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 428Fundació Institut Germans Trias i Pujol
The purpose of this study is to assess the efficacy of RUTI® vaccine preventing SARS-CoV-2 infection (COVID-19) in healthcare workers.
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.
CHU de Reims
Pancreatic adenocarcinoma will be the 2nd cause of death by cancer in Europe in 2030. Pancreatic adenocarcinoma has poor prognosis with an all-stages combined 5-year survival rate below 8%. Since December 2019, a new coronavirus (Severe Acute Respiratory Syndrome Corona Virus 2, SARS-CoV-2) is responsible of COVID-19 infection with potentially severe respiratory syndrome or even multi-organ failure. An increased risk of severe COVID-19 infection in cancer patients is suggested in several Chinese series. Cancer care structures quickly reorganized to limit high-risk situations (diagnostic procedure, major surgery, cytotoxic poly-chemotherapy) and use alternatives such as on-hold chemotherapy. These reorganizations could be associated with a loss of chance for pancreatic adenocarcinoma.
Assistance Publique - Hôpitaux de Paris
The current pandemic caused by the newly identified coronavirus responsible for COVID-19 is a major threat to our populations and societies. Hypothesis/Objective The acquisition of protective immunity at the level of the individual, either through vaccination or natural resolution of the infection, progressively leads at the level of the population to the reduction of the fraction of the population that can be productively infected and transmit the virus, hence, leading to the diminution of the rate of transmission, a phenomenon called herd immunity. Herd immunity was proposed as a strategy to control the infection. However, it remains difficult to model group immunity given the limited knowledge of the interaction between the host immune system with the virus, whose capacity to evolve in face of a neutralizing response is also not known. It is therefore important to acquire a better knowledge of the immunological memory that ensures the resolution of COVID-19 after SARS-CoV2 infection. Method To study single-cell B and T memory cells specific for the anti-SARS-CoV-2 response and characterize somatic mutations of immunoglobulin genes and TCR, in hospitalized and symptomatic patients and in patients cured of SARS-CoV-2.
Ain Shams University
Doctors are at high risk of corona virus infection (COVID-19) during pandemic. The investigators are aiming to explore the emotions, perceived stressors, knowledge and coping strategies of doctors who are working during COVID-19 pandemic in different specialties and in different hospitals by a self assessment questionnaire that was designed and modified from two previously published articles (mentioned in the references), including 7 sections with 88 questions.
Dhaka Medical College
As of March 18, 2020, COVID-19 cases were reported in approximately 195 countries. No specific therapeutic agents or vaccines for COVID-19 are available. Several therapies, such as remdesivir and favipiravir, are under investigation, but the antiviral efficacy of these drugs is not yet known. The use of convalescent plasma (CP) was recommended as an empirical treatment during outbreaks of Ebola virus in 2014. A protocol for treatment of Middle East respiratory syndrome coronavirus (MERS-CoV) with CP was established in 2015. This approach with other viral infections such as SARS-CoV, H5N1 avian influenza, and H1N1 influenza also suggested that transfusion of CP was effective. In previous reports, most of the patients received the CP by single transfusion. In a study involving patients with pandemic influenza A(H1N1) 2009 virus infection, treatment of severe infection with CP (n = 20 patients) was associated with reduced respiratory tract viral load, serum cytokine response, and mortality. In another study involving 80 patients with SARS, the administration of CP was associated with a higher rate of hospital discharge at day 22 from symptom onset compared with patients who did not receive CP. Accordingly, these findings raise the hypothesis that use of CP transfusion could be beneficial in patients infected with SARS-CoV-2. The objective of this study is to describe the initial clinical experience with CP transfusion administered to severe COVID-19 patients. The primary endpoint of this trial would be to assess the tolerability, efficacy, and dose-response of CP in severe COVID-19 patients. The secondary endpoint would be to assess the clinical and laboratory parameters after therapy, in-hospital mortality, length of hospital stay, reduction in the proportion of deaths, length of ICU stay, requirement of ventilator and duration of ventilator support. All RT-PCR positive cases with features of severe infection will be enrolled in this study. Apheretic CP will be collected from a recovered patient (consecutive two RT-PCR samples negative) between day 22 to 35 days of recovery and those with the antibody titre above 1:320. This RCT will consist of three arms, a. standard care, b. standard care and 200 ml CP and c. standard care and 400 ml CP as a single transfusion. Twenty (20) patients will be enrolled for each arm. Randomization will be done by someone not associated with the care or assessment of the patients by means of a random number table. Allocations will be concealed in sequentially numbered, opaque, sealed envelopes. Clinical parameters [fever, cough, dyspnea, respiratory rate, PaO2/ FiO2 level, pulse, BP, the requirement of O2, and others] will be recorded before and after CP. Laboratory parameters such as complete blood count, CRP, chest X-ray, SGPT, SGOT, S. Ferritin, and serum antibody titre will be measured before and after transfusion. Allergic or serum sickness-like reactions will be noted and adjusted with outcome. Laboratory tests including RT-PCR will be done at BSMMU virology and laboratory medicine department. Apheretic plasma will be collected at the transfusion medicine department of SHNIBPS hospital, ELISA, antibody titre will be done at CMBT, and patients will be enrolled at DMC and MuMCH. All necessary screening tests will be done before transfusion. Graphpad Prism v 7.0 will be used for analysis. One way ANOVA test, a non-parametric Mann-Whitney test, and a Kruskal-Wallis test will be performed to compare the arms. For parametric outcomes, the investigators will compare the odds ratios across the pairs.
Istanbul University
Behcet' disease (BD) is a chronic inflammatory disease which is characterized by oral and genital ulcers, uveitis and skin lesions. Musculoskeletal involvement such as arthrits, arthralgia, enthesis and sacroiliitis can be seen in course of BD. FMF is an autosomal recessive family disease characterized by abdominal pain, chest pain, joint pain and fever attacks as a result of inflammation of the serous membranes. FMF patients have been shown to experience higher levels of pain, fatigue, depression and anxiety than healthy controls, and this has increased sleep disturbance and reduced quality of life. FMF and BiH have common characteristics such as ethnicity, etiopathogenetic mechanisms, symptoms, and treatment. In December 2019, after the officially detected coronavirus (severe acute respiratory syndrome coranavirus-2 [SARS-CoV-2]) resistant to unknown treatment and rapidly spreading coronavirus in our country on March 11, 2020 in Hubei province of China, the number of cases increased rapidly and virus was isolated in 670 patients within 10 days. Ongoing concerns about the spread of Covid-19 infections have caused many measures to be taken. Among them, social isolation, home quarantine and avoiding collective places are the most important. In our country, in the process of social isolation, the areas of movement of Behçet and FMF patients, like everyone else, were restricted, their stress and anxiety levels increased and their motivation decreased. The aim of our study is to compare the pain, sleep, fatigue, physical activity level and quality of life and question exercise habits before and after the covid-19 outbreak in patients with Behçet and FMF.
Zagazig University
Assess response and attitude of general population living in Sharkia Governerate, Egypt as regard COVID-19 pandemic through arabic questionnaire.
Clinique Saint Pierre Ottignies
To build simple and reliable predictive scores for intensive care admissions and deaths in COVID19 patients. These scores adhere to the TRIPOD (transparent reporting of a multivariable prediction model for individual prognosis or diagnosis) reporting guidelines. The outcomes of the study are (i) admission in the Intensive Care Unit admission and (ii) death. All patients admitted in the Emergency Department with a positive reverse transcription-polymerase chain reaction SARS-COV2 test were included in the study. Routine clinical and laboratory data were collected at their admission and during their stay. Chest X-Rays and CT-Scans were performed and analyzed by a senior radiologist. Generalized Linear Models using a binomial distribution with a logit link function (R software version X) were used to develop predictive scores for (i) admission to ICU among emergency ward patients; (ii) death among ICU patients. A first panel of Number Models with the highest AIC (BIC) was preselected. Ten-fold cross-validation was then used to estimate the out-of-sample prediction error among these preselected models. The one with the smallest prediction error was in the end singled out .