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 130 of 387Northwell Health
The FDA has provided an emergency waiver for the use of non-invasive continuous glucose monitors (CGM) in hospitals, so frontline health care providers (in hospitals) can remotely monitor patients with diabetes thus reducing patient's discomfort, limiting exposure to COVID-19 and preserving critical personal protective equipment (PPE). The FreeStyle Libre 14-day system is a continuous glucose monitoring system consisting of a handheld reader (smart phone may be used) and a sensor applied with adhesive to back of the upper arm. In order to evaluate the reliability of the Freestyle Libre CGM for in-patient use, we propose a study which will examine the correlation between the libre CGM data and capillary blood glucose test - the current standard of care taken by the Accuchek Inform II platform.
University of Texas at Austin
The primary aim of this study is to examine the efficacy of a one-session, hour-long HIPAA-compliant video platform-based mindfulness + compassion telehealth intervention on reducing feelings of loneliness during COVID-19 quarantine. Participants (n=120) currently isolating due to COVID-19 will be randomized to one of three interventions: (a) mindfulness + compassion (MC); (b) mindfulness alone (MO); and (c) waitlist control (WL). The investigators predict that participants in the active intervention groups (mindfulness or mindfulness + compassion) will show a significantly greater reduction in subjective feelings of loneliness at one week follow-up compared to those in the waitlist control group. Additionally, investigators predict that participants in the active intervention groups will show a significantly greater reduction in stress at one week follow-up compared to those in the waitlist control group. Last, investigators predict that participants in the mindfulness + compassion group will show a significantly greater reduction in subjective feelings of loneliness at the 2-week follow-up follow-up relative to those in the mindfulness only group.
Cedars-Sinai Medical Center
The COVID-19 pandemic has undoubtedly elevated levels of stress to people all over the globe, but none more than to the providers on the front-line. The purpose of the study is to first, assess the effects of the pandemic on burnout, team cohesion, and resiliency among healthcare providers battling COVID-19 together in a medical ICU (MICU). Secondly, the investigators hope to then assess the effects of simple positive feedback on transforming culture and attitudes during times of major stress.
Promundo, United States
This proposed study will assess how COVID-19 and the associated 'stay at home' orders are affecting low-income Rwandan couples' relationships and family dynamics. The study builds on an existing randomized controlled trial of the Bandebereho fathers/couples intervention (NCT02694627), which will allow us to assess not only the current conditions in households, but also whether or how the significant impacts of the intervention are sustained under extreme stress.
Assistance Publique - Hôpitaux de Paris
The purpose of this study is to define seroprevalence of anti-SARS-CoV2 among children of Hospital Workers in APHP, particularly exposed population, according to parents' SARS-CoV2 serological status.
European Institute of Oncology
In COVID-19 pandemic, it is of critical importance to identify a rapid and simple diagnostic method to be used in clinical settings to timely inform and refine strategies that can prevent, control, and stop the spread of SARS-CoV-2. The 2019-nCoV IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a qualitative, membrane-based immunoassay for the detection of immunoglobulin G (IgG) and Immunoglobulin M (IgM) antibodies to SARS-CoV-2 in whole blood, serum or plasma specimen. Clinical specimens from patients who were suspected of being infected with 2019-nCoV will be used to evaluate the performance of the assay.
Yale University
The purpose of this study is to evaluate the performance of a non-invasive olfactory device as a rapid indicator of COVID-19 in positive subjects.
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.
KGK Science Inc.
Corona virus disease 2019 (COVID-19) is caused by SARS-CoV-2, a plus-sense single-stranded RNA virus. After an incubation period, which typically lasts for 5-6 days, COVID-19 patients present with a mild illness that lasts for a few days. Common symptoms are reminiscent of the flu, and include fever, dry cough and dyspnea. A large percentage of patients resolve the infection whereas others progress onto adult respiratory distress syndrome (ARDS) which impedes gas exchange between the alveolar space and the bloodstream and creates the need for assisted respiration. The objective of this study is to investigate the safety and efficacy of CARDIO supplementation in the recovery of those with COVID-19 infection following the guidance from public health by reducing the need for mechanical respiratory support, alleviating respiratory symptoms and reducing mortality.