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 330 of 381Institut National de la Santé Et de la Recherche Médicale, France
Study of COVID-19 seroprevalence in precarious population living in shelters of Samusocial de Paris and in staff working in these centers during COVID-19 epidemic.
Bioreference, Inc
This study compares SARS-CoV-2 immune responses in high pretest probability swab negative hospitalized PUI patients vs. low pretest probability swab negative hospitalized APS (Asymptomatic Persons being Screened) patients to try to understand the appropriateness and safety of clinical decisions made in these patient populations based on swab results.
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.
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.
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.
Children's Hospital Medical Center, Cincinnati
As the global and pandemic spread of the novel coronavirus (SARS-CoV-2, COVID-19) continues, many knowledge gaps remain with regard to the epidemiology and transmission of infection, as well as the normal immunological responses after viral exposure. Cincinnati had its first confirmed case of COVID-19 on March 14, 2020, and despite extensive shelter-in-place and social distancing efforts, community spread continues at over 150-200 new cases per week. As new residents and fellows arrive in July 2020 to Cincinnati Children's Hospital Medical Center (CCHMC), many of whom come from metropolitan areas across the country, it is imperative that investigators determine the current prevalence of infection, measure the cumulative incidence of infection over the next 12-24 months, investigate the normal antibody patterns after infection, and help elucidate what constitutes a protective immunological response. The investigators have a unique but time-limited opportunity to optimally track the epidemiology and natural history of SARS-CoV-2 infection among trainees at CCHMC, including risk factors for transmission and immunological recovery. SCREEN will investigate epidemiological and immunological features of SARS-CoV-2 virus infection within the cohort of CCHMC residents and fellows who have patient contact. By collecting and analyzing weekly serial samples for SARS-CoV-2 (nasal swab for virus by PCR) and monthly serological exposure (serum antibodies by ELISA), the investigators will determine the prevalence and cumulative incidence of infection by SARS-CoV-2; the investigators will also document the antibody responses over time and identify cases of apparent viral recrudescence or re-infection.
Lahore General Hospital
This study is about the current knowledge on the immunological changes observed in various healthcare workers in this part of the world, who remained asymptomatic while working in high exposure areas of COVID-19 infection.
Helix OpCo, LLC
"This is a prospective, single-center specimen collection study. Subjects 18 years of age or older who do not have symptoms of COVID-19 will be enrolled. Two nasal swab samples and one saliva sample will be collected from each subject. The saliva sample will be tested with the COVIDSeq Test and one nasal swab will be tested with an EUA approved COVID test. The other nasal swab sample will be stored and a subset (approximately 250 specimens) will be tested with the COVIDSeq Test. Results of all testing will be provided to the sponsor for statistical analysis. Results from the comparator EUA test will be provided to the collection site investigator or designated collection site study staff. No medical treatment, guidance on treatment decisions, nor medical care will be provided. "
Helix OpCo, LLC
"This is a prospective, multi-center specimen collection study. Subjects 18 years of age or older who do not have symptoms of COVID-19 will be enrolled. Two nasal swab samples and one saliva sample will be collected from each subject. The saliva sample will be tested with the COVIDSeq Test and one nasal swab will be tested with an EUA approved COVID test. The other nasal swab sample will be stored and a subset (approximately 250 specimens) will be tested with the COVIDSeq Test. Results of all testing will be provided to the sponsor for statistical analysis. Positive results from COVIDSeq Test using saliva and/or the comparator EUA test will be provided to subjects so participants can be referred for further evaluation (outside the study). No medical treatment, guidance on treatment decisions, nor medical care will be provided. "
Withings
Currently, COVID+ infected patients who are on ambulatory home monitoring self-assess their health status simply by completing questionnaires and measuring their temperature twice a day. The SECURADOM project proposes to facilitate the follow-up of COVID+ or suspected COVID+ infected patients, followed at home, by collecting clinical signs on a telephone application and to monitor physiological safety parameters (respiratory rate, heart rate, temperature, blood pressure, activity) using connected objects developed by the company WITHINGS. This daily monitoring, which can be transmitted by patients to the doctors in charge of their surveillance, will improve the quality and safety of home monitoring.