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 160 of 1043Jeremia Held
COVID-19 has a big impact on individuals and society as a whole. Especially persons with (multiple) comorbidities such as stroke are affected. The impact of COVID-19 on stroke rehabilitation delivery and stroke patients' functioning is unclear.
University Health Network, Toronto
Endothelial injury as a consequence of SARS-CoV-2 infection leads to a dysregulated host inflammatory response and activation of coagulation pathways. Macro- and micro-vascular thrombosis may contribute to morbidity, organ failure, and death. Therapeutic anticoagulation with heparin may improve clinical outcomes in patients with COVID-19 through anti-thrombotic, anti-inflammatory, and anti-viral activities of heparins. This pragmatic, Bayesian adaptive randomized controlled trial will determine whether therapeutic anticoagulation with heparin (subcutaneous low molecular weight heparin or intravenous unfractionated heparin) versus usual care reduces the need for intubation or death in hospitalized patients with COVID-19. The trial uses an adaptive design which was chosen to overcome limitations in available data to inform a priori estimation of event rates and possible effect sizes. The adaptive design also includes response-adaptive randomization based on baseline D-dimer level, probing for differential efficacy across subgroups defined based on initial D-dimer level. This Bayesian adaptive randomized trial will stop at a conclusion 1) when the posterior probability that the proportional odds ratio is greater than 1.0 reaches 99% (definition of benefit); 2) when the posterior probability that the proportional odds ratio is greater than 1.2 is less than 10% (definition of futility) or; 3) when the posterior probability that the proportional odds ratio is less than 1.0 is greater than 90% (definition of harm). The trial will enroll a maximum of 3,000 patients, although in many simulations the trial may require fewer patients. The trial is strategically aligned with the international REMAP-CAP/COVID platform trial to accelerate evidence generation.
National Bureau of Economic Research, Inc.
Recent data have shown that covid19 is disproportionately infecting and killing African Americans and Latinx people in the United States. The aim of the study is to determine which messages are most effective at increasing knowledge and changing behaviors that can protect individuals and their communities from the virus. To accomplish this aim, we plan to recruit approximately 20,000 Hispanic and African-American individuals and randomly assign them to videos that vary either the sender or the framing of the message, while providing the relevant public health information.
Poitiers University Hospital
The SARS-CoV-2 coronavirus pandemic is responsible for more than 180,000 deaths worldwide and 20,000 deaths in France. To date, no treatment or vaccine has been successful. Povidone-iodine is an antiseptic suitable for use on the skin and mucosa with potent virucidal activity, particularly against coronaviruses. It is marketed for oro-nasopharyngeal decolonization. 24 patients with positive nasopharyngeal SARS-CoV-2 carriage will be randomized (1:1) in an experimental group (benefiting from povidone iodine decolonization) or a control group. Patients in the experimental group will be asked to gargle with a 1% povidone-iodine solution, spray their nose with the same antiseptic solution, and finally applied 10% povidone-iodine cream in each nostril, all four times a day for five days. Patients will be followed for 7 days to evaluate the efficacy and safety of povidone iodine decolonization.
St. Francis Hospital, New York
This is a randomized, open-label trial to assess the safety and efficacy of hydroxychloroquine, and zinc in combination with either azithromycin or doxycycline in a higher risk COVID-19 positive outpatient population.
Genentech, Inc.
This study (EMPACTA) will a) evaluate the efficacy and safety of tocilizumab (TCZ) compared with a placebo in combination with standard of care (SOC) in hospitalized participants with COVID-19 pneumonia, and b) include an optional long-term extension for eligible participants to explore the long-term sequelae of resolved COVID-19 pneumonia.
Oslo University Hospital
The project is a longitudinal cohort study based on an electronic questionnaire on views and experiences of COVID-ICU Health care professionals during the pandemic. In addition, a few of the informants participating in the cohort study will be asked to participate in focus groups to get a deeper understanding of the experiences of Health care professionals. Leaders at the randomized hospitals will be asked to participate in individualized interviews.
Guangzhou Blood Center
The fight against the spread of the 2019-nCoV epidemic has achieved some success in China, but the epidemic is far from over. A key factor making the epidemic under control in China is the government's call for social distance, which has led to few people going out for donation. As a result, the number of blood donors on the streets has been continuing to decline. Urgent recruitment of blood donors is therefore planned during the period from 30 April to 10 May via emergency recruitment SMS . This study has been designed to compare which information extraction frameworks would be more sensitive to blood donors in emergency situations.
National Institute of Allergy and Infectious Diseases (NIAID)
This surveillance study will collect detailed clinical, laboratory, and radiographic data in coordination with biologic sampling of blood and respiratory secretions and viral shedding in nasal secretions in order to identify immunophenotypic and genomic features of COVID-19 -related susceptibility and/or progression. The aim: for the results obtained from this study to assist in generating hypotheses for effective host-directed therapeutic interventions, to help to prioritize proposals for such interventions, and/or optimize timing for administration of host-response directed therapeutics.
Nemechek Technologies
This trial is designed to determine if the inflammation modulating effect of vagus nerve stimulation can improve pulmonary function and limit progression to ARDS in hospitalized COVID-19 hospitalized patients.