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 380 of 1526Istituto Clinico Humanitas
COVID-19 (SARS-CoV-2) infection in health professionals represent a significant criticality both for the risk of spreading the disease and for the organizational aspects that follow. The objective of the study is to evaluate the spread of COVID-19 virus within the hospital population of Humanitas through the monitoring of the levels of IgG antibodies. Moreover, viral load will be measured by RT-PCR in the subgroup positive to IgG antibodies.
Hôpital Privé Jacques Cartier, service réanimation Dr Bougouin
Coronavirus 2 (SARS-CoV2) has been identified as the pathogen responsible for severe acute respiratory syndrome associated with severe inflammatory syndrome and pneumonia (COVID-19). Haemostasis abnormalities have been shown to be associated with a poor prognosis in these patients with this pneumonia. In a Chinese series of 183 patients, the hemostasis balance including thrombin time, fibrinogenemia, fibrin degradation products and antithrombin III were within normal limits. Only the D-Dimer assay was positive in the whole cohort with an average rate of 0.66 µg / mL (normal
University of California, San Francisco
Prospective nationwide cohort study of pregnant women enrolled early in gestation and followed for Covid-19 exposure and infection, with follow up of obstetrical outcomes and infant development through the first year of life.
Azienda Sanitaria-Universitaria Integrata di Udine
Aim. The emerging outbreak of coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) continues to spread worldwide. Beside the prescription of some promising drugs as chloroquine, azithromycin, antivirals (lopinavir/ritonavir, darunavir/cobicistat) and immunomodulating agents (steroids, tocilizumab), in our patients with mild to moderate pneumonia due to SARS-CoV-2 we planned a randomize study to evaluate, respect the best available therapy (BAT), the use of autohemotherapy treatement with an oxygen/ozone (O3) gaseous mixture as adjuvant therapy. Design. Multicentric, randomized study. Participants. Clinical presentations are based upon clinical phenotypes identified by the Italian Society of Emergency and Urgency Medicine (SIMEU - Società Italiana di Medicina di Emergenza-Urgenza) and patients that meet criteria of phenotypes 2 to 4 were treat with best available therapy (BAT), and randomized to receive or not O3-autohemotherapy. Main outcome measures. The end-point were the time of respiratory improvement and earlier weaning from oxygen support: these parameters were included in the SIMEU clinical phenotypes classification.
Roche Pharma AG
The investigators will follow a single prospective cohort of 50 Health Care Workers in the Hospital Italiano de Buenos Aires (Argentina) from May 15th to August 31st 2020 using antibody testing for SARS-CoV-2 IgM and IgG at baseline and every 2 weeks in order to assess the incidence of COVID-19, the prevalence of anti-SARS-CoV-2 antibodies (IgM and IgG) and incidence of reinfection or reactivations of previous COVID-19 using viral gene sequencing in this cohort.
IRCCS Policlinico S. Matteo
The objective of the study is to assess the efficacy and safety of Baricitinib in the treatment of patients with COVID-19 pneumonia. This will be a proof-of-concept trial with an exploratory single-arm proof of concept Phase IIa study to assess the efficacy and safety profile of Baricitinib in a limited number of patients with severe acute respiratory syndrome (SARS)-CoV-2 pneumonia. If the initial proof of concept phase will lead to favourable results, an open-label, Phase II, randomized controlled trial will be then designed and performed to confirm the results obtained in the proof of concept phase. The proof-of-concept phase guarantees that no safety issues arise on a limited number of patients in the use of a drug new to the current condition being treated.
University of Malaga
Professionals and residents of nursing homes are one of the most vulnerable groups in this public health crisis of COVID-19, since they have the highest rate of positives for COVID-19, despite the restriction measures carried out, such as prohibition of family visits to these centers, the infection occurs by cross transmission with the care staff of the centers, or with other residents. At the moment, there are no clinical trials to test the hypothesis that hydroxychloroquine is effective in coronavirus treatment. Although what has been observed is a better prognosis in infected patients, since this drug inhibits the replication of the virus and its expansion to other tissues. This study is a clinical trial to test the effectiveness of hydroxychloroquine as a preventive drug for SARS-CoV-2 infection. This drug will be applied to 1050 people residing in nursing home care and 880 professionals who work in close contact with these people and who have not yet contracted the infection. This project will be carried out in the territories of Madrid, Navarra, Aragon and Andalusia (Spain). Hydroxychloroquine is a widely known drug that is used in two scenarios, against autoimmune diseases, such as lupus or rheumatoid arthritis, and as an antimalarial drug. It is also intended to demonstrate that the presumed reduction in viral load that would be obtained with hydroxychloroquine prophylaxis, would have no effect in development of immunity against the virus. This fact can create a new paradigm for the de-escalation of the confinement to which the population has been subjected to stop the virus spread, allowing the development of general immunity in controlled populations until reaching total immunity. In addition to testing the effect of this drug, a non-pharmacological intervention based on a safety record will be tested in the management of infection on nursing home, to assess its effectiveness in detecting risk areas or bad practices carried out in this vulnerable environment. The study is led by researchers of the Institute of Biomedicine of Malaga (Spain), and has obtained a financing of 1,024,199 euros from Carlos III Health Institute (Spain). The period of execution of the clinical trial is one year, and with this intervention, the intention is to reduce cross-infection in residents by a minimum threshold of 15%, as well as to decrease infection in the professionals.
Dr Sze-Yuan Ooi
This is a multi-site, prospective, non-randomised trial assessing the implementation of a smartphone application-based model of care for patients with COVID-19 infection managed in community isolation. We will recruit 2000 COVID +ve patients aged 18 years and over who are managed at home. The objective will be to describe the rates of avoidable presentations to ED and 30 day all case mortality per diagnosed COVID-19 case and to compare these to a propensity matched and synthetic control group.
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Currently, due to the effects of COVID-19 pandemic, there is an imperative need to change the healthcare model. In this regard, telemedicine has proved very useful in health crises, in which there is a possibility of infection between people, offering remote access to medical care. Telemedicine has been used in many chronic diseases such as asthma and chronic obstructive pulmonary disease, diabetes mellitus, and appears to be well accepted by patients. However, few studies have been conducted in surgical services and in other diseases. Therefore, the aim of this study is to assess the level of acceptance of the patients, in this pandemic situation, to a telemedicine follow-up in different departments. This is an observational, cross-sectional, multicenter and international study with prospective and retrospective data collection. To evaluate patients' acceptance, we used the validated questionnaire Telehealth usability questionnaire (TUQ). In addition, all patients will provide an overall satisfaction score for telemedicine on a scale from 1 to 5 (1=lowest; 5=highest satisfaction).
Kanuni Sultan Suleyman Training and Research Hospital
Novel Coronavirus 2019 Disease (COVID-19) mortality is highly associated with viral pneumonia and its complications. Accurate and prompt diagnosis shown to be effective to improve outcome by providing early treatment strategies. While chest X-ray (CXR) and computerized tomography (CT) are defined as gold standard, given the advantage of being an ionized radiation free, practical technique point of care ultrasound (POCUS) is also reported as a diagnostic tool for COVID-19. There are limited studies regarding the importance of POCUS in diagnosis and review of COVID-19. Therefore the aim of this study is to evaluate the utility of bedside lung ultrasound on diagnosis of COVID-19 for patients admitted to emergency department .