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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Healthcare workers (HCW) at risk of Covid-19 will have baseline serology for SARS-CoV-2 to see if they are already immune to Covid-19. HCW will get baseline assessment and if meeting inclusion criteria and no exclusion criteria they will be randomized in a 2:1 ratio to hydroxychloroquine or Vitamin C on a weekly basis for three months. Subjects will complete daily diary of symptoms and temperature, and will have repeat SARS-CoV-2 serology at 6 weeks and 3 months to determine seroconversion.
Ludwig Boltzmann Institute for Lung Health
Summary of the study Study population: A representative sample of the Viennese population stratified by age and gender (data from the Vienna Health Study LEAD) Potential output and analysis: - Extent of age-specific infection and antibody formation - Cumulative incidence of infection - Rate of asymptomatic infection - Relationship with socioeconomics, lifestyle and risk factors (comorbidities) Study design: Prospective, longitudinal, stratified by age and gender Duration of study: Initial testing as soon as possible and repeat based on monitoring of the pandemic curve (probably after 2-3 months) Information to be obtained from participants: - serum samples for information on SARS-CoV2 infection and antibody formation - data on clinical symptoms
Chinese University of Hong Kong
The investigators had designed weekly mindfulness sessions (details see intervention below), which is free-of-charge and will be made available to general public who feel distressed during the outbreak of COVID-19. Face-to-face delivery of mindfulness interventions was not possible due to mandatory quarantine. The investigators hypothesize that this intervention is feasible and acceptable by the participants. As secondary outcomes, the investigators also hypothesize that the intervention can reduce stress, depressive and anxiety symptoms and enhance participants' sense of coherence This will be a quasi-experimental study. Participants will be invited to fill in an online informed consent and questionnaire around 2 days before each mindfulness online session and another set of questionnaire immediately after each session (see outcome measures). Participants will be identified by their e-mail and therefore serial data could be obtained.
Istinye 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
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.