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 20 of 183University of Alabama at Birmingham
This proposal addresses the problem of preventing the very high mortality and morbidity associated with the development of Cytokine Storm Syndrome (CSS) associated respiratory failure in Covid-19 infection.
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.
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.
ElectroCore INC
The study is a prospective, randomized, controlled investigation designed for comparison of two groups for the reduction of respiratory distress in a CoViD-19 population, using gammaCore Sapphire (nVNS) plus standard of care (active) vs. standard of care alone (SoC), the control group. The gammaCore® (nVNS) treatments will be used acutely and prophylactically. The aims of this study are to summarize and compare the incidence of clinical events and pro-inflammatory cytokine levels in patients randomized to use of gammaCore Sapphire plus standard of care vs standard of care alone in patients hospitalized for CoViD-19. Secondary objectives are demonstrate the safety of gammaCore Sapphire use in patients hospitalized for CoViD-19.
Ola Blennow, MD, PhD
Randomized open label clinical trial carried out at study centers in Sweden, including Karolinska University Hospital, S:t Göran Hospital, Danderyd Hospital and Västmanlands Hospital. Patients with COVID-19 who are hospitalized with oxygen therapy are eligible for inclusion. Subjects are randomized to 14 days of inhalation with ciclesonide 360 µg twice daily or to standard of care. Primary outcome is duration of received supplemental oxygen therapy. Key secondary outcome is a composite outcome of death and received invasive mechanical ventilation within 30 days.
ImmunityBio, Inc.
This is a phase 1b, randomized, blinded, placebo-controlled study in adult subjects with COVID-19. This clinical trial is designed to assess the safety and immunostimulatory activity of N-803.
Centre for Addiction and Mental Health
The current study aims to assess the feasibility, acceptance and clinical outcomes of a practical high-dose aiTBS protocol, including tapering treatments and symptom-based relapse prevention treatments, in patients with unipolar depression previously responsive to ECT and patients needing urgent treatment due to symptom severity during the COVID-19 pandemic.
Organicell Regenerative Medicine
The purpose of this research study is to evaluate the safety and potential efficacy of Intravenous Infusion of Zofin for treatment of moderate to severe Acute Respiratory Syndrome (SARS) related to COVID-19 infection vs Placebo.
Kanuni Sultan Suleyman Training and Research Hospital
Evaluation of the effects of ozone therapy given in addition to the treatment they received in covid 19 positive patients (hydroxychloroquine + azithromycin)
Novartis is the Marketing Authorization Holder for Jakavi outside the US.
The purpose of this Cohort Treatment Plan is to allow access to ruxolitinib for eligible patients diagnosed with severe/very severe COVID-19 illness. The patient's Treating Physician should follow the suggested treatment guidelines and comply with all local health authority regulations. The requesting Treating Physician submitted a request for access to drug (often referred to as Compassionate Use) to Novartis which was reviewed and approved by the medical team experienced with the drug and indication. Please refer to the latest Investigator's Brochure (IB) or approved label for overview of ruxolitinib including: non-clinical and clinical experience, risk and benefits. Novartis will continue to provide any new safety information to the Treating Physician as they emerge.