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 200 of 562Masonic Cancer Center, University of Minnesota
This is a multi-center, randomized, placebo controlled, interventional phase 2A trial to evaluate the safety profile and potential efficacy of multi-dosing of mesenchymal stromal cells (MSC) for patients with SARS-CoV-2 associated Acute Respiratory Distress Syndrome (ARDS). After informed consent, treatment assignment will be made by computer-generated randomization to administer either MSC or vehicle placebo control with a 2:1 allocation to the MSC: placebo arm.
Obafemi Awolowo University
Finding effective strategies to treat or prevent the novel coronavirus disease that started in 2019 (COVID-19) is a global public health priority. Potential therapeutics and vaccines are now being investigated in over 1500 clinical trials. Clinical features of the disease include overproduction of reactive oxygen species which induces oxidative stress responses and contribute to acute lung injury. This presents a potential treatment strategy involving antioxidation therapy. In this pilot study, 90 COVID-19 patients aged 18-75 years will be recruited into two groups. The 45 patients in group 1 will receive the standard of care determined by their primary care providers while the 45 patients in group 2 will receive both the standard of care combined with daily antioxidant supplement for 14 days. All patients will be monitored for a total of 28 days with daily monitoring of symptoms and nasopharyngeal swab for SARS-CoV-2 test on days 3, 7, 14 and 28. The study will compare the following between the two groups: (1) the proportion of patients with clinical improvement (defined as live discharge from hospital, decrease of at least 2 points from baseline on a 7-point ordinal scale, or both), and (2) the proportion of patients with negative SARS-CoV-2 test by PCR on days 3, 7, and 14.
Baqiyatallah Medical Sciences University
180 people from the medical staff and high-risk people in Baqiyatallah Hospital, who are in close contact with patients, will enter the study. Participants will be divided into two intervention groups and one control group. The control group will use the full protective equipment assigned to the treatment staff. In addition to protective equipment, the first intervention team will receive a daily diet of 200 mg hydroxychloroquine tablets. The second intervention team, while observing and using the complete protective equipment, will place a thin layer of Mucodentol gel in the vestibular area of the mouth daily, every 6 to 8 hours. At the beginning of the treatment, qualified people will participate in the study while recording demographic and clinical information, PCR test will be performed, and if they have negative PCR, they will be in one of the 3 study groups. During the study, if the symptoms of the disease occur in each of the participants, the test will be taken again. If the test is positive, the person will withdraw from the study, and the patient's information will be recorded. Finally, the people present in the study will be tested for PCR, and the results of the disease and the side effects of the drugs will be compared.
Misr International University
Spread of COVID-19 in the world has led to a shift in teaching and learning techniques to online methods in order to prevent transmission of the disease. Misr International University (MIU) has an established online learning system that has been used together with face-to-face classes. The aim of this study is to assess and compare the satisfaction and perceptions of full-time teaching staff and undergraduate students regarding online learning during COVID-19 crisis.
Takeda
The purpose of this study is to assess safety, tolerability, preliminary efficacy, and PK of TAK-671 in participants with COVID-19.
Oslo University Hospital
NORPLASMA COVID-19 includes both the production of convalescent plasma from approved blood donors who have recovered from covid-19 (coronavirus disease 2019), and clinical studies to evaluate efficacy and safety of the treatment, as recommended by European health authorities. Patients who receive convalescent plasma in a clinical setting will be invited to participate in the monitoring study NORPLASMA MONITOR, where clinical data about safety and effect on clinical parameters including virus load and recovery time will be collected and compared to european patients in a common database for the European countries. The treated patients can be compared to a historical control group.
University of California, Los Angeles
This study will provide access to investigational anti-SARS-CoV-2 human convalescent plasma for pediatric patients with underlying medical conditions (cardiovascular disease, lung disease, immunosuppression) who are either infected with SARS-CoV-2 or who have had a high-risk exposure. Study participants will be transfused once with compatible convalescent plasma obtained from an individual who has recovered from documented infection with SARS-CoV-2. Safety information and pharmacokinetic data will be collected.
Instituto Materno Infantil Prof. Fernando Figueira
A prospective and retrospective cohort study. The objective will to determine the frequency of COVID-19 in pregnant and postpartum women hospitalized with flu syndrome, to evaluate clinical and laboratory predictors of COVID-19 progression and to determine the factors associated with adverse maternal and perinatal outcomes in healthcare centers in two states of Northeast Brazil.The study will be conducted including pregnant and postpartum women with clinical or laboratorial diagnosis of COVID-19, admitted in six healthcare centers in the Northeast of Brazil. All pregnant and postpartum women with clinical and/or diagnosis of COVID-19, attended in prenatal care, in emergency (maternity triage), high-risk pregnancy ward, obstetric intensive care unit and rooming-in ward will be included. The data will be collected in specific forms. The exams will be carried out by trained professionals within each institution.
Vironix Health Incorporated
This feasibility study is being conducted to understand how discharged emergency department patients who were tested for the SARS-CoV-2 virus (COVID-19) engage with a symptom-tracking web application. Study participants that are enrolled in the study will be asked to enter daily information about their health into the CovidX web application (app.). In addition, patients will answer questions regarding anxiety levels, use a pulse oximeter to record information (if you own one or are given one). The investigators predict that participants will be able to engage with the CovidX web application over several days to weeks for the purposes of symptom tracking, and may have decreased anxiety over the study period.
Big Corona Ltd.
This study seeks to determine whether dual or quadruple therapy is more effective in treating COVID-19.