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 1370 of 1460Universidad del Desarrollo
Intensive care unit (ICU) survivors and their families frequently present mental, cognitive and physical impairments lasting years. The ongoing pandemic could affect the duration, variety, and severity of these impairments. Our aim is to determine the impact of the COVID-19 pandemic on the physical, mental, and cognitive health of survivors, the experience of their families and their treating healthcare professionals in the long-term. This is a prospective, multicentre, mixed-methods cohort study in seven Chilean ICUs. The perceptions of family members regarding the ICU stay and the later recovery will be explored 3 months after discharge. Health care professionals will be invited to discuss the challenges faced during the pandemic using semi-structured interviews.
Sebastian Videla
To study the efficacy and safety of icatibant in adult patients admitted to hospitalization units for pneumonia caused by COVID-19, without mechanical ventilation, 10±1 days after starting treatment or discharge from hospital if this occurs before 10 days.
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.
National Institute of Allergy and Infectious Diseases (NIAID)
Background: Some people have allergic reactions to COVID-19 mRNA vaccines. Researchers want to learn more about these reactions to provide guidance on who can safely receive the vaccines, including a second dose in people who had a reaction to the first. Objective: To study the safety of giving a second mRNA COVID-19 vaccine dose to people who had a systemic allergic reaction to their first dose. Eligibility: People aged 16-69 who had a systemic allergic reaction to their first dose of COVID-19 vaccine. Design: Individuals who have underlying health issues may need to come to the NIH for screening tests to make sure they are safe to receive the vaccine. People who are eligible to participate in the study will be admitted to the NIH hospital and stay for at least 4 days. They will give urine samples. They will have a nasal swab SARS-CoV-2 test. They will have an intravenous line placed in each arm. They will get the study vaccine (Pfizer-BioNTech COVID-19 vaccine) and one dose of placebo on different days. They will have breathing tests. They may have clinical photography if they develop a rash. Participants will have 4 follow-up visits - 2 by phone and 2 in-person visits at the NIH campus . They will have allergy skin testing at one visit. Drops of different allergens or controls will be placed on their back or arm. The skin under each drop will be scratched with a tool. If the results are negative, a small amount of allergen will be injected just below the surface of their skin. Participants who have no or only a mild allergic reaction to the second dose of the vaccine may be eligible to receive a Booster dose at the NIH. Participation will last for approximately 5 months.
University of Nimes
Since the beginning of the pandemic, several authors (Lee, 2020; Sahu, 2020; Zhai & Du, 2020) have highlighted the various challenges faced by university students, as well as their negative effects on their mental health. A deterioration in their mental health was observed, particularly during lockdown, with very high levels of anxiety and depressive symptoms (Essadek & Rabeyron, 2020; Husky et al., 2020; Le Vigouroux et al., 2021; Odriozola-González et al., 2020). In addition, COVID-19 has brought about a digital revolution in higher education (Strielkowski, 2020). However, distance learning was not without consequences on student stress (IAU, 2020). The detrimental effects of distance education, in terms of stress and anxiety, could also have important consequences for students' learning and academic success. Our research proposes to evaluate effects of an intervention focused on stress and learning on mental health and learning strategies. This intervention will be proposed to students from University of Nimes. Its primary objective is to prevent psychological health alterations and to improve students' learning strategies. Three groups will be constituted: a group that will participate in an online program (online group), a group will participate in a hybrid program, i.e. with online content and face-to-face support (hybrid group) and a group that will not be receiving any interventions (control group). The investigators plan to include between 150 and 200 university students, between 40 and 70 in each group. The levels of mental health and learning strategies of the two experimental group (online and hybrid group) will be compared to a control group with the realization of pre and post intervention measures. Sociodemographic (e.g., level education) and situational variables (e.g., diagnostic of COVID-19) will be considered in the analyses.
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.
Eastman Dental Insitute and Hospital
An observational study of patients with COVID-19 confirmed cases (with various degrees of severity) and controls. Oral and nasal swabs will be taken from 150 patients (50 with mild form and 50 with severe form of COVID-19 with or without mechanical ventilation, 50 healthy controls).
Hospices Civils de Lyon
Unlike other respiratory viruses such as influenza and Respiratory Syncytial Virus (RSV) where the child is the essential reservoir and central vector of intrafamilial contamination, the child is likely to be a small player in the transmission of Severe Acute Respiratory Syndrome CoronaVirus 2 (SRAS-CoV2) infection. This study aims to describe the age category of the first contact, within 14 days before the appearance of the first symptoms of the index case in order to describe the age categories of this first contaminant, globally, in the group of children and finally in the group of adults. This work is intended to provide food for discussion and to justify the distancing and containment measures imposed on children when their isolation has a deleterious impact that has now been established for some children.
National Institutes of Health (NIH)
The purpose of this study is to test over time immunity to the COVID-19 vaccines. Adults who are receiving COVID-19 vaccines will be invited to participate.
National Cancer Institute (NCI)
This phase II trial studies the effects of ibrutinib in treating patients with B-cell malignancies who are infected with COVID-19. Ibrutinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Ibrutinib is a first in class Bruton tyrosine kinase inhibitor (BTKi), for the treatment of B-cell malignancies. This study is being done to determine if taking ibrutinib after contracting COVID-19 will make symptoms better or worse.