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 110 of 3140Istinye University
An epidemic of pneumonia , which is thought to have developed due to a new coronavirus, was detected in Wuhan, Hubei Province of the People's Republic of China, and this epidemic could not be brought under control, leading to other provinces of China in a short time and then to a pandemic. It has spread all over the world including the European continent. Causative Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) and the disease caused by the new virus (novel) coronavirus-2019 (2019-nCoV) and subsequently the COVID-19. After the virus was officially detected in our country on 11 March 2020, the number of cases increased rapidly and the virus was isolated in 670 patients within 10 days. The group that is most affected by the outbreak and has the highest mortality rate is the elderly with known cardiovascular diseases. It is important to ensure the social isolation of elderly patients and to minimize all hospital applications as much as possible if they do not have life-threatening urgent problems. To this end, Turkey on 21 March 2020, 65 years of age and older people and patients with chronic curfew was implemented. Individuals moving away from social life are dealing with their body more, their level of depression and anxiety increase, and their physical functions decrease. The therapy service is offered to people who cannot travel with telerehabilitation, which is defined as the transmission of rehabilitation service to long distances by using electronic information and communication technology. The purpose of this study is to investigate the effects of telerehabilitation exercises given to elderly individuals on sleep quality, quality of life and balance within the scope of geriatric rehabilitation.
Istinye University
In December 2019, the new coronavirus pneumonia (COVID-19) exploded in Wuhan (Hubei, China) and spread rapidly from one city to the whole world. This virus resulted in a total of 1679720 confirmed cases and 101734 deaths worldwide. All countries in the world are taking some precautions to prevent the spread of this epidemic disease, which World Health Organization (WHO) declared as "epidemic". Staying home and social isolation are among these precautions. For this purpose, it began to implement the curfew for all individuals on 10 March 2020, Turkey. However, not leaving the house and social isolation bring about the limitation of physical activity. Physical activity (PA) is defined as anybody's movement produced by WHO by contraction of skeletal muscles. Studies investigating the relationship between social isolation and health behavior report consistent findings. Individuals with smaller social networks report less healthy diets, excessive alcohol consumption, and less physical activity. Traditional exercises; It takes place outdoors in gyms or rehabilitation centers. However, with the increase in the time we spent at home due to the coronavirus (COVID-19) epidemic, technologies have been used as an alternative method. Home-based exercise programs are also a viable solution to prevent various health problems that may be encountered in this direction. The decrease in physical performance is associated with loss of muscle strength, low quality of life, emotionalization, comorbidity, premature death, and increased health costs. When today's conditions are evaluated, technology-supported education programs are effective in increasing motivation for physical support. The purpose of this study; To prevent the spread of the COVID-19 outbreak, to evaluate the physical activity levels of individuals between the ages of 18-40 who have social isolation due to the measures taken in our country and to investigate the effectiveness of their video-based exercises.
Istinye University
In the postmenopausal period when the woman spent 1/3 of her life; Due to the lack of estrogen, some physical and psychological changes occur. These changes may cause some problems. For women who perceive menopause as the first step of old age, loss of physical strength, energy, attraction and fertility, menopause can also lead to anxiety. In addition to these, they are among the emotional changes in the menopausal period in symptoms such as hypersensitivity to events, fatigue, and insomnia. Sometimes it can even be seen in psychological disorders such as melancholy and depression. The new coronavirus pneumonia (COVID-19), which appeared in Wuhan in December 2019, started to appear in different countries soon after. All countries have taken measures to prevent the spread of this virus. To this end, Turkey remains at home on March 21, 2020, and has commissioned social isolation measures. Studies investigating the effects of social isolation show that psychological and physical problems occur in individuals. Studies have shown that yoga and mindfulness programs have an impact on people's anxiety, depression, and the ability to control themselves. The purpose of this study; To investigate the effectiveness of telerehabilitation based yoga and mindfulness programs on psychological resilience, physical awareness and physical activity in postmenopausal women in social isolation due to the COVID-19 outbreak. Using telerehabilitation-based home programs aims to use an innovative model.
Ain Shams University
Prospective interventional study, single arm of purified convalescent plasma transfusion as an add on therapy for the standard of care treatment (national guideline) (Oseltamivir (75mg/12 hours for 5-10 days) and hydroxychroquine (400mg twice in first day, 200 twice for 4-9 days) ± Azithromycin 500mg daily for 5 days
William Beaumont Hospitals
The purpose of this study is to determine how peoples' bodies respond to exposure to COVID-19. Employees of Beaumont Health in Michigan who are older than 18 years may be eligible to participate. Participants from other high-risk groups who are not Beaumont employees may also be recruited, as may family members of Beaumont employees who have tested positive for COVID-19. Participants will have blood drawn two or more times for serology testing. This serology test will determine if participants have detectable levels of the antibodies that our bodies develop to fight COVID-19 infection. Participants will fill out a questionnaire each time they provide a blood sample. The questionnaires include questions about participants' personal traits; their health; general questions about their risk to exposure; job and risk of exposure; symptoms, diagnosis, treatment of COVID-19 since last blood draw. Researchers will monitor participants' medical records in a confidential manner for one year after the last blood draw to help determine if people who develop antibodies to COVID-19 are protected against developing a COVID-19 infection in the future.There may be no direct benefits for participants; however, information from this study may benefit other people by increasing our understanding of COVID-19, how it spreads from person to person, and how people respond to fight off the infection.The results of the serology test are used for research only and will not affect clinical decisions regarding participants' treatment or quarantine
Ain Shams University
Randomized controlled interventional trial (Clinical Trial) phase 3 to assess the safety and efficacy of favipiravir versus the standard care therapy in the treatment of patients with COVID-19.
Ain Shams University
A prospective investigation and screening of all HCWs working in all governmental university hospitals and the affiliated COVID-19 quarantine hospitals using an online survey and laboratory testing using rapid serological tests and PCR. To date, the Ministry of Higher Education has dedicated quarantine hospitals at the following governmental universities: Ain Shams, Cairo, Helwan, Alexandria, Mansoura, Assiut, Minia. This list may be expanded in the future. The project will be pilot tested in Ain Shams University, then extended to other universities subsequently. For risk categorization of HCWs exposed to COVID-19 virus and assessment of infection control needs, an online survey questionnaire will be administered to all HCWs in the governmental university hospitals involved in emergency and intensive care and in the provision of care for COVID-19 patients in the affiliated COVID-19 quarantine hospitals. For confirmation of infection and determination of the secondary infection rate, paired serological samples at baseline and after exposure will be collected. For measuring the validity of the available rapid serological tests, a respiratory sample will be taken for viral detection by RT-PCR. A real-time interactive map using geographical information system programming will be developed to flag hotspots for HCWs' risk and infection control needs that originated from the online survey risk categorization in governmental university and COVID-19 quarantine hospitals. Policy and decision makers will use the map to manage emergency healthcare resource mobilization based on HCWs' risk and infection control needs.
Karyopharm Therapeutics Inc
The main purpose of this study is to evaluate the activity of low dose oral selinexor (KPT-330) and to evaluate the clinical recovery, the viral load, length of hospitalization and the rate of morbidity and mortality in participants with severe COVID-19 compared to placebo. The study had 2 arms and evaluated selinexor 20 mg + standard of care (SoC) and placebo + SoC. As the treatment for COVID-19 is rapidly evolving, the SoC varied over time and across regions of the world.
Apices Soluciones S.L.
COVID-19's mechanism to enter the cell is initiated by its interaction with its cellular receptor, the angiotensin-converting enzyme. As a result of this union, a clathrin-mediated endocytosis process begins. This route is one of the therapeutic targets for which available drugs are being investigated in order to treat COVID-19 infection. This is one of the mechanisms blocked by drugs like ruxolitinib and chloroquine. Various drugs approved for clinical use that block the clathrin-mediated endocytosis pathway have been explored. It has been found that the best in vitro and in vivo results were obtained with statins, which also allowed generating a greater potent adaptive immune response. Therefore, statins and specifically simvastatin make it possible to block the entry process used by COVID-19, block inflammation by various mechanisms and increase the adaptive immune response. All of these processes are desirable in patients infected with COVID-19. Statins have been proposed to have beneficial effects in patients infected with MERS-COV, another coronavirus similar to COVID-19, but there have been no randomized studies supporting the use of statins in patients with COVID-19 infection. In this project we propose the combined use of one of these drugs, ruxolitinib with simvastatin, looking for a synergistic effect in the inhibition of viral entry and in the anti-inflammatory effect.
National Institute of Dental and Craniofacial Research (NIDCR)
Background: COVID-19 is a worldwide pandemic and currently there is no effective therapy or vaccine. SARS-CoV-2, the virus that causes the COVID-19 respiratory infection, appears to be very contagious however all the modes of transmission are unclear. Transmission may occur in up to 25 percent of cases when there are no symptoms (asymptomatic). Before there are any symptoms, droplet spray during speaking may increase transmission from person to person; most of the spray is saliva. Researchers at the NIH would like to test saliva for the virus before symptoms are reported. Additionally, they would like to examine the importance of using masks to prevent transmission. They hope to better understand how COVID-19 is spread among people and how it can be prevented. For this study they would like to collect samples from the nose (nasopharyngeal swab), mouth (spit sample), eye (conjunctival fluid) and blood to test for the virus and if it is contagious. Objectives: To determine if the SARS-CoV-2 virus is present in saliva in asymptomatic individuals who are COVID-19 positive. To determine if using masks can prevent transmission. Eligibility: People ages 18 and older without symptoms or with mild symptoms (e.g., low grade fever, mild malaise, minor sore throat, runny nose, or sneezing) who have been in close contact (e.g. live in the same house) with someone who has tested positive for COVID-19 or people who have tested positive for COVID-19 and have mild (e.g., low grade fever, mild malaise, minor sore throat, runny nose, or sneezing) or no symptoms. Design and Procedures: For screening, interested participants will contact a study team member. The interested participant will be asked to provide documentation of COVID-19 positive status, their symptoms, or their contact to a COVID-19 positive person. Participants will be asked to come to the NIH drive-up COVID-19 testing site or NIH Clinical Center (Bethesda, MD) for 2 or more visits in 15 days for the following procedures: nasal swab for COVID-19 and viral load, verbal symptom assessment, saliva collection, and speaking exercise to capture oral fluid. During this time, participants will also be asked to participate in phone calls with the study staff and to complete questionnaires electronically. Participants will have weekly telephone calls to discuss their symptoms and 2-5 drive-up visits to the NIH within 28 days. If visits are scheduled at the Clinical Center, participants will have the option to participate in providing blood sample(s), a conjunctival swab and 1-2 salivary gland biopsies. If a participant has tested positive, they may be asked to return to the NIH after they have recovered from COVID-19 for additional sampling. The following procedures are part of this research: - Speaking exercise - participants will be asked to read a short script with and without wearing a mask. The droplets they produce while they speak will be collected. - Saliva collection - participants will spit into a cup and have saliva collected from different areas of the mouth. They should not eat 90 minutes before this but drinking water or juice is acceptable. They may have their tongue painted with a sour liquid to increase their saliva. - Nasal swab- participants will have a swab rubbed inside their nose. - Nasopharyngeal swab - participants that are close contacts of COVID-19 positive individual(s) and need a COVID-19 test, will have a swab inserted through the nose to rub the back of their throat. - Questionnaires - participants will complete questionnaires about their symptoms electronically at home. The following procedures are optional for participants to agree to participate in and will be performed in the Clinical Center: - Blood sample(s) - participants will have blood collection via venipuncture. - Conjunctival swab - participants will have the inner lower eyelid wiped with swab. - Minor salivary gland biopsy - participants will have tiny glands in mouth removed. Procedure will be done in the hospital. Participants will be paid up to a total of $300 for the study, based on the number of visits to NIH and the types of procedures performed. Payment will be: $50 on Day 1, Day 15 and at the recovery visit. Participants who agree to the optional conjunctival swab and/or biopsy will be paid $50 for each conjunctival swab (up to 1) and/or $50 for each salivary biopsy (up to 2). If at any time the participants start to have moderate or severe respiratory symptoms, their participation in the study will end and they should seek care with their local provider.