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 120 of 671Institute of Biotechnology, Academy of Military Medical Sciences, PLA of China
This is a phase II, randomised, double-blinded and placebo-controlled clinical trial in healthy adults above 18 years of age. This clinical trial is designed to evaluate the immunogenicity and safety of Ad5-nCoV which encodes for a full-length spike (S) protein of SARS-CoV-2.
Prothya Biosolutions
Passive immunization with immunoglobulins is occasionally used as therapy for the treatment of viral infectious diseases. Immunoglobulins are used for the treatment of CMV disease, and is effective as prophylaxis when given soon after exposure to varicella zoster virus, rabies, and hepatitis B virus. Neutralizing antibodies against MERS, SARS-CoV-1 and SARS-CoV-2 have been shown to be present in patients previously infected with MERS, SARS-CoV-1 and SARS-CoV-2 respectively. During the 2003 SARS outbreak in Hong-Kong,a non-randomized study in hospitalized SARS patients showed that treatment with convalescent plasma (convP) from SARS-recovered donors significantly increased the day 22 discharge rate and decreased mortality. A study in non-human primates showed that rhesus macaques could not be re-infected with SARS-CoV-2 after primary infection. With no proven effective therapy against COVID, this study will evaluate the safety and efficacy of convalescent plasma from COVID-recovered donors as a treatment for hospitalized patients with symptomatic COVID-19. The study will focus on patients who tested positive for SARS-CoV-2 in the last 96 hours before inclusion Primary objectives • Decrease overall mortality in patients within COVID disease Study design: This trial is a randomized comparative trial. Patients will be randomized between the infusion of 300mL of convP with standard of care. Patient population: Patients with PCR confirmed COVID disease, age >18 years Donors will be included with a known history of COVID who have been asymptomatic for at least 14 days. Intervention: 300mL of convP Duration of treatment: ConvP will be given as a one-time infusion Duration of follow up: For the primary endpoint: until discharge or death before day 60, whichever comes first. For the secondary endpoints (with separate consent) up to 1 year. Target number of patients: 426 Target number of donors: 100 Expected duration of accrural: 36 months
Mayo Clinic
The purpose of the study is to develop a clinical test based on breath analysis that can be used for disease diagnosis or prognosis.
Henry Ford Health System
This is a prospective, multi-site study designed to evaluate whether the use of hydroxychloroquine in healthcare workers (HCW), Nursing Home Workers (NHW), first responders (FR), and Detroit Department of Transportation bus drivers (DDOT) in SE, Michigan, can prevent the acquisition, symptoms and clinical COVID-19 infection The primary objective of this study is to determine whether the use of daily or weekly oral hydroxychloroquine (HCQ) therapy will prevent SARS-CoV-2 infection and COVID-19 viremia and clinical COVID-19 infection healthcare workers (HCW) and first responders (FR) (EMS, Fire, Police, bus drivers) in Southeast Michigan. Preventing COVID-19 transmission to HCW, FR, and Detroit Department of Transportation (DDOT) bus drivers is a critical step in preserving the health care and first responder force, the prevention of COVID-19 transmission in health care facilities, with the potential to preserve thousands of lives in addition to sustaining health care systems and civil services both nationally and globally. If efficacious, further studies on the use of hydroxychloroquine to prevent COVID-19 in the general population could be undertaken, with a potential impact on hundreds of thousands of lives.
University of Colorado, Denver
The current COVID-19 pandemic is providing healthcare organizations with considerable challenges and opportunities for rapid cycle improvement efforts, in diagnostic and patient management arenas. Healthcare providers are tasked with limiting the use of personal protective equipment while minimizing unnecessary exposures to the virus. Results from real-time PCR tests to detect active COVID-19 infections may not be available in a timely fashion during emergent trauma assessments. Since the start of the COVID-19 pandemic, a rapidly expanding body of literature has identified a pattern of imaged lung abnormalities with CT and ultrasound (US) characteristic of an active viral infection. US evaluation provides a reliable, portable, and reproducible way of evaluating acute patients in a real time setting. During initial trauma evaluations, patients may also receive adjunct imaging modalities like the Focused Assessment with Sonography in Trauma (FAST) exam designed to discover life threatening findings that may require urgent interventions. We therefore propose a study expanding on the current FAST adjunct evaluation in the trauma bay that may include lung parenchyma imaging at the initial assessment to help stratify patients into low or high-risk groups for active COVID-19 infections. We believe the use of point of care US in the initial assessment of the trauma patient may help identify potentially infected individuals and aid ED providers to best directing subsequent laboratory and imaging evaluations for these patients, while further directing the necessary protective measures for additional team members involved in the care of the injured patient.
Fundacion Arturo Lopez Perez
Currently there is no standard treatment for SARS-CoV-2 infection. Use of convalescent plasma has been studied in outbreaks of other respiratory infections, including SARS-CoV-1 , MERS-CoV and Hantavirus infection. This study is an open-label randomized trial in which patients with high risk of COVID19-associated respiratory failure will be randomized to early treatment with convalescent plasma (≤ 7 days from symptoms start) or at early signs of respiratory failure or prolonged hospitalization. COVID-19 convalescent plasma will be collected from individuals according to the institutional protocol.
National Institute of Mental Health (NIMH)
Background: Researchers think that people s mental health and behavior will be very affected by the steps taken to slow the spread of COVID-19, such as social distancing. Also, the threat of disease and death, to people and their loved ones, can cause much stress. Researchers want to learn more about these stressors and how they are affecting people. Objective: To study the relationship of affective, cognitive, and behavioral responses to stressors related to COVID-19 with neuroimaging and behavioral data collected before COVID-19. Eligibility: English-speaking adults age 18 and older Design: This online study will include both new participants and those who have taken part in past National Institute of Mental Health studies. All will complete the same surveys and tasks. Participants will give their name and email address. They will get a username and password. The file that links their username to their personal data will be kept secure. Participants will complete a set of surveys about the following: - Sociodemographic data, such age, race, and income - Education and work status - Mental and medical illness and treatment - Family medical history - Mood - COVID-19 experience - Anxiety - Substance and alcohol use - Attention control - Other mental health related topics. Participants will complete a finger-tapping task. For this, they will press a key a certain number of times in a limited period. They will get to practice the task. After the task, they will complete a survey about it. It will take about 1 hour to complete the surveys and the task. About 8 months later, participants will be contacted to repeat the surveys and task. Compensation is provided.
Johns Hopkins University
The purpose of this study is to evaluate the safety of administration of plasma containing antibodies to the SARS-CoV-2 virus (i.e., convalescent plasma) and if it is able to prevent disease or lessen the severity of disease in individuals who are at high risk of developing COVID-19 due to a recent exposure. This study will also measure the level of anti-SARS-CoV-2 antibodies in patient's blood after the administration of the convalescent plasma.
Hospices Civils de Lyon
The new Severe acute respiratory syndrome coronavirus (SARS-CoV-2) named coronavirus disease 2019 (COVID-19) is currently responsible for a pandemic spread of febrile respiratory infections, responsible for a veritable global health crisis. In adults, several evolutionary patterns are observed: i) a/pauci-symptomatic forms; ii) severe forms immediately linked to rare extensive viral pneumonia; and iii) forms of moderate severity, some of which progress to secondary aggravation (Day 7-Day 10). Children can be affected, but are more rarely symptomatic and severe pediatric forms are exceptional. Like some other coronaviruses (SARS-CoV and Middle East respiratory syndrome coronavirus (MERS-CoV)), these differences in clinical expression could be based on a variability in the immunological response, notably either via inhibition of the type I interferon (IFN-I) response, or on the contrary an immunological dysregulation responsible for a "cytokine storm" associated with the aggravation. Little is known about the impact of these innate immune response abnormalities on the adaptive response. In addition, certain genetic factors predisposing to a state of "hyper-fragility" and certain viral virulence factors could also be predictive of the clinical response. In this context, the main hypothesis is that the virological analysis and the initial biological and immunological profiles are correlated with the initial clinical presentation of COVID-19 infection. In particular, children forms and pauci-symptomatic disease in adults may be linked to a more robust innate immune response, including better production of IFN-I.
Susanne Arnold
This is a multi-arm, phase II trial for rapid efficacy and toxicity assessment of multiple therapies immediately after COVID19 positive testing in high-risk individuals. Therapies include stand-alone or combination treatment with hydroxychloroquine, azithromycin, ivermectin, or camostat mesilate, artemesia annua. The hypothesis of this study is that the addition of agents that inhibit viral entry or replication of SARS-CoV-2 virus replication in will be devoid of additional moderate to severe toxicities, will prevent clinical deterioration, and will improve viral clearance in high risk individuals.