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 70 of 476Louisiana State University Health Sciences Center in New Orleans
Although the novel SARS-CoV-2 virus (COVD-19) is classified as an acute respiratory infection, emerging data show that morbidity and mortality are driven by disseminated intravascular coagulopathy. Untreated CAC leads to microangiopathic thromboses, causing multiple systems organ failure and consuming enormous healthcare resources. Identifying strategies to prevent CAC are therefore crucial to reducing COVID-19 hospitalization rates. The pathogenesis of CAC is unknown, but there are major overlaps between severe COVID-19 and vitamin D insufficiency (VDI). We hypothesize that VDI is a major underlying contributor to CAC. Preliminary data from severe COVID-19 patients in New Orleans support this hypothesis. The purpose of the proposed multi-center, prospective, randomized controlled trial is to test the hypothesis that low-risk, early treatment with aspirin and vitamin D in COVID-19 can mitigate the prothrombotic state and reduce hospitalization rates.
Swiss National Science Foundation
Mental health disorders are common during pregnancy and the postnatal period, and can have serious adverse effects on the well-being of woman and child. Every tenth woman has depressive symptoms and 5% suffer major depression during pregnancy. The consequences for global mental health due to the novel coronavirus disease, COVID-19, are likely to be significant and may have long-term impact on the global burden of disease. Pregnant women may be particularly vulnerable due to partial immune suppression. Besides physical vulnerability, the women could be at increased risk of mental health problems, such as anxiety, depression, and post-traumatic stress disorder (PTSD), due to social distancing leading to less support from the family and friends, and in some cases, partners not being allowed to be present during prenatal visits, labor and delivery. Furthermore, many pregnant women may feel insecure and worried about the effect of COVID-19 on their unborn child, if the women get infected during pregnancy. Today, young urban women are used to utilizing internet services frequently and efficiently. Therefore, providing mental health support to pregnant women via web-based support may be effective in ameliorating their anxiety/depression and reduce the risk of serious mental health disorders leading to improved maternal and perinatal outcomes.
Centre Hospitalier Régional et Universitaire de Brest
Coronavirus (COVID-19) is a pandemic-like disease caused by a new coronavirus called Severe Acute Respiratory Syndrome Coronavirus 2 (SARSCoV-2) isolated in China in 2019. Clinical manifestations vary widely from one individual to another, from asymptomatic carrier to a febrile cough that can rapidly lead to acute respiratory distress syndrome. Since the beginning of the COVID-19 epidemic, screening by chest X-ray (RT) and polymerase chain reaction (PCR) SARS-CoV-2 conducted by the Cornwall Hospital Union laboratory has shown that among symptomatic patients and hospital staff suspected of being COVID-19, only 7.8% were attributable to COVID-19. Two nosocomial clusters were also identified, in the emergency department (10 carers) and in the cardiology department (6 carers and one patient). However, direct diagnosis by RT-PCR has sensitivity limits and can lead to false negative results when the subject is indeed suffering from COVID-19. This lack of sensitivity is inherent to the technique on the one hand, but also to the quality of the sample and the kinetics of the infection. Indeed, the virological window during which the virus is present in the respiratory mucous membranes sampled seems relatively narrow, hence a progressive negativation of the respiratory samples as the disease progresses. Moreover, clinical symptoms vary from one individual to another, and it is now recognized that some infected persons are asymptomatic but carry the virus. Thus, the use of a second diagnostic technique is a necessity, and serology could be a relevant diagnostic support. In the literature, several publications report the performance of COVID-19 serology in clusters of cases or cohorts of subjects. The serological techniques employed are variable (target epitopes in particular) and frequently homemade. Serology is mainly studied in comparison or association with RT-PCR in order to highlight the increased performance of COVID-19 diagnosis when the two techniques are combined. Correlation with chest CT imaging data is also encountered. Numerous serological tests are therefore being tested to determine retrospectively whether the individual has been exposed to the virus by looking for specific antibodies to the virus. The supreme health authority has drawn up specifications dated 16 April 2020, defining the methods for evaluating the performance of serological tests detecting antibodies directed against SARSCoV-2 in order to provide a framework for these practices. Several clinical studies are also underway, in particular to assess the kinetics of the appearance of the antibodies, whether these specific antibodies would be protective and whether their appearance would coincide with a cessation of contagiousness. Thus, the main objective of this study is to evaluate the diagnostic performance of the COVID-19 immunoglobulin (IgG) Dia-Pro serological test, in view of its deployment at the Cornish Hospital Union Laboratory. Subsequently, given the low prevalence of COVID-19 in Brittany and the risk of a second epidemic wave when the confinement is lifted, the evaluation of the seroprevalence of the staff of the Cornish Hospital Union is necessary in order to assess the attack rate of COVID-19 within the establishment and particularly within departments where nosocomial clusters have been reported; and to prevent the impact of deconfinement. Indeed, knowledge of the proportion of immunized personnel and its distribution according to services will make it possible to establish internal recommendations and to effectively manage personal protective equipment inventories, in conjunction with the deconfinement strategy that will be implemented by the government. The goal is to protect hospital staff from overexposure to the virus;
Pfizer
This is a Phase 1/2/3, randomized, placebo-controlled, observer-blind, dose-finding, vaccine candidate-selection, and efficacy study in healthy individuals. The study consists of 2 parts: Phase 1: to identify preferred vaccine candidate(s) and dose level(s); Phase 2/3: an expanded cohort and efficacy part. The study will evaluate the safety, tolerability, and immunogenicity of 3 different SARS-CoV-2 RNA vaccine candidates against COVID-19 and the efficacy of 1 candidate: - As a 2-dose (separated by 21 days) schedule; - At various different dose levels in Phase 1; - As a booster; - In 3 age groups (Phase 1: 18 to 55 years of age, 65 to 85 years of age; Phase 2/3: ≥12 years of age [stratified as 12-15, 16-55 or >55 years of age]). The candidate selected for efficacy evaluation in Phase 2/3 is BNT162b2 at a dose of 30 µg. Participants who originally received placebo will be offered the opportunity to receive BNT162b2 at defined points as part of the study. In order to describe the boostability of BNT162, and potential heterologous protection against emerging SARS-CoV-2 VOCs, an additional dose of BNT162b2 at 30 µg will be given to Phase 1 participants approximately 6 to 12 months after their second dose of BNT162b1 or BNT162b2. This will provide an early assessment of the safety of a third dose of BNT162, as well as its immunogenicity. The assessment of boostability will be further expanded in a subset of Phase 3 participants at selected sites in the US who will receive a third dose of BNT162b2 at 30 µg or a third and potentially a fourth dose of prototype BNT162b2VOC at 30 µg (BNT162b2s01, based upon the South African variant and hereafter referred to as BNT162b2SA). A further subset of Phase 3 participants will receive a third, lower, dose of BNT162b2 at 5 or 10 µg. To further describe potential homologous and heterologous protection against emerging SARS-CoV-2 VOCs, a new cohort of participants will be enrolled who are COVID-19 vaccine-naïve (ie, BNT162b2-naïve) and have not experienced COVID-19. They will receive BNT162b2SA given as a 2-dose series, separated by 21 days. To reflect current and anticipated recommendations for COVID 19 vaccine boosters, participants in C4591001 who meet specified recommendations and have not already received one, will be offered a third dose of BNT162b2 after their second dose of BNT162.
Coalition for Epidemic Preparedness Innovations
2019nCoV-101 is a 2-part, randomized, observer-blinded, placebo-controlled, Phase 1/2 trial. Part 1 (Phase 1) of the study is designed to evaluate the safety and immunogenicity of SARS-CoV-2 rS nanoparticle vaccine with or without Matrix-M adjuvant in 131 healthy participants ≥ 18 to 59 (inclusive) years of age at 2 sites in Australia. An interim analysis of Part 1 safety and immunogenicity will be performed prior to optional expansion to Part 2. Part 2 (Phase 2) of the study is designed to evaluate the immunogenicity, safety, and preliminary efficacy of a single construct of SARS-CoV-2 rS nanoparticle vaccine with Matrix-M adjuvant in up to 1,500 healthy participants ≥ 18 to 84 (inclusive) years of age at up to 40 sites across Australia and/or the United States.
Centre Hospitalier René Dubos
The purpose of this study is to determine whether sleep disturbances in children aged 7 to 12 during COVID-19 containment are more prevalent in children who received routine psychiatric care before containment compared to children who don't have any psychiatric care.
Assistance Publique Hopitaux De Marseille
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is currently spreading rapidly around the globe, causing a major public health issue. There is currently very few data about the impact of COVID-19 on pregnancy, and potential in utero infection. This is a prospective observational study of COVID-19 diagnosed pregnant patients. This objective is to examine the impact of COVID-19 during pregnancy on the rates of obstetric and perinatal complications.
Lake Erie College of Osteopathic Medicine
This interventional study will investigate the effect of daily use of a mindfulness app on measures of participant anxiety, well-being, and future outlook during the Covid-19 pandemic, by comparing pre-intervention survey responses to post-intervention survey responses.
Assistance Publique - Hôpitaux de Paris
The COVID epidemics is responsible for a huge number of death following COVID acute respiratory failure. First instance treatment includes oxygenotherapy up to 15L/min in spontaneous ventilation. However COVID infection can ultimately lead to an acute respiratory distress syndrome (ARDS) requiring mechanical ventilation in the intensive care unit (ICU). Guidelines on ARDS management are based on small ventilation volume (6 mL/kg), a pulmonary end expiratory pressure (PEEP) chosen to get the best pulmonary compliance, a plateau pressure lower than 30 cm of water and daily prone positioning when PaO2/FiO2 ratio is lower than 150. In ventilated ARDS patients, prone positioning has shown survival improvement. Though they applied this optimized management of ARDS patients, Chinese intensivists have recently reported mortality rate higher than 50% in ARDS COVID patients requiring intubation and mechanical ventilation. Before being intubated and admitted to ICU, COVID patients require increasing rate of oxygen delivery. From the start of the epidemics, we have observed that an oxygenotherapy rate higher than 3L/min at the initial phase of the disease was associated with a high risk of severe acute respiratory distress (30%) The investigators hypothesize that prone positioning in patients in spontaneous ventilation (not tubed) from the stage of oxygenotherapy higher than 3L/min (to get an SpO2 of 95% or higher) would prevent respiratory worsening and the need for intubation. Prone positioning is easy to apply in patients in spontaneous ventilation since they can change position by themselves.
Jean Liu
In this protocol, we seek to examine the role of popular messaging platform WhatsApp in information spread during a crisis. As there have been few global crises in the last decade (coinciding with the rise of social media), the role of private messaging platforms such as WhatsApp during crisis contexts remains understudied. During the current COVID-19 global health crisis, we undertook this study to: (1) characterize the nature of WhatsApp use during crises, (2) characterize the profiles of WhatsApp users (3) understand how WhatsApp usage links to well-being (fear and thoughts about COVID-19).