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 110 of 117Instituto 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.
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).
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.
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.
Tanta University
The aim of this effort is to study host-pathogen interaction in Egyptian patients infected with COVID-19. The investigators will perform genome-wide miRNA and transcriptome screens in the infected patients along with healthy ones for comparison. All types of cytokines play pivotal roles in immunity, including the responses to different viral infections. Therefore, The investigators will study the cytokines profile in response to that infection. By comparing miRNA and transcriptome screens along with cytokines profiles, an important molecule might be identified that could play role in the inhibition of the COVID-19 outbreak. In addition, this information will help us gaining awareness of the immune process and knowing about the genes involved in the immune response against COVID-19 with an emphasis on the expression of cytokines.
Tongji Hospital
Some patients infected with the COVID-19 can develop uncontrolled immune response, leading to potentially life-threatening damage to lung tissue. Tocilizumab was first approved by the U.S. FDA in 2010 for rheumatoid arthritis and might now be used to treat serious COVID-19 patients with lung damage, according to China's National Health Commission updated its treatment guidelines in 7th version.Continuous Renal Replacement Therapy (CRRT) was recommended by China's National Health Commission treatment guidelines in 1st-7th version to control sever COVID-19 patients.
Department of Health, Philippines
This is an open label randomized controlled clinical trial which was designed to confirm the potential efficacy and safety of favipiravir in the management of patients with mild to moderate COVID-19 compared to best supportive care.
University of Milano Bicocca
The study aims to evaluate if the early prone-positioning in awake patients with mild Covid-19 pneumonia can reduce the need of high-flow oxygen-therapy, invasive or non-invasive ventilation and prevent the worsening of clinical conditions. Patients will be randomized on a 1:1 ratio and stratified based on the onset of symptoms (10 days) and need of oxygen therapy (no need; need). One branch of patients (interventional) will undergo standard of care treatment + prone-positioning cycles, the other one (controll) will undergo standard of care treatment alone. Patients will be evaluated evaluated on the day of the enrolment, on day 1, day 3, day 7 and every 7 days until the patient dismissal or until day 28 (whichever occurs first). Adverse events and concurrent medications will be noted as well. The analysis will be conducted according to "intention to treat" criteria; primary outcomes will be calculated using survival-based methods.
University Hospital, Ghent
This study aims to gain more insight in the immunological characteristics and immune response on a local level (the nose) and systemic level (the blood) of healthy people vaccinated with the current available COVID-19 messenger ribonucleic acid (mRNA; BNT162b2) and viral vector based (ChAdOx1) vaccines.