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 350 of 423Federal Research Clinical Center of Federal Medical & Biological Agency, Russia
As coronavirus disease 2019 (COVID-19) spreads across the world, the intensive care unit (ICU) community must prepare for the challenges associated with this pandemic. Providing an efficient care to the patients of the most severely affected category - intensive care unit (ICU) patients - has become one of the serious problems appearing in the COVID-19 pandemics. A typical patient's clinical portrait in ICU of COVID centers is very similar in different countries, however, the key to improve the treatment results for critically ill patients has not yet been found. Data on predictors of severe course in COVID-19 is limited. Knowledge of predictors of severe course of disease can lead to different selection of therapeutic strategy, determine the group of risk of patients for severe course of disease, and improve outcomes.
University of Sao Paulo
Coronavirus disease 2019 (COVID-19) was declared an emergency public health problem by the World Health Organization (WHO) in March 2020. Since then, several initiatives by the medical and scientific community have sought alternatives to treat infected individuals, as well as identifying risk or protective factors for the contamination and prognosis of patients. In this perspective, vitamin D supplementation can improve some important outcomes in critically ill patients, being considered a potent immunomodulatory agent. Vitamin D deficiency is a common outcome in critically ill patients, thus making it a modifiable risk factor with great potential for reducing hospital stay and intensive care and mortality. The investigators speculate that vitamin D supplementation could have therapeutic effects in patients with COVID-19.
Corporacion Parc Tauli
Prospective observational trial in patients admitted to ICU diagnosed with COVID-19 requiring invasive mechanical ventilation. Characterization of Reverse Triggering asynchrony during the first 5 days of invasive mechanical ventilation and other asynchronies, and its correlation with different outcomes.
Medical College of Wisconsin
This study will evaluate the feasibility of self-sampling with the iAMP® COVID-19 Detection Kit (Atila BioSystems, Mountain View, CA), a new, low-cost SARS-CoV-2 test that does not require RNA extraction. The investigators will compare the sensitivity and specificity of the iAMP® assay on self-sampled mid-turbinate, anterior nares, and saliva swabs against the gold standard, a nucleic acid amplification testing assay on a clinician-collected nasopharyngeal swab.
University Hospital, Montpellier
Our society is going through an unprecedented situation: the COVID 19 Pandemic is forcing many populations, worldwide, into confinement for their own protection. The very characteristics of this confinement and of the disease (isolation, potential severity of the illness, being psychologically unprepared for such a circumstance) have a significant impact on one's psyche, like emotional disorders -anxiety/depression-, difficulties when returning to normal life, vicarious traumas… Confinement is paradoxical in as although well-intended to protect the individual, it leads to the isolation of the individual. This paradox is destabilizing one's feelings, because when the investigators feel the need for protection and reassurance, the investigators are left alone and feel abandoned. The investigators therefore understand that this confinement framework is in essence a situation that might revive unresolved deprivation situations from the childhood. How to react in front of this upsurge in anxiety? Strategies used may include, among others, escape in the imaginary through numerical tools or others, and /or going to the actual characterized by deviant sexual behaviours. The investigators know in fact that certain moments, like anxiety, depression, boredom, psychological unrest are propicious for acting, for violent sexual offenders. The investigators therefore pay extra attention to our patients in such periods favoring these kinds of trouble. This study will enable us to understand if the confinement associated with COVID 19 has generated anxiety that lead sexual offenders or individuals with paraphilic disorders to engage into deviant fantasies or, potentially sexual activities.
I.M. Sechenov First Moscow State Medical University
Data on respiratory mechanics and gas exchange in acute respiratory failure in COVID-19 patients is limited. Knowledge of respiratory mechanics and gas exchange in COVID-19 can lead to different selection of mechanical ventilation strategy, reduce ventilator-associated lung injury and improve outcomes. The objective of the study is to evaluate the respiratory mechanics, lung recruitability and gas exchange in COVID-19 -associated acute respiratory failure during the whole course of mechanical ventilation - invasive or non-invasive.
Azienda Ospedaliero-Universitaria Careggi
This study is part of the current global emergency scenario due to infection with Coronavirus, SARS-CoV-2 as indicated by the international taxonomy. Study aim is to investigate the possibility of the presence of the virus within the seminal fluid and in the urine of infected patients, both during the acute phase and remotely. Current evidences show that Coronaviruses can be present inside the testicle and sperm in other species, such as in feline and avian models. In human beings, current researches have mixed results regarding the presence of SARSCoV-2 in urine, as several studies with a large sample found no traces of the same with Real-Time Reverse method Transcriptase - Polymerase Chain Reaction or with method of nucleic acid amplification. By contrast, in just over 6% of 58 patients with Real Time Polymerase Chain Reaction method have found the presence of SARS-CoV-2 in the urine, even at a distance from the last negative nasopharyngeal swab. Given the topicality of the problem, our study has the objective of specifically researching the presence and possible persistence over time of SARS-CoV-2 in seminal fluid and urine. A saliva sample will also be collected as a control. At the moment there are no studies in literature that tested this possibility. If confirmed, it would lead to find out another potential method of transmission, the sexual one, in asymptomatic patients or apparently no longer infectious with negative buffer. The rationale for our study is the evidence that in other species this type of transmission by coronaviruses is possible and that at present it has not been verified in mankind. The relevance of the study would be both in the case of a negative result, as the first study in its generally, both in the case of a positive result, due to the possibility of introducing new prevention measures in the long run.
National University Hospital, Singapore
In December 2019, a novel coronavirus, now called COVID-19, emerged as a global health threat from Wuhan, China. Within weeks, the contagious virus spread within and between communities, causing a lower respiratory tract infection dominated by symptoms of fever, cough and sore throat. The incubation period was estimated at between 5 to 7 days, but could last as long as 14 days. Although COVID-19 causes a mostly mild and self-limiting disease, respiratory involvement has been reported in about 5% of the population, requiring supplemental oxygen and even ventilatory support to relieve hypoxia. Alveolar damage, fibrosis and consolidation have been reported in radiologic and post-mortem studies. Existing data suggest a mortality rate of COVID-19 is approximately 1-2%, higher among individuals with pre-existing comorbidities and in healthcare systems with suboptimal access to ventilatory support. Given its high transmissibility, COVID-19 has quickly spread across the globe within a short interval. By 27 April 2020, over 3 million people around the world have been diagnosed with COVID-19, and more 200,000 have succumbed to the disease. As a proportion of patients manifest mild or no symptoms, these numbers are likely an underestimate of the actual number of patients with COVID-19. More disconcertingly, patients are known to shed viruses despite mild or no symptoms, making it essential that a collective approach against COVID-19 incorporate active pharmacological treatment to prevent or mitigate virus pathogenesis prior to its potential evolution to cause respiratory distress. To date, clinical trials have focused on the treatment of hospitalised patients diagnosed with COVID-19; only few have examined the clinical benefits of pharmacological agents despite few compelling in vitro data. The relatively high transmission of COVID-19 in a closed dormitory environment of migrant workers in Singapore presents a real-life scenario where a prophylaxis treatment could reduce the impact of the disease. In Singapore, there are well grounded concerns an excess in cases could pose the possibility of strain in healthcare system and mentally drain her workers. The availability of an effective prophylaxis treatment is highly desirable to potentially reduce this burden. Data from the current study could also have implications on how future outbreaks in high-density areas should be managed, especially when residents are subjected to quarantine and isolation.
Bandim Health Project
Since the 1960s, studies have shown that oral polio vaccine (OPV) may have beneficial non-specific effects, reducing morbidity and mortality from other infections than polio. Such beneficial non-specific effect have been observed for other live vaccines, including measles, smallpox and BCG vaccine. For BCG, the vaccine for which the mechanism has been studied the most, the effects appear to be mediated through the innate immune system. The COVID-19 pandemic caused by the novel coronavirus SARS-CoV-2 has now caused over 7.1 million cases and >400,000 deaths worldwide. As everywhere else, it is anticipated that in Africa the older part of the population will be at risk of severe COVID-19. OPV is widely used in Africa, but for children. Both polio and coronavirus are positive-strand RNA viruses, therefore it is likely that they may induce and be affected by common innate immune mechanisms. In a randomised trial at the Bandim Health Project in Guinea-Bissau, the investigators will assess the effect of providing OPV vs no vaccine to 3400 persons above 50 years of age. The trial will have the power to test the hypothesis that OPV reduces the combined risk of morbidity admission or death (composite outcome) by at least 28% over the subsequent 6 months.
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
By applying polymerase chain reaction (PCR) test for Covid-19 to preeclampsia patients who applied to our hospital during the Covid-19 pandemic period, we investigated the frequency of Covid-19 related preeclampsia-like syndrome in this patient group.