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 370 of 439University of Edinburgh
COVID-19 is a community acquired pneumonia caused by infection with a novel coronavirus, SARS CoV2 and is a serious condition with high mortality in hospitalised patients, for which there is no currently approved treatment other than supportive care. Urgent investigation of potential treatments for this condition is required. This protocol describes an overarching and adaptive trial designed to provide safety, pharmacokinetic (PK)/ pharmacodynamic (PD) information and exploratory biological surrogates of efficacy which may support further development and deployment of candidate therapies in larger scale trials of COVID-19 positive patients receiving normal standard of care. Given the spectrum of clinical disease, community based infected patients or hospitalised patients can be included. Products requiring parenteral administration will only be investigated in hospitalised patients. Patients will be divided into cohorts, a) community b) hospitalised patients with new changes on a chest x-ray (CXR) or a computed tomography (CT) scan or requiring supplemental oxygen and c) hospitalised requiring assisted ventilation. Participants may be recruited from all three of these cohorts, depending on the experimental therapy, its route of administration and mechanism of action. The relevant cohort(s) for any given therapy will be detailed in the therapy-specific appendix. Candidate therapies can be added to the protocol and previous candidates removed from further investigation as evidence emerges. The trial will be monitored by an independent Data Monitoring Committee (DMC) to ensure patient safety. Each candidate cohort will include a small cohort of patients randomised to candidate therapy or existing standard of care management dependent on disease stage at entry. Cohort numbers will be defined in the protocol appendices. This is a Phase IIa experimental medicine trial and as such formal sample size calculations are not appropriate.
Spartan Bioscience Inc.
This study will evaluate the efficacy of various sample collection methods for use with the Spartan COVID-19 System. It will compare the results from the Spartan COVID-19 System with results that are obtained using a predicate lab-based COVID-19 test that uses a nasopharyngeal swab sample. The goal is to determine which sample collection methods are most effective in capturing SARS-CoV-2 virus.
SAb Biotherapeutics, Inc.
Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). SAB Biotherapeutics has developed SAB-185, an Anti-SARS-CoV-2 Human Immunoglobulin Intravenous (transchromosomic [Tc] bovine-derived), as a potential therapeutic to treat COVID-19. This study will evaluate the safety, immunogenicity, and pharmacokinetics of SAB-185 in healthy participants.
Escola de Saúde Pública do Ceará
The number of COVID-19 cases has been growing exponentially, so that the industrialized economies are facing a significant shortage in the number of ventilators available to meet the demands imposed by the disease. Noninvasive ventilatory support can be valuable for certain patients, avoiding tracheal intubation and its complications. However, non-invasive techniques have a high potential to generate aerosols during their implementation, especially when masks are used in which it is virtually impossible to completely prevent air leakage and the dispersion of aerosols with viral particles. In this context, a helmet-like interface system with complete sealing and respiratory isolation of the patient's head can allow the application of ventilatory support without intubation and with safety and comfort for healthcare professionals and patients. This type of device is not accessible in Brazil, nor is it available for immediate import, requiring the development of a national product. Meanwhile, a task force under the coordination of the School of Public Health (ESP) and Fundação Cearense de Apoio à Pesquisa (FUNCAP), with support from SENAI / FIEC and the Federal Universities of Ceará (UFC) and the University of Fortaleza (UNIFOR) advanced in the development of a prototype and accessory system capable of providing airway pressurization through a helmet-type interface, which was called the Elmo System.
Universitätsklinikum Hamburg-Eppendorf
In this phase I first-in-human clinical trial, healthy volunteers in two different dose cohorts will be vaccinated twice with the candidate vaccine MVA-SARS-2-S. A subgroup will receive a heterologous booster vaccination with a licensed COVID-19 vaccine. The aim of the study is to assess the safety and tolerability of the candidate vaccine and to characterize its immunogenicity.
Stanford University
The aim of the study is to demonstrate the feasibility and validity of a saliva based home surveillance monitoring test for SARS-CoV-2 infection. Participants will be asked to carry out as many tests as are included in the bag they are provided, on a daily basis until they are used up.
Azienda Ospedaliera "Sant'Andrea"
SARS-CoV-2 infection is a condition characterized by excessive leukocyte infiltration, massive release of chemokines, proteases and cytokines, the so-called "cytokine storm", which promote the inflammatory process and contribute to exacerbation of COVID-19 symptomatology. Because of the abnormal release of pro-inflammatory cytokines by non-neuronal cells of the immune system, such as the mast cells in periphery, and microglia at central level, the body activates a defensive neuroinflammatory process that, if not controlled, can become pathological. Therefore it's important to intervene early on neuroinflammation, in order to limit the progression of the disease. A possible intervention is represented by Palmitoylethanolamide (PEA), an endogenous molecule of the N-acylethanolamine family synthesized "on demand" in response to "stress factors" to restore tissue homeostasis, able to control mast cells and microglia uncontrolled activation. Experimental evidence in vitro and in vivo demonstrated the anti-inflammatory and neuroprotective effect of micronized and ultra-micronized PEA (mPEA and umPEA), confirmed in various clinical investigations conducted in patients with different pathological conditions. The aim of this study is to investigate the efficacy of a compound containing mPEA + umPEA on peripheral inflammatory markers, neuroinflammation, and others clinical parameters in intensive care patients with COVID-19 interstitial pneumonia.
CanSino Biologics Inc.
This study is a randomized, double-blind, placebo -controlled IIb clinical trial, in order to evaluate the safety and immunogenicity of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) in people 6 years old and above and .
Chulalongkorn University
This study will be conducted in 2 phases. Phase 1 of this study will be a single-centre, open label, dose escalation first in human (FIH) study conducted in 2 groups of healthy participants. Group 1 will enrol adults aged 18-55 years (inclusive); Group 2 will enroll elderly adults (elderly) aged 56-75 years (inclusive). Phase 2 of this study will be a single centre, the proposed design will be observer-blind, placebo-controlled study to assess the safety, reactogenicity, and immunogenicity of ChulaCov19 vaccine in healthy adults (18-75 years of age inclusive).
National Cancer Institute (NCI)
This is a phase I trial followed by a phase II randomized trial. The purpose of phase I study is the feasibility of treating patients with acute respiratory distress syndrome (ARDS) related to COVID-19 infection (COVID-19) with cord blood-derived mesenchymal stem cells (MSC). The purpose of the phase II trial is to compare the effect of MSC with standard of care in these patients. MSCs are a type of stem cells that can be taken from umbilical cord blood and grown into many different cell types that can be used to treat cancer and other diseases. The MSCs being used for infusion in this trial are collected from healthy, unrelated donors and are stored and grown in a laboratory. Giving MSC infusions may help control the symptoms of COVID-19 related ARDS.