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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Displaying 40 of 247Canadian 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.
BioClever 2005 S.L.
The purpose of the study is to confirm if BACTEK-R (MV130) provides clinical benefit in subject with mild pneumonia (CURB-65≤2) by COVID-19 admitted to the Hospital.
University Medicine Greifswald
The main objectives of this study are 1) to establish the prevalence of SARS-CoV-2 in asymptomatic healthcare workers (HCWs) in an early phase of community spread as well as 2) to monitor the future spread of the disease by assessing serological responses to SARS-CoV-2 in symptomatic and asymptomatic HCWs over time and 3) to improve the assessment of the immune response and its protective effect as well as the assessment of infectivity of affected HCWs and 4) to evaluate the value and significance of antibody formation and serological antibody tests and 5) to be able to evaluate possible future preventive and / or therapeutic approaches against SARS-CoV-2, e.g. to assess vaccination effects
University of Campinas, Brazil
To date, there is no vaccine or treatment with proven efficiency against COVID-19, and the transmissibility of the SARS-CoV-2 virus can be inferred by its identification in the oro-nasopharynx. The bacillus Calmette Guérin (BCG) has the potential for cross-protection against viral infections. This study evaluates the impact of previous (priming effect, from the titer of anti-BCG interferon-gamma) or current BCG exposure (boost with intradermal vaccine) on 1) clinical evolution of COVID-19; 2) elimination of SARS-CoV-2 at different times and disease phenotypes; and 3) seroconversion rate and titration (anti-SARS-CoV-2 IgA, IgM, and IgG).
Queen Mary University of London
COVID-19 is associated with complications including ARDS and myocardial injury, which informs prognosis and patient outcome. The laboratory plans to perform immunophenotyping of peripheral T-cells in patients with COVID-19 and complications (ARDS, ITU admission, myocardial injury) and map this against clinical patient outcomes. The aim is to determine if there is a specific T-cell immunophenotype associated with COVID-19 and/or complications, which can be used to inform prognosis and potential therapies.
Lawson Health Research Institute
The study will be a randomized controlled trial, involving patients with hyposmia/anosmia of onset immediately after an upper respiratory viral illness, assigned to three distinct study arms. Nasal irrigations will be prescribed to all three groups (BID). In addition, one arm will receive a paper hand-out about post-viral anosmia with instructions to smell common household items (current care) and act as a control group. The second group will receive an essential oil retraining kit, whereas the third group will receive the same olfactory training kit and a prescription to use budesonide with the nasal irrigations. Olfactory scores will be tested at the enrollment, 3 months and at 6 months.
Aarhus University Hospital
The purpose is to investigate the COVID-19 prevalence, associated morbidity and long-term cognitive deficits in consecutive patients presenting with acute neurological symptoms
University of California, Irvine
The Harnessing Online Peer Education COVID-19 (HOPE COVID-19) intervention will assess whether a peer-led online support community can improve behavioral health outcomes related to COVID-19.
C17 Council (regulatory sponsor)
This is a multicentered, open-label, randomized controlled Phase 2 trial to evaluate the safety and efficacy of providing human coronavirus-immune convalescent plasma as treatment for COVID-19 disease in hospitalized children in the context of the COVID-19 pandemic.
Memorial Sloan Kettering Cancer Center
The study researchers think that a medication called N-acetylcysteine can help fight the COVID-19 virus by boosting a type of cell in your immune system that attacks infections. By helping your immune system fight the virus, the researchers think that the infection will get better, which could allow the patient to be moved out of the critical care unit or go off a ventilator, or prevent them from moving into a critical care unit or going on a ventilator. The US Food and Drug Administration (FDA) has approved N-acetylcysteine to treat the liver side effects resulting from an overdose of the anti-inflammatory medication Tylenol® (acetaminophen). N-acetylcysteine is also used to loosen the thick mucus in the lungs of people with cystic fibrosis or chronic obstructive pulmonary disease (COPD). This study is the first to test N-acetylcysteine in people with severe COVID-19 infections.