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 50 of 225Università degli Studi dell'Insubria
SARS-CoV-2 belong to beta-coronavirus family and its transmission route and symptoms follow those of all community-acquired coronaviruses. The main difference of the novel Coronavirus is the higher mortality rate, that is around 3%. Death rate is over 1% only for patients over 50 years old, whereas until 40 years old is under 0,4%. No fatalities are declared among children under 10 years old to date. Death rate is almost double for male rather than female. This distribution of mortality rate according to age of infected patients could be only partially ascribed to other comorbidities in addition to great age. In fact, patients with no pre-existing conditions have however a case fatality rate of 0,9%. The almost null rate of severe illness in children and generally in patients younger than 40 years old is quite un-explicable. Infant, children and young people could be infected but infection is rapidly self-limited or without symptoms. Older patients undergo severe lung injury as consequence of an immune response that is late in coming. Possible explanation of these phenomena could be something, which assure ability to prompt response to SARS-CoV-2 in younger people independently from the novelty of the virus itself. It would seem to be that younger people are already sensitized to the antigens of the virus without a previous contact. This immunity is not really specific, but "partially specific" for many antigens of the virus, however able to limit the infection in the organism. Something stimulated the immune system and it scattered immunity against more and more antigens present. Children are the age group mostly exposed to all community-circulating viruses. This immunity is not persistent but progressively fade out. It protects from the age of two, when the hypothetical stimulation occurs, to the fifth decade because of its slow decrease. The only external stimulation, which healthy people receive are vaccines. All vaccinations and especially tetanic, diphtheria toxoids and inactivated bacteria as pertussis could stimulate immune system. They develop the specific immunity but generate also a sprouting immunity against antigens in transit, as coronaviruses and other community-circulating viruses. The developed immunity gives some protection against multiple viral infection for years until the natural fade out. After the fifth decade, that immunity is slower to be recall and reactivated. Additionally, transplant recipients and HIV infected patients, which have an immune system inhibited, unexpectedly, do not seem to suffer the worst complications of SARS-CoV-2 infection. An immune system imbalance could be play a pivotal role during the reaction to the virus, limiting destructive consequences of excessive inflammation. According to the medical hypothesis on which the protocol is based on, young people could benefit from a functional adaptation of innate immune cells induced through epigenetic reprogramming and, especially, a pre-existing "partially specific" immunity to the community viruses caused by "bystander effect" of preceding vaccinations. In this study, we will explore the main differences existing among patients infected by SARS-CoV-2 who experience the illness at different degree of severity. We suppose to recognize different populations of patients, each one with a specific immunological pattern. It could differ in terms of cytokines, soluble factors serum level and immune cells activity both of the innate compartment and of the acquired one. The proof of a role of these immunological phenomena in the pathogenesis of Covid-19 are bases for implementation of therapeutic immunomodulatory treatments. In addition, the definition of an immunological risk profile could tailor established therapies to each kind of patient.
Assistance Publique - Hôpitaux de Paris
Coronavirus disease 2019 (COVID-19) is an infectious disease responsible for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The infection is highly contagious requiring restrictive and stressful measures for patients, family members and ICU healthcare providers. To avoid contagion, patient isolation has become the rule. For patients, these measures add stress to the ICU environment and deprive them of unrestricted family visits. Family members are not only left with fear but also many unanswered questions. In end-of-life situations, many family members are unable to say good-bye and unable to provide support to their loved-one throughout the process. The impact of exclusion or limited inclusion certainly needs to be explored. Moreover, ICU caregivers are having to face new challenges and to work in a unknown situation, juggling with both professional issues such as increased workload, working longer hours and safety issues, and personal issues such as child care and transport as well as family transmission of the virus. The main objective of this study is to demonstrate that the COVID-19 pandemic, as compared to seasonal flu and community acquired pneumonia, significantly increases post-traumatic stress disorder (PTSD) in family members of critically ill patients. PTSD-related symptoms will be assessed in family members using the IES-R (impact of event scale revised) during a telephone interview 90 days after ICU discharge. The IES-R is a 22-item self-report measure that assesses subjective distress caused by traumatic events. It will be compared across the three groups (COVID-19, FLU and CAP).
Karolinska Institutet
The purpose of this study is to investigate if a brief online-delivered cognitive-behavioral intervention can reduce the degree of dysfunctional worry related to the Covid-19 pandemic, compared to a wait-list control condition.
Poitiers University Hospital
All patients included in this search will be on anonymized file: Symptomatic patients consulting for suspicion of COVID 19 with indication to a screening (RT-PCR, Scanner) according to the criteria of the Ministry of Health. To evaluate the diagnostic performance of chest CT in screening for COVID-related lung injury in patients with a clinical suspicion of COVID. CT scan results for COVID according to French thoracic imaging society will be dichotomized into evocative or compatible (considered positive) non-evocative (considered negative) The results will be compared to the gold standard corresponding to a multiparametric element: the discharge summary. Ct Scan performance will be recorded and analyzed.
Port Said University
Clinical Picture: Symptomatic COVID-19 presents with a recognizable clinical syndrome that is predictable prior to testing. Clinical judgement remains important, particularly when interpreting negative test results; 2. Biomarkers Associated with COVID-19 Patients: The most common laboratory features reported in patients with COVID-19
Corporacion Parc Tauli
The aim of the study is to identify the knowledge that CCSPT nurses have in relation to care aimed at addressing anxiety, fear or loneliness and the use they have made of it in the recent crisis. The design of the research/action will also enable the training of the participating professionals to improve nursing care in these areas in the future
Agence de La Biomédecine
During the COVID-19 pandemic, the French Agency of Biomedicine has recommended maintaining fertility preservation for patients requiring immediate oncological treatments exhibiting gonadotoxic effects. However, no study has examined the presence of SARS-CoV-2 in sperm from cancer patients. This study aims therefore to detect the presence of SARS-CoV-2, specifically in the seminal fluid and the spermatozoa fractions of cancer patient semen. The investigators will determine if the virus presence in sperm is associated with its presence in the nasal swabs, COVID symptoms, specific serological profiles and particular oncological pathologies/treatments.
Glasgow Royal Infirmary
As of 27th May 2020, approximately 5.7 million people worldwide are known to have been infected with COVID-19 coronavirus and more than 350,000 have died (1). The severity of this viral disease for an individual is associated with a widespread perturbation of immune, physiological and metabolic parameters (2, 3). These whole body changes could be considered characteristic of a systemic inflammatory response to tissue injury and it has been long recognised that a large and ongoing systemic inflammatory response is associated with the development of multiple organ failure and infective disease (4, 5). One of the cardinal signs of severe COVID-19 infection is a marked systemic inflammatory response (2). This response bears striking similarity to the systemic inflammatory response experienced by patients undergoing major elective surgical resections for cancer (6, 7). Indeed, the systemic inflammatory response and the associated metabolic stress has been most well characterised in major elective surgery, where the relationship between the magnitude of the post-operative systemic inflammatory response and the development of post-operative complications is now well recognised, as is the effect of patient comorbidity on this relationship (8, 9). Such work has informed therapeutic manoeuvres including minimally invasive surgery, pre-operative optimisation (e.g. anaesthesia, nutrition and steroids) and enhanced recovery protocols. The aim of the present study was to examine whether routinely collected clinicopathological characteristics of patients with COVID-19 on admission were informative on the immune and metabolic stress experienced by patients with COVID-19 and whether such characteristics were informative on subsequent outcome.
Istinye University
Due to the COVID-19 pandemic in our country, individuals over 65 are prohibited from leaving their homes by T.C. The Ministry of Internal Affairs on March 21, 2020. While social isolation provides protection from COVID-19, it also brings some side effects that pose health risks. Studies investigating the relationship between social isolation and health behavior report that individuals with smaller social networks report less healthy diets, excessive alcohol consumption, and less physical activity. The effects of social isolation are related to physical inactivity, smoking. Physical activity is any body movement produced by the contraction of skeletal muscles that increases energy consumption. 150 minutes of moderate PA, 75 minutes of severe PA per week, or combined moderate and severe intensity PA plus twice a week strength training is recommended for elderly. The prevalence of physical inactivity increases significantly with increasing age. At the global level, approximately 45% of people over the age of 60 do not meet the recommended level of PA. The decrease in physical performance is associated with the risk of falling, sarcopenia, fragility, decreased quality of life, emotionalization, comorbidity, early death, and increased health care costs. The purpose of this study; to evaluate the physical activity level, functional capacity and quality of life of individuals over the age of 65 who socially isolated due to the precautions COVID-19 pandemic, and to investigate the effectiveness of video based home exercise program.
University of Roma La Sapienza
The first person-to-person Coronavirus disease (COVID-19) transmission in Italy was reported on Feb 21st, 2020, causing one of the most massive outbreak in Europe so far that stopped immediately all elective surgical procedures. Bariatric surgery represents the most effective treatment to obtain an important, long-term weight loss and comorbidities' resolution, including respiratory disorders. A sensitive decrease of epidemic has been observed lately and a gradual and progressive stop of the lockdown (phase 2-3) was planned, when the virus is supposed to be under control and protocols are guiding the restart of the elective bariatric surgery. Several questions are currently open: Laparoscopic bariatric surgery is safe in the phase 2-3? What's the expected complications rate? The actual hospital protocols are effective to minimize the risk of postoperative COVID-19 infection? Aim: to analyse results of bariatric surgery during phase 2-3 COVID-19 pandemic in Italy. Primary end point: 30 days COVID-19 infection, mortality and complications. Secondary end points: readmission rate 30 days, reoperations for any reason related to surgery. Study design: prospective multicenter observational. Setting: Italian National Health Service 8 high-volume bariatric centres. Enrollment criteria: No previous Covid-19 infection; Primary, standard IFSO approved bariatric procedures; No concomitant procedure; No previous major abdominal surgery; >18