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 280 of 354LifeBridge Health
Coronavirus disease 2019 (COVID-19), a viral respiratory illness caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has been shown to predispose patients to thrombotic diseases (venous and arterial) with reported rates in hospitalized patients between 17-40%. The influence of SARS-CoV-2 infection on the coagulation is hypothesized to be regulated by platelet activation, proinflammatory cytokines, endothelial cell injury and stasis. The elevated levels of d-dimer and fibrinogen and clinical signs of organ damage point to a significant hypercoagulable state. The latter induces a high risk for micro-thrombi and multi-organ ischemia. Therefore, early detection and a comprehensive understanding of the influence of the virus on the coagulation and platelet pathways are essential to address this epidemic. It is critical at this time to make all efforts possible to optimize our available technology to care for COVID-19 patients who are at risk for thrombotic disease through appropriate choice, dosing, and laboratory monitoring of antithrombotic therapy. The investigators hypothesize that COVID-19 is a heightened prothrombotic/hypercoagulability state that can be characterized using platelet function testing and thrombelastography. More information is required to study the effect of COVID-19 on coagulation and platelet pathways to develop effective antithrombotic treatment strategies. This is a multi-center center, non-interventional study enrolling patients who are COVID-19 positive or who have tested negative showing indication of the disease (high D-dimer and positive lung imaging). The study specific laboratory assessments will be obtained at baseline (closest to time of hospitalization), Day 3, and Day 8 from baseline and at hospital discharge. Laboratory measurements for TEG 6S , platelet aggregation, T-TAS, urinary thromboxane, genotyping, serum and plasma biomarkers will be analyzed . In-hospital and clinical follow-up data will be entered into a COVID registry Patients will be followed for clinical events during hospitalization, and up to 6 months after discharge. Patients (n=100) hospitalized with at least one of the following will be enrolled. 1. With a confirmed diagnosis of COVID-19 infection using a positive RT- PCR or a positive IgG antibody test prior to or during hospitalization or 2. With a negative COVID-19 RT-PCR test but with symptoms of possible COVID-19 infection and: 1. an elevated D-dimer and/or 2. positive imaging results showing unilateral or bilateral pneumonia or ground-glass opacity in lungs.
PUNEET MITTAL
While novel drug discovery and vaccine studies are time taking process, re-purposing old drugs against the COVID-2019 epidemic can help identify treatments, with known pre-clinical, pharmacokinetic, pharmacodynamic, and toxicity profiles, which can rapidly enter Phase 3 or 4 or can be used directly in clinical settings. Immunofree has many of the herbs which have been evaluated by other trials published for Covid-19 treatment. The Immunofree tablet of the test product is an Ayurvedic proprietary medicine and is a combination of polyherbal mixture. The components of this formulation are known for their anti-viral and immunomodulatory effects. Also, Reginmune, owing to its immunomodulatory effect might help in easing the symptoms and decrease the viral load.
Corporacion Parc Tauli
Ycovid-19 aims to be a rapid diagnostic test for SARS-CoV-2 infection, which will allow a reliable diagnosis to be made in 10 minutes, and on easy-to-use devices. This test will be developed using innovative technology developed at the Parc Taulí University Hospital, which increases the immunogenicity of SARS-CoV-2 differential antigens. The increased immunogenicity of these antigens will allow to detect, with a high sensitivity and specificity, the antibodies in the serum of patients infected with SARS-CoV-2. This test will serve to confirm dubious results as well as reduce false negatives from the PCR test, which will ultimately help reduce transmission of the infection.
Hong Kong Sanatorium & Hospital
Achieved serum samples of persons with or without evidence of COVID-19 infection are tested using the different commercial SARS-CoV-2 antibody immunoassays. The performance of the immunoassays is then assessed by comparing the 2 groups of samples.
University Hospital, Basel, Switzerland
The study is to investigate the antibody response in the blood and saliva of people with a known COVID-19 infection in the canton of Baselland.
Ministerio de Salud de Ciudad Autónoma de Buenos Aires
The pandemic of a new coronavirus SARS-COV-2, which causes COVID-19 disease, has spread rapidly and is a major public health challenge. While the focus is primarily on containing the number of cases and finding alternative therapies, information is still lacking to elucidate the dynamics of viral circulation and to understand the distribution of the infection in the population. The cases reported in Argentina and worldwide could plausibly represent only a small proportion of the number of asymptomatic or poorly symptomatic cases that exist in society. However, the magnitude of this dissociation between symptomatic cases and asymptomatic persons is unknown. Knowing this information is of strategic importance as it will allow the estimation of a community prevalence and the evaluation of the best containment strategy. In fact, although all social distancing measures are now indispensable, the feasibility of prolonging the measure over time is a complex issue and in any case will require population-based information. The best way to approach the estimation of a true population prevalence is to take representative samples from the population and test them periodically. These experiences were carried out in other contexts showing heterogeneous results within the community studied. In Spain, for example, the range of antibodies present in the population varied from 1.1% to 14.2%, also showing that an important part of the population had had contact with the virus without symptoms. Studies in Switzerland and the United States also show similar findings. However, these estimates are not automatically transferable to other settings. The city of Buenos Aires has a particular demographic composition with an important group of the population living in shantytowns (it is estimated that between 7% and 10% of the population lives in shantytowns) and with much heterogeneity among the different communes of the city. In the villas, the incidence rates of COVID-19 infection differ significantly from those present in the group "outside the village". However, there is also an important difference in the incidence rates by commune, even without considering the villas. Thus, it is important to know the sero-epidemiology of antibodies against SARS-COV2 in a representative sample of the city of Buenos Aires. For this purpose, a nationally produced test (COVIDAR IgG) developed by professionals from CONICET and Instituto Leloir will be used. The aim of this initiative is to estimate the true dimension of the COVID-19 epidemic in the City of Buenos Aires, by studying the immunological status of the Buenos Aires population in relation to SARS-Cov2, as well as to observe the evolution of the infection among the population, since this information is essential to guide future public health measures related to the control of COVID-19. To achieve this objective, a comprehensive sero-epidemiological study will be carried out to provide estimates of past SARS-Cov2 infection with sufficient precision to be representative of the sero-epidemiological status of the Buenos Aires city population.
Port Said University
Clinical Picture: Symptomatic COVID-19 presents with a recognizable clinical syndrome that is predictable prior to testing. Clinical judgement remains important, particularly when interpreting negative test results; 2. Biomarkers Associated with COVID-19 Patients: The most common laboratory features reported in patients with COVID-19
Presidency of Health Institute Turkey (TUSEB)
COVID-19 is an infectious disease caused by a newly discovered Coronavirus which was first identified in Wuhan, China in December 2019. Then the novel coronavirus outbreak was described and announced as a pandemic by World Health Organization (WHO) on March 11, 2020. Reverse transcription-polymerase chain reaction (RT-PCR) is currently the gold standard test for diagnosis of COVID-19. Nevertheless, due to its high false-negative rates (%10-50), diagnosis and treatment decisions do not depend on RT-PCR alone. Clinical presentation of patient and radiological findings are also important. However, neither clinical presentation nor computed tomography (CT) findings are specific for COVID-19. As a consequence of these challenges, the diagnosis of the disease and the protection of the community health become more difficult. The investigators of this study hypothesized that deep learning-based decision support system may help for definitive diagnosis of COVID-19. The aim is to develop a deep learning-based decision support system algorithm based on clinical presentation of patient, laboratory and CT findings and RT-PCR data. Previously, deep learning algorithms with the use of widely known deep neural network architectures such as Inception, UNet, ResNet were developed. However all of these studies were based on CT findings. There are not any deep learning study in literature combining the clinical, radiological, and laboratory findings of patients. The project is based on the available data of COVID-19 patients that will be obtained from the Ministry of Health. Then the data will be evaluated for relevance and reliability and labeled for the training of machine. Following the anonymization of data, data will be processed according to the predetermined inclusion-exclusion criteria. Thorax CT data will be labeled as typical / indeterminate / atypical / negative for COVID-19 pneumonia. Also, CT images of patients with known non-COVID-19 diseases will be labeled for the training of machine. Then, fever, lymphocyte count, neutrophil to lymphocyte ratio, contact information, RT-PCR findings will be labeled. Subsequently, the patients will be labeled and the machine will be trained with deep learning method with the help of this grouped and labeled data. Following the training phase, the algorithm will be tested and if the machine reaches the target specificity and sensitivity, the prototype will be tested. And then, the prototype will be embedded into the hospital software system. This software and algorithm will serve as an early warning system for clinicians and provide a better diagnostic rate especially with decreasing false-negative results. The effects of a pandemic cannot be measured by only the number of people diagnosed and isolated, or treatment provided. A pandemic affects not only community health but also individuals' psychological status, education, teaching methods, working models, daily lifestyles, producer/consumer behaviors, supply/demand balance; in other words every single area of life. On top of that, a pandemic causes long-term damages hard to reverse. The software will increase the diagnostic success rates, help to control the pandemic and minimize the collateral damages mentioned above. The investigators believe that, the product that will be produced at the end of this project will be of great benefit in controlling the secondary wave of COVID-19 expected to occur.
Agence de La Biomédecine
During the COVID-19 pandemic, the French Agency of Biomedicine has recommended maintaining fertility preservation for patients requiring immediate oncological treatments exhibiting gonadotoxic effects. However, no study has examined the presence of SARS-CoV-2 in sperm from cancer patients. This study aims therefore to detect the presence of SARS-CoV-2, specifically in the seminal fluid and the spermatozoa fractions of cancer patient semen. The investigators will determine if the virus presence in sperm is associated with its presence in the nasal swabs, COVID symptoms, specific serological profiles and particular oncological pathologies/treatments.
Glasgow Royal Infirmary
As of 27th May 2020, approximately 5.7 million people worldwide are known to have been infected with COVID-19 coronavirus and more than 350,000 have died (1). The severity of this viral disease for an individual is associated with a widespread perturbation of immune, physiological and metabolic parameters (2, 3). These whole body changes could be considered characteristic of a systemic inflammatory response to tissue injury and it has been long recognised that a large and ongoing systemic inflammatory response is associated with the development of multiple organ failure and infective disease (4, 5). One of the cardinal signs of severe COVID-19 infection is a marked systemic inflammatory response (2). This response bears striking similarity to the systemic inflammatory response experienced by patients undergoing major elective surgical resections for cancer (6, 7). Indeed, the systemic inflammatory response and the associated metabolic stress has been most well characterised in major elective surgery, where the relationship between the magnitude of the post-operative systemic inflammatory response and the development of post-operative complications is now well recognised, as is the effect of patient comorbidity on this relationship (8, 9). Such work has informed therapeutic manoeuvres including minimally invasive surgery, pre-operative optimisation (e.g. anaesthesia, nutrition and steroids) and enhanced recovery protocols. The aim of the present study was to examine whether routinely collected clinicopathological characteristics of patients with COVID-19 on admission were informative on the immune and metabolic stress experienced by patients with COVID-19 and whether such characteristics were informative on subsequent outcome.