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 160 of 190KK Women's and Children's Hospital
The overall objective of this project is to develop an emergent treatment protocol using adoptive T-cell therapy for the treatment of severe COVID-19. The central hypothesis is that SARS-CoV-2 specific T cells from convalescent donors who have recovered from COVID-19 can be manufactured expeditiously for the treatment of severe SARS-CoV-2 infections.
Cwm Taf University Health Board (NHS)
Emerging clinical details of the current SARS-CoV-2 pandemic have illustrated that there are multiple clinical presentations and outcomes of this viral infection. People with an infection have been reported to have a spectrum of disease from severe acute respiratory distress requiring ventilation, to mild respiratory or gastrointestinal symptoms and asymptomatic presentations. Mechanisms explaining the heterogeneity of host response to infection are yet to be characterised. The aim of this project is to understand the host immune response to infection with SARS-CoV-2 over time in convalescent adults, including acquired immune responses, circulating levels of immune signalling molecules, gene expression profiling in peripheral blood and to identify host genetic variants associated with disease progressions or severity. Participants will be healthcare workers who had a diagnosis of COVID-19 (confirmed by positive RT-PCR assay) more than 28 days ago and have recovered and are employed by Cwm Taf Morgannwg University health board. Samples will be processed and analysed to explore immunological, host genetic factors and virological factors that explain pathogenesis and predict outcomes of infection.
InCor Heart Institute
This is a prospective, randomized, single-center, open-label controlled trial, designed to compare the efficacy of two ventilation strategies (Low Tidal Volume and positive end-expiratory pressure (PEEP) based on the Acute Respiratory Distress Syndrome (ARDS) Network low PEEP-fraction of inspired oxygen inspired oxygen fraction (FIO2) Table versus Low Driving Pressure and PEEP guided by Electrical Impedance Tomography (EIT) in reducing daily lung injury score in patients with acute respiratory distress syndrome caused by COVID-19. The two strategies incorporate different prioritizations of clinical variables. The PEEP-FIO2 table strategy aims to reduce lung overdistension, even if it requires tolerating worse gas exchange. EIT-guided strategy prioritizes mechanical stress protection, avoiding alveolar overdistension and collapse.
Institut Català de la Salut
Recently, a new clinical presentation called "long covid" has been reported, for patients with symptoms lasting for more than 4 weeks from the onset of the disease. Typically, the symptoms comprise dyspnea, cough, headache, arthralgia, fever, abdominal pain, asthenia and skin manifestations This project aims to evaluate the efficacy of Montelukast in improving the quality of life associated with respiratory symptoms in patients with persistent COVID-19 symptoms. The main objective is to compare the efficacy of low-dose Montelukast versus placebo to improve respiratory symptoms in patients with persistent COVID-19 symptoms.
University Hospital, Toulouse
For the last years, studies have described the " Post-intensive care Syndrome " (PICS), which consists in alteration of quality of life, cognition, autonomy and psychological disorders within the months after intensive-care. Patients with COVID-19 in intensive care units are at high risks to develop PICS. The primary objective is to analyse the incidence of the post-traumatic stress disorder at 12 months after intensive-care for a COVID-19 Acute Respiratory Distress Syndrome (ARDS).
University of Sao Paulo
The physical inactivity promoted by the patient's hospitalization, including those infected with the coronavirus, can lead to an important health impairment, including atrophy and loss of muscle function. Thus, a prospective study will be conducted to assess the effect of a home-based exercise training program on health outcomes and quality of life in COVID-19 survivors.
Imperial College London
The Multi-arm trial of Inflammatory Signal Inhibitors for COVID-19 (MATIS) study is a two-stage, open-label, randomised controlled trial assessing the efficacy of ruxolitinib (RUX) and fostamatinib (FOS) individually, compared to standard of care in the treatment of COVID-19 pneumonia. The primary outcome is the proportion of hospitalised patients progressing from mild or moderate to severe COVID-19 pneumonia. Patients are treated for 14 days and will receive follow-up assessment at 7, 14 and 28 days after the first study dose. Patients with mild or moderate COVID-19 pneumonia will be recruited. Initially, n=171 (57 per arm) patients will be recruited in Stage 1. Following interim analysis to assess the efficacy and safety of the treatments, approximately n=285 (95 per arm) will be recruited during Stage 2.
Laval University
The health crisis imposed by COVID-19 is forcing major worldwide social reorganization that will have profound consequences on our society. Currently, one-third of the world's population (~3 billion individuals) is living under some kind of isolation or quarantine measures, causing an unprecedented and rapidly evolving psychosocial crisis. The psychosocial consequences of this health crisis will persist long after restriction measures are lifted and the pandemic is over. This impact will be significant for individuals facing unique contexts or challenges (e.g., older adults, individuals living with a disability, underprivileged families) and will most likely exacerbate existing social and gender inequalities in health and human development. There is an urgent need for information on the evolution of the psychosocial dimensions of health and coping strategies used by our population and our health and social services structures. Thus, this study is designed to accelerate the availability of high-quality, real-time evidence within health and social services structures to address, support and minimize psychosocial consequences of the COVID-19 pandemic. Through constantly evolving research questions responsive to the course of the pandemic evolution, the rapid system transformations and adaptation of services, and knowledge users (KUs) needs, MAVIPAN aims to address, document, monitor, and evaluate the following: 1. Individuals and families' adjustments and mitigation strategies, especially for those considered vulnerable and in high-risk contexts. 2. Healthcare and social services workers and managers' adjustments and mitigation strategies. 3. The organization of service structures. 4. The social and economic response. To achieve these objectives, we use a mixed methods study design that combines quantitative questionnaires and qualitative interviews to deepen our understanding of elements such as the coping strategies used during the pandemic. A first measure was taken during lock-down as well as a follow-up at 3 months. Another follow-up will be made at 7 months. At least one per year follow-up will be made over the course of the study (5 years). Additional measures may be taken depending on the evolution of the pandemic and the sanitary measures put in place by the authorities.
Universitaire Ziekenhuizen KU Leuven
We aim to understand the mechanism of olfactory dysfunction in COVID-19.
Methodist Health System
This is a prospective cohort observational registry study that will include data on all patients who are treated at MHS facilities for COVID-19.