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 70 of 379Inmune Bio, Inc.
The purpose of this study is to determine whether XPro1595 can prevent the progression of respiratory complications in COVID19 patients.
State University of New York - Downstate Medical Center
Treatments for COVID-19 are urgently needed. Hydroxychloroquine (HCQ) is an antimalarial and immunomodulatory agent being repurposed for COVID-19 therapy based off in vitro data suggesting a possible antiviral effect. However, HCQ's effect on COVID-19 in human infection remains unknown. To fill this knowledge gap, we will enroll 626 adult patients hospitalized with laboratory-confirmed COVID-19 and randomize them 1:1 to a five-day course of HCQ or placebo. Notable exclusion criteria include ICU admission or ventilation on enrollment, prior therapy with HCQ, and baseline prolonged qTC. Our primary endpoint is a severe disease progression composite outcome (death, ICU admission, mechanical ventilation, ECMO, , and/or vasopressor requirement) at the 14-day post-treatment evaluation. Notable secondary clinical outcomes include 30-day mortality, hospital length of stay, noninvasive ventilator support, and cytokine release syndrome (CRS) grading scale. Secondary exploratory objectives will examine SARS-CoV-2 viral eradication at the EOT, changes in COVID-19 putative prognostic markers and cytokine levels, and titers of anti-SARS-CoV-2 antibodies. This randomized trial will determine if HCQ is effective as treatment in hospitalized non-ICU patients with COVID-19.
Hospital Universitario Ramon y Cajal
The COVID-19 Androgen Sensitivity Test is a non-invasive In-Vitro Diagnostic device that utilizes Next Generation Sequencing Technology (NGS). The results of the test are used by a physician to assess the risk of developing severe symptoms following COVID-19 infection, The COVID-19 Androgen Sensitivity Test requires a health care professional to collect a DNA sample using an FDA cleared DNA sample collection kit.
Columbia University
The novel coronavirus (SARS-CoV-2) has spread all around the world and testing has posed a challenge globally. Health care providers are highly exposed and are an important group to test. On top of these concerns, health care workers are also stressed by the needs on responders in the COVID-19 crisis. The investigators will look at different ways to measure how common COVID-19 is among health care workers, how common is the presence of antibodies by serological tests (also known as serostatus). The investigators will describe health worker mental and emotional well-being and their coping strategies in their institutional settings. Lastly, the investigators will describe how knowing serostatus can affect individuals' mental and emotional well-being and how to cope in the midst of the COVID-19 response. This will help to how to better test and help healthcare workers in the COVID-19 pandemic and prepare for possible future outbreaks.
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
The world is currently facing a pandemic due to the outbreak of a new coronavirus causing acute respiratory failure called SARS-Cov2. The majority of patients (8 out of 10) are known to have mild disease, manifested by respiratory tract symptoms associated with fever, headache, and body pain. However, it is possible that the disease progresses to a severe stage, whith the need for mechanical ventilation support associated with high morbidity and mortality. The progression of the disease is mainly due to the appearance of uncontrolled inflammation that also favors the development of disseminated clots. So far, there is no effective treatment to combat coronavirus; however, the use of anti-inflammatory drugs is potentially effective in preventing complications from the disease. In this regard, low dose colchicine is relatively safe and effective as an anti-inflammatory. It has been used for many years in the control of inflammation secondary to the accumulation of uric acid crystals. The aim of this study is to test if the administration of colchicine at a dose of 1.5 mg the first day and subsequently 0.5 mg BID until completing 10 days of treatment is effective as a treatment for inflammation related symptoms in patients with mild and severe disease secondary to coronavirus infection. The primary outcome is improvement of symptoms related to inflammation and avoiding progression to severe and critical stages of the disease. Colchicine can be discontinued before the end of 10 days in case of serious adverse effects or if the patient progresses to the critical stages of the disease.
University Hospital, Lille
The objective of study is to estimate the sensitivity and specificity of the COR-DIAL based on nasopharyngeal samples taken at the patient's admission in relation to the final diagnosis of COVID-19 made by the medical team.
Consorci Sanitari de Terrassa
Some authors have proposed the use of the flu vaccine to reduce the severity of COVID-19 cases, while some have proposed the use of ACE Inhibitors (ACEI) or Angiotensin Receptor blockers (ARB), since this virus shares hemagglutinin as a transmission mechanism and acts on the ACE2 enzyme during infection. Other authors described how none of the elderly patients receiving antihistamines and azythromycin in two nursing homes in Toledo -Spain- during the first wave died or needed hospital admission, even considering that 100% of residents had a positive serological test after that wave. Other authors have described a positive evolution in patients receiving amantadine for their Parkinson's disease. The aim is to evaluate whether the admitted patients who are previously vaccinated or those who were already receiving these treatments showed a better evolution.
Hospices Civils de Lyon
Covid-SER is a prospective multi-center study for the evaluation of diagnostic performance of available serological tests
University Hospital Tuebingen
The current outbreak of COVID-19 caused by SARS-CoV-2 is a global health emergency with a case fatality rate so far approximately 4% and a growing number of confirmed cases (>9500) in Germany. There is no data available on the efficacy of antiviral agents for the treatment of COVID-19. In vitro data show that hydroxychloroquine can inhibit SARS-CoV-2 replication and anecdotal reports from COVID-19 patients in China and France suggest that chloroquine or hydroxychloroquine is a good candidate for treatment. In the French study a favourable effect was seen when hydroxychloroquine was used together with azithromycin in a small series of COVID-19 patients. However, so far all published evidence is based on non-controlled use of hydroxychloroquine. We propose to conduct a placebo-controlled trial in COVID-19 patients with mild to moderate disease in Germany to assess virological efficacy, tolerability and safety of hydroxychloroquine in the treatment of COVID-19. The objective of this trial is to identify an effect of hydroxychloroquine on viral clearance in vivo. This data will inform practice for the design of larger trials on clinical efficacy of hydroxychloroquine in the treatment and post-exposure prophylaxis of COVID-19.
Washington University School of Medicine
This Phase III trial four treatment strategies non-critically ill hospitalized participants (not requiring ICU admission and/or mechanical ventilation) with SARS CoV-2 infection, Participants will receive hydroxychloroquine or chloroquine with or without azithromycin.