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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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
Instituto Ecuatoriano de Enfermedades Digestivas
The novel COronaVIrus Disease 19 (COVID-19) outbreak has impacted daily activities in nearly 210 countries and territories worldwide. In Ecuador, the city of Guayaquil has nearly two-thirds of the COVID-positive patients in the country and nearly 40% of infected individuals are health-care related personnel. Nonemergent, emergent and urgent endoscopic procedures are necessary to be performed during the COVID-19 pandemic. Several experiences in the management of the endoscopic unit during the pandemic has been proposed. We aimed to prospectively evaluate a strict protocol for preventing potential nosocomial infection of COVID-19.
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.
Association Française pour l'Etude du Foie (AFEF)
Background: The COVID19 and liver relationships are very rare. The preliminary Chinese data indicate that 2-11% of patients treated for COVID19 had an underlying chronic liver disease. However, there is no clinical data on morbi-mortality in this context. Objectives: Primary Objective: Evaluate the mortality related to Covid-19 in patients with a chronic liver disease Secondary objectives: - Evaluate the mortality (liver-related and no liver-related) due to the Covid-19 according to the cirrhotic status, an history of hepatocellular carcinoma, an immunosuppressive treatment and its type, the etiology-ies of liver disease at the diagnosis of Covid-19 (viral hepatitis -B and/or C-, liver disease related to alcohol consumption, metabolic syndrome, hemochromatosis, immune liver disease, other or unknown), and comorbidities - Evaluate the liver morbidity related to Covid-19, including - incidence of liver biochemical abnormalities in patients with normal liver enzymes values or of a 2-fold increase of usual values for AST, ALT, GGT, Alcalines Phosphatasis - incidence of liver complications (acute hepatitis, liver insufficiency, decompensation of cirrhosis, encephalopathy, renal insufficiency) Patients: All patients with a liver disease (chronic or acute) with a positive diagnosis of Covid-19 assessed either by positive PCR or specific thoracic abnormalities at TDM Methodology: Observational ambispective study consisting exclusively of a collection of data from patients with liver diseases and managed for COVID 19 The data is collected and transcribed on a secure electronic eCRF hosted at the Assitance Publique des Hôpitaux de Paris and accessible online from the AFEF website Duration and organisation of the research: After information of the patients and making available a non-opposition form, the main demographic and clinical data related to the liver disease and to the COVID19 already collected in the patient's medical record will be collected in a dedicated e-CRF. Effective of the study: All consecutive patients included in the study whose data are collected e-CRF until 31/12/2020.
Damanhour University
During the COVID-19 pandemic, governments issued movement restrictions and placed areas into quarantine to reduce the spread of the disease.Community pharmacists and their teams are a vital healthcare provider during the outbreak; they remain on the frontline of public health by serving as direct points of access for their patients. The retail pharmacists should provide public community, costumers and patients with right and trusted information about covid-19. They also should have role in awareness spreading regarding personnel safety and hygiene
University Hospital, Strasbourg, France
Acute respiratory failure (ARF) is a common condition and a common reason for urgent medical consultation. Assessing the extent of respiratory impairment is important to improve the management of patients with ARF. When Acute respiratory failure is caused by pathology of the pulmonary parenchyma, quantification of pulmonary radiographic involvement may be a component of the initial assessment of severity. This radiographic quantification would only be usable in clinical routine if it can be automated and provide a real-time result. The objective of this work is to assess the feasibility of an automated technique for quantifying radiological lung damage in situations of known or potential ARF.
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.
London Health Sciences Centre
The research team is investigating administering exogenous surfactant in COVID-19 patients with ARDS. The overall goal is to improve the outcome (mortality) of mechanically ventilated COVID-19 patients. Although the investigators anticipate that clinical outcomes may improve in the small group of patients receiving exogenous surfactant therapy in this small, single center study, the primary goal is to first determine feasibility and safety.
Prisma Health-Upstate
This protocol will evaluate the efficacy of Therapeutic Plasma Exchange (TPE) alone or in combination with ruxolitinib in COVID positive patients with PENN grade 2, 3, 4 cytokine release syndrome (CRS). It is hypothesized that dual intervention of acute apheretic depletion of cytokines and concomitant suppression of production will produce superior amelioration of the cytokine load and to help to prevent cytokine load rebound. This protocol is envisioned as a pilot study (n=20) for hypothesis generation for future investigation.
UnitedHealth Group
Minimal risk research study: 1. Comparing polyester nasal swabs and foam nasal swabs to detect SARS-CoV-2 virus; 2. Quantifying the development and trajectory of the disease through clinic visits and blood values.