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 260 of 1494University of Ljubljana
The investigators are conducting a national COVID-19 prevalence survey on a sample of 3,000 inhabitants that were randomly selected from the Slovenian population. The sample is representative in age, gender, and geographical distribution. The main objective is to assess how many people in Slovenia have COVID-19 in April/May 2020 and how many were infected with SARS-CoV-2 previously. The investigators are using a direct detection of SARS-CoV-2 RNA in nasopharyngeal samples with validated two-target PCR-based commercial assay. For a serological response to the etiological agent, IgG and IgA anti-SARS-CoV-2 antibodies are measured in plasma samples using a validated commercial assay.
GlaxoSmithKline
OSCAR (Otilimab in Severe COVID-19 Related Disease) is a multi-center, double-blind, randomized, placebo-controlled trial to assess the efficacy and safety of otilimab for the treatment of severe pulmonary COVID-19 related disease. The study is being conducted in 2 parts (Part 1 and Part 2). Otilimab is a human monoclonal anti-granulocyte macrophage colony stimulating factor (GM-CSF) antibody that has not previously been tested in participants with severe pulmonary COVID-19 related disease in Part 1. The aim of this study is to evaluate the benefit-risk of a single infusion of otilimab in the treatment of hospitalized participants with severe COVID-19 related pulmonary disease with new onset hypoxia requiring significant oxygen support or requiring early invasive mechanical ventilation (less than or equal to [
King Fahad Specialist Hospital Dammam
. Coronavirus (SARS-CoV2) appeared first in China late 2019 and caused an acute respiratory disease referred to as Coronavirus disease 2019 (COVID-19). SARS-CoV2 is considered by the World Health Organization (WHO) as pandemic and affected nations worldwide, leading to close borders and major economical struggle. The ongoing viral threat due to the lack of effective therapies and vaccination might prolonged this economical challenge and many businesses will face huge financial constraints leading to laying off labors, an increase in the unemployment rate, and major companies' bankruptcies. However, returning to normal business operations should be done with a safety focus and not be at the cost of global health and wellbeing. Immunity against COVID-19 is going to be a major determinant for a future safe work environment and will reduce the viral infection risk. Therefore, PI is suggesting that if an employee has antibodies against SARS-CoV-2 confirmed by serological testing, he or she could go back to work safely with taking the necessary precautions.
Hadassah Medical Organization
Title: The use of Tocilizumab in the management of patients who have severe COVID-19 with suspected pulmonary hyperinflammation. This is a study designed to assess the therapeutic value of intravenous tocilizumab administered as single 8mg/Kg dose in patients affected by SARS-CoV2 infection with a pulmonary manifestation causing hypoxia. Aim of the study is to test the hypothesis that anti-IL6 treatment can be effective in reducing the virus-induced cytokine storm, blocking deterioration of lung function or even promoting a rapid improvement of clinical conditions, preventing tracheal intubation and/or death. This drug will be administered to those patients entering the ICU with severe acute respiratory failure COVID-19 disease. The endpoints are death and duration of hospitalization. The patients will be assessed with surrogate markers determining the level of the cytokine storm.
Ain Shams University
The aim of this project is to introduce way for treatment of patients with severe COVID-19 disease with respiratory complications.
University of Toledo Health Science Campus
This project will test the efficacy of fluoxetine to prevent serious consequences of COVID-19 infection, especially death. Becoming sick with COVID-19 virus or any other serious respiratory condition is not fun. However, the dramatic effects of the COVID-19 pandemic on human society stem from its significant mortality, not the number of individuals who become sick. This project aims to prevent serious outcomes such as hospitalization, respiratory failure and death during the time it takes to develop vaccinations and other strategies to prevent COVID-19 infectionPoor outcomes with COVID-19 infection such as hospitalization, respiratory failure, organ failure and death are associated with a dysfunctional exaggerated immune response, called a cytokine storm, that is triggered by Interleukin-6 expression (IL-6) and seems to occur around day 5 to 7 of symptoms. Fluoxetine has extraordinarily strong evidence in its action as a blocker of IL-6 and cytokine storms in both animal models of infection and in human illness such as rheumatoid arthritis and others. This action of fluoxetine is an entirely separate pathway than the serotonergic pathway that allows fluoxetine to act as an antidepressant. This pathway has been demonstrated in cell culture, in animal models, in human illness and by novel bioinformatics analyses of protein transcripts to be relatively unique for fluoxetine and appears to be a novel pathway. This project aims to inhibit the increase in IL-6 expression and thereby prevent the cytokine storm that causes poor outcomes. Patients who have tested positive or are presumptively positive for COVID-19 will be entered into the study and given the option to start the medication fluoxetine, which is demonstrated to prevent IL-6 surges in infectious and inflammatory conditions. Participants will be monitored daily for COVID-19 symptoms and weekly for side effects and tolerance of fluoxetine. A subset of patients will have blood drawn weekly and stored to monitor IL-6 and other cytokine levels at a later date. This project aims to reduce the serious outcomes of COVID-19 infection by preventing or inhibiting the cytokine storm associated with organ failure, respiratory failure and death.
Covis Pharma S.à.r.l.
The purpose of this study is to assess the safety and efficacy of Alvesco (ciclesonide) Inhalation Aerosol in non hospitalized patients with symptomatic COVID-19 infection in a multicenter, randomized, double-blind, placebo controlled study
Baqiyatallah Medical Sciences University
This is an open-label, non-randomized clinical trial study. The number of 40 COVID-19 patients with moderate severity will be admitted in progressive care units (PCUs) and intensive care units (ICUs) enrolled in the study. The sampling will be purposive and based on the same independent variables, including age, gender, past medical histories, and the situation of the patient at the admission day, and ventilator support. The patients will be allocated into two groups with different regimens. Group "A" (regimen A)will be defined as Favipiravir 1600 mg a first dose and 600 mg in 3 divided doses daily plus 400 mg in 2 divided doses of Hydroxychloroquine every day. The group "B" (regimen B) will be contained 400 mg of Lopinavir/Ritonavirin 2 divided doses plus the first dose (400 mg) of Hydroxychloroquine. Hydroxychloroquine will not be used for adverse drug reactions. The regimen remained at least 7 up to 10 days. Data will be analyzed using statistical package for social sciences (SPSS) version 18 (SPSS Inc. Chicago, IL, USA) for windows. The variables will be compared using independent and paired T-test for normally distributed variables and Wilcoxon, Chi-square for non-normal distributed variables. The Kaplan Meier test will be used for survival analysis and the one-sample Kolmogorov-Smirnov test for the evaluation of distributions.
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.
University of Virginia
This is a single arm phase II trial to assess efficacy and confirm safety of infusions of anti-SARS-CoV-2 convalescent plasma in hospitalized patients with acute respiratory symptoms,with or without confirmed interstitial COVID-19 pneumonia by chest Xray or CT. A total of 29 eligible subjects will be enrolled to receive anti-SARS-CoV-2 plasma.Outcomes will be compared to hospitalized controls with confirmed COVID-19 disease through retrospective chart review.