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 210 of 270Janssen Vaccines & Prevention B.V.
The study will evaluate the efficacy of Ad26.COV2.S in the prevention of molecularly confirmed moderate to severe/critical coronavirus disease-2019 (COVID-19), as compared to placebo, in SARS-CoV-2 seronegative adults in the double-blind phase and to describe COVID-19 outcomes, safety, and immunogenicity in the different study cohorts in open-label phase.
University of Manitoba
Canada is entering the important yet dangerous phase of the COVID-19 pandemic: the reopening of industry. As such, there is an urgent need for a quick and accurate screening tool to help ensure people re-entering the workplace are COVID-19 negative. This proposal offers an innovative, simple-to-implement and quick screening tool for this purpose. This study hypothesize that breathing sounds of a COVID-19 positive person would have different characteristics even if the person is asymptomatic. This study aim the development of an integrated diagnostic pattern recognition tool in the form of a smartphone app, using audio and temperature as inputs to identify COVID-19 positive individuals. The proposed digital technology will screen individuals as healthy or possibly COVID-19 positive. The latter group will then be recommended for further testing. The goal of the proposed app is to provide much more accurate early screening (currently only temperature is taken), and to reduce the burden of COVID-19 tests. This digital technology will be used and tested in Manitoba initially and later nationally in Canada, with the potential of being publicly available in the future. To use the proposed screening tool, a smartphone is held within 1 cm of an individual's mouth and the individual instructed to take five deep breaths through the mouth. The individuals' breathing sounds will be recorded by the smartphone, while the participant's temperature will also be recorded by the heat camera. The app will first use its acoustic analysis to identify sounds as healthy or abnormal. If the outcome is abnormal, then a questionnaire will be provided, along with a further acoustic analysis to rule out other common comorbid conditions (e.g. chronic lung disease). Finally, based on the inputs, the diagnostic algorithm will decide if the individual should be referred for further testing or not. Since the proposed end product is a smartphone app, the two software partner companies will play a crucial role in the final integration and development.
Pluristem Ltd.
This clinical trial will examine if a new treatment of Mesenchymal-like Adherent stromal Cells (called PLX-PAD) can help patients intubated and mechanically ventilated due to COVID-19 to recover more quickly with less complications.
Department of Health and Human Services
This is a phase 3, randomized, observer-blinded, placebo-controlled study to evaluate the efficacy, safety, and immunogenicity of SARS-CoV-2 rS with Matrix-M1 adjuvant in adult participants and adolescent participants. Additionally providing a Booster Dose to fully vaccinated participants. A substudy is to be conducted at selected sites to evaluate the safety and immunogenicity of a fourth dose (second booster) of NVX-CoV2373 in adults and adolescents, previously fully vaccinated and subsequently boosted with a third dose (first booster)
Biocon Limited
This is a randomized controlled trial to evaluate the efficacy and safety of itolizumab in subjects hospitalized with COVID-19.
Uniformed Services University of the Health Sciences
This is a multi-center, observational study that will enroll 1) patients with severe COVID-19 who have agreed to undergo therapy with Seraph® 100 under the existing EUA; 2) patients (medical record data) that have been previously treated with the Seraph® 100 after the date of the EUA approval (17 April 2020), but before the date that the study is approved at the study site, and 3) a convenience sample of patients (medical record data) in a historical control group who were admitted to the ICU at participating sites with severe COVID-19 infection, meeting the EUA treatment criteria, but not treated with Seraph® 100 up to the time the PURIFY-OBS protocol is approved at the site
Vastra Gotaland Region
Paroxysmal atrial fibrillation (AF) induce, in the affected patient, a prominent negative effect on health-related quality of life (HR-QoL) and physical fitness. The health care utilisation is high and the patient does never know when the next attack of atrial fibrillation occurs. Therefore, is physical exertion often avoided due to fear of new attacks. Further, are shortness of breath and fatigue often present despite of prescribed modern drugs. Paroxysmal AF per se enhance markedly the risk to develop stroke and heart failure, which both are syndromes that cause further negative effect on the patient´s HR-QoL and physical fitness. Altogether, cause the symptoms in paroxysmal AF a vicious spiral where both VO2max and muscle function deteriorate. The problems with shortness of breath might be due to dysfunction in respiratory muscles. Physiotherapy led exercise within cardiac rehabilitation (PT-X) in combination with inspiratory muscle training (IMT) has shown positive effects in patients with permanent atrial fibrillation. However, to our knowledge, not yet investigated in patients with paroxysmal AF. Aim: Primary to investigate, in a multicentre randomised controlled trial, if PT-X in combination with IMT can impact HR-QoL in patients with paroxysmal AF. Secondary to investigate the effect of PT-X in combination with IMT regarding symptoms, physical fitness, physical activity and the number of atrial fibrillation attacks and health care costs compared to the control group, asked to live their usual life, during the study period. Expected outcome: PTX in combination with IMT can improve HR-QoL, respiratory muscle function, level of symptoms, physical fitness and physical activity in patients with paroxysmal AF. In addition, a reduced number of atrial fibrillation attacks could decrease the direct cost of health care.
Commissariat A L'energie Atomique
According to different projections, the COVID-19 outbreak currently happening in France and worldwide could result in millions of deaths in the absence of efficient therapies. The COVID-19 causative agent, the SARS-CoV-2, is a virus leading to respiratory system infections in human and for which there is currently no vaccine or treatment scientifically validated in clinical studies. In that context, therapeutic human neutralizing antibodies targeting the SARS-CoV-2 envelop glycoproteins and which enable inhibition of the viral replication represent an innovative therapeutic alternative with great potential. These antibodies are also critical tools for vaccine development. Simultaneously, CHUGA researchers coordinate with each other to set up a collective biological collection to achieve others objectives such as biomarkers identifications.
LumiraDx UK Limited
Evaluation of the agreement between fingerstick samples, venous blood, serum and plasma samples when using the LumiraDx SARS-CoV-2 Ab Test against the reference method, using standard qualitative comparison techniques.
Institut National de la Santé Et de la Recherche Médicale, France
The purpose of this study is to analyze in depth the relationship of myeloid cell subpopulations during infection by Severe acute respiratory syndrome coronavirus 2 (SARS-Cov2), the virus mediating Covid-19. Myeloid cells include neutrophils, monocytes and dendritic cells, each divided into subpopulations with different functions in immune defense and immune pathologies. The study is based on the following hypotheses: - Infection and the interferon response to infection may induce hyperactive or immunosuppressive differentiation of myeloid cells, that may be treated by specific inhibitors. - Some myeloid cell subpopulations currently identified in our laboratories might be markers for Covid-19 prognosis. - Alternative receptors may be present on myeloid cells, inducing the cytokine storm, a target for therapy. - The expression of Interferon (IFN) receptor and IFN responding genes on myeloid cells and on respiratory epithelial cells may correlate with prognosis and indicate potential treatment targets. - Interferon responses are known to be skewed during Covid-19, but some IFN subtype polymorphisms may correlate with prognosis and these subtypes migt be supplemented or inhibited for therapy.