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 380 of 536University Hospital, Rouen
At present, the offer of tests for the serological diagnosis of CoVID-19 (detection of IgG, IgM or IgA antibodies against CoV-2 SARS) is plethoric and is based on the use of a very large number of rapid diagnostic unit tests, a few dedicated high throughput automated systems or reagents on existing open systems. The offer will continue to expand in the coming months. In order to meet the objectives mentioned by the Prime Minister, and confirmed in the HAS report of April 16, 2020 and in the opinion n°6 of the COVID-19 scientific council concerning the potential use of these serological tests at the end of the COVID-19 epidemic, the Virology laboratory wishes to validate the sensitivity and specificity of the tests it intends to use.
University of Michigan
To better understand the role of inflammation in COVID-19, we established the Michigan Medicine COVID-19 Cohort (M2C2). M2C2 is a funded and ongoing cohort which has currently enrolled over 1500 adult patients (≥18 years) with severe COVID-19 admitted at the University of Michigan. The purpose of M2C2 is to define the in-hospital course of these patients and understand the role of inflammation as a determinant of organ injury and outcomes in COVID-19.
Genova Inc.
A multicenter, randomized, double-blind, placebo-controlled trial for hospitalized moderate COVID-19 patients
Assiut University
The recent Coronavirus Disease 2019 (COVID-19), has caused a global pandemic, and development of safe, effective vaccines is mandatory to return back to pre pandemic life. Many vaccines have been developed and requested by the authorities after the emergency license issued. The main mechanism of protection is through humoral and cell-mediated immune responses that might reduce the potential for disease development or severity. Cytotoxic T cells clear virus-infected host cells and contribute to control of infection. Preliminary data are now available indicating safty and effecacy of different vaccines . The vaccines were tolerated, with induction of neutralizing antibodies and antigen-specific T cells against the SARS-CoV-2 spike protein. The aim of this work is to evaluate the immune responses in adults, aged 25-65 years, up to 8 weeks after vaccination with a single and double doses live inactivated (Sinopharm), mRNA (Pfizer/ Biontech) and viral vector (Oxford/AZ- ChAdOx1 nCoV-19) vaccines. The Th1- response ( interferon-γ and tumor necrosis factor-α cytokine secretion by CD4+ T cells) and antibody production predominantly of IgG1 and IgG3 subclasses as well as CD8+ T cells mono, polyfunctional and cytotoxic phenotypes, will be also measured.
Masaryk University
This study is a multicenter cross-sectional survey-based study conducted in four European countries (Czech Republic, Germany, Slovak Republic, and Turkey). An online questionnaire will be utilized to collect data from volunteer subjects following the STROBE reporting guidelines of cross-sectional studies.
University of Campania "Luigi Vanvitelli"
COVID-19, the coronavirus responsible for the pandemic that began at the end of 2019 in China, spreads through respiratory droplets and direct contact. The most common symptoms of the disease include fever, cough, asthenia or myalgia, wheezing and headache, and the most serious complication is acute respiratory distress syndrome (ARDS). The new coronavirus has continued to spread to multiple countries and continents so much so that the epidemic was declared a Public Health Emergency of International Interest (PHEIC) by the World Health Organization (WHO) on January 30, 2020. In the first phase of emergency worldwide, characterized by high morbidity and mortality, scientific interest has been mainly directed to the study of the transmission mechanisms of the infection, diagnostic tools and therapies for ARDS, especially in elderly and co-morbid patients. Interest has rapidly spread to other categories of patients and in particular to pregnancy, on which the virus could impact in different ways, with consequences for both the mother and the fetus. A recent systematic review that included all published reports on Coronaviruses (COVID-19, SARS, and MERS) in pregnancy showed that preterm delivery is the most frequently reported adverse event in these women, and that COVID-19 is associated with an increased risk of preeclampsia and caesarean section. Nonetheless, the limited sample size, the main inclusion of cases reported for acute respiratory symptoms, the lack of information on previous pathologies potentially capable of complicating pregnancy, do not allow for the extrapolation of strong evidence on the course of infection in pregnancy. Therefore, the current status of the scientific literature does not allow for general and wide-ranging implications. THe investigators therefore believe it is particularly useful to investigate maternal and fetal outcomes in this new broader scenario, including all pregnancies associated with asymptomatic or symptomatic SARS-CoV-2 infection, found in any gestational period, in order to evaluate in a "real world scenario" "Actual rates of maternal-fetal and neonatal adverse events
Laval University
People with chronic diseases including atherosclerotic heart disease, high blood pressure and diabetes are considered as a group with a high vulnerability. The COVID-19 pandemic ranging the world is rendering these people with chronic diseases even more vulnerable as they are subjected to a higher risk of COVID-19 related complications. General recommendations issued by the public health departments (PHD) do not take into consideration the personal situation of every citizen and therefore do not provide a personalized guidance to people with high vulnerability. The investigators hypothesis is that if participants receive adapted and personalized public health recommendations, they will be more adherent to the recommendations issued by the PHD and have better health outcomes than those who receive only general recommendations. In the current trial, the investigators propose to co-develop a web-based portal (Vigie-COVID) that provides tailored recommendations based on the situation of each participant and adapted to the COVID-19 status, the behavior risk associated to contamination, the risk of complications and the health risks related to confinement. Using a cohort of people aged 18 and over in the province of Quebec, this randomized clinical trial will use a nested a double-blind experimental design where the tailored recommendations will be compared to the general recommendations of the PHD. The expected results from this trial include: 1) Improvement in the rate of compliance with the PHD recommendations in the group receiving the tailored recommendations; 2) Improvement of the quality and the quantity of the COVID 19 epidemiological data available for population health research in the Quebec region; 3) Decrease in the load in clinics (self-diagnosis); 4) Improving the state of health of individuals. The portal will be co-constructed in collaboration between various key players (citizens, patient partners, clinicians, researchers, companies, managers, decision-makers and representatives of the PHD) and aims to allow the recommendations of the PHD to be tailored according to the specific situation of each citizen-user in order to promote preventive behavior in times of pandemic. Overall, the ultimate goal is to obtain a global epidemiological portrait in order to identify the determinants and indicators of sustainable health and their impacts. After the pandemic, this might enable the implementation of a personalized monitoring of chronic diseases.
Centre Hospitalier Universitaire de Nice
Loss of smell is very frequently found in Europe during Covid-19 attack. This symptom was not initially expected as part of the classic symptomatology. This loss of smell mainly concerns patients with few or no symptoms, without criteria of severity and usually treated on an outpatient basis. As a result, given the unexpected occurrence of this symptom (with less awareness in the general and medical population) and the potential risk of contamination of Covid+ and anosmic subjects (due to their less symptomatic form), it is interesting to be able to propose large-scale screening for loss of sense of smell in order to preferentially direct subjects diagnosed as anosmic towards RT-PCR-type screening. In the medium term, the loss of smell seems to persist after the infectious phase, with delayed or persistent recovery, which can lead to negative psychological repercussions. The objective is to propose large-scale screening of the general population for loss of sense of smell during a pandemic period, in order to facilitate diagnostic orientation of the population. The diagnosis of loss of smell will be carried out using a simple olfactory test in the form of an olfactory stick to be smelled.
University of Aberdeen
The World Health Organization (WHO) declared the 2019 novel coronavirus (COVID-19) a pandemic on March 11, 2020. As of 19 July 2020, there have been 14.3 million confirmed cases and over 600,000 confirmed deaths. Up to 14% of infected patients develop interstitial pneumonia, which may evolve to acute respiratory distress syndrome. COVID-19 associated pulmonary arterial microthrombosis and coagulopathy has prompted physicians to implicate pulmonary embolism (PE) as a potential cause for acute respiratory deterioration. Literature review reveals few studies of varying size, quality and design. Recent meta-analysis reports venous thromboembolism in approximately 20% of COVID-19 patients. There has yet to be a case-controlled study which proves and quantifies the associated between COVID-19 and PE.Confirming and quantifying this association has numerous clinical implications for the treatment of critically unwell patients with COVID-19 infection. For example, clinicians will be more inclined to investigate and treat sudden deteriorations with the knowledge that pulmonary embolism is the commonest cause for said deteriorations.
Liverpool University Hospitals NHS Foundation Trust
The aim of this study is to explore the acceptability and feasibility of a novel medical device system for autonomously monitoring of breath and heart sounds in Covid-19 (detecting and monitoring the progression of Covid-19 pneumonitis, by evaluating sounds captured through a wearable device (Senti)). As a first-in-man study, the investigators will investigate the safety of the Senti device, the usability and acceptability of the device; and ensure technical and practical feasibility of the device in a real-world clinical setting. Healthcare resources have been stretched substantially by Covid-19. Devices which enable patients to be monitored at home and direct these precious resources to those who require them are needed more than ever. 10 patients will be recruited (the study participants) in two tranches (6 and 4) who are being discharged from A&E into the community, with Covid-19. These patients will wear the Senti device. The first tranche will use the device over a single session lasting 20 minutes only. The second tranche (which will include patients from tranche one, and which will only proceed if no adverse events are detected in tranche one), participants will wear the device at their discretion (particularly encouraged to wear overnight) over the course of 5 days. The investigators will survey the study participants to answer three key questions: What is the feasibility of the Senti data-capture device? Is this device usable in clinical practice? What are the requirements to train patients to use the device? The investigators will also consider: Does the device function technically and practically, in real-world clinical scenarios? What are the key expected and unexpected safety issues related to using the device (with a particular emphasis on whether the device is likely to cause pressure sores)? These questions will establish the feasibility of using the Senti data capture device as part of a novel medical device system for the autonomous evaluation and monitoring of bioacoustic signals for Covid-19.