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 740 of 1019University Medicine Greifswald
The main objectives of this study are 1. to establish the prevalence of SARS-CoV-2 in schools and kindergartens in the State of Mecklenburg-Vorpommern in autumn and winter 2020/2021 2. to monitor the future spread of the disease by assessing serological responses to SARS-CoV-2 in teachers and childcare educators over time
Codagenix, Inc
This is the first study of COVI-VAC in humans. The purpose of the study is to evaluate the safety and immune response of COVI-VAC (a live attenuated vaccine to prevent COVID-19) in healthy adults aged 18 to 30 years. Approximately 48 participants will be enrolled into 1 of 3 dose groups (low, medium, high). Within each of these dose groups, participants will be assigned randomly to receive either 2 doses of COVI-VAC 28 days apart, 2 doses of placebo (saline), or 1 dose of COVI-VAC and 1 dose of placebo. COVI-VAC or placebo is administered by drops into each nostril. Neither the participants nor the researchers will know whether COVI-VAC or placebo has been received. To assess the safety of the vaccine, each participant will record symptoms and oral temperature in a diary daily for 14 days after each dose. Safety laboratory tests, physical exams, ECGs, and a chest X-ray will also be performed, and peak expiratory flow and vital signs will be measured. Adverse events and medication use will be recorded. Blood samples and intranasal samples will be collected to assess the immune response from the vaccine.
Centre Antoine Lacassagne
Study Rational Since December 2019, outbreak of COVID-19 caused by a novel virus SARS-Cov-2 has spread rapidly around the world and became a pandemic issue. First data report high mortality in severe patients with 30% death rate at 28 days. Exact proportions of the reasons of death are unclear: severe respiratory distress syndrome is mainly reported which can be related to massive cell destruction by the virus, bacterial surinfection, cardiomyopathy or pulmonary embolism. The exact proportion of all these causes is unknown and venous thromboembolism could be a major cause because of the massive inflammation reported during COVID-19. High levels of D-dimers and fibrin degradation products are associated with increased risk of mortality and some authors suggest a possible occurrence of venous thromboembolism (VTE) during COVID-19. Indeed, COVID-19 infected patients are likely at increased risk of VTE. In a multicenter retrospective cohort study from China, elevated D-dimers levels (>1g/L) were strongly associated with in-hospital death, even after multivariable adjustment. Also, interestingly,the prophylactic administration of anticoagulant treatment was associated with decreased mortality in a cohort of 449 patients, with a positive effect in patients with coagulopathy (sepsis-induced coagulopathy score ≥ 4) reducing the 28 days mortality rate (32.8% versus 52.4%, p=0.01). However the presence/prevalence of VTE disease is unknown in COVID-19 cancer patients with either mild or severe disease. Cancer patients are at a higher risk of VTE than general population (x6 times) and could be consequently at a further higher of VTE during COVID-19, in comparison with non-cancer patients. The exact rate of VTE and pulmonary embolism during COVID-19 was never evaluated, especially in cancer patients, and is of importance in order to understand if this disease needs appropriate prophylaxis against VTE. The largest series of cancer patients so far included 28 COVID-19 infected cancer patients: the rate of mortality was 28.6%. 78.6% of them needed oxygen therapy, 35.7% of them mechanical ventilation. Pulmonary embolism was suspected in some patients but not investigated due to the severity of the disease and renal insufficiency, reflecting the lack of data in this situation. The aim of the present study is to analyze the rate of symptomatic/occult VTE in a cohort of patients with cancer. Expected benefits Anticipated benefits of the research are the detection of VTE in order to treat it for the included patient. For all COVID-19 positive cancer patients it will enable to provide some guidelines and determine which patient are at risk for VTE and which will need ultrasound to detect occult VTE. Foreseeable risks Foreseeable risks for patients are non-significant because the additional procedures needed are ultrasound exam, and blood sample test. Methodology Retrospective and prospective (ambispective), multicentric study to evaluate the occurrence of venous thromboembolism during COVID-19 infection. Indeed, because the outbreak can end within the next 3-6 months, Investigators may not be able to answer the question if Investigators only focus on patients investigated prospectively. Investigators then decided to include patients from medical team who are already systemically screening patients with COVID-19 disease for VTE. Trial objectives Main objective To evaluate the rate of venous thromboembolism at 23 days during COVID-19 infection in cancer patients.
Sunnybrook Health Sciences Centre
The study proposes to test photodisinfection (PDF) on SARS-CoV-2 in the nose. The study will use Health Canada approved Steriwave™ Nasal Decolonization (ND) in he nostril of patients infected with SARS-CoV-2. Participants are swabbed for SARS-CoV-2 before and after the PDF treatment. For the study, a small group of healthcare workers who have tested positive for SARS-CoV-2 will be included. They will not undergo the treatment but will need to swab their noses multiple times over the next 5 days. This nil group will provide the effect (if any) of swabbing SARS-CoV-2 levels in the nose.
University of Manitoba
Canada is entering the important yet dangerous phase of the COVID-19 pandemic: the reopening of industry. As such, there is an urgent need for a quick and accurate screening tool to help ensure people re-entering the workplace are COVID-19 negative. This proposal offers an innovative, simple-to-implement and quick screening tool for this purpose. This study hypothesize that breathing sounds of a COVID-19 positive person would have different characteristics even if the person is asymptomatic. This study aim the development of an integrated diagnostic pattern recognition tool in the form of a smartphone app, using audio and temperature as inputs to identify COVID-19 positive individuals. The proposed digital technology will screen individuals as healthy or possibly COVID-19 positive. The latter group will then be recommended for further testing. The goal of the proposed app is to provide much more accurate early screening (currently only temperature is taken), and to reduce the burden of COVID-19 tests. This digital technology will be used and tested in Manitoba initially and later nationally in Canada, with the potential of being publicly available in the future. To use the proposed screening tool, a smartphone is held within 1 cm of an individual's mouth and the individual instructed to take five deep breaths through the mouth. The individuals' breathing sounds will be recorded by the smartphone, while the participant's temperature will also be recorded by the heat camera. The app will first use its acoustic analysis to identify sounds as healthy or abnormal. If the outcome is abnormal, then a questionnaire will be provided, along with a further acoustic analysis to rule out other common comorbid conditions (e.g. chronic lung disease). Finally, based on the inputs, the diagnostic algorithm will decide if the individual should be referred for further testing or not. Since the proposed end product is a smartphone app, the two software partner companies will play a crucial role in the final integration and development.
University Hospital Augsburg
Examination of the prevalence of thrombosis in COVID-patients, especially in an out-patient setting. Assessment by duplex sonography. If thrombosis is detected, we will correlate it with immunity status. Assessment of health issues and cognitive function as late complication after infection.
Hopital Foch
In the context of the actual pandemia of the Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) which requires a better diagnostic strategy for the management of patients. The study of volatile organic compounds (VOC) detected in exhaled air or in sweat, is an innovative research area for respiratory diseases. The analysis of VOC can be done either by the technique of the mass spectrometry which allows the identification of each VOC in the exhaled air or by the technique of electronic nose, simpler and faster, which provides an idea of the general profile of the VOC without identifying them. The VOC have shown their interest in some situations, such as diagnostic or prognostic tool in patients followed for thoracic tumorous pathology or bronchial or pulmonary vascular diseases. Moreover, it has recently been shown that properly trained dogs would be able to detect an olfactory signature of SARS-CoV-2 infection with a specificity greater than 90%; this olfactory signature corresponds to VOCs detectable by the flair of dogs (Nosaïs-Covid19 study). Validation of the diagnostic value of VOC analyzes by non-invasive and rapid methods (electronic nose analysis or mass spectrometry; detection by the scent of dogs) for the rapid detection and early diagnosis of a SARS-CoV-2 infection warrants the performance of this clinical study.
Cristina Avendaño Solá
A double-blind, randomized, controlled, clinical trial to evaluate the efficacy and safety of MSC (mesenchymal stromal cells) intravenous administration in patients with COVID-induced ARDS compared to a control arm.
University Ghent
Children are relatively spared from the direct clinical impact of COVID-19. Pediatric patients with regular follow-up at tertiary pediatric centres and presenting one or more chronic conditions might be at increased risk for severe COVID-19. With a prospective seroprevalence study, we aim to study COVID-19 incidence, disease course and risk factors associated with SARS-CoV-2 infection in this specific context.
University Hospital, Toulouse
The current pandemic situation (SRAS COV2) is an unprecedented event and a source of stress potentially aggravated by containment. The Child Revised Impact Event Scale (CRIES-13) was evaluated in children 8 years or older in survivors of traumatic events, flood, stay in intensive care, or war (Bosnia). In this study CRIES-13 will be used to determine the prevalence of precursor signs of post-traumatic stress in children aged 8 to 15 confined between March 17, 2020 and May 2020