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 350 of 1018Royal College of Surgeons in Ireland - Medical University of Bahrain
This is an open-label, interventional exploratory study to evaluate the safety and efficacy of 5-ALA-Phosphate + SFC in subjects with acute moderate or severe respiratory illness secondary to infection with SARS-CoV-2 virus (COVID-19) involving 40 subjects. The primary objective is to evaluate the safety of 4-week oral administration of 5-ALAPhosphate + SFC. This study is expected to last for 4 weeks and will include follow-up until day 28 in the hospital or in an outpatient setting if the subjects are discharged earlier.
Namida Lab
This study objective is to collect tear and blood samples from individuals with positive SARS-COV2 diagnosis and test those samples for the presence of various SARS-COV2 viral antigens and autoantibodies.
Charles Drew University of Medicine and Science
African American adults, specifically those managing chronic disease and social isolation, are one of the most vulnerable groups susceptible to COVID-19. This intervention involves a multi-disciplinary and culturally sensitive approach to address two major COVID-19 related challenges in this population. First, this program collaborates with predominantly African American churches to implement Federal and State guidelines aimed at preventing outbreaks of COVID-19 at faith-based gatherings. Second, this program trains church-based health advisors to help African American older parishioners manage their chronic health conditions and reduce psychological distress during the pandemic.
University of Colorado, Denver
Lung ultrasound (LUS) has also been shown to be more accurate than chest x-ray in identifying pulmonary consolidation and pulmonary edema, both of which are found in patients with COVID. The investigators hypothesize implementation of LUS by hospitalists in the management of suspected or diagnosed patients with COVID-19 will reduce the need for Chest CT and chest x-ray, thereby conserving PPE, reducing risk of transmission to technicians and conserving the resources of radiology services that would otherwise be overwhelmed by patients with COVID-19 in need of chest imaging. Using the methods of implementation science, the investigators propose to respond to the urgent need for rapid implementation of LUS by hospitalists in management of adult patients hospitalized for COVID. Aim 1a: Using a rapid-cycle weekly Plan-Do-Study-Act cycle and Rapid Iterative RE-AIM, to optimize the implementation of LUS by adult hospitalists in the management of COVID-19 patients in a pilot study Aim 1b: Evaluate this pilot implementation of LUS by adult hospitalists using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework.
Grupo Mexicano para el Estudio de la Medicina Intensiva
The new SARS-CoV-2 coronavirus is an emerging virus originating in Wuhan, China that has spread rapidly throughout the world. As of March 24, 2020, China had reported 81,767 cases with 3,281 deaths, and the World Health Organization (WHO) declared coronavirus 19 (COVID-19) a pandemic. COVID-19 disease is currently a pandemic without specific therapeutic agents and substantial mortality. So it is of utmost importance to find new treatments. Various therapies, such as Remdesivir and Favipiravir, are being investigated but the antiviral efficacy of these drugs is not yet known. The use of convalescent plasma was used as an empirical treatment during the Ebola virus outbreaks in 2014 and in 2015 a protocol was established for the treatment of the Middle East respiratory syndrome coronavirus (MERS) with convalescent plasma. This approach with other viral infections such as SARS-CoV, H5N1 avian influenza and H1N1 influenza suggesting that plasma transfusion from convalescent donors was effective. For this study, plasma from convalescent donors will be collected from those donors who have recovered from SARS-CoV-2 and are between 10 and 14 days after illness. Immunoassays will be carried out to detect total IgM and IgG antibodies against SARS-CoV-2. Patients will receive 1 to 3 convalescent plasma transfusions, depending on the response to treatment. The expected results are: normal body temperature, decrease in viral load or negative between 10-12 days after transfusion of convalescent plasma, which does not progress to ARDS, extubation of mechanical ventilation within two weeks of treatment, recovery of patient.
National Institute of Cardiology, Laranjeiras, Brazil
Considering that the intensity of systemic microvascular changes in patients in the acute phase of COVID-19 could be related to disease progression and prognosis, the present cross-sectional and observational study aims to investigate the presence of endothelial dysfunction in these patients, also looking for to evaluate associations between the presence of endothelial dysfunction and demographic, clinical and laboratory variables.
Public Health England
Hospitals are recognised to be a major risk for the spread of infections despite the availability of protective measures. Under normal circumstances, staff may acquire and transmit infections, but the health impact of within hospital infection is greatest in vulnerable patients. For the novel coronavirus that causes COVID-19, like recent outbreaks such as the SARS and Ebola virus, the risk of within hospital spread of infection presents an additional, significant health risk to healthcare workers. Infection Prevention and Control (IPC) teams within hospitals engage in practices that minimise the number of infections acquired within hospital. This includes surveillance of infection spread, and proactively leading on training to clinical and other hospital teams. There is now good evidence that genome sequencing of epidemic viruses such as that which causes COVID-19, together with standard IPC, more effectively reduces within hospital infection rates and may help identify the routes of transmission, than just existing IPC practice. It is proposed to evaluate the benefit of genome sequencing in this context, and whether rapid (24-48h) turnaround on the data to IPC teams has an impact on that level of benefit. The study team will ask participating NHS hospitals to collect IPC information as per usual practice for a short time to establish data for comparison. Where patients are confirmed to have a COVID-19 infection thought to have been transmitted within hospital, their samples will be sequenced with data fed back to hospital teams during the intervention phase. A final phase without the intervention may take place for additional information on standard IPC practice when the COVID-19 outbreak is at a low level nationwide.
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
The virus SARS-CoV-2 causes severe pneumonia which, in a proportion of patients progresses towards an Acute Respiratory Distress Syndrome (ARDS) mainly related to the antiviral immune response. To date, there is no available treatment that significantly improves outcome of patients with COVID-19 pneumonia. Sphingosine-1-phosphate receptor 1 (S1P1) ligands control vascular leakage in the airways and sphingosine-1-phosphate (S1P) receptor ligands devoid of activity on sphingosine-1-phosphate receptor 3 (S1P3) show an excellent safety profile, including ozanimod. Critically, S1P1 ligands mildly impact, but do not compromise viral clearance and they reduced lung injury in preclinical models, even without concomitant use of antivirals and with a synergistic effect when associated to antiviral agents. Ozanimod was approved by the FDA for the treatment of relapsing multiple sclerosis at the end of March 2020, and was recently (October 2020) approved by Health Canada for the same indication. The investigators believe that this immune modulator is at the top of the list of agents that should be trialed in order to mitigate the morbidity and mortality of COVID-19. The primary objective is to substantiate the impact of ozanimod on key outcomes of COVID-19 patient progression, which will guide decision making around sample size and the choice of endpoints for future clinical trial.
State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia
The SARS-CoV-2 infection was detected in December 2019 in Wuhan City, China. The infection affects all age groups, although childhood is the lowest proportion of those affected. The main clinical manifestations that require hospitalization of infected patients are SARS pneumonia, which may require treatment in the intensive care unit (27%) and its progression into acute respiratory distress syndrome (67%) with life-threatening conditions in almost 25% of patients diagnosed with "SARS-CoV-2 infection". Nervous system damage with SARS-CoV-2 infection has been practically not investigated, but neurological disorders have been reported in 36% of these patients. Finally, the mortality rate associated with the new virus is high in patients who require treatment in intensive care units (62% of cases). Therefore, we are conducting a prospective study to identify acute encephalopathy predictors in patients with COVID-19.
University Hospital, Montpellier
About 5% of COVID-19 patients may present symptoms related to acute ischemic stroke (AIS). Treatment-management and outcomes related to mechanical thrombectomy (MT) for COVID-19 infected patients harboring large vessel occlusion is largely unknown. This multicentric study aims to investigate morbidity, mortality and neurological outcomes after MT performed in patients with COVID-19 infection.