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 690 of 1422Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Coronavirus disease 2019 has forced worldwide the implementation of unprecedented restrictions to control its rapid spread and mitigate its impact. The Spanish government has enforced social distancing, quarantine and home confinement. This restriction of daily life activities and separation from loved ones may lead to social isolation and loneliness with health-related consequences in community-dwelling older adults with mild cognitive impairment or mild dementia and their caregivers. Additionally, an inadequate access to healthcare and social support services may aggravate chronic conditions. Technology home-based interventions emerge for combating social isolation and loneliness preventing the risk of viral exposure. The aim of this multicentre cohort study is to explore, analyze and determine the impact of social isolation on: 1) cognition, quality of life, mood, technophilia and perceived stress of community-dwelling older adults with mild cognitive impairment or mild dementia, and on caregiver burden; 2) health and social care services access and utilization, and 3) cognitive, social and entertainment use of ICTs. This study will be conducted in two Spanish regions Andalucía (Málaga) and Cataluña (Tarrasa). In total 200 dyads, consisting of a person with mild cognitive impairment or mild dementia (PMCI/MD) and their informal caregiver will be contacted by telephone. Potential respondents will be participants of the SMART 4 MD (N=100) and TV-AssistDem (N=100) clinical trials. The change in means in the variables will be analyzed comparing baseline results in the previous studies with those during and after confinement using the ANOVA test of repeated measures or the non-parametric Friedman test if appropriate. The performance of a multivariate analysis of variance (ANCOVA) to introduce possible covariates will also be contemplated. A 95% confidence level will be used.
University of Padova
Observational, cross-sectional, multi-center, multi-wave survey, assessing characteristics and predictors of physical and mental health as well as health behaviors during COVID-19 pandemic, targeting the general population (children, adolescents and adults).
Kirby Institute
The objectives of this study are to characterise immune responses in people with CoV-SARS-2 infection and use this knowledge to advance vaccine design, treatment options, and diagnostic reagents. Eligible participants will include people diagnosed with SARS-CoV-2 infection, and may include recently returned travellers and non-travellers in the community presenting to tertiary hospital healthcare facilities. Recruitment will be opportunistic, and sampling intensity may vary depending on the phase of the outbreak. Participants can be enrolled at any timepoint (up to 6 months) following diagnosis of SARS-CoV-2 infection (COVID-19). Blood samples and clinical data will be collected.
Bordeaux PharmacoEpi
It has been suggested that ibuprofen might be associated with more severe cases of coronavirus infections, based on the observation that severe COVID cases had been exposed to ibuprofen, resulting in a warning by the French authorities. This was attributed to: 1. a suggestion that ibuprofen might upregulate ACE-2 thereby increasing the entrance of COVID-19 into the cells, 2. an analogy with bacterial soft-tissue infections where more severe infections on NSAIDs are attributed to an immune-depressive action of NSAIDs, or to belated treatment because of initial symptom suppression, 3. fever is a natural response to viral infection, and reduces virus activity: antipyretic activity might reduce natural defenses against viruses. However fever reduction in critically ill patients had no effect on survival. However, these assertions are unclear: upregulation of ACEII would increase the risk of infection, not necessarily its severity, and would only apply to the use of NSAIDs before the infection, i.e. chronic exposure. It would be irrelevant to the infection once the patients are infected, i.e., to symptomatic treatment of COVID-19 infection. Anti-inflammatory effect masking the early symptoms of bacterial infections resulting in later antibiotic or other treatment is not applicable: there is no treatment of the virus that might be affected by masking symptoms. Antipyretic effect increasing the risk or the severity of infection would apply equally to all antipyretic agents including paracetamol, which share the same mechanism of action for fever reduction. EMA remains prudent about this assertion In addition, excess reliance on paracetamol while discouraging the use of ibuprofen might increase the risk of hepatic injury from paracetamol overdose. Paracetamol is the prime drug associated with liver injury and transplantation, in voluntary and inadvertent overdose or even at normal doses. This might be increased by COVID-related liver function alterations. It is therefore proposed to conduct a case-control study in a cohort of patients admitted to hospital in France with COVID-19 infection.
Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara
We have to be aware of the challenge and concerns brought by 2019-nCoV to our healthcare workers. Front-line healthcare workers can become infected in the management of patients with COVID-19; the high viral load in the atmosphere, and infected medical equipment are sources for the spread of SARS-CoV-2. If prevention and control measures are not in place, these healthcare workers are at great risk of infection and become the inadvertent carriers to patients who are in hospital for other diseases. Nowadays a question that has not yet been clarified by science has been arises: is hydroxychloroquine associated with zinc compared to ivermectin associated with zinc effective as a prophylaxis for asymptomatic professionals involved in the treatment of suspected or confirmed case of COVID-19?
Bursa Yüksek İhtisas Education and Research Hospital
In the course of COVID disease, some patients need intensive care treatment. We aim to find an answer to the question of whether the patient's CRP, ferritin, D-dimer, Oxygen Saturation, lymphocyte count, and body mass index can be used as a criterion for admitting patients with COVID to the intensive see unit.
Assiut University
Preparation of safe purified hyper immunoglobulins containing anti-Corona VS2 immunoglobulins from plasma collected from COVID19 convalescent patients to be used to: 1. To determine efficacy of COVID19 hyper immunoglobulins prepared from convalescent plasma using VIPS Mini-Pool IVIG medical device in the treatment of COVID19 2. To determine efficacy of anti-SARS-CoV-2 hyper immunoglobulins in the prevention of infection in high risk groups exposed to SARS-CoV-2 infection
National Blood Center Foundation, Hemolife
Convalescent plasma is a way to provide passive immunity to a person exposed to an infectious agent. It has been used as a therapeutic tool for emerging viral infections without specific treatment and with high morbidity and mortality, such as Influenza H1N1, H5N1, H7N9, Ebola, MERS, SARS-CoV1, and even SARS-Cov2, with satisfactory results regarding evolution clinic of patients treated and without significant adverse events reported. One of its main advantages of convalescent plasma is to generate a rapid immune response (even faster than a vaccine), against a pathogen that circulates in a specific geographic area, probably common for both donor and recipient.
Bilogical Research Centre, Szeged
Prospective assay for SARS-CoV-2 antibody detection indirectly by immunofluorescence: SARS-CoV2 IIF method
Trustem
The disease caused by the new coronavirus, SARS-CoV-2, called COVID-19, it has considered a worldwide pandemia by the WHO. Suddently, it produces a lot of patients severe ill, in a little geographic area, that could surpase the resourses of the any health system in the world. There is no documentation of an effective alternative for the treatment of the severe ill patients, that can reduce the mortality or the adverse events suffered by these people. It is has suggested the usefulness of the Mesenchymal Stem cells (MSC) for the management of these patients, thanks to their direct and indirect antiviral capacity, and its potency as immunomodulator, that could ameliorate the lung disease and the severity of COVID-19.