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 180 of 943Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Older age is an independent poor outcome predictor among COVID-19 hospitalized patients . Among 72,314 COVID-19 cases, case fatality rate (CFR) was 2.3% in total population, 8% in people aged 70 to 79, and 14.8% in those aged 80 and older. In the whole population, CFR was higher in people with comorbidities, ranging from 5-6% in persons with hypertension, chronic respiratory disease, diabetes or cancer, up to 10% in those with cardiovascular diseases. Sars-CoV-2 seems to be able to induce a functional exhaustion of specified T and NK lymphocyte subpopulations, breaking down antiviral immunity. One possible explanation is that the immune system of elderly people, might be exhausted by chronic stimulation associated with comorbidities and more susceptible to this Sars-CoV-2 effect. As a result, in these patients, the activation of the innate immune system might fail to produce an adequate adaptive response (i.e., virus-specific CD8+ T-cells). This results in persistent self-induced inflammation that eventually causes mortality. The investigators hypothesize that transfusing convalescent plasma (containing neutralizing antibodies) at an early phase of COVID-19 infection could prevent or switch off the persistent inflammatory response elicited by the virus. The objective of this study are: - To demonstrate the superiority of COVID-19 convalescent plasma (CCP) plus standard therapy (ST) over ST alone - To prevent progression of pneumonia in COVID-19 patients aged ≥65 with chronic comorbidities - To decrease viral load - To raise anti-SARS-CoV-2 antibody titer in recipients
AdventHealth
Convalescent plasma has been administered to treat different infectious diseases previously with some success. There is currently no approved and proven treatment options available for the novel coronavirus disease (COVID-19 virus). Some early data has shown a potential benefit in treating hospitalized patients who have tested positive for COVID-19 with convalescent plasma infusions of fresh plasma donated by fully recovered COVID-19 patients. The antibodies present in the recovered patients' plasma may be of benefit in helping critically ill and infected patients recover from the COVID-19 virus.
Barts & The London NHS Trust
In early 2020 the evolving COVID-19 Pandemic provided the world and medical community with a generational challenge. As a novel disease, countries were left with strategic decisions and many went into social lockdown. Initial resources and research were directed at upscaling internal medicine and intensive care services, understanding the disease pathophysiology, and testing treatments. It soon became evident that COVID-19 had multi-system effects at it's worst. In orthopaedics one of the most vulnerable groups to COVID-19 were the elderly, specifically those who suffered fractured neck of femur at this time. More literature is needed urgently if we are to understand and mitigate the negative impacts in this group of patients. This observational study assesses the early morbidity and mortality of patients with this diagnosis during the evolving COVID-19 Pandemic.
Kanuni Sultan Suleyman Training and Research Hospital
Novel Coronavirus is reported to cause COVID-19, recently. It's known that this virus uses ACE (angiotensin converting enzyme) 2 receptors to enter human cells and also blocks the activity of ACE 2. Upon these data the investigators hypothesize that, mortal hyper-inflammation state which is shown in COVID-19 cases, can be a result of angiotensin peptide (1-7) deficiency. Therefore, the aim of this study is to evaluate the possible effect of angiotensin peptide (1-7) supplementation on treatment of COVID-19 cases.
Memorial Sloan Kettering Cancer Center
The study researchers think that a medication called N-acetylcysteine can help fight the COVID-19 virus by boosting a type of cell in your immune system that attacks infections. By helping your immune system fight the virus, the researchers think that the infection will get better, which could allow the patient to be moved out of the critical care unit or go off a ventilator, or prevent them from moving into a critical care unit or going on a ventilator. The US Food and Drug Administration (FDA) has approved N-acetylcysteine to treat the liver side effects resulting from an overdose of the anti-inflammatory medication Tylenol® (acetaminophen). N-acetylcysteine is also used to loosen the thick mucus in the lungs of people with cystic fibrosis or chronic obstructive pulmonary disease (COPD). This study is the first to test N-acetylcysteine in people with severe COVID-19 infections.
University of Minnesota
Objective: To determine if pre-exposure prophylaxis with hydroxychloroquine is effective for the prevention of COVID-19 disease.
Flanders Institute of Biotechnology
Phase IV study to evaluate the effectiveness of additional inhaled sargramostim (GM-CSF) versus standard of care on blood oxygenation in patients with COVID-19 coronavirus infection and acute hypoxic respiratory failure.
Johns Hopkins University
Evaluate the efficacy of treatment with high-titer Anti- SARS-CoV-2 plasma versus control (SARS-CoV-2 non-immune plasma) in subjects exposed to Coronavirus disease (COVID-19) at day 28.
Nantes University Hospital
COVID-19 (Coronavirus Disease-2019) is a life-threatening infectious disease caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that appeared in December 2019 in the Wuhan district. COVID-19 has since affected more than 150 countries across the world and especially France. The first epidemiological data, mostly from Chinese studies, indicate that diabetes is one of the most common comorbidities, with high blood pressure, in patients with COVID-19. Moreover, the presence of diabetes at admission would be a risk factor for both ICU hospitalization and death. Nevertheless, specific data on people with diabetes and COVID-19 are fragmentary, justifying the achievement of a dedicated prospective observational study. The French nationwide CORONADO study aims to specifically describe the phenotypic characteristics of patients with diabetes admitted to hospital with COVID-19 infection. Particular attention will be devoted to glycemic control at admission (i.e. the level of HbA1c), the diabetic complications, as well as anti-diabetic and antihypertensive therapies. This study will provide answers to caregivers and patients with diabetes regarding the risk factors related to diabetes for COVID-19 prognosis. This pilot study will be used for the development of new studies and for the establishment of recommendations for the cost of care in patients with diabetes and COVID-19.
Institut Pasteur
On January 2020, the discovery of a new coronavirus (SARS-CoV-2) was officially announced by the Chinese health authorities and the World Health Organization (WHO). Its complete genome was sequenced by the laboratory of respiratory infection viruses at the Institut Pasteur on 29 January 2020 in France. This will allow the identification of antigenic structures involved in the immune response and the development of serological diagnostic tests. Many questions are being asked about this new virus and the infection it causes, including questions about the percentage of asymptomatic and pauci-symptomatic forms. Serological studies can provide answers to these questions. There is no serological test for SARS-COV-2 yet, but the laboratory of respiratory infection viruses at the Institut Pasteur is working on its development. This study proposes to carry out a collection of samples taken from subjects who travelled to China before the epidemic outbreak or suspected of being infected with SARS-CoV-2. As soon as it is available, serology will be performed on the collected samples.