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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To search this directory, simply type a drug name, condition, company name, location, or other term of your choice into the search bar and click SEARCH. For broadest results, type the terms without quotation marks; to narrow your search to an exact match, put your terms in quotation marks (e.g., “acute respiratory distress syndrome” or “ARDS”). You may opt to further streamline your search by using the Status of the study and Intervention Type options. Simply click one or more of those boxes to refine your search.
Displaying 1810 of 2124Jarmo Oksi
Evaluating the efficacy of Tocilizumab in hospitalized patients in the inflammatory phase of COVID-19. Randomization 2:1 (TCZ:standard of care).
National Institute of Allergy and Infectious Diseases (NIAID)
The purpose of this study is to measure immunity to the flu vaccine over time in patients who had COVID-19. Adults who have been diagnosed with COVID-19 as well as controls without COVID-19 will be invited to participate in this study.
Biotest
The objectives of the trial are to evaluate the efficacy and safety of trimodulin as add-on therapy to standard of care (SoC) compared to placebo treatment in adult hospitalized subjects with severe COVID-19. Additionally, pharmacodynamic (PD) and pharmacokinetic (PK) properties of trimodulin will be evaluated in all subjects.
UNION therapeutics
This is a Phase 1 Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Assess the Safety of Ascending Doses of UNI911 INHALATION in Healthy Volunteers in Preparation for Evaluation in Adults with COVID-19
Asklepion Pharmaceuticals, LLC
Prospective, Randomized, Double-Blind, Placebo-Controlled Phase II Trial of Intravenous L-Citrulline (Turnobi) to Delay and Potentially Prevent the Need for Invasive Mechanical Ventilation for Acute Hypoxemic Respiratory Failure in Patients with COVID-19 (SARS-CoV2) Illness. To evaluate safety and efficacy of a bolus loading dose and continuous intravenous infusion of L-Citrulline compared to placebo in patients hospitalized with COVID-19 infection (SARS-CoV-2).
University of California, San Francisco
Coronavirus disease 2019 (Covid-19) is now a leading cause of death among U.S. adults. In addition to profound respiratory and multi-organ failure, hypercoagulable states and venous thromboembolism (VTE) have been increasingly reported in patients with severe Covid-19. The aim of this study is evaluate the risk of VTE related to Covid-19 infection in a real-world community-based population.
Jiangsu Province Centers for Disease Control and Prevention
The 2019 novel-coronavirus (2019-nCov) is the cause of a cluster of unexplained pneumonia that started in Hubei province in China. It has manifest into a global health crisis with escalating confirmed cases and spread across many countries. In view of the fact that there is currently no effective antiviral therapy, the prevention or treatment of diseases caused by COVID-19 can be tough for current treatment. This study is a phase I clinical trial of booster vaccination of adenovirus type-5 vectored COVID-19 vaccine 6 months after prime vaccination. The investigators intent to evaluate the safety and immunogenicity of booster vaccination of adenovirus type-5 vectored COVID-19 vaccine in healthy adults aged aged 18-60 years.
Groupe Hospitalier Paris Saint Joseph
The COVID-19 attack is polymorphic with otorhinolaryngological, pneumological, cardiac, digestive, neurological, muscular attacks with a higher mortality in subjects with comorbidity [> 70 years old, cardiovascular history in particular Arterial hypertension (hypertension ), heart disease…]. This polymorphism is linked to vasculitis and the immune response. Patients with cardiovascular disease are particularly at risk of decompensating, particularly due to the increased metabolism induced by viral infection and reduced cardiovascular capacities. On the cardiovascular level, two sides can be considered. On the one hand, cardiovascular disease (hypertension, coronary artery disease) is a comorbid factor. On the other hand, the myocardial damage reflected by the increase in troponin or an alteration of the ejection fraction is a very clear risk factor for death or severe form. Cardiovascular involvement is particularly high in hospitalized and deceased patients. The odds ratio calculated in a meta-analysis of severe forms of covid-19 with hypertension is 3 [1.9; 3.1], for cardiovascular pathologies of 2.93 [1.73; 4.96]. Recommendations were made for pulmonary rehabilitation but not for cardiovascular rehabilitation. Cardiac rehabilitation is indicated in most cardiovascular pathologies (after acute coronary syndrome, after coronary angioplasty, in heart failure, after coronary or valve heart surgery, etc.). It consists of a multidisciplinary approach combining therapeutic pharmacological adjustment, physical activity, therapeutic education in order to improve physical capacities for exertion and reduce morbidity and mortality. The physical exercises can be endurance or resistance type. Capacity gain at the end of rehabilitation is measured by visual scales, quality of life questionnaires, and a stress test at the start and end of rehabilitation. Most often, rehabilitation centers only do the stress test and estimate through questioning for subjective improvement. The hypothesis is that patients who contracted COVID-19 would have lower cardiac capacities after recovery from the infection than patients without COVID-19 or that their capacity for recovery would be less. There could be a difference in recovery after cardiac rehabilitation between the two populations regardless of whether the cardiac damage requiring rehabilitation was triggered by COVID-19 or was pre-existing.
Clinical Hospital Center, Split
It is planned to include patients over 18 years of age of both sexes, admitted to the Intensive Care Unit of Clinical Hospital Centre Split for respiratory insufficiency caused by severe acute respiratory syndrome coronavirus 2 in need of invasive mechanical ventilation. The patients will be divided into four groups. Group 1 will receive N-acetylcysteine inhalation, Group 2 will receive inhalation with a 5% sodium chloride solution, and Group 3 will receive inhalation of 8.4% sodium bicarbonate, group 4 is a control group and will not routinely receive inhaled mucolytics preventively. All inhalations will be given twice a day 12 hours apart. The first inhalation will be included within 12 hours of the patient being enrolled in the Intensive Care Unit. Patients will be randomized according to the type of inhalation they will receive, randomization will be done by all researchers through the random.org website, and the inhalation will be given by a nurse according to the agreed protocol. RESEARCH GOALS The aim of this study is to determine whether there is a difference in the frequency and duration of ventilator-associated pneumonia (VAP) and whether there is a difference in the number of days spent on mechanical ventilation and in mortality in these four groups of patients. Hypothesis Coronavirus disease 2019 patients on invasive mechanical ventilation and preventive sodium bicarbonate inhalation will have a lower incidence of ventilator-associated pneumonia and fewer days spent on invasive mechanical ventilation than patients inhaled with N-acetylcysteine, 5% saline, or patients without preventive inhalation.
Assistance Publique - Hôpitaux de Paris
European countries faced another wave of the SARS-CoV2 pandemic, which has led to a second lockdown in France in November 2020 in order to avoid overwhelming health services. To prevent or reduce another wave, the strategy calls for vaccination, maintaining barrier measures and testing and isolating infected persons in order to break the cycles of infection. The latter objective is made difficult by the existence of asymptomatic carriers or symptomatic carriers that have very few symptoms and that aren't tested. Identification of these carriers in the general population is usually based on a search for close contact persons from those who were tested positive or from identified clusters. Experiments of mass testing are being carried out or were carried out, for example in Liverpool or Slovakia but, in order for them to be effective, they must be repeated, which limits feasibility. Another strategy of wide screening in the general population to identify asymptomatic persons is to offer a systematic screening during medical consultations and particularly in the emergency departments (ED). This strategy grants access to the entire population attending health facilities, including persons with lower income. This strategy can be conducted continuously in order to: 1) contribute to controlling the epidemic by identifying and isolating asymptomatic persons and their close contacts; 2) provide an observatory on the evolution of viral circulation in the general population. To the best the knowledge, this strategy has not been evaluated and will be tested it in 18 emergency departments in the Paris Metropolitan area, one of the most SARS-CoV2 affected regions. The aim is to evaluate the benefit of a systematic offer of SARS-Cov2 screening by rapid testing (molecular multiplex PCR/ RT-LAMP) to identify infected persons, associated with the usual practice of the EDs (intervention strategy) compared to a period based on usual practice of the EDs (control strategy) The strategies will be compared during two periods following a cluster-randomized two-period crossover design. During intervention periods, nurses will suggest performing a SARS-CoV2 test to patients using a PCR multiplex for symptomatic patients and a RT-LAMP for asymptomatic patients.