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 370 of 1969IRCCS San Raffaele
Collect informations on the health status of transplanted patients (kidney, kidney / pancreas, pancreas or pancreatic islet) during the COVID-19 pandemic. All informations will be collected by short questionnaire via phone.
Johns Hopkins University
The purpose of this study is to evaluate the safety of administration of plasma containing antibodies to the SARS-CoV-2 virus (i.e., convalescent plasma) and if it is able to prevent disease or lessen the severity of disease in individuals who are at high risk of developing COVID-19 due to a recent exposure. This study will also measure the level of anti-SARS-CoV-2 antibodies in patient's blood after the administration of the convalescent plasma.
Hospices Civils de Lyon
The new Severe acute respiratory syndrome coronavirus (SARS-CoV-2) named coronavirus disease 2019 (COVID-19) is currently responsible for a pandemic spread of febrile respiratory infections, responsible for a veritable global health crisis. In adults, several evolutionary patterns are observed: i) a/pauci-symptomatic forms; ii) severe forms immediately linked to rare extensive viral pneumonia; and iii) forms of moderate severity, some of which progress to secondary aggravation (Day 7-Day 10). Children can be affected, but are more rarely symptomatic and severe pediatric forms are exceptional. Like some other coronaviruses (SARS-CoV and Middle East respiratory syndrome coronavirus (MERS-CoV)), these differences in clinical expression could be based on a variability in the immunological response, notably either via inhibition of the type I interferon (IFN-I) response, or on the contrary an immunological dysregulation responsible for a "cytokine storm" associated with the aggravation. Little is known about the impact of these innate immune response abnormalities on the adaptive response. In addition, certain genetic factors predisposing to a state of "hyper-fragility" and certain viral virulence factors could also be predictive of the clinical response. In this context, the main hypothesis is that the virological analysis and the initial biological and immunological profiles are correlated with the initial clinical presentation of COVID-19 infection. In particular, children forms and pauci-symptomatic disease in adults may be linked to a more robust innate immune response, including better production of IFN-I.
Institute of Tropical Medicine, Belgium
Due to the situation this study, originally planted until September 2020, was extended with 7 months until April 2021. This extension was approved by the ethical committee University hospital Ghent, Belgium. The novel SARS-CoV-2 (Severe Acute Respiratory Syndrome-associated Coronavirus type 2) is rapidly spreading over the world causing a condition called Coronavirus disease 2019 (COVID-19). Hospital health care workers (HCW) have received detailed instructions to protect themselves against this infection, but it is likely that at least some of the HCW will get infected either at their workplace or elsewhere. It would be useful to document prevalence and seroprevalence of SARS-CoV-2 and their monthly evolution among Belgian active hospital HCW during a period of 12 months starting beginning of April 2020 and the number of new cases (incidence) of COVID-19 and SARS-CoV-2 seroconversions among Belgian hospital HCW during a period of 12 months which are the primary objectives of this study. Additionally the study will validate serological tests (subject to change/addition depending on the evolution of scientific research) against the plaque reduction neutralization test (PRNT) (gold standard); validate the saliva sample (sampling with Oracol or equivalent) against the standard naso/oro pharyngeal swabbing (NOPS) to perform RT-qPCR for SARS-CoV-2 diagnostic purposes, as well as against the standard serology (serum); validate the nasal swab against the standard (NOPS) to perform RT-qPCR for SARS-CoV-2 for diagnostic purposes; investigate potential risk factors for the infection; quantify the proportion of asymptomatic cases among new cases that develop during a period of 12 months. To reach these primary and secondary objectives the researchers will conduct a prospective cohort study in which a random selection of HCW currently working in Belgian hospitals will be tested monthly (with for the first month an additional testing point at 14 days). The testing will include four kind of laboratory tests, being; a molecular (PCR) test on a nasopharyngeal, a saliva and nasal sample (for nasal and saliva sample only testing until 50 PCR positive and 50 PCR negative samples are collected) and a serological test for which a blood sample is needed. To asses risk factors, at each testing point a questionnaire providing basic socio-demographic and health characteristics of the HCW including presence of symptoms since the previous testing point and the HCW's involvement in caring for COVID-19 patients will be completed. Laboratory data and epidemiological data (questionnaire) will be collected simultaneously. In each of the participating hospitals, one contact person will be designated to coordinate the study locally (ideally a staff member of the local infection and prevention control team) and communicate with the researchers. The sample size calculation indicated the inclusion of 17 randomly selected Belgian hospitals and in each hospital 50 randomly selected HCW. HCW can only be enrolled in the study after give a written informed consent. Laboratory testing will be performed at the Virology Diseases and Immune Response services of Sciensano, Ukkel, and the Virology Laboratory of the Institute of Tropical Medicine, Antwerp. The laboratory test results will be communicated by the laboratory to each participant. Each participant and sample will have a unique code assigned. Data collected through the questionnaire will be send psuedonymised (using the unique code) to the epidemiologist at Sciensano. The laboratory will prepare a list of test results by unique code to be linked for further analysis with the questionnaire data. None of the researchers who will analyse the data will be involved in data collection, nor in the care of COVID-19 patients. This study is a Belgian multicentric study executed by Sciensano, Brussels, in collaboration with the Institute of Tropical Medicine, Antwerp.
University of Virginia
This is a single arm phase II trial to assess efficacy and confirm safety of infusions of anti-SARS-CoV-2 convalescent plasma in hospitalized patients with acute respiratory symptoms,with or without confirmed interstitial COVID-19 pneumonia by chest Xray or CT. A total of 29 eligible subjects will be enrolled to receive anti-SARS-CoV-2 plasma.Outcomes will be compared to hospitalized controls with confirmed COVID-19 disease through retrospective chart review.
Fondazione 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
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