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 980 of 1279Jessa Hospital
The SARS-CoV-2 pandemic causes a major burden on patient and staff admitted/working on the intensive care unit (ICU). Short, and especially long admission on the ICU causes major reductions in skeletal muscle mass (3-4% a day) and strength. Since it is now possible to reduce mortality on the ICU, short and long-term morbidity should be considered another principal endpoint after SARS-CoV-2 infection. Cachexia is defined as 'a complex metabolic syndrome associated with underlying illness and characterized by loss of muscle mass'. Its clinical features are weight loss, low albumin, anorexia, increased muscle protein breakdown and inflammation. There is strong evidence that cachexia develops rapidly in patients hospitalized for SARS-CoV-2 infection, especially on the ICU. Several mechanisms are believed to induce cachexia in SARS-CoV-2. Firstly, the virus can interact with muscle cells, by binding to the angiotensin converting enzyme 2 (ACE-2). In vitro studies have shown the virus can cause myofibrillar fragmentation into individual sarcomeres, in addition to loss of nuclear DNA in cardiomyocytes. Similar results were found during autopsies. On a cellular level, nothing is known about the effects of SARS-CoV-2 infection on skeletal muscle cells. However, up to 19.4% of patients present with myalgia and elevated levels of creatine kinases (>200U/l), suggesting skeletal muscle injury. Moreover, patients with SARS-CoV-2 infection are shown to have elevated levels of C-reactive protein and other inflammatory cytokines which can all affect skeletal muscles. The above mentioned factors are not the only mediators by which skeletal muscle mass might be affected in SARS-CoV-2. There are other known factors to affect skeletal muscle mass on the ICU, i.e. immobilization and mechanical ventilation, dietary intake (anorexia) and inflammatory cytokines. SARS-CoV-2 infection in combination with bed rest and mechanical ventilation can lead to severe muscle wasting and functional decline resulting in long-term morbidity. Until know there are no studies investigating acute skeletal muscle wasting in patients infected with SARS-CoV-2 and admitted to the ICU. As a result, there is a need of more in-depth understanding the effects of SARS-CoV-2 infection on muscle wasting. An optimal characterization of these effects may lead to improvement in morbidity and even mortality in the short and long term by the establishment of evidence-based rehabilitation programs for these patients.
Ankara University
The world is facing an extremely important global epidemic. Coronavirus disease 2019 (COVID-19) epidemic, which first appeared in Wuhan, China in late 2019 and rapidly affected all countries of the world, was declared as a pandemic by the World Health Organization (WHO) on March 11, 2020. Coronavirus disease 2019 affects both the upper (i.e. sinuses, nose and throat) and lower (i.e. trachea and lungs) airways, causes respiratory tract diseases ranging from asymptomatic or cold to more severe lung diseases (Acute Respiratory Distress Syndrome-ARDS). COVID-19 has many symptoms (i.e. fever, loss of appetite). In cases where the disease has a more severe course, in addition to the symptoms mentioned above, complications such as a severe pneumonia, acute respiratory distress syndrome (ARDS) kidney failure and fatal heart damage may develop. Dyspnea is one of the most prominent symptoms for COVID-19. Since COVID-19 affects the respiratory system, pulmonary rehabilitation has an important place in the treatment of patients. Dyspnea is one of the most prominent symptoms for COVID-19. Our clinical observations are of the opinion that dyspnea is observed even in patients with mild COVID-19 pneumonia. Applying deep breathing exercise with triflo in COVID-19 patients, can contribute to relieving dyspnea, reducing / eliminating anxiety, and increasing quality of life. In the light of this information, the aim of this study is to determine the effect of deep breathing exercise with triflo on dyspnea, anxiety and quality of life in patients with dyspnea who are hospitalized for COVID-19. Research Hypotheses H1: Patients with COVID-19 pneumonia who undergo deep breathing exercise with triflo will have a lower dyspnea level than the patient group in which this exercise is not applied. H2: Patients with COVID-19 pneumonia who underwent deep breathing exercise with triflo will have a lower anxiety level than the patient group in whom this exercise was not applied. H3: Patients with COVID-19 pneumonia who underwent deep breathing exercise with triflo will have a higher quality of life than the patient group in whom this exercise was not applied.
Medigen Vaccine Biologics Corp.
The purpose of this study is to assess the safety and immunogenicity of MVC-COV1901 vaccine compared to placebo in participants who are generally healthy or with stable pre-existing health conditions.
Izmir Bakircay University
With the rapid spread of COVID-19 (SARS-CoV-2) disease all over the world and the announcement of a pandemic, researches on many different drug approaches have begun and these researches continue today. Considering the absence of a specific treatment for the disease yet and the urgency of the situation, drugs previously licensed for the treatment of other diseases and thought to be effective in COVID-19 have started to be used. Ongoing studies are conducted on the effectiveness, possible side effects and safety of these drugs in COVID-19, but there is no clear information yet. It is thought that the anti-inflammatory and antioxidant properties of some vitamins and trace elements may be associated with positive results in COVID-19 patients, and the physiological roles of these vitamins and trace elements in COVID 19 have been demonstrated by studies. It is important to investigate the levels of free radicals known to be effective in the development of cardiovascular disease due to homocysteine and oxidative stress, which can provide information on determining the risk of cardiovascular complications in the COVID-19 pandemic. In addition, as the decrease in physical activity levels of individuals in the COVID-19 pandemic may cause possible secondary complications such as an increase in the risk of cardiovascular disease, determining the physical activity levels of individuals and encouraging them to physical activity is another important parameter to minimize the negative effects of the process. It is thought that investigating the effects of the treatment approaches used in COVID-19 on trace element, homocysteine, oxidative stress parameters and physical activity levels will provide useful information in determining the factors underlying better clinical results. This study was planned to be carried out between 6-31 January 2021 in order to compare the trace element, homocysteine, oxidative stress parameters and physical activity levels before and after treatment for COVID-19 disease in COVID-19 patients who applied to Izmir Bakircay University Cigli Training and Research Hospital (Cigli Regional Training Hospital) and hospitalized in the COVID-19 service. Research data will be obtained from blood samples taken from participants. In addition, data on physical activity levels will be collected through a questionnaire. After analyzing the data obtained from the research with appropriate statistical methods, the data will be evaluated.
Liverpool School of Tropical Medicine
It is unknown whether malaria or malaria treatment affects COVID-19 severity, immune responses to SARS-CoV-2 virus, or viral loads and/or duration of shedding and therewith the onwards spread of SARS-COV-2. An observational cohort study will be conducted in 708 newly diagnosed COVID-19 patient of all ages in western Kenya and Burkina-Faso. They will be enrolled in hospitals with COVID-19 testing facilities from a source population screened for SARS-CoV-2 (N~4,720). Approximately 142 of the 708 COVID-19 patients are expected to be co-infected with malaria. They will be enrolled in the nested malaria treatment trial and randomized to receive 3-days of artemether-lumefantrine (the current standard of care) or pyronaridine-artesunate, a highly effective antimalarial with known antiviral properties against SARS-CoV-2 in-vitro, that is newly registered and being rolled out in Africa. Disease progression will be assessed and nasal swabs and blood samples will be taken during home/clinic visits on days 1, 3, 7, 14, 21, 28, and 42. Patients self-isolating will be phoned daily in between scheduled visits for the first 14 days to assess signs and symptoms. Hospitalisation, self-isolation and home-based care will follow national guidelines. The WHO clinical progression scale and FLU-PRO plus scales will be used to compare disease progression between COVID-19 patients with and without malaria, and by malaria. Other endpoints include seroconversion/reversion rates, chemokine/cytokine responses, T and B cell responses, viral load and duration of viral carriage. Infection prevention and control (IPC), including the use of personal protection equipment (PPE), and measures for patient transport will follow national guidelines in each country. Written informed consent/assent will be sought. The study is anticipated to start in January 2021 and last for approximately 18 months.
Research Institute for Biological Safety Problems
Multicenter, randomized, blind, placebo-controlled clinical study of III phases on the assessment of preventive efficiency, safety and immunogenicity QazCovid-in®-vaccine against COVID-19 in healthy adult volunteers
TC Erciyes University
The objective is to determine the safety and immunogenicity of two different strengths (3 µg and 6 µg) of an inactivated COVID 19 Vaccine compared to placebo so that to demonstrate the safety and efficacy in prophylaxis of COVID-19.
TSB Therapeutics (Beijing) CO.LTD
This is a phase 1 study in which healthy adult volunteers will receive BRII-196/BRII-198 or placebo and will be assessed for safety, tolerability, and pharmacokinetics.
Aivita Biomedical, Inc.
This is an adaptive Phase I trial of a vaccine consisting of autologous dendritic cells previously loaded ex vivo with SARS-CoV-2 spike protein, with or without GM-CSF, to prevent COVID-19 in adults.
University of Lahore
In current analysis moderate to severely ill Covid-19 infected patients will be nebulized with nitroglycerin, and they will be compared with the standard nebulization