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 160 of 406Assiut University
COVID19 is n outbreak with unpredictable outcome
Beijing Normal University
Under the COVID-19, individuals who were home Quarantine experienced new challenges on their parent-child relationship and couple relationship. The current project aimed to provide psychological interventions for both parents and couples in order to improving their relationship. The online intervention of group intervention and individual intervention are going to be conducted. The relationship between parent-child, couples and emotion regulation will be tested.
Hospital Universitario Dr. Jose E. Gonzalez
In Mexico the total number of confirmed cases of COVID-19 is 232, 000 and 28,510 deaths. Health workers are at high risk of COVID-19 infection. Their absence from work dramatically limits the ability to contain the disease. There is currently no vaccine to prevent the disease. Since the introduction to the vaccination schedule of the Bacillus Calmette-Guerin (BCG) live attenuated vaccine directed towards tuberculosis prevention, a decrease in infant mortality has been reported, not related only to tuberculosis. BCG vaccine has been hypothesized to have a non-specific role towards other unrelated pathogens such as viruses that cause airway disease, with reduced morbidity and mortality. In murine as well as in human models it has been shown to decrease the incidence of acute respiratory influenza infections. Likewise, in countries with a high endemicity for tuberculosis, the BCG vaccine reduces the incidence of respiratory infections by up to 80% . In healthy subjects, the BCG vaccine increases the production of proinflammatory cytokines in monocytes. Likewise, it increases the epigenetic response, causing an increase in the transcription of genes important in the antimicrobial response, as well as an improvement in cellular function. This is the first national clinical trial to evaluate prospectively the effect that the BCG vaccine offers towards the prevention and reduction of severity in cases of COVID-19.
Direction Centrale du Service de Santé des Armées
Since March 2020, SARS-CoV2 virus (nCoV19; COVID-19) is considered pandemic. Its high rate of spread and infection in the human population and the lack of effective and validated treatment have led the authorities of several countries to confine their populations to slow the spread of COVID-19. As part of the management of this health crisis, the screening of individuals is essential in order to isolate "infected cases". These screening tests are currently performed on nasopharyngeal swabs using RT-PCR for the detection of viral RNA. Although sensitive and specific, these tests remain relatively long (2-5 hours), expensive and the strong international demand for nucleic extraction kits and enzymes are factors limiting the implementation of widespread screening (problem of supply of swabs, molecular biology consumables). In order to prevent the risks of a shortage of screening means, we propose to develop an innovative alternative strategy, PCR-free, based on the detection of specific protein signatures in human saliva by MALDI-TOF MS profiling. MALDI-TOF MS profiling is a method used in routine diagnostics by microbiology laboratories for the identification of microorganisms. MALDI-TOF MS profiling has been successfully used to classify individuals according to their infectious status (oral pathologies) based on the analysis of their saliva, but also as a tool for the identification of respiratory viruses from cell culture supernatants. In addition, we have expertise and skills in the field of MALDI-TOF MS profiling and have implemented new strategies to improve the quality of profiles and their analysis, particularly in the context of entomological and vector identification projects. Finally, recent Chinese studies have reported that COVID-19 was detectable in saliva by RT-PCR. The main objective of this study is to develop a test based on the MALDI-TOF profiling method to detect individuals infected with SARS-CoV2 from saliva sample.
Hospices Civils de Lyon
Context: Based on currently available data, most of national health authorities and consensus expert groups have written guidelines for the management of cancer patients in the context of COVID. However, the preparation of these guidelines was limited by the scarcity of solid epidemiological data. For example, the experts were uncomfortable to formulate precise guidelines on which anti-cancer treatment should be interrupted or replaced, on which patients, and how to adapt supportive drug prescriptions. Objectives : - To measure the excess risk of mortality and morbidity of patients with a history of cancer among patients hospitalized for a SARS-CoV-2 infection. - To identify factors associated with the risk of death and morbidity among patients with cancer. Methodology: Retrospective inclusion of n=200 cancer patients hospitalized for COVID and n=400 matched (based on age, gender, and comorbidity) non-cancer patients hospitalized for COVID. Two analyses will be performed (after the inclusion of n=100 and n=200 patients with cancer). A logistic modeling of the odds ratio of death associated to the exposition factor (i.e. cancer) and adjusted for the matching parameters (age, gender, comorbidities) will be proposed. We will then look for the factors (related to the patients, the cancer or the treatment) that modify the odds radio. Expected results: The data generated will help the medical and scientific community to evaluate the increasing risk of cancer patients infected by SARS-CoV-2 compared to the non-cancer population, to identify patients at higher risk of severe infection, but also the anticancer treatments associated with an increased risk of severe infections. Impact: These data will contribute to guide the future recommendations concerning cancer patient's care in the context of the COVID-19 pandemic. There is a real risk that the SARS-CoV epidemic, or other respiratory viruses epidemic, will become recurrent in the future. Thus, it is of crucial importance for now and for the future to know which are the major factors associated with severe infections
Centre d'Investigation Clinique et Technologique 805
Description of the neurological impairment: clinico-radiological and electrophysilogical correlations
Hospices Civils de Lyon
The actual COVID-19 epidemy is an unprecedented healthcare problem. Although acute respiratory distress syndrome is the main organ failure, acute kidney injury (AKI) has appeared to be more frequent and more severe than expected. Some data suggested a potential direct renal tropism of the virus, or undirect injury by "cytokine storm". The aims of this study are: 1. To describe incidence, severity and mortality associated with AKI during covid-19 infection in ICU 2. To identify specific risk factors for AKI 3. To explore pathophysiologic mechanism of AKI during COVID-19 infection
University of Sao Paulo
Data show that the coronavirus disease 2019 (COVID-19) symptoms can be severe in 4% and 3% of the adolescents aged 11-15 years and ≥ 16 years, respectively. In addition, the prevalence of chronic diseases among adolescents has increased in the last years. About 20% of the adolescents have some chronic disease, resulting in increased morbidity and mortality. In march, 2020, the quarantine was officially implemented in Sao Paulo, while elective medical appointments for adolescents with chronic disease were temporarily suspended. To mitigate the deleterious effect of the social isolation on physical and mental health among these patients, this study aims to test the effects of an online, home-based, exercise training program.
Silesian Centre for Heart Diseases
SAR-Cov-2 infection and its clinical manifestation known as COVID-19 beside the respiratory and lung involvement may include the cardiovascular system, the nervous system and the liver. In the acute phase of the disease, all of these conditions may be life-threatened. As a result, after the acute phase of COVID-19, early complications may be observed, including heart, lungs, brain, muscles and liver. A few papers to date have been reported of myocarditis, ventricular arrhythmias, post-inflammatory changes in the lung and liver, as well as ischemic changes in the brain, diseases of skeletal muscle, which may have adverse prognostic effects. Due to the extent of the pandemic, the severity of the complications and the expected high complications' prevalence in the early post-recovery period, a study was designed to determine the extent of the problem of early complications after COVID-19. Complex cardiological, pulmonary, neurological and hepatological diagnostics are planned, including laboratory, imaging and functional tests. The results obtained, in addition to determining the scale of the problem, will allow the selection of studies that optimally identify patients with early complications. The purpose of this procedure is to enable rapid treatment of diseases that are complications of SARS-COV-2 infection. An additional aspect raised in the project will be the issue of psychiatric disorders (anxiety, depression, post traumatic disorders). The main three purposes of the study include: 1. the assessment of prevalence of particular complications after COVID-19. 2. identification of the demographic and clinical risk factors of COVID-19 complications 3. determining the diagnostic tests which are sufficient to detect early complications of COVID-19
Imperial College London
A novel Coronavirus (COVID-19) infection leading to pneumonia and severe acute respiratory failure [acute respiratory distress syndrome (ARDS)] and death is a global threat. On 11/03/2020, WHO declared the Covid-19 outbreak a global pandemic. As of 18th of March, there are 202,309 confirmed cases with 8,013 deaths. Patients with severe illness may develop dyspnoea and hypoxemia within 1week after onset, which may quickly progress to ARDS or end-organ failure 1. Based on Chinese data abnormal coagulation parameters (Prolonged Prothrombin time [PT] and raised D dimer) are reported to predict a poor prognosis and may therefore be important therapeutic targets. The number of patients with infected with COVID- 19 in UK is rapidly rising as with many other European countries. Eventually >50% of people will have become infected and COVID-19 will remain a public health threat in the long term. It is therefore very important to understand every aspect of this disease, including the associated coagulopathy leading bleeding, blood clots (thrombosis) and death. Emerging data from Europe and some centres in UK, indicates that venous thromboembolism (VTE), mainly pulmonary embolism (PE), is major problem in COVID patients. In this retrospective-prospective: multicentre study, investigators will document the patient characteristics, presenting haematological parameters and associated comorbidities and their association with bleeding, thrombosis and mortality in patients admitted for hospital treatment. Determining the predictive value of patient characteristics and presenting laboratory measurements for clinical outcomes in these patients will allow us to optimise management of these patients in the future. Furthermore, by comparing these data with data from patients without Covid-19, investigators will be able to modify existing protocols and tailor them to the management of COVID -19.