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 330 of 435Lei Li
COVID-19 pandemics have changed extensively the lives around the world. Although most physicians of obstetrics and gynecology have no critical role in the frontline against COVID-19 pandemics, their work, research and education activities still underwent great changes. The primary aim of this study is to analyze change of workload during the COVID-19 pandemics in physicians of obstetrics and gynecology in China. A customized questionnaire will be delivered by the social software WeChat to the specific hospital which has been randomly sampled, and all physicians of Obstetrics and Gynecology in this hospital will fill the questionnaire anonymously. A random sampling will be performed in all 32 provinces, municipality or autonomous regions in the mainland of China. It is assumed that acceptable 95% confidence interval is P±4%, and the sample size under the condition of simple random sampling is 600 persons. If the homogeneity is set as 0.15 or 0.2, and each population (unit) has 10 or 15 persons accepting survey, we will achieve a design effect of 2.35 to 3.80. If we choose the design effect of 3, the sample size of every level needs is 1800. Considering 10% population refusing to be surveyed, in all mainland of China, three levels of hospitals will include at least 6000 physicians who accept survey.
Ospedale Policlinico San Martino
Covid 19 pandemia is causing millions of deaths worldwide. To date, the evidence gathered suggests that the subgroup of patients who present the most serious clinical feature of COVID-19 could have a "cytokine storm syndrome" better defined as secondary hemophagocytic lymphohistiocytosis (sHLH), characterized by acute respiratory distress (ARDS) and septic shock, followed by multi-organ failure due to an excess of cytokines induced by the inflammatory response to the virus. The reduction of phagocytic hyperactivation represents a possible treatment for HLH. Lowering the availability of glucose, the only substrate of aerobic glycolysis and of the Warburg effect in activated macrophages, through the use of ketogenic diets could be a promising solution. Actually diet is not recognized as impacting on the evolution of COVID-19, however, scientific literature data show that a low carbohydrate and high lipid diet (ketogenic diet) can inhibit inflammation and lead to a clinical improvement of respiratory function. The hypothesis of this study is that the administration of a ketogenic diet could improve mortality, lower the access to ICU and the need of NIV. The plan is to enroll 50 patients with COVID 19 infection and administer a 1:4 ketogenic formula during hospitalization in order to verify these outcomes.
Franklin Health Research
The purpose of this study is to assess the potential for a non-invasive sensory based intervention to reduce the stress associated with a COVID-19 diagnosis.
Restem, LLC.
ULSC-CV-01 is a clinical trial that comprises both Phase 1 and Phase 2a, which will be conducted sequentially. This trial will evaluate the safety and potential efficacy of allogeneic Umbilical Cord Lining Stem Cells (ULSC), which are a type of umbilical cord tissue derived mesenchymal stem cells (MSC), with intravenous (IV) administration in hospitalized patients with acute respiratory distress syndrome (ARDS) due to COVID-19.
Istinye University
The aim of this study is to evaluate the knowledge level of healthcare professionals such as physicians, nurses, physiotherapists and nutritionist about published COVID-19 guidelines. The listed healthcare workers are take part in the primary treatment of the Corona virus infected patients in hospitals. Therefore the knowledge of the world wide spreading Corona Virus and its effects for the human being is should be known for the effective treatment and for raising public awareness.
Hôpital Necker-Enfants Malades
The paediatric population present mild or asymptomatic form of SARS-CoV-2 infection. This study asses the frequency of patients with SARS-CoV2 Antibodies (Ab) (seroprevalence) and the neutralizing typology of those Ab (immunoprotection) in children from 7 days to 18 years of age hospitalized for no more than 4 days and whose clinical status requires blood sample regardless of the symptoms Patients are included on a given day, after information, before blood sampling performed as part of the care. 500 µL of sera, normally discarded will be kept to perform SARS-Cov2 serology.
The University of Queensland
This study is being conducted to look at the safety and immune response (how the immune system of the human body reacts) to a vaccine for SARS-CoV-2 (the virus responsible for COVID-19 infection) when administered as an intramuscular injection (an injection directly into the muscle) to the upper arm of healthy participants, on two occasions at least 28 days apart.
University of Sao Paulo
This research aims to investigate the incidence, clinical condition, mode of transmission and laboratory data of women and their babies, who were exposed to COVID-19 infection during pregnancy. This project will consist of 4 subprojects, being that Subprojects 1 and 2, will be of the observational, longitudinal type of prospective Cohort; Subproject 3 will be of prevalence; Subproject 4 will be case-control. Subproject 1- This study aims to assess periodontal condition and quality of life before and after delivery of women with excess weight gain or not, with exposure to coronavirus-sars-cov2. Subproject 2- Identify the proteins differentially expressed in saliva associated with COVID-19 infection during the 3rd trimester of pregnancy in obese and eutrophic patients. Subproject 3- Assess the prevalence of congenital syndrome in babies associated with the presumed maternal infection with SARS-CoV-2. Subproject 4- Case-control study in which newborns are submitted to clinical examination, being a group with congenital malformations and their respective controls and an interview with the mother was carried out.
DILEK SAYIK
The coronavirus outbreak has adversely affected individuals in the community, as in the rest of the world. However, in order to carry out this epidemic period in a healthy and conscious manner, determining the anxiety levels of individuals in the society and supporting them psychologically is of great importance. In order to achieve this, healthcare professionals working clinically or academically have important duties. This study was planned to test its validity and reliability in order to adapt the Coronavirus Anxiety Scale to Turkish.
Assiut University
Since the outbreak of coronavirus disease - COVID-19 pandemic, most attention has focused on mode of transmission, clinical picture of the disease, treatment and prevention. In the coming weeks and months emphasis will gradually involve the post- acute care of COVID-19 survivors. It is anticipated that COVID-19 may have major impact on physical, cognitive, mental, social health status even in patients with mild disease. Moreover, pulmonary, radiologic, laboratory, sleep issues remain to be addressed