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 390 of 517LifeBridge Health
Coronavirus disease 2019 (COVID-19), a viral respiratory illness caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has been shown to predispose patients to thrombotic diseases (venous and arterial) with reported rates in hospitalized patients between 17-40%. The influence of SARS-CoV-2 infection on the coagulation is hypothesized to be regulated by platelet activation, proinflammatory cytokines, endothelial cell injury and stasis. The elevated levels of d-dimer and fibrinogen and clinical signs of organ damage point to a significant hypercoagulable state. The latter induces a high risk for micro-thrombi and multi-organ ischemia. Therefore, early detection and a comprehensive understanding of the influence of the virus on the coagulation and platelet pathways are essential to address this epidemic. It is critical at this time to make all efforts possible to optimize our available technology to care for COVID-19 patients who are at risk for thrombotic disease through appropriate choice, dosing, and laboratory monitoring of antithrombotic therapy. The investigators hypothesize that COVID-19 is a heightened prothrombotic/hypercoagulability state that can be characterized using platelet function testing and thrombelastography. More information is required to study the effect of COVID-19 on coagulation and platelet pathways to develop effective antithrombotic treatment strategies. This is a multi-center center, non-interventional study enrolling patients who are COVID-19 positive or who have tested negative showing indication of the disease (high D-dimer and positive lung imaging). The study specific laboratory assessments will be obtained at baseline (closest to time of hospitalization), Day 3, and Day 8 from baseline and at hospital discharge. Laboratory measurements for TEG 6S , platelet aggregation, T-TAS, urinary thromboxane, genotyping, serum and plasma biomarkers will be analyzed . In-hospital and clinical follow-up data will be entered into a COVID registry Patients will be followed for clinical events during hospitalization, and up to 6 months after discharge. Patients (n=100) hospitalized with at least one of the following will be enrolled. 1. With a confirmed diagnosis of COVID-19 infection using a positive RT- PCR or a positive IgG antibody test prior to or during hospitalization or 2. With a negative COVID-19 RT-PCR test but with symptoms of possible COVID-19 infection and: 1. an elevated D-dimer and/or 2. positive imaging results showing unilateral or bilateral pneumonia or ground-glass opacity in lungs.
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.
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.
Hong Kong Sanatorium & Hospital
Achieved serum samples of persons with or without evidence of COVID-19 infection are tested using the different commercial SARS-CoV-2 antibody immunoassays. The performance of the immunoassays is then assessed by comparing the 2 groups of samples.
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.
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
Sanatorio Anchorena San Martin
The combination of different ventilatory strategies and its effects on respiratory mechanics and gas exchange in patients under mechanical ventilation with acute respiratory distress syndrome secondary to coronavirus-19 has been scarcely described.