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 50 of 90Derek Yellon
The coronavirus disease (COVID-19) emerged in late 2019 and has since been diagnosed in over a million persons worldwide. As this virus progresses, it causes an extreme and uncontrolled response from the patient's immune system accompanied by reduced oxygen flow to major organs, and subsequent ischaemic injury. The current treatment of COVID-19 is largely supportive without any cure or vaccine available at this time. Developing new methods to reduce this heightened inflammatory response is essential to halting progression of COVID-19 in patients and reducing the severity of damage. The cellular mechanisms seen in COVID-19 are similar to those seen in patients with sepsis. A process known as Remote Ischemic Conditioning (RIC) is an intervention which has been shown to prevent cellular injury including those associated with sepsis. Based on the evidence from studies looking at sepsis, it is anticipated the same benefit would be seen in patients diagnosed with COVID-19. RIC is a simple, non-invasive procedure where a blood pressure cuff is applied to the arm for repeated cycles of inflating and deflating (typically 3-5 cycles of 5 minutes each). This process activates pro-survival mechanisms in the body to protect vital organs and improve the immune system. Therefore, we believe it represents an exciting strategy to protect organs against reduced blood flow and extreme immune response, as seen in COVID-19 infections. This study has already been fully approved
Russian Direct Investment Fund
Randomized, open, multicenter, collaborative and adaptive non-inferiority trial to evaluate the immunogenicity and reactogenicity of the heterologous vaccination schedules made up of the combination of vaccines available in Argentina (Sputnik-V, AstraZeneca, Sinopharm and Moderna); and to compare the immunogenicity and reactogenicity of heterologous and homologous vaccination schedules.
International Vaccine Institute
To expand the access and delivery of COVID-19 Vaccines in Africa (ECOVA), the investigators will conduct a phase 3, individually randomized, observer-blind, controlled (influenza vaccine) trial to evaluate the safety and efficacy of the BBIBP-CorV vaccine against any severe acute respiratory syndrome 2 (SARS-CoV- 2) infection among adults 18 years and older. The BBIBP-CorV vaccine is an inactivated SARS-CoV-2 vaccine (Vero cell) manufactured by the Beijing Institute of Biological Products (BIBP), China National Biotec Group (CNBG), Sinopharm, Beijing, People's Republic of China and received emergency use authorization (EUA) from World Health Organization (WHO).
Kementerian Riset dan Teknologi / Badan Riset dan Inovasi Nasional, Indonesia
The increased risk of transmission of COVID-19 infection causes the incidence of death in health workers to escalate. It requires further research on risk factors and intervention in health worker professionals, especially on immunity factors and nutritional status. Quality of diet and nutrition is very important to support the immune system when infected. Several probiotic strains have been shown to decrease the duration and incidence of diarrhea and respiratory infections, suggesting the Gut-Lung Axis pathway. Some probiotics also improve the balance of diversity in the composition of the gut microbiota and affect body weight in obese people. Probiotics have also been shown to improve vitamin D absorption. A combination of vitamin D and probiotics may be an alternative to reduce gut dysbiosis that will directly or indirectly reduce the risk and severity of viral infections including SARS-CoV-2.
GeoVax, Inc.
This phase II trial studies the immune response to COH04S1 compared to Emergency Use Authorization (EUA) SARS-COV-2 vaccine in patients with blood cancer who have received stem cell transplant or cellular therapy. COH04S1 belongs to a category called modified vaccinia Ankara (MVA) vaccines, created from a new version of MVA, called synthetic MVA. COH04S1 works by inducing immunity (the ability to recognize and fight against an infection) to SARS-CoV-2. The immune system is stimulated to produce antibodies against SARS-CoV-2 that would block the virus from entering healthy cells. The immune system also grows new disease fighting T cells that can recognize and destroy infected cells. Giving COH04S1 after cellular therapy may work better in reducing the chances of contracting coronavirus disease 2019 (COVID-19) or developing a severe form of COVID-19 disease in patients with blood cancer compared to EUA SARS-CoV-2 vaccine.
Argentina Servin, MD, MPH
The United States (U.S.) is the country with the largest number of infections and deaths due to COVID- 19 and racial/ethnic minorities are disproportionately affected. Acceptance and uptake of COVID-19 vaccines will be instrumental to ending the pandemic. To this end, 2VIDA! (SARS-CoV-2 Vaccine Intervention Delivery for Adults in Southern California) is a multilevel intervention to address individual, social, and contextual factors related to access to, and acceptance of, the COVID-19 vaccine by implementing and assessing a COVID-19 vaccination protocol among Latino and African American (AA) adults (>18 years old) in San Diego. 2VIDA! builds on our previous CBPR efforts and centers on conducting COVID-19 Individual awareness and education, linkages to medical and supportive services, and Community Outreach and Health Promotion in the intervention sites (Phase 1); and offering the COVID-19 vaccine to Latino and AA adults (>18 years old) in federally-qualified health centers and pop-up vaccination stations in communities highly impacted by the pandemic and identifying individual and structural barriers to COVID-19 immunization (Phase 2).
National Institute of Allergy and Infectious Diseases (NIAID)
Long-term neurocognitive and psychiatric consequences of COVID-19 remain mostly unknown to date. It has been reported that coronaviruses cause direct central nervous system infection (Needham et al. 2020). Besides that, new or worsening cognitive impairment commonly occurs and persists in survivors of intensive care unit (ICU) stay (Hosey & Needham. 2020). The purpose of our study is to search and describe the cognitive and psychiatric long-term consequences of COVID-19 on patients who have been discharged from critical care units. This is an ambidirectional cohort study, that attempts to follow adults discharged from critical Care Units Adults due to COVID-19 up to 12 months after discharge, to evaluate the presence of cognitive impairment, linguistic and phonation function, depression, fatigue, functional gastroenterological symptoms, anxiety, or post traumatic disorder, and performance in activities of daily living and physical response to exercise as well.
University of Arizona
Viruses are a major health problem for the general public and at risk populations. Normally, detection of antibody titers is the gold standard for determining the effectiveness of the immune system following natural or vaccine caused immunization. However, determining the effectiveness of other parts of the immune system are less common due to the difficulties with testing. Furthermore, there is a critical need to address other therapies in case vaccination is not successful in immuncompromised populations. Exercise has been shown to increase the strength of the immune system against many types of viruses and therefore could be simple way to improve immunity against the COVID-19 virus. The aim of this research is to determine the effects of exercise on anti-viral immunity against many types of common viruses before and after vaccination. We hypothesize that exercise will enhance the anti-viral immunity before and after vaccination. Up to 30 healthy volunteers (age 18-44 years) will be recruited to participate in this study. For completion of Aim 1, three visits are needed totaling around 7 hours of the patient's time and for Aim 2, three visits are needed totaling around 4.5 hours of the patient's time. The initial visit will be for pre-screening and if deemed healthy enough to participate, an exercise test to determine the VO2 max of the participant will be conducted. The following visits will require a trained phlebotomist to insert an in-dwelling catheter and participants will undergo a 20-minute incremental exercise trial. Approximately 50mL of blood will be collected at four different timepoints: at rest, 60% VO2 max, 80% VO2 max, and 1-hr post-exercise. All four collected blood samples will be used to expand viral specific T-cells and compare IFN-γ rele
Beijing 302 Hospital
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has caused pandemic since outbreak in 2020.Patients with chronic liver disease (CLD) are at higher risk of mortality and morbidity due to COVID-19. Despite there is a large number of clinical trials of COVID-19 vaccines, only a few participants with chronic liver diseases were included.
Beijing 302 Hospital
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has caused pandemic since outbreak in 2020. Patients with cancers may be at higher risk than those without cancer for coronavirus disease 2019 (COVID-19). At present, limited data are available on the safety and immunogenicity of COVID-19 vaccination for patients with cancer.