symptoms of anxiety or posttraumatic stress. During the patient's ICU stay, caregivers experience peri-traumatic distress, such as helplessness, grief, frustration and anger, that may predict later posttraumatic stress disorder (PTSD). Symptoms of anxiety and PTSD may last for months to years after the patient's discharge. Further, caregivers of patients who die in an ICU may be at greater risk of prolonged grief disorder. Supportive interventions may reduce psychological late effects in ICU caregivers, but the primary focus of the majority of interventions has been on communication or surrogate decision making. The CO-CarES study aims to develop and test the feasibility of a tele-delivered psychological intervention to enable caregivers of ICU patients with COVID-19 to better endure the overwhelming uncertainty and emotional strain and reduce the risk of posttraumatic stress and prolonged grief. The study hypothesizes that providing psychological intervention during and after the patients' hospitalization, can decrease peri-traumatic distress during ICU hospitalization and decrease risk of post-traumatic stress, anxiety, depression and perceived stress following discharge, as well as prolonged grief in bereavement. A secondary hypothesis is that changes in emotion regulation mediate effects of the intervention on long-term psychological outcomes.
Adaptive Phage Therapeutics, Inc.
Phage Treatment in Covid-19 Patients with Bacterial Co-Infections
Northwestern University
This is a single-center, randomized double blind placebo controlled trial to evaluate the efficacy and safety of novel PAI-1 inhibitor (TM5614) for high-risk patients hospitalized with severe COVID-19 at Northwestern Memorial Hospital. The patients will be randomized in a 1:1 ratio to receive standard of care plus TM5614 or standard of care plus placebo.
Longeveron Inc.
A Phase I, double- blinded, randomized, placebo- controlled study to test the safety of Lomecel-B in Adults suffering from mild to severe acute respiratory distress syndrome (ARDS) due to COVID-19 resultant from 2019-nCoV coronavirus infection, or resultant from influenza virus infection.
George Washington University
This is a pilot feasibility study of remotely delivered Problem Management Plus, a low-intensity psychological intervention, delivered in five sessions to adults affected by crisis. The current study will evaluate the feasibility and acceptability of the intervention when delivered remotely via Zoom to community members in New York City impacted by the COVID-19 pandemic. The investigator's goal is to use qualitative and quantitative approaches to inform procedures for a subsequent cluster randomized control trial of Problem Management Plus versus enhanced usual care. A mixed-methods design will be used to evaluate the feasibility, acceptability, perceived utility, and impact of the remotely delivered PM+ intervention, to determine recruitment and retention rates, to assess ethics and safety of trial procedures. Additionally, the study will evaluate the acceptability, feasibility and fidelity of the remote training and supervision of helpers trained to deliver the intervention.
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 coronavirus disease-2019 (COVID-19), as compared to placebo, in SARS-CoV-2 seronegative adults in the double-blind phase and to describe COVID-19 outcomes, safety, and immunogenicity in the different study cohorts in open-label phase.
University of Michigan
This study is an open trial designed specifically to address the need for evidence-based treatment delivered via telehealth to individuals that are currently struggling with mental health issues during the COVID-19 pandemic, with the overarching goal of helping residents of New York adversely impacted by the pandemic to effectively manage their anxiety, stress, and depression during this unprecedented time in human history.