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 1030 of 1934University Hospital, Strasbourg, France
A SARS-CoV-2 infection emerged in China in December 2019, the severity of which is linked to acute respiratory distress syndrome1. The rate of emergency visits in Bas-Rhin for suspected Covid-19 increased, compared to the French average, at the end of the 10th week of 2020. Compared to the onset of symptoms, Chinese studies estimate the onset of dyspnea on the 7th day3 and admission to the emergency room between the 5th and the 9th day4. But this duration varies according to the epidemic period5, the geographical location6 and a later emergency admission is associated with an increase in mortality in the Chinese population7. The need for oxygen, which is not noted in Chinese studies8, is a reflection of the onset of respiratory worsening and a major factor in hospitalization. There is no study on the changing profile of the French population to date its onset.
Hospices Civils de Lyon
Since the start of 2020, the new SARS-CoV-2 coronavirus is causing a real global health crisis. In France, nasopharyngeal swabs are used to obtain the sample needed for respiratory infection screening. There are three major difficulties with this type of sampling: I) It is really unpleasant for the patient because the device has to be pushed into the nostril to reach the nasopharynx. It causes some patients to bleed or even feel uncomfortable. II) It is not easily accepted by children. III) It is dependent on the availability of swabs. Faced with these difficulties linked to the initial sampling, new methods are being studied to enable a rapid and non-invasive diagnosis of COVID-19 based on the instantaneous identification of metabolites or volatile organic compounds (VOCs). Due to their sensitivity and the wealth of information that can be provided, the most promising techniques are based on mass spectrometry coupled with a soft ionisation system. For example, on-line exhaled air analysis is capable of detecting a very large number of VOCs. Various tests on metabolites in the exhaled air have already been carried out without being totally conclusive because the existing instruments suffer from various limitations: I) poor repeatability/accuracy in the chemical characterisation of exhaled air ; II) too high specificity (detection of only part of the emitted compounds); III) too limited sensitivity; IV) and poor adaptation to be deployed in a clinic. In order to overcome these various limitations, we propose the use of a new generation of mass spectrometer: Vocus PTR-TOF. The Vocus PTR-TOF is a Proton Transfer Mass Spectrometer (PTR-MS) developed for the detection, in real time, of trace VOCs in industrial environments, laboratories or directly in the environment. This new generation of instrument offers the following advantages: I) unequalled sensitivity : II) a robust ionisation system not affected by environmental conditions (relative humidity...) ; III) a high mass resolution allowing precise identification of compounds ; IV) a compact and durable architecture allowing deployment in a constrained environment such as hospital, airport… The sensitivity and speed of measurement allow the expiration process to be monitored in real time, bringing an additional dimension to the measurement and the chances of success.
Fonds IMMUNOV
The purpose of this study is to describe the immunological and virological response of patients infected with CoV-2-SARS and presenting an asymptomatic or mildly symptomatic form, in particular the innate and adaptive response as well as the virological clearance kinetics. The research hypothesis is that patients with an ambulatory form of SARS-CoV-2 infection, whether asymptomatic or mildly symptomatic, are able to mount an innate and adaptive immunological response capable of rapidly clearing the virus, in contrast to severe forms in which an early deficit of type 1 IFN response has been demonstrated, possibly responsible for a defect in the control of viral replication in the blood.
Assistance Publique - Hôpitaux de Paris
To assess the proportion of post-intensive care syndrome (PICS) of patients who received high flow humidified oxygen with FiO2 ≥50% for more than 48h and / or who received mechanical ventilation for more than 48h in a context of hospitalization in intensive care for COVID-19 pneumonia
University Hospital, Strasbourg, France
Epidemics have always affected the most disadvantaged social categories more intensely. This social inequality is expressed in the use of care and emergencies: greater frequency but also greater seriousness. Our hypothesis is that, during a period of confinement, the most disadvantaged populations are more affected by the COVID-19 infection than the rest of the population. The number of remedies is greater, as is the severity of the forms of infection.
Merck Sharp & Dohme LLC
The overall purpose of this study is to address the factors associated with an individual's personal willingness to get the vaccine and attitudes about potential public policy approaches to implementation of a Coronavirus Disease 2019 (COVID-19) vaccine. Additionally, to evaluate how these attitudes change over time. The 1200 participants will be recruited by Ipsos (Ipsos KnowledgePanel®) from their nationally representative panel to participate in a survey at Time 1 and 1 year later. The information collected will include demographics, health status, household composition, experiences with COVID-19, attitudes about vaccines in general, COVID-19 vaccine specific attitudes, willingness to get a COVID-19 vaccine acceptability, and attitudes regarding COVID-19 vaccine mandates. The investigators anticipate that those who live in urban areas and who are older, have greater knowledge of COVID-19, who have known someone who was hospitalized for COVID-19, and have generally positive attitudes about vaccines will be more willing to get a vaccine. The primary reasons for willingness will be personal safety and desire to return to normal activities. The investigators also anticipate that those who vary on socio-demographics (e.g., live in urban areas, have more liberal political views), have greater knowledge of COVID-19, who have known someone who was hospitalized for COVID- 19, and have generally positive attitudes about vaccines will be more supportive of mandatory vaccination strategies. The investigators anticipate that attitudes will change over time in response to the current status of the pandemic and of available data about the vaccine's efficacy and safety.
Centre Hospitalier Universitaire, Amiens
Since its emergence in late December 2019, the SARS-CoV-2 coronavirus has spread rapidly, causing a global health crisis. The disease caused by this highly contagious respiratory virus is called COVID-19. At the beginning of August 2020, there were more than 194,000 confirmed cases in France - including approximately 16,000 cases in the Hauts-de-France area - and more than 30,300 deaths. Cancer patients are generally susceptible to respiratory infections, and CoV-2-SARS is no exception. Early Chinese studies reported a higher rate of CoV-2-SARS infection in people with cancer (or a history of cancer) than in the general population, with more severe forms and with an increased risk if surgery or chemotherapy is performed in the month prior to infection. The purpose of this study is to describe the management modalities of patients with H&N (Head and Neck) cancer during the COVID-19 pandemic in the Maxillofacial Surgery Department of CHU Amiens-Picardie.
University of Minnesota
The research objective of the UNITE Study is to assess the potential efficacy of ultrasound application to the spleen in the treatment of coronavirus disease 2019 (COVID-19) in a pilot study. Specific Aims: 1. Determine the efficacy of splenic ultrasound in affecting markers of systemic inflammation in COVID-19 infection. 2. Evaluate the potential efficacy of splenic ultrasound in affecting clinical outcomes in COVID-19 infection.
University of Saskatchewan
VIDO has developed a vaccine called COVAC-2. The study vaccine contains a portion of the SARS-CoV-2 spike protein, called S1. The spike protein is the part of the virus that is responsible for attaching to the surface of host cells. COVAC-2 contains a SWE adjuvant. An adjuvant is a compound that is added to a vaccine to help the vaccine produce a better immune response. The SWE adjuvant belongs to a family of oil-based adjuvants that have been given to millions of people around the world as part of influenza vaccines. The COVAC-2 vaccine is expected to stimulate the body to make antibodies against the S1 protein. The antibodies will recognize the viral spike protein if the body is exposed to the virus and prevent or reduce the severity of COVID-19 illness. In animal studies, the immune response generated by the COVAC-2 vaccine was able to protect the vaccinated animals against a severe SARS-CoV-2 infection. Phase 1 is a multi-centred trial of the COVAC-2 vaccine to be completed in Canada. It will be a randomized, observer-blinded, and placebo-controlled study to assess the safety and immunogenicity of three dosing levels (25, 50, and 100 µg protein) administered twice (4 weeks apart) in healthy adults 18 through 54 years of age (Phase 1a) and 55 years of age and older (Phase 1b). Enrolment and vaccination of participants will be staggered over time based on participant age and vaccine dose. Approval will be sought from the Data Safety Monitoring Board (DSMB) to proceed with the second dose in each group, to enroll at each dose level, and to enroll in the older age group for each dose level. Within the same age group, the 8 participants receiving the lowest dose are randomized with 4 participants receiving placebo; the 8 participants receiving the medium dose are randomized with 4 participants receiving placebo; and the 8 participants receiving the highest dose are randomized with 4 participants receiving placebo. Within each dose level of 12 participants, it is proposed to immunize a first cohort of 3 participants (including at least 2 active vaccine participants) and pending no holding rule is met after 48 hours, to immunize the remaining 9 participants within that dose level.
AbCellera Biologics Inc.
The purpose of this study is to find out whether bamlanivimab is able to stop COVID-19 from getting worse. Participants with mild-to-moderate COVID-19 will receive bamlanivimab via an injection into a vein. These participants will be matched to similar COVID-19 patients who received other treatment at a local medical center. All participants will be followed to learn how their disease responds. Participation could last about 3 months and includes two required visits to the study site, with the remainder of assessments performed by phone or by medical record review.