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 370 of 562The Christie NHS Foundation Trust
Since emerging in December 2019, coronavirus disease 2019 (Covid-19) has developed into an unprecedented global pandemic. The causative pathogen, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has the potential to cause a wide range of clinical syndromes, from fever, dyspnoea and cough to respiratory failure and cardiac injury necessitating critical care support. A number of patients have a more indolent clinical course and can be safely managed in the community. Characterising the clinical course of Covid-19 infection in the oncology population and distinguishing this from other acute oncology presentations which can mimic Covid-19 is a key unmet research need. Current standard of care for monitoring patients at high risk of chemotherapy associated neutropenic sepsis involves asking them to contact their cancer centre when they feel unwell or develop a fever. No standard of care for monitoring ambulatory Covid-19 patients has yet been established. We hypothesise that using wearable biosensors to detect patients who exhibit 'red flags' for sepsis or deterioration due to Covid-19 may allow earlier assessment and intervention. There is no current evidence for wearable biosensors in ambulatory patients receiving chemotherapy, and there is no existing research into this proposed use of biosensors in patients with suspected or confirmed Covid-19 infection. In order to justify performing a randomised controlled study comparing standard of care with biosensor driven monitoring it is important to establish the tolerability and validity of these devices. We aim to collect patient reported outcome measures (PROMs) on tolerability and assess the reliability of data transmission to a central data collection server. We will also perform an initial analysis of physiological data and correlation with clinical events
CCTU- Cancer Theme
The COVID-19 pandemic, commonly referred to as "coronavirus", first began in the city of Wuhan, China in December 2019. This virus has since spread globally, with infections reported in nearly every country. COVID-19 targets the body's respiratory system, where infections can be found in the nose, throat and lungs. The effect of COVID-19 infection is very variable, where many people might not know that they have been infected and have recovered from COVID-19. However, COVID-19 infection can cause people to have difficulty breathing. This can be severe enough to require hospitalisation and potentially intensive care treatment. While they are being treated in hospital, COVID-19 infected patients can be found to have inflamed tissue in their lungs (referred to medically as "pneumonitis"). This inflammation is thought to be caused by their body's immune systems overacting to the infection rather than the COVID-19 virus itself. By potentially dampening down this overreaction of their immune system, it is hoped that COVID-19 patients with inflamed lungs have better and quicker chance to survive. Mesenchymal stromal cells (MSCs) have been shown to have anti-inflammatory and healing properties on injured tissue. MSCs have been trialled in various diseases but have not yet been tested on patients with COVID-19. In this study, the investigators will obtain bone marrow from healthy volunteers to develop a cell-based treatment for COVID-19-related pneumonitis. The investigators will also determine whether it is feasible to recruit bone marrow donors in a clinically useful timeframe to treat COVID-19 patients. A future trial, COMET20, will use the bone marrow-derived MSCs (BM-MSCs) manufactured in COMET20d to treat COVID-19 patients suffering with pneumonitis, to determine whether the BMMSCs can reduce the likelihood for mechanical ventilation and reduce hospitalisation.
NHS Greater Clyde and Glasgow
This study will refine and pilot the feasibility of introducing a thermal imaging test to detect fever in 100 patients being triaged within the Emergency Department. The only additional research requirement for the patient is to have a thermal image of their face taken. Other triage tests will be routine. The aims of the feasibility study are to: - Understand the acceptability of introducing the intervention within the Emergency Department setting - Establish indicative patient recruitment numbers per week - Determine the likely proportion of patients recruited from this group who have a high temperature - Provide preliminary evidence that the technology can identify a high temperature in this diverse group of patients - Provide preliminary data for machine learning training to support classification of patients as being with or without fever The feasibility study will then inform the design and size of larger study to further develop and validate the the thermal imaging screening test to provide a 'with/ without' fever result.
Hôpital de Verdun
Prone positioning is an established intervention in mechanically ventilated acute respiratory distress syndrome (ARDS) patients, with demonstrated reductions in mortality. Preliminary data suggest that awake proning in patients with COVID-19 treated with high-flow nasal oxygenation (HFNO) improves gas exchanges, and might be associated with a reduced need of mechanical ventilation, and reduced mortality. Further investigation in a formal randomized-controlled trial is need.
SeaStar Medical
Selective Cytopheretic Device (SCD) treatments will improve survival in patients testing positive for COVID-19 infection diagnosed with Acute Kidney Injury (AKI) or ARDS.
Exact Sciences Corporation
The primary objective is to determine the usability of the SARS-CoV-2 Specimen Collection Materials for at-home collection and mailing of sample to the testing laboratory.
Fondation Ophtalmologique Adolphe de Rothschild
In patients treated for exudative age-related macular degeneration (AMD), diabetes, retinal venous occlusion (OVR), or other conditions causing macular edema, treatments with anti-angiogenic intravitreal injections (IVT) are widely used both for their anti-angiogenic action. Patients often have injections for many years, sometimes monthly or every 2 months. The discontinuation of treatment with repeated injections of anti-angiogenic agents, linked to the COVID-19 coronavirus pandemic will potentially impact the visual acuity, the ophthalmological state and the quality of life of the patients concerned, therefore it is relevant to analyze the consequences the breakdown of usual care in this population.
Centre Hospitalier Régional d'Orléans
One case of maternal-fetal transmission of SARS Cov-2 was published (1). Ig M and Ig G were found at two hours after birth of a new born from a mother COVID-19. Another study on few newborns COVID-19 reported that the SARS-Cov-2 was not transmitted in utero but only after birth. Although there are few data on COVID-19 during pregnancy, according to our national data collections, it appears to be responsible for miscarriages and fetal deaths. There are also intrauterine growth restrictions and an increase of the rate of cesarean sections for maternal indications. Therefore, it is essential to know if there is a maternal viremia which infects the fetus because the consequences in terms of management would be completely different. In fact, the potential intrauterine infection will lead to antenatal monitoring of these patients with an antenatal diagnosis and may be a treatment. Therefore, it seems essential to explore the mode of transmission to the newborn since many newborns have COVID-19 infection The investigators will propose to all pregnant women SARS- Cov-2 positive to perform PCR SARS-Cov-2 tests and /or serology's (IgM and Ig G) on the amniotic fluid, the blood cord and the placenta.
Herlev and Gentofte Hospital
The study is a prospective clinical cohort study of consecutive patients hospitalized at all hospitals of greater Copenhagen with a laboratory confirmed diagnosis of COVID-19. The investigators aim to examine if continuous ECG monitoring can be used to understand the contribution of COVID-19 infection in the acute phase to the development of cardiac arrhythmias, especially focusing on cardiovascular outcomes. In all patients included, the investigators aim to examine if continuous ECG monitoring - alone and in combination with biomarkers - can be used to detect early signs of cardiac complications and predict long-term risk of cardiovascular morbidity and mortality following COVID-19 infection.
Meshalkin Research Institute of Pathology of Circulation
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection is a pandemic disease with worldwide spreading. Limited data are existed regarding SARS-CoV-2 positive carriers among asymptomatic medical employees in non-profile infectious clinic, e.g. cardiovascular clinic, routinely working in the pandemic region with two million inhabitants. The aim is to test the percentage and increase of the SARS-CoV-2 positive carriers among asymptomatic medical employees in high-volume cardiovascular center in routine clinical practice.