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 30 of 369Sultan Qaboos University
Background: COVID-19 (Corona Virus Disease 2019) is a virulent infectious disease with an incubation period ranging between 2-14 days. This highly contagious disease is caused by Sars-Cov-2 (Severe Acute Respiratory Syndrome Coronavirus 2). The number of people infected by COVID-19 has increased exponentially since January as a result of traveling and contact with COVID-19 infected individual. Initially, the seriousness of COVID-19 was not gauged properly until World Health Organization classified it as Pandemic type infectious disease and rapidly made plans actions to fight against it on 20 January, 2020. The uncertainty and low predictability of COVID-19 not only threaten people's physical health, but also affect people's mental health, especially in terms of emotions and cognition. As consequence of public emergency, with its economic health and social impacts, psychological repercussions among people are inevitable at the short and long term. Importance and justify the study: This study will assess the effectiveness of e therapy in treating anxiety and depression during a pandemic. This would be a novel way of providing therapy during crises Hypothesis: We hypothesize that compared to self-help email delivered therapy, the therapist guided e-Therapy is more efficacious in reducing the level of psychosocial stress among distressed individuals in Oman during COVID19. Objective: The aim of this study is to assess the efficacy of six weeks therapist guided e-Therapy versus Self-help e-mail delivered therapy on Psychological distress among random sample of individuals live in Oman during COVID 19 pandemic. This study will recruit 60 participants from a list respondents to public survey who reported high levels of depression and anxiety, and randomize them to either therapist guided e-psychotherapy(intervention) or (control) self-help arms. Participants in the intervention arm will receive six sessions of therapist guided e therapy as described in the study schedule. Participants in the control arm will receive self-help psychotherapy contents similar to the intervention arm as detailed in the study schedule. Throughout the study, outcome and safety assessments will be conducted.
University Hospital Tuebingen
To evaluate the safety, toxicity and immunological effects of infusion of allogeneic bone marrow-derived human mesenchymal stem (stromal) cells (MSCs) and whether this therapy has an influence on the resolution processes in ARDS patients infected with Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Ain Shams University
The aim of this project is to introduce way for treatment of patients with severe COVID-19 disease with respiratory complications.
Athersys, Inc
Multicenter investigation featuring an open-label lead-in followed by a double blinded, randomized, placebo-controlled Phase 2/3 part to evaluate the safety and efficacy of MultiStem therapy in subjects with moderate to severe Acute Respiratory Distress Syndrome (ARDS) due to pathogens including COVID-19.
Royan Institute
Acute Respiratory Distress Syndrome (ARDS) is the major cause of death in the COVID-19 pandemic. In this trial, the safety and efficacy of Mesenchymal Stem Cells (MSC) for the treatment of ARDS in COVID-19 patients will be assessed.
Enos Bernasconi
The purpose of this proof of concept study is to provide COVID-19 convalescent plasma to patients with moderate to severe COVID-19 and assess: - the titer of anti-COVID-19 antibodies in the donors and in the patients before and after treatment; - the in-depth analysis of immunological parameters in the donors and in recipient before and after treatment; - the impact of plasma transfusion on the reduction of viral load and inflammation - safety and tolerability - clinical efficacy
Celularity Incorporated
This study is a Phase 1 / 2 trial to determine the safety and efficacy of CYNK-001, an immunotherapy containing Natural Killer (NK) cells derived from human placental CD34+ cells and culture-expanded, in patients with moderate COVID-19 disease.
University of Colorado, Denver
This expanded access program will provide access to COVID-19 convalescent plasma 150 or more individuals with moderate to severe or life-threatening manifestations of COVID-19, or documented to be at high risk of developing such manifestations at participating hospitals in Colorado.COVID-19 convalescent plasma is the liquid part of blood that is collected from patients who have recovered from COVID-19. Convalescent plasma collected from individuals who have recovered from COVID-19 contains antibodies to SARS-CoV-2. Preliminary evidence and data collected during other respiratory virus outbreaks (including the 2003 SARS-CoV-1 epidemic, the 2009-2010 H1N1 influenza virus pandemic, and the 2012 MERS-CoV epidemic) suggest that the antibodies in convalescent plasma may be effective in fighting the infection.
University of California, Los Angeles
The novel coronavirus (COVID-19) is affecting the way many people live their lives, including seeking medical care and maintaining good self-care to keep healthy. Additionally, in the event many people become critically ill at once, COVID-19 has the possibility of overwhelming hospitals to the point where they have to make decisions about how to determine who receives intensive care and life-support measures. Many hospitals as well as local or state governments have been working on policies to determine how to make these decisions. This study seeks to learn about how COVID-19 has affected the way patients and healthcare providers care for themselves and about their thoughts and concerns about policies that may "ration" life-support resources.
Canadian Institutes of Health Research (CIHR)
Experience from the 2003 Severe Acute Respiratory Syndrome (SARS) outbreak taught that healthcare workers (HCWs) often experience chronic stress effects for months or years after such an event, and that supporting HCWs requires attention to the marathon of occupational stress, not just the sprint of dramatic stressors that occur while infections are dominating the news. This study will test if the well-being of hospital workers facing a novel coronavirus outbreak is improved by adding either of two interventions: (1) Peer Resilience Champions (PRC): an interdisciplinary team of professionals who actively monitor for early signs of heightened stress within clinical teams, liaise between staff and senior management to improve organizational responsiveness, and provide direct support and teaching (under the supervision of experts in resilience, infection control, and professional education). Investigators will test the effectiveness of this PRC Intervention by rolling it out to different parts of the hospital in stages and comparing levels of burnout before and after the intervention reaches particular teams and units (a stepped wedge design). By the end of the study, PRC Support will have been provided to all clinical and research staff and many learners (> 6,000 people). Note that the provision of PRC support will be directed to the entire organization. The research portion of the study is the evaluation of PRC support through a repeated survey completed by consenting staff. Investigators will test the effectiveness of the PRC by measuring trends in burnout and other effects of stress over the course of the study in a subgroup of hospital workers (as many as consent, target ~1000 people) through an online questionnaire (called "How Are You?"). (2) The second intervention is an enriched version of the "How Are You?" Survey, which provides personalized feedback about coping, interpersonal interactions and moral distress. Participants will be randomized (1:1) to receive the shorter Express Survey (identifying data and outcome measures only), or the Enriched survey (all of the Express measures plus additional measures with feedback based on responses). It is hypothesized that both the PRC intervention and the Enriched Survey intervention will help prevent or reduce instances of burnout in HCWs.