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 120 of 172San Bortolo Hospital - Vicenza
The novel coronavirus disease (COVID-19) is posing a serious challenge to the health-care systems worldwide, with an enormous impact on health conditions and loss of lives. More than 30 millions of recoveries worldwide were registered at the end of October 2020 with more than 1 million of deaths. As the disease continues to spread, strategies aimed to reduce hospitalization time in sub intensive unit care, thus reducing pressure on health system, but also to reduce some of the pathological features of COVID-19 such as inflammation and the "cytokines storm". The ketogenic diet is a high fat, low carbohydrate, adequate-protein diet that promotes a physiological ketosis (due to an increase of liver ketone bodies production). High fat, low carbohydrate diets have been shown to reduce duration of ventilator support and partial pressure carbon dioxide in patients with acute respiratory failure. Moreover, the physiological increase in plasma levels of ketone bodies exerts important anti-inflammatory and immunomodulating effects, which may reveal as precious tools to reduce potential adverse outcomes of COVID-19 disease. The hypothesis of this study is that the administration of a ketogenic diet will improve gas exchange, reduce inflammation, and the duration of hospitalization. The plan is to enrol 28 patients with diagnosis of COVID-19 hospitalized but not in ICU with SPO2 higher than 88%.
University of Michigan
This study is an open trial designed specifically to address the need for evidence-based treatment delivered via telehealth to individuals that are currently struggling with mental health issues during the COVID-19 pandemic, with the overarching goal of helping residents of New York adversely impacted by the pandemic to effectively manage their anxiety, stress, and depression during this unprecedented time in human history.
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Chronic Migraine and Migraine without aura at high frequency are disabling conditions also in adolescence age (2% of adolescents report chronic migraine) Common pharmacological treatments are often inadequate. It has been reported that clinical results can be improved when traditional therapies are combined with behavioral approaches in particular mindfulness, that help patients to become more conscious about their symptoms and able to manage pain without medication. Generally, according to standard clinical practice, young patients (12-17 yrs old) treated by mindfulness practice come to the hospital to practice mindfulness in small groups of patients for 6 weekly 45 minutes sessions. As the emergency situation due to the Corona-virus pandemic phenomenon in Italy, patients missed the possibility to come for the regular practice to the hospital: for this reason the investigators propose a small pilot study to enforce the use of technology for patients so that they can continue to be followed during their therapeutic process. This preliminary study will be conducted on 25 patients They will be trained to practice mindfulness daily by a standard session of 12 minutes on their smartphone recorded by the expert who generally manage their sessions at the hospital. Also a weekly video-session will be performed to evaluate the clinical condition, to practice guided mindfulness sessions and to encourage to use strategies for pain management . This modality will allow patients to continue their therapeutic process and to be followed regularly during the one year after treatment. Follow up sessions are planned every three months: these meetings at the hospital will be face-to-face with every patient to check the clinical condition by the patient's diary. Last follow up one year after treatment.
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Abstract Title: Randomized,open-label, controlled trial to evaluate efficacy and safety of a highly selective semipermeable membrane (AN69-Oxiris) in comparison with a selective semipermeable membrane ( standard AN69) in COVID-19 associated acute kidney injury: oXAKI-COV study Rationale: Acute kidney injury (AKI) in critically ill mechanically ventilated patients with COVID-19 disease, is present in up to 30% of this group and more than 50% of them will need renal replacement therapy in the form of continuous renal replacement therapy (CRRT). Acute kidney injury in this context seems to be a marker of multiorgan dysfunction and it produces increased mortality in this population. There is a vast amount of mechanisms that lead to AKI in critically ill patients with COVID-19; however, the cytokine storm could be the strongest mechanism implicated in AKI development in individuals with continuous renal replacement therapy requirements. Therefore, blocking or reducing the cytokine storm is thought to be a therapeutic target. Highly selective semipermeable membranes (AN69-Oxiris) have been shown able to adsorb endotoxins and to eliminate inflammatory cytokines, thus representing a valuable therapeutic option in this infection. Objective: To demonstrate clinical efficacy of AN69-Oxiris membrane to reach a stable MAP, with less vasopressor dosing (at least 0.1 micrograms/kg/min) after 72h of treatment, compared to a conventional membrane (standard AN69) in critically ill patients with AKI, COVID-19 infection and requirement of continuous renal replacement therapy. Study design: Randomized,open-label, controlled trial in critically ill patients with suspected or confirmed COVID-19 disease, AKI, and criteria for continuous renal replacement therapy initiation admitted in any of the two participating institutions. Patients meeting inclusion criteria will be randomized to receive CRRT with AN69-Oxiris membrane or standard AN69 membrane during a 72h period.
Won Sook Chung Foundation
The Cooper vitamin D3 study is a randomized study investigating whether daily vitamin D3 supplementation can prevent respiratory tract infections, influenza-like illness and covid-19 in hospital workers.
Nottingham Biomedical Research Centre
This is a prospective observational cohort study that will aim to recruit 60 participants who have had COVID-19, were admitted to hospital, required intensive care, and/or developed AKI during their hospital stay. Potential participants will be approached either by telephone by a member of the research team or via clinics (nephrology, post-ICU follow up clinics).
University Health Network, Toronto
The aims of this study are to assess whether the use of a MBI therapy delivered remotely is associated with a reduction of perceived stress among HCPs in the Radiation Medicine Program (RMP) and with a decrease risk of burnout during and post COVID-19.
Cambridge University Hospitals NHS Foundation Trust
Prone positioning is known to improve the PaO2/FiO2 ratio and reduce mortality in patients with ARDS managed in the critical care setting. Therefore, it is incorporated into regular clinical practice of managing patients with ARDS in critical care and is being used as such in the COVID-19 outbreak. Given that prone positioning is recommended by the Intensive Care Society in non-ventilated patients with COVID-19, there is an urgent need to better understand the physiological effects of prone positioning in such cases. Furthermore, the translation and applicability of such a low-cost non-invasive intervention in a wider group of patients with pneumonia not specific to covid-19 infection, is an important consideration that merits investigation. This single-centred observational study conducted at Cambridge University Hospitals NHS Foundation Trust aims to improve understanding of physiological effects of prone positioning in non-ventilated patients with COVID-19 and a control group of patients with non-COVID-19 related pneumonia. The study also aims to incorporate a small subset of patients, with an approximately even spread of COVID-19 and non-COVID cases, which allows for an additional exploratory descriptive report on prone positioning over a 24-hour period. This study proposes that prone positioning improves oxygenation in non-ventilated patients with pneumonia (COVID-19 related or not) requiring supplemental oxygen managed outside of the critical care setting.
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.
Sheri Kashmir Institute of Medical Sciences
Due to COVID 19 (Corona virus disease)pandemic, majority of surgeries, including surgery for cancer patients got delayed across the globe. Surgeries were limited to emergency set up only. At our institute we tried to perform colorectal cancer surgeries through out the pandemic, albeit in less numbers, as we thought cancer in itself is an emergency setting. we are planning to analyse the prospectively managed database of this particular group of patients over a period of last six 6 months and look out at 30 day post operative morbidity and mortality. Besides we will try to analyse the implications of our decision to carry on with cancer surgeries in terms of number of health care workers who got infected while being involved in primary care of these patients.