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 170 of 446Direction Centrale du Service de Santé des Armées
Since March 2020, SARS-CoV2 virus (nCoV19; COVID-19) is considered pandemic. Its high rate of spread and infection in the human population and the lack of effective and validated treatment have led the authorities of several countries to confine their populations to slow the spread of COVID-19. As part of the management of this health crisis, the screening of individuals is essential in order to isolate "infected cases". These screening tests are currently performed on nasopharyngeal swabs using RT-PCR for the detection of viral RNA. Although sensitive and specific, these tests remain relatively long (2-5 hours), expensive and the strong international demand for nucleic extraction kits and enzymes are factors limiting the implementation of widespread screening (problem of supply of swabs, molecular biology consumables). In order to prevent the risks of a shortage of screening means, we propose to develop an innovative alternative strategy, PCR-free, based on the detection of specific protein signatures in human saliva by MALDI-TOF MS profiling. MALDI-TOF MS profiling is a method used in routine diagnostics by microbiology laboratories for the identification of microorganisms. MALDI-TOF MS profiling has been successfully used to classify individuals according to their infectious status (oral pathologies) based on the analysis of their saliva, but also as a tool for the identification of respiratory viruses from cell culture supernatants. In addition, we have expertise and skills in the field of MALDI-TOF MS profiling and have implemented new strategies to improve the quality of profiles and their analysis, particularly in the context of entomological and vector identification projects. Finally, recent Chinese studies have reported that COVID-19 was detectable in saliva by RT-PCR. The main objective of this study is to develop a test based on the MALDI-TOF profiling method to detect individuals infected with SARS-CoV2 from saliva sample.
KK Women's and Children's Hospital
The overall objective of this project is to develop an emergent treatment protocol using adoptive T-cell therapy for the treatment of severe COVID-19. The central hypothesis is that SARS-CoV-2 specific T cells from convalescent donors who have recovered from COVID-19 can be manufactured expeditiously and these cells are safe and effective for the treatment of severe SARS-CoV-2 infections.
Indonesia University
Novel Coronavirus (2019nCoV) or Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) that causes Coronavirus Disease 2019, or known as Covid-19 has recently become a global health emergency since it was first detected in Wuhan, the People Republic of China in December 2019. Since then, the prevalence has rapidly increased worldwide. In Indonesia, by the end of April 2020, around 10,000 patients have been tested positive for Covid-19 infection, with a case fatality rate of around 8%. The pathogenesis of Covid-19 is still under investigation and to our understanding, ACE2 receptors in the alveoli serve as the binding site of the S-protein of envelope spike virus of SARS-CoV-2. TMPRSS2 enzyme aids the fusion between cell membrane and capsid of the virus, allowing penetration of virus into the cell. Vesicles containing virion fuse with cell membrane and released as new virions. Cytopathic effect of the virus and its ability to overcome immune response determines the degree of infection. Differences in immunological profile among degrees of severity of Covid-19 may vary especially for the number of pro-inflammatory cytokines such as tumor necrosis factor alpha (TNF-α), interleukin (IL)-1, IL-6, IL-8, leukemia-inhibiting factors (LIF), immunological markers such as CXCR3+CD4+, CXCR3+CD8+ T cell and CXCR3+ NK cells, implying the ongoing cytokine storm. The previous studies also found increasing number for infection markers such as procalcitonin, ferritin, and C-reactive protein. The decreasing number of anti-inflammatory cytokines in such as IL-10 also supports this finding. Previous studies have shown immunomodulating and anti-inflammatory capacity of the mesenchymal stem cells (MSCs). MSCs contributed to the shifting of pro-inflammatory Th2 into anti-inflammatory Th2. One of the most recent study on the usage of MSCs on Covid-19 patients showed increased expression of leukemia inhibitory factor (LIF), which give rise to inhibitory effect of T lymphocyte and natural killer (NK) cell population. Vascular epithelial growth factor (VEGF) is found increasing following MSCs administration, which indicates the ability to improve the disrupted capillaries due to SARS-Cov-2 infection. The ability of MSCs in differentiating to alveolar cells is proven by the presence of SPM and SPC2, surfactant proteins produced by type II alveolar cells. MSCs are unable to be infected by SARS-CoV-2 since they don't have ACE2 receptors and TMPRSS2 enzyme.
Corporacion Parc Tauli
OBJECTIVE: The aim of the study is to demonstrate that the intracorporeal resection and anastomosis in left-sided colon cancer, sigma and upper rectum, is not inferior to extracoprporeal resection and anastomosis, in terms of anastomotic leakage. BACKGROUND: Due to the recent events of a pandemic respiratory disease secondary to infection by SARS-CoV-2 virus or coronavirus 19 (COVID19), surgeons have been forced to adapt our surgical procedures in order to minimize exposure to the virus as much as possible. Based on the recommendations in case of surgery in patients with highly contagious viral diseases, the latest studies suggest minimally invasive accesses to minimize the risk of contagion. One of the proposed measures is the performance of intracorporeal anastomoses. Therefore, given the extensive experience of our center in minimally invasive surgery and studies on the validation of intracorporeal anastomosis techniques in both laparoscopic surgery of the right colon and rectum (TaTME), and the study of advantages that they can provide to the patient, our intention is to apply it to surgery on the left colon, sigma and upper rectum. Our hypothesis is that exteriorization of the colon through an accessory incision increases the risk of tension at the mesocolon level, thus increasing the risk of vascular deficit at the level of the staple area and it may increase the rate of anastomotic leakage. In this sense, studies that validate a standard technique of intracorporeal anastomosis in left colon surgery and that demonstrate its benefit with respect to extracorporeal anastomosis are lacking. We intend to describe a new intracorporeal anastomosis technique (ICA) that is feasible and safe for the patient and that can be applied universally. Once the ICA technique is established, it will allow us to determine its non-inferiority compared to the standard technique performed up to now with extracorporeal anastomosis. METHODS: All consecutive patients with left-sided, sigma and upper rectum adenocarcinoma will be included into a prospective cohort and treated by laparoscopy with totally intracorporeal resection and anastomosis. They will be compared with a retrospective cohort of consecutive patients of identical characteristics treated by laparoscopy with extracorporeal resection and anastomosis, in the immediate chronological period.
Sinovac Life Sciences Co., Ltd.
This is a phase III clinical trial to assess efficacy and safety of the Adsorbed COVID-19 (inactivated) vaccine manufactured by Sinovac in health care professionals
Instituto de Medicina Regenerativa
This is a pilot phase, open label, non-randomized study for the treatment of ARDS in patients infected with COVID-19. Subjects will be enrolled and treated with one dose of mesenchymal stem cells and follow-up will occur 90 days post-treatment.
Fundació Institut Germans Trias i Pujol
The purpose of this study is to assess the efficacy of RUTI® vaccine preventing SARS-CoV-2 infection (COVID-19) in healthcare workers.
Jacobs University Bremen gGmbH
As a result of the pandemic, hygiene and distancing rules must be followed in Health care/ rehabilitation clinics to ensure the safety of patients and staff. This has led to extensive changes in the therapy processes, including a reduction in group sizes and maintaining distances within the groups, resulting in a reduction in the range of therapies available to individuals, since the number of employees remains unchanged and cannot be increased at will and in the short term due to the lack of qualified staff. In order for the treatment/rehabilitation goals to be achieved nonetheless, new forms of implementation of therapy programs must be developed in addition to organizational adjustments. Digitalization can be a significant support in this respect. The majority of patients in psychosomatic rehabilitation possess smartphones, meaning that the necessary infrastructure for the utilization of digital offers is available and can be used to the greatest possible extent. The use of digital measures within the therapeutic services supports the independence of the patients, as they can use the digital offers independently and flexibly in their own time. How should Health care/rehabilitation services be designed in light of the SARS-CoV-2 pandemic and which services have the potential to buffer future crises: What general recommendations can be derived for the design of such services for routine care? What are support measures to encourage social participation and return to work?
Reig Jofre Group
The purpose of this study is to assess the efficacy of Manremyc® food supplement for reduce the incidence of SARS-CoV-2 infection in a high risk population, as healthcare workers.
National Council of Science and Technology, Mexico
The health contingency established against the Severe Acute Respiratory Syndrome associated type 2 Coronavirus (SARS-CoV-2) has promoted a race against the clock for the search on treatment against the disease related with coronavirus (COVID-19). There are no current approved therapeutic options against the virus, although there is a rush for the development of drugs, vaccines and even the passive immunization through plasma from convalescent patients. This passive immunization is made with the administration of antibodies from patients that went through the infectious state of the disease and progress to clinical remission. SARS-CoV-2, and its predecessor SARS-CoV-1, have great similarities between their genes and proteins; tis allow to hypothesize that the antibodies developed against SARS-CoV1 can recognize the antigens of SARS-CoV-2. In this manner, the transfusion of convalescent plasma to patients with the infection brings the probability on eliminating the infection, in this case SARS-CoV-2. There are evidence of this phenomenon observed in previous pandemics caused by SARS-CoV-1, Influenza AH1N1 and Ebola virus. The objective of the study is to develop a therapeutic strategy based on the administration of plasma from patients with COVID-19 with clinical remission to patients that are coursing with the infection. The expected results hopes to establish an effective treatment and satisfactory recovery of patients with COVID-19. Also, we expect to describe the respective antibodies related against the SARS-CoV-2 infection.