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 90 of 115Palas GmbH
The proposed study will investigate respiratory aerosols in SARS-CoV-2 (Severe Acute Respiratory Syndrome Corona Virus 2) positive and negative children and adults with the Resp-Aer-Meter (Palas GmbH). For this purpose, first, the measurement of respiratory aerosols (particle sizes and concentration) with the Resp-Aer-Meter will be established. Thereafter, a comparison between polymerase chain reaction (PCR) SARS-CoV-2 positive and negative participants (children and adults) will be conducted. In addition to the measurement of aerosols, the clinical symptoms, lung function (FEV1) and laboratory inflammatory markers will be analyzed.
Nottingham Biomedical Research Centre
This is a prospective observational cohort study that will aim to recruit 60 participants who have had COVID-19, were admitted to hospital, required intensive care, and/or developed AKI during their hospital stay. Potential participants will be approached either by telephone by a member of the research team or via clinics (nephrology, post-ICU follow up clinics).
Istanbul University
A prospective non-interventional study to evaluate the performance of EASYCOV IVD as point-of-care (POC) test by comparing SARS-CoV-2 positive patients with SARS-CoV-2 negative controls on paired specimens (nasopharyngeal swabs & saliva samples).
University of Erlangen-Nürnberg Medical School
Since the beginning of the year, the entire world has been concerned with the novel SARS-CoV2 virus. After the first case descriptions in Wuhan, there has been a rapid increase in the number of cases in Germany as well. In case of an illness with the virus, the affected patients can suffer from a slight infection of the upper respiratory tract up to severe lung failure and death. Interestingly, up to now, children are usually less severely affected than adults. However, the actual infection rates are probably similar to those of adults, even if the actual prevalence in children is difficult to quantify so far. The extent of the disease in children has also been less researched to date than in adults, and the same applies to pregnant women and their newborns. In addition, intensive research into possible therapeutic strategies and new vaccines is necessary. Here, however, the number of clinical studies in children is also far behind. In order to be able to understand the infection process and to protect the population with their children, comprehensive testing is necessary. However, this poses great challenges for local health authorities. Scientific investigations are also costly, but are already being carried out by many institutes. So far, for example in the SeBlueCo study, a very low prevalence of antibodies (1.3% of people) has been show. In children, however, both the routes of infection and the way the immune system deals with the virus are probably different than in adults. In this study the investigators now want to examine residual blood samples from pediatric patients of the pediatric and adolescent clinic in the time course after the beginning of the pandemic in order to better understand and monitor the development of antibody prevalence.
Centre Hospitalier Universitaire de Saint Etienne
Current data in the literature demonstrate that the immune response to CoV-2-SARS is much more complex than initially assumed. In fact, beyond the humoral response, including the existence of neutralizing CAs, the adaptive lymphocyte T-type immune response also appears to play an important role in controlling the infection and reducing the severity of the disease. At this stage, the analysis of this T response is still rudimentary and underdeveloped, but it seems crucial to be able to analyze it effectively in COVID-19 patients, which could help predict the evolution of the infection. It is also currently difficult to know the evolution of this response over time and especially after the resolution of the infection. To this end, we will analyze the T lymphocyte response (ELISPOT and QUANTIFERON) based on the secretion of IFN (Th1) and IL-4 (Th2) by CoV-2-SARS specific T cells from COVID-19 patients. We will compare the T response to the quality of the systemic and mucosal humoral response. Finally, we will evaluate in parallel two new biomarkers of the severity of COVID-19: plasma calprotectin and the presence of antibodies to type 1 IFN antibodies.
Centre Hospitalier de Cayenne
Multicenter observational study of diagnostic test validation (Research Involving the Human Person, type 3) In addition to the diagnosis by the reference method (nasopharyngeal swab), the patient will be asked to provide a saliva sample via a salivary spit. The clinical circumstances of the diagnosis, the age of the patient, the associated terrain (diabetes, immunodepression, pregnancy) will be noted. The nasopharyngeal and saliva samples will be analyzed in Cayenne and the remaining samples will be frozen and stored at the CRB before being sent to the University Hospital of Caen for analysis and concordance verification. The expected benefits are: Possibility of repeating tests in the same person more easily due to the absence of pain and thus reduce the barriers to diagnosis and screening. Possibility of self-sampling, which could simply be sent to the laboratory, which would relieve the diagnostic sites that mobilize staff and require a fairly heavy organization. Avoid long waiting lines that can be an obstacle and lead to a renunciation of the diagnosis.
Department of Health, Philippines
This is an open label randomized controlled clinical trial which was designed to confirm the potential efficacy and safety of favipiravir in the management of patients with mild to moderate COVID-19 compared to best supportive care.
Assiut University
To measure the frequency of persistent liver dysfunction (raised liver enzymes, serum albumin, prothrombin time, etc) in recovered COVID -19 patients. To compare the hepatic manifestations in post COVID -19 patients with and without liver disease
Chinese University of Hong Kong
Safe and effective severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines may reduce the transmission of and achieve population immunity against the COVID-19 pandemic, which accounted for more than 3.75million deaths worldwide. With World Health Organization's (WHO) effort on ensuring equitable access to COVID-19 vaccines, vaccination rate may increase in the near future. On the other hand, vaccination hesitancy has emerged as a major hindrance on the global vaccination campaigns in certain areas due to safety concerns, social factors, and public health policies. For instance, a recent survey conducted in Hong Kong showed a low vaccine acceptance rate of 37%. Long-term safety concerns and post-vaccination events relayed by the social media maybe reasons for vaccination hesitancy. Among which, cerebrovascular accidents (CVA) after vaccination were one of the most frequently reported post-vaccination events. These reports ranged from ischemic strokes in elderly patients with multiple cardiovascular co-morbidities, to hemorrhage strokes in otherwise "young-and-fit" adults. While many of these events were investigated by the COVID-19 immunization expert committee, an important premise to address the apprehension of CVA after vaccination is the provision of evidence-based information of the impact of COVID-19 vaccines on brain health. In this prospective, longitudinal, observational study, we aim to elucidate the relationship between COVID-19 vaccines and cerebrovascular health in healthy citizens in a population-based cohort.
Sher-E-Bangla Medical College
An outbreak of the novel coronavirus nCoV-19 (SARS-CoV-2), responsible for the coronavirus disease-19 (COVID-19), was first detected in Hubei province, Wuhan, China, on December 31, 2019. It has rapidly spread globally with approximately 157,343,044 confirmed cases and 3,278,510 deaths till 7th May, 2021 [1]. World Health Organization (WHO) declared COVID- 19 pandemic on 11th March 2020. The world is facing the second wave of Coronavirus Disease 2019 (COVID-19) pandemic which is the most troublesome challenge to public health. The second wave is running and nobody knows where we are in the course of this disease. It becomes a significant challenge for the public health, science, and medical sectors [2]. According to the World Health Organization, about 80% of infections are mild or asymptomatic, 15% result in moderate to severe symptoms (requiring oxygen) and about 5% are critical infections, which require ventilation. We are learning something new every day. Our understanding of the pandemic is growing and changing daily. The world is focusing on the short term - flattening the curve, treating the sick and discovering a vaccine. But there is more to this pandemic than the short term. We know a lot about the transmission and clinical feature of COVID-19, but relatively little about what happens after someone recovers. Much is still unknown about how COVID-19 will affect people over time. There's still much to be learned from those who have recovered from COVID-19.