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 350 of 600Istanbul Training and Research Hospital
COVID-19, spreading rapidly all over the world, causes serious morbidity and mortality. In severe COVID-19 infections, after pulmonary inflammation, cardiovascular organ failure, cytokine storm, hemophagocytosis, septic shock, develops due to uncontrolled hypoxia, and isolated organ failure turns into multi-organ failure. It is noteworthy that it causes lymphopenia in patients. In the studies, the blood levels of certain inflammatory cytokines, interleukin-1β,interleukin-6 and TNF-α, were evaluated. In addition, blood values of a limited number of cytokines were investigated similarly in a limited number of studies published in our country.
FGK Clinical Research GmbH
The aim of this study is to investigate whether vaccination of elderly with VPM1002 could reduce hospital admissions and/or severe respiratory infectious diseases in the SARS-CoV-2 pandemic . VPM1002 is a vaccine that is a further development of the old Bacillus Calmette-Guérin (BCG) vaccine, which has been used successfully as a vaccine against tuberculosis for about 100 years, especially in developing countries. VPM1002 has been shown in various clinical studies to be significantly safer than the BCG vaccine. VPM1002 strengthens the body's immune defence and vaccination with BCG reduces the frequency of respiratory diseases. It is therefore assumed that a VPM1002 vaccination could also provide (partial) protection against COVID-19 disease caused by the "new corona virus" SARS-CoV 2.
University of Miami
The purpose of this research study is to collect information to better understand caregiver responses to COVID-19 stress and to help caregivers cope with these stressors.
Gaziosmanpasa Research and Education Hospital
In COVID-19 patients hospitalized in the intensive care unit due to respiratory failure, lung ultrasonography will be tried to be given an appropriate position that will effectively use lung capacity and its effect on oxygenation will be investigated.
University of Wisconsin, Madison
This study is a randomized controlled trial (RCT) of the four-week Healthy Minds Program (HMP) app Foundations training in employees of a mid-size urban school district in the United States during the summer of 2020, in the midst of the novel coronavirus pandemic. A 3-month follow-up in the fall of 2020 will also be conducted. Participants will be recruited via email and mailed postcards, and will first complete an online screen. Eligible participants will then enter a waiting zone for between 2-days and 2-weeks before they are sent the online pre-test. Upon completion of the pre-test, participants will be assigned to condition via a simple random number generator. If assigned to the intervention (i.e., the Healthy Minds Program App), participants will receive instructions and support in downloading and activating the app. Every 7-days over the 4-week intervention period participants in both conditions will complete the same set of measures. A full battery of measures will be administered a second time post-test, following the 4-week intervention period. Three-months after post-test, a follow-up assessment will be conducted. The investigators predict that participants assigned to the intervention will demonstrate significantly reduced psychological distress after the intervention, and these decreases will persist at the 3-month follow-up. Further, it is hypothesized that baseline participant characteristics and early experience of the intervention will predict treatment adherence, study drop-out and outcomes, and that treatment engagement will moderate outcomes.
Central Hospital, Nancy, France
Several studies have shown that smokers have a higher risk of developing a severe form of COVID-19 once a person has been infected. This is explained by the damage caused by smoking at the bronchopulmonary level and an overexpression of some coronavirus receptors at the pulmonary level when exposed to tobacco. In contrast, recent data indicate that smokers are proportionally less infected with the COVID-19 virus since all available cohort data from around the world show a very low rate of smokers among COVID-19 infected subjects. The mechanisms at the origin of this protective effect are not known. All of these data lead us to question the real role of nicotine in the protective effect of tobacco observed in the general population against infection by the COVID-19 virus. The objectives are : - To show that subjects taking nicotine substitutes as part of a smoking cessation program are less infected with COVID-19 than non-smokers. - To show that active smokers are less infected with COVID-19 than non-smokers. - To compare the percentage of positive serological tests in subjects taking nicotine substitutes to the percentage of positive serological tests in active smokers.
Tychan Pte Ltd.
The emergence and rapid spread of the coronavirus disease 2019 (COVID-19) since December 2019 across 188 countries globally has become a major public health crisis. COVID-19 was declared a pandemic by the World Health Organisation (WHO) on the 11th March 2020. To date, more than 14,000,000 cases and 600,000 deaths have been reported. COVID-19 is an acute respiratory disease caused by the novel SARS-CoV-2 virus from the Betacoronavirus genus, just like SARS-CoV and MERS-CoV. SARS-CoV-2 is primarily transmitted person-to-person through respiratory droplets or close contact. Fomite transmission has also been implicated as a transmission route. Common respiratory symptoms such as fever, sore throat, cough and shortness of breath, may appear 2 - 14 days after exposure. About 20% of infected cases progress to severe disease resulting in an estimated 2 - 5% mortality reported. With the unrelenting increase in cases being reported worldwide, there is thus an urgent need for therapeutics to be developed and used to disrupt the ongoing pandemic. To date, there is no specific proven antiviral treatment for COVID-19. Supportive care is recommended for symptom relief and for severe cases, organ support is critical for optimal outcome. Numerous vaccine candidates against SARS-CoV-2 are under development and a couple have entered Phase 1 clinical trials. Remdesivir, a nucleotide analog, developed by Gilead Sciences as a treatment for Ebola virus disease is currently being repurposed and undergoing multiple clinical trials to evaluate safety and efficacy in COVID-19 patients. In a preliminary study, convalescent plasma containing neutralizing antibodies against SARS-CoV-2 has also been experimentally administered in critically ill COVID-19 patients with promising results. Donor plasma used was rich in virus specific IgG and IgM antibodies as determined by ELISA. Within days of convalescent plasma treatment, patients showed decrease in viral load (via qRT-PCR), as well as improved clinical status being observed. Tychan's TY027 will be the first biologics in the world, specifically targeting SARS-CoV-2, to enter human clinical trials. It is anticipated that a SARS-COV-2 specific monoclonal antibody therapeutic administered to acutely infected patients could reduce disease severity as well as prevent transmission by reducing viral load and viral shedding. It could also be used as prophylaxis against COVID-19 amongst high risk contacts.
Tourcoing Hospital
Understanding the SARS-Cov2 epidemic is a major public health issue, both in the community and in the hospital sector. Because of their central position in the management of patients infected with COVID-19, hospital staff may be considered at high risk of infection. The development of serological tests makes it possible to reliably document a contamination, symptomatic or not, that is more than 3 weeks old. These tests, combined with clinical questioning of the symptoms, make it possible to determine the proportion of asymptomatic infections whose impact in the transmission of this disease appears to be major. The duration of the presence of the antibodies that are hoped to neutralize after infection with CoV2-SARS remains uncertain. Documenting the evolution of antibody levels and their monitoring in a population at high risk of re-exposure to CoV2-SARS is a major issue in understanding this disease and in assessing the risk of infection among healthcare workers.
Federal Knowledge Centre (KCE)
This a phase II, proof-of-concept study. In the present study, we investigate if the administration of blood-plasma from patients recovered from COVID-19, could be effective to treat patients who are severely ill because of a COVID-19 infection. The general idea behind the transfusion, is that plasma of recovered patients contains antibodies that could eliminate the novel coronavirus causing COVID-19, and lead to a less severe course of the disease, or a faster healing. Simply put, in this study we would like to investigate whether 'borrowed immunity' from a person who has cured from this disease, could be applied to cure other patients more rapidly.
Royal Marsden NHS Foundation Trust
People with cancer may be at higher risk of poor outcomes with COVID-19 infection. This observational study aims to describe the clinical course of COVID-19 infection in people with cancer and evaluate the utility of antibody and antigen tests for COVID-19. The results of this study will inform clinical practice in the management of cancer patients with COVID-19.