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 230 of 411Cambridge University Hospitals NHS Foundation Trust
This study aims to evaluate several of Owlstone Medical's Breath Biopsy aerosol respiratory droplet capture techniques for the detection of nCOVID-19. These are single use disposable breath capture devices with removable filters and fitted PVA strip that directly sample exhaled breath aerosols and therefore, directly sample the primary transmission route for the virus. They can be used independently and shipped for analysis for the presence of nCOVID-19 using established existing assays available in any reference lab. The trial is a non-inferiority trial comparing diagnostic accuracy of collection via face mask vs. available diagnostic procedures in standard care and will also asses the feasibility of patient use of the equipment. Subjects will be recruited at the Addenbrookes Hospital, Cambridge. Minimal patient characteristics (e.g. age, sex) are collected. Between 20 and 100 subjects with with a positive nCOVID-19 diagnosis will be sampled to obtain to address the primary study hypothesis. Due to the pre-test probability of patients being positive for nCOVID-19 is unknown we will monitor the number of sampled subjects with a positive diagnosis on a weekly basis. The clinical diagnosis of the subject based on a combination of imaging, viral diagnostics and clinical assessment will be used as the reference standard. When this number hits 100 the study will be discontinued. In total no more than 500 subjects shall be sampled in this trial.
Direction Centrale du Service de Santé des Armées
COVID-19 is a pathology linked to the SARS-CoV-2 virus, a new virus of the coronaviridae family that emerged in China in December 2019 before rapidly becoming a pandemic according to the WHO on March 11, 2020. The epidemic affected France from February 2020. On February 24, a patient hospitalized at Percy hospital was the cause of a major nosocomial epidemic, potentially responsible for more than 250 symptomatic people in the hospital as of April 6. The outbreak was identified by Percy hospital management on March 16, and barrier measures were immediately put in place. From March 20, a mixed investigation unit set up a chain of nasopharyngeal swabs for Percy hospital staff. A COVID-19 case reporting unit was set up at Percy hospital in response to the identification of the outbreak within the hospital. This unit carried out rapid identification and regular follow-up until the return to work of the staff. Thus all symptomatic patients are identified and the COVID-19 case census cell will follow all Percy hospital staff, including volunteers recruited to deal with the epidemic, throughout the duration of the epidemic. This population, captive by nature, will be one of the few described in the world during this epidemic. Current data on short-, medium- and long-term immunity induced by COVID-19 infection are fragmentary, as is the existence of a large asymptomatic population, making it difficult to cut the chains of transmission in the absence of an effective diagnostic tool. Another important issue is the quality of immunity induced by the infection, as it conditions the future of the pandemic, which could become endemic and recurrent if immunity were not sterilizing. As yet unpublished data in primates show that in the primate model re-infection is not possible in the short term, while patients cured from the Wuhan epidemic seem to be detected again positive for virus shedding. The objective of this study is to characterize the immunity (systemic and local) induced by SARS-Cov-2 infection among Percy hospital staff who are at high risk of contamination even in a period of confinement.
Biofarma
Scientists and medical workers all around the world were running out of time to manage COVID-19. Several studies have been done to understand the disease and ultimately to find possible treatment. Based on those studies, one of the potential treatment was antibody transfer from recovered COVID-19 patients. Passive antibody transfer was a fast and easy choice. The rational use of antibody from the patient's plasma is a natural neutralizing protein to the cell-infected virus and could possibly slow the active infection down. Investigators initiate an intervention study with purposes to produce quality convalescent plasma from the recovered patients, define the safety of plasma for human use and as an alternative treatment to improve the clinical outcomes of severe COVID-19 patients. The study hypothesis is convalescent plasma is safe and could possibly improve outcome of severe (non-critical) COVID-19 patients. This research will conduct the plaque reduction neutralizing test (PRNT) of recipient blood in vitro. The plasma will be collected in the blood transfusion unit (BTU) in Gatot Soebroto hospital. The storage, testing, transfer, and transfusion of eligible convalescent plasma are the authority of Gatot Soebroto BTU. PRNT and plasma antibody titer measurement from donor plasma will be conducted at Eijkman Institute of Molecular Biology. Investigators enroll approximately 10 patients consecutively, who will be admitted at Gatot Soebroto hospital. Baseline demographic characteristics of samples are recorded. Clinical dan laboratory data will be measured before and after plasma transfusion periodically. The measured variables are pharmacological therapy (antivirus, antibiotics, steroids), invasive oxygen therapy, oxygen index, sequential organ failure assessment (SOFA) score, and laboratory parameters such as leukocyte count, blood chemical panel include liver and renal function, C-reactive protein, procalcitonin, IL-6 and immunoglobulin titer of the recipient and also chest X-ray evaluation. The potential expected risk of plasma transfusions is transfusion reaction (immunological or non-immune related) and transferred foreign pathogen. Investigator will report and treat all adverse events after plasma transfusion has been done. A severe adverse event (SAE) will also report in a special form to sponsor and data safety monitoring board (DSMB). There is theoretically antibody-dependent enhancement (ADE) mechanism from COVID-19 whom will receive plasma transfusion to progress to severe immune response. This preliminary study is supposed to provide supporting data and experience of plasma processing to a larger study in the near future.
Advanced Cooling Therapy, Inc., d/b/a Attune Medical
The purpose of the proposed pilot study is to determine if core warming improves respiratory physiology of mechanically ventilated patients with COVID-19, allowing earlier weaning from ventilation, and greater overall survival.
Emory University
The objective of this study is to determine the safety, feasibility and efficacy of a bidirectional oxygenation Positive End Expiratory Pressure (PEEP) mouthpiece in coronavirus disease 2019 (COVID-19) patients requiring supplemental oxygen by non-rebreather mask.
Robert W. Alexander, MD
COVID-19 Viral Global Pandemic resulting in post-infection pulmonary damage, including Fibrotic Lung Disease due to inflammatory and reactive protein secretions damaging pulmonary alveolar structure and functionality. A short review includes: - Early December, 2019 - A pneumonia of unknown cause was detected in Wuhan, China, and was reported to the World Health Organization (WHO) Country Office. - January 30th, 2020 - The outbreak was declared a Public Health Emergency of International Concern. - February 7th, 2020 - 34-year-old Ophthalmologist who first identified a SARS-like coronavirus) dies from the same virus. - February 11th, 2020 - WHO announces a name for the new coronavirus disease: COVID-19. - February 19th, 2020 - The U.S. has its first outbreak in a Seattle nursing home which were complicated with loss of lives.. - March 11th, 2020 - WHO declares the virus a pandemic and in less than three months, from the time when this virus was first detected, the virus has spread across the entire planet with cases identified in every country including Greenland. - March 21st, 2020 - Emerging Infectious Disease estimates the risk for death in Wuhan reached values as high as 12% in the epicenter of the epidemic and ≈1% in other, more mildly affected areas. The elevated death risk estimates are probably associated with a breakdown of the healthcare system, indicating that enhanced public health interventions, including social distancing and movement restrictions, should be implemented to bring the COVID-19 epidemic under control." March 21st 2020 -Much of the United States is currently under some form of self- or mandatory quarantine as testing abilities ramp up.. March 24th, 2020 - Hot spots are evolving and identified, particularly in the areas of New York-New Jersey, Washington, and California. Immediate attention is turned to testing, diagnosis, epidemiological containment, clinical trials for drug testing started, and work on a long-term vaccine started. The recovering patients are presenting with mild to severe lung impairment as a result of the viral attack on the alveolar and lung tissues. Clinically significant impairment of pulmonary function appears to be a permanent finding as a direct result of the interstitial lung damage and inflammatory changes that accompanied. This Phase 0, first-in-kind for humans, is use of autologous, cellular stromal vascular fraction (cSVF) deployed intravenously to examine the anti-inflammatory and structural potential to improve the residual, permanent damaged alveolar tissues of the lungs.
Mario Negri Institute for Pharmacological Research
The study aims at clarifying whether early treatment with continuous positive airway pressure (CPAP) ventilation is able to reduce the need for intubation or death in patients visiting an emergency department (ED) with known or suspected COVID-19 infection and insufficiency respiratory.
Rush University Medical Center
Coronavirus disease 2019 (COVID-19) is an emerging infectious disease that was first reported in Wuhan, China, and had subsequently spread worldwide. Twenty-nine percent of COVID-19 patients may develop ARDS. Based on the potential beneficial mechanisms of HFNC and PP, whether early use of prone positioning combined with HFNC can avoid the need for intubation in COVID-19 induced moderate to severe ARDS patients needs to be further investigated.
PEEP Medical, LLC
This study will utilize a single center internal control study design. The objective of this study is to determine the feasibility and safety of a bidirectional oxygenation PEEP generating mouthpiece when combined with oxygen by non-rebreather face mask, compared to support by oxygen non-rebreather face mask alone.
Dr. Alexander Supady
In December 2019 in the city of Wuhan in China, a series of patients with unclear pneumonia was noticed, some of whom have died of it. In virological analyses of samples from the patients' deep respiratory tract, a novel coronavirus was isolated (SARS-CoV-2). The disease spread rapidly in the city of Wuhan at the beginning of 2020 and soon beyond in China and, in the coming weeks, around the world. Initial studies described numerous severe courses, particularly those associated with increased patient age and previous cardiovascular, metabolic and respiratory diseases. A small number of the particularly severely ill patients required not only highly invasive ventilation therapy but also extracorporeal membrane oxygenation (vv-ECMO) to supply the patient's blood with sufficient oxygen. Even under maximum intensive care treatment, a very high mortality rate of approximately 80-100% was observed in this patient group. In addition, high levels of interleukin-6 (IL-6) could be detected in the blood of these severely ill patients, which in turn were associated with poor outcome. From experience in the therapy of severely ill patients with severe infections and respiratory failure, we know that treatment with a CytoSorb® adsorber can lead to a reduction of the circulating pro- and anti-inflammatory cytokines and thus improve the course of the disease and the outcome of the patients. Our primary goal is to investigate the efficacy of treatment with a CytoSorb® adsorber in patients with severe COVID-19 disease requiring venous ECMO over 72 hours after initiation of ECMO. The primary endpoint is the reduction of plasma interleukin-6 levels 72 hours after initiation of ECMO support. As secondary endpoints we investigate 30-day survival, vasopressor and volume requirements, lactate in terms of lactate and platelet function. As safety variables, we further investigate the levels of the applied antibiotics (usually ampicillin and sulbactam).