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 440 of 1634Regenexx, LLC
To evaluate and compare nebulized platelet lysate to placebo control of saline administered via handheld nebulizer 1x daily for eight weeks to determine effect on lung function in patients with post-COVID-19 ARDS syndrome.
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.
University Hospital, Toulouse
There is a pandemic in the world by COVID-19. Currently, the pharmacological curative or prophylactic treatments for this infection are not known. Recent studies have suggested that Hydroxy-Chloroquine could be effective in vitro and in vivo against COVID-19. The main objective of this study is to assess in patients with autoimmune disease treated with long course Hydroxy-Chloroquine initiated before the pandemic COVID-19 had an independent protective effect on the risk or the severity of infection with COVID-19.
Kaleido Biosciences
This exploratory, open-label clinical study aims to explore the physiologic effects of KB109, a novel glycan, on adult patients with COVID-19 illness on gut microbiota structure and function in the outpatient setting.
National Cancer Institute (NCI)
This phase I trial investigates breathing techniques and meditation for health care workers during COVID-19 pandemic. Breathing techniques and medication may help manage stress and improve lung health. The goal of this trial is to learn if breathing techniques and meditation may help to reduce stress and improve lung health in health care workers during the COVID-19 pandemic.
Koç University
The aim of the study is to investigate the potential effects of face-to-face supervised tele-rehabilitation to home exercise program on walking speed, handgrip strength, muscle endurance, quality of life, physical activity level and perceived respiratory disability in COVID-19 patients who hospitalized in ICU due to ARDS and discharged from hospital.
Centre Hospitalier Universitaire, Amiens
Postpartum depression (PPD) represent around 15% of birth in developed countries. The context of the COVID-19 epidemy represents a possible source of additional emotional distress. The objective of this study is to determine the screening prevalence and risk factors of postpartum depression, among women who deliver in fourth hospital in the North of France in the context of the COVID epidemy.
Confederation of Latin American Societies of Anaesthesiology (CLASA)
The objectives of this study are to analyze the best device for intubation in patients infected by SARS-CoV2 virus during COVID-19 pandemics and to review the optimal methods for airway management in such patients for elective surgery and in the Critical Care environment. Also, the safest methods for airway management in thoracic surgery will be analyzed. This study has a descriptive design with no hypothesis contrast, and it will explore the current picture in airway management in Spain. It is a multicentric international study, for all the centers where intubations of tracheostomies have been performed in patients diagnosed with SARS-CoV2 with positive PCR, either in the Critical Care setting or the operating room. A survey will be distributed among professionals who have been involved in airway management in COVID-19 patients in the following specialties: Anesthesiology and Critical Care Medicine, Emergency Medicine, Prehospital Medicine, Cardiology and Pulmonology. The study started on april 2020 after receiving approval from the Ethics Committee (General University Hospital of Valencia) COVID-19 infection causes respiratory failure needing ventilatory support, which required endotracheal intubation or tracheostomy. This situation poses a significant risk of transmission due to its usual urgent nature, and it often happens in the context of respiratory claudication. For this reason, studying the safest and useful methods for airway management in this kind of patients, using data based on the clinical experience, may be of great interest in the future. Statistical analysis will be performed using Statistical Software R, . Technical characteristics will be described using frequencies and percentages for categorical variables, and means and standard deviations or medians and interquartile ranges for continuous variables, depending on normality tests. Base characteristics, center and years of experience will be compared. A sample size calculation is not necessary, since it is an explorative and voluntary study, trying to establish which are the regular routines in airway management in COVID-19 patients in Spain and Latin America.