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 310 of 426Guangzhou Institute of Respiratory Disease
This study is a multicenter, randomized, open, parallel-controlled study. Qualified subjects will randomly be assigned to the experimental arm or the control arm according to the ratio of 1:1, with age (> 60 years or ≤ 60 years), smoking status (yes/no) and forced expiratory volume in one second/prediction (FEV1 %pred > 60% or ≤ 60%) as the random stratification factors.
ANNA FALANGA
Coronavirus disease-2019 (COVID-19), a viral respiratory illness caused by the severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2), has been associated with the occurrence of cardiovascular adverse events including acute myocardial injury, acute heart failure, cardiac arrhythmias, and thromboembolic disease. These complications represent an important issue in COVID-19 patients accounting for the increased morbidity and mortality of this syndrome. According to a scoping review, venous thromboembolism and stroke occurred in approximately 20% and 3% of patients, respectively, with higher frequency observed in severely ill patients admitted to intensive care units. Despite the use of pharmacological thromboprophylaxis, the thrombotic risk still remained elevated in severe COVID-19 patients, and the optimal doses and timing of anticoagulation are not yet defined. The pathogenesis of COVID-19 associated thrombosis recognizes a prominent role of endothelial damage induced by both direct viral injury and an excessive and aberrant hyper-inflammatory host immune response associated to an increase in infection-related cytokines and chemokines. The occurrence of a hypercoagulable state in COVID-19 patients associated to a profound endothelial cell activation/dysfunction can result in the pathological phenomenon of immunothrombosis. In this study, in a prospective cohort of consecutive COVID-19 hospitalized patients, an extensive characterization of the hemostatic alterations were performed, in order to: 1) clarify mechanisms underlying the coagulopathy in these patients; 2) how and to what extent the concomitant infection with SARS-CoV-2 affect this coagulopathy; and 3) identify biomarkers potentially predictive of disease outcome (i.e. any thrombotic recurrence and death).
Hamad Medical Corporation
The purpose of this study is to assess the effectiveness of a telemental health intervention on the mental health of pregnant women during the COVID-19 crisis in Qatar.
Institut National de la Santé Et de la Recherche Médicale, France
The purpose of this study is to analyze in depth the relationship of myeloid cell subpopulations during infection by Severe acute respiratory syndrome coronavirus 2 (SARS-Cov2), the virus mediating Covid-19. Myeloid cells include neutrophils, monocytes and dendritic cells, each divided into subpopulations with different functions in immune defense and immune pathologies. The study is based on the following hypotheses: - Infection and the interferon response to infection may induce hyperactive or immunosuppressive differentiation of myeloid cells, that may be treated by specific inhibitors. - Some myeloid cell subpopulations currently identified in our laboratories might be markers for Covid-19 prognosis. - Alternative receptors may be present on myeloid cells, inducing the cytokine storm, a target for therapy. - The expression of Interferon (IFN) receptor and IFN responding genes on myeloid cells and on respiratory epithelial cells may correlate with prognosis and indicate potential treatment targets. - Interferon responses are known to be skewed during Covid-19, but some IFN subtype polymorphisms may correlate with prognosis and these subtypes migt be supplemented or inhibited for therapy.
Terra Biological LLC
We will conduct a double arm, randomized, double-blinded placebo controlled trial of oxaloacetate for treatment of fatigue in women with a history of COVID-19 infection, resolution of the infection, and remaining fatigue that interfere with everyday activities, based on use of a standardized questionnaire to screen for impairment. Participants will receive a 6-week supply of the active or placebo and will be asked to take one capsule twice a day with water and food. They will be contacted weekly for two weeks by the study coordinator to assess for any side effects or difficulty taking the medication. They will be asked to again to complete the standardized questionnaire to screen for impairment after 2 weeks, and again at the end of the study at 6 weeks. Finally, any adverse reactions and symptoms will be evaluated once again four weeks later to ensure that any symptoms that may have been present during treatment have resolved.
Uşak University
The charts of patients who developed pulmonary embolism in the course of COVID-19 will be evaluated, retrospectively. Clinical features and laboratory data will be analyzed.
Uşak University
All hospitalised patients with COVID-19 who have positive RT-PCR for SARS-COV-2 will be included in the study. The patients will be divided into two groups, as diabetics and non-diabetics. The COVID-19 patients' medical records will be evaluated and compared in terms of the duration of hospitalization, the presence of lung involvement in Computerised Tomography, the need for intensive care unit and mortality rates in patients with and without diabetes.
Larkin Community Hospital
Given the current lack of an effective drug or therapy, a clinical trial to better understand the safety and efficacy of therapeutic plasma exchange (TPE) in COVID-19 patients is urgently needed. The goal of this trial is to study the efficacy and safety of TPE therapy in subjects with moderate to severe COVID-19 by determining the morbidity and mortality after TPE therapy.
Ottawa Hospital Research Institute
This is a feasibility study taking place at The Ottawa Hospital (TOH), Hôpital Montfort, and Queensway Carleton Hospital that seeks to evaluate the impact of the COVID-19 pandemic on family member bereavement and study the effect of virtual support groups on reducing risk of developing Severe Grief Reaction (SGR). This project is inviting family members of deceased patients at either of the three before mentioned sites to enroll in this study.
University of Exeter
More than 400,000 people in the UK live in care homes. These individuals are particularly vulnerable to COVID-19; many are frail and the majority have concurrent physical health problems and dementia. This group are at the highest risk of becoming severely ill with COVID-19 and are dependent on a stretched care workforce. The isolation, together with the stresses and distressing nature of the current work environment is also likely to have an impact on the mental health and well-being of care staff. It is vital to provide good quality support to enable care staff to remain resilient, and to enable good quality care that maintains the well-being of residents with dementia and reduces emerging neuropsychiatric symptoms in residents without increasing harmful sedative medications. COVID E-WHELD is based on the optimized WHELD training intervention on successfully completed in randomised clinical trials (RCTs) in 86 care homes, more than 1000 people with dementia. WHELD reduced use of anti-psychotics, improved agitation and overall neuropsychiatric symptoms, improved quality of life and reduced mortality for people with dementia. A digital version of WHELD (eWHELD) with virtual supervision in a further care home RCT including 130 people with dementia has demonstrated benefits for staff carers and improvements in the quality of life of people with dementia, with eWHELD combined with virtual supervision, but not with e-learning alone. The current project will evaluate a COVID-19 adapted version of eWHELD to address current needs of care homes during the COVID-19 pandemic. This will be undertaken in a 2 arm, 4 month, randomized cluster RCT in 1280 care homes (allowing for 75% drop out with COVID-19 outbreaks) to determine whether COVID-19 adapted eWHELD improves quality of life and mental health for people with dementia in care homes and the mental health of care staff.