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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To search this directory, simply type a drug name, condition, company name, location, or other term of your choice into the search bar and click SEARCH. For broadest results, type the terms without quotation marks; to narrow your search to an exact match, put your terms in quotation marks (e.g., “acute respiratory distress syndrome” or “ARDS”). You may opt to further streamline your search by using the Status of the study and Intervention Type options. Simply click one or more of those boxes to refine your search.
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The present study seeks to investigate the levels of parental burnout in the general parental population during the COVID-19 pandemic. Parental burnout is measured three months following (T2) the initiated viral mitigation protocols in Norway, a period where schools and kindergartens were closed, involving a period of home isolation for parents with their children. The burden of parents during this period is thought to have increased, as they were expected to conduct their own work virtually where possible, while at the same time acting as teachers for their children. The study aims to investigate the level of burnout among parents after months of viral mitigation strategies involved in the pandemic, in addition to predictors of parental burnout measured at (T1) are associated with parental burnout after three months (T2). Hypothesis and research question: Research Question 1: What is the level of parental burnout in the general parental population three months following initiated viral mitigation protocols (i.e., physical distancing) as compared to other similar pre-pandemic samples? Hypothesis 1: Parental burnout will be higher in the present sample three months into the pandemic as compared to similar pre-pandemic samples in similar populations. Hypothesis 2: Levels of parental stress, parental satisfaction, general self-efficacy, positive metacognitions, negative metacognitions, unhelpful coping strategies, marital quality and insomnia, all at T2 will significantly predict levels of parental burnout at T2. Exploratory: Do the predictors parental stress, parental satisfaction, general self-efficacy, positive metacognitions, negative metacognitions, unhelpful coping strategies, all at baseline (T1), predict parental burnout at T2, beyond and above these same aforementioned predictors at T2 and pre-existing mental health condition, age, gender, and education? Exploratory: Levels of parental burnout will be explored across subgroups in the sample.
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Study description: The present study seeks to investigate the impact of various sources of information on psychopathology, and specifically health anxiety, depression, and general anxiety, during the COVID-19 pandemic. The study will investigate the divergent impact of various information sources on these psychopathological symptoms during the pandemic. Hypotheses and research questions: Hypothesis 1: Media consumption across all information sources will significantly be associated with depression and anxiety symptoms, with increased media consumption in general associated with higher levels of health anxiety, depression, and general anxiety. Hypothesis 2: Using social media and online interactive platforms to obtain news about the pandemic in comparison to using traditional media (e.g., TV, radio, and newspapers) will be associated with higher levels of health anxiety, depression, and general anxiety. Actively staying away from information will further significantly be associated with higher levels of higher levels of health anxiety, depression, and general anxiety. Research Question 1: Is there a differential effect among different information sources on health anxiety, depression and general anxiety? To what extend and how are different information sources related to symptoms of health anxiety, depression, and general anxiety. Exploratory: Additionally, we will exploratory investigate to what extent the amount of use of different information sources impact health anxiety, depression, and general anxiety. We will also examine effect sizes with part correlations, to investigate information sources with the most and least detrimental impact on health anxiety, depression, and general anxiety. Furthermore, we will report which information platforms participants reported as most useful with regards to information concerning how to best deal with the pandemic.
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Study description: The present study seeks to investigate the predictors and maintaining mechanisms of depression and anxiety symptoms during the COVID-19 pandemic, exactly 3 months following the strictest viral mitigation strategies initiated in Norway in response to the pandemic. This is the time period where the major pandemic protocols are lifted in Norway, following three months of strict pandemic mitigation protocols. The study further aims to identify subgroups with highest levels of depressive and anxiety symptoms during the measurement period, to identify vulnerable subgroups with maintained symptoms three months following the pandemic. Hypotheses and research questions: Research Question 1: What is the level of depressive and anxiety symptoms three months following the employment of the strict viral mitigation protocols (i.e., physical distancing protocols) in the general adult population? What are the proportion above the validated cut-offs for depression and general anxiety? Hypothesis 1: There will be a significant decrease in the levels of depression and anxiety symptoms from the baseline (T1) with the strictest mitigation protocols to measurement the measurement period three months into pandemic (T2) where major pandemic mitigation protocols are lifted. Additionally, there will be a significant decrease in the proportion of the sample meeting validated cut-offs for depression and anxiety from T1 to T2. Hypothesis 2: Higher level at T1 and less reduction from T1 to T2 in positive metacognitions, negative metacognitions, and unhelpful coping strategies all measured with CAS-1, will be related to less reduction in depression and anxiety, above and beyond age, gender, and education. Higher level at T1 and increases from T1 to T2 in physical activity and perceived competence will be related to greater reduction in depression and anxiety, above and beyond, age, gender, and education. Exploratory: The investigators will further explore the proportion showing reliable change in depression and anxiety and investigate the differences in changes in depression and anxiety across different demographic subgroups in the sample
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The aim of this study is to investigate the levels of trauma and mental symptoms (i.e., depression and anxiety) among health workers and public service providers 3 months after (T2) the strict social distancing government initiated non-pharmacological interventions (NPIs) related to the COVID-19 pandemic (T1), in a period of lifted distancing protocols. The study also aims to investigate predictors of trauma-symptoms, by analyzing how predictors measured during the COVID-19 pandemic are associated with change in PTSD symptoms from T1 to T2.
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Difficulties in Emotion-regulation and Interpersonal Problems During and After the COVID-19 Pandemic
Central indicators of psychological functioning such as difficulties in emotion regulation and habitual problems in one's relating to others are likely to have been substantially impacted by the COVID-19 amelioration measures of societal lock-down and physical (ne social) distancing. In turn, as these amelioration measures have been relaxed, that impact will presumably be reduced, gradually returning these factors to pre-crisis levels. Also, these factors are likely to predict mental health outcomes such as symptoms of depression and anxiety throughout the pandemic and beyond, so that levels of emotion regulation difficulties and interpersonal problems early on will predict later symptom status. Similarly reductions in such difficulties during the various phases of the outbreak will be associated with a concurrent reduction in psychological symptoms and reduced symptom levels at later stages.
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Study description: The preset study seeks to investigate factors associated with of hygiene-related behaviors and adherence to viral mitigation protocols during the COVID-19 pandemic. In particular, factors associated with of adherence to WHO-advised hygiene-related behaviors and adherence to governmental mitigation protocols are investigations. The aim of the project is to: - Inform the policymakers, the general public, scientists, and health practitioners about the cognitive, behavioral, emotional, motivational, and trait components underlying hygiene-related behaviors and adherence. - Help policymakers better understand adherence and the factors it is associated with, providing empirical grounds to advance societies battle against the COVID-19-virus from an epidemiological perspective by promoting factors that increase adherence. Hypothesis/Research questions Hypothesis 1: Risk perception, altruism and governmental trust will significantly be associated with both adherence and hygiene-related behavior, with increased risk perception, altruism, and governmental trust associated with higher rates of adherence and hygiene-related behavior. The personality traits conscientiousness and agreeableness will significantly be associated with both adherence and hygiene related behavior, with increased conscientiousness, and agreeableness associated with higher rates of adherence and hygiene-related behavior. Furthermore, beliefs about pandemic protocol efficacy and beliefs about collective mitigation behavior (i.e., "it is only useful to follow transmission protocols if everyone else does") will be associated with adherence to viral mitigation protocols and hygiene-related behaviors. Research Question 1: Is there a difference between the use of various platforms to obtain information about COVID with regards to adherence to viral mitigation protocols and hygiene-related behaviors? Research Question 2: To what extend are different sources of obtaining information associated with adherence to hygiene-related behavior and adherence to viral mitigation protocols? Research Question 3: To what extent are different personality traits (measured with the Short Big Five Inventory-10 (BFI-10)) associated with adherence to viral mitigation protocols and hygiene-related behaviors?
IRCCS Policlinico S. Donato
The investigating group aims at performing an observational, prospective study that involves the evaluation of circulating biomarkers predictive of clinical evolution in patients suffering from COVID-19 disease. In particular, the aim will be to verify whether there are transcripts or cytokines / chemokines in peripheral blood, modulated differently in patients with COVID-19, distinguished on the basis of the evolution towards more severe clinical pictures that require patient intubation or that show signs of cardiovascular damage. The study will be based on the transcriptional analysis of the entire genome and serum protein to evaluate the expression of a broad spectrum of cytokines and chemokines. Genome analysis will allow the genotype to be correlated to the identified gene expression profiles.
Hospital Clinic of Barcelona
BACKGROUND AND RATIONALE: There is very limited literature available on the arrhythmia occurrence in the context of an infection by the SARS-CoV2 virus. On the other hand, treatment strategies against the SARS-CoV2 virus may carry a risk of QTc prolongation and pro-arrhythmia/sudden death which may be amplified by concomitant use of other QTc-prolonging drugs and/or ion disbalances. COVIDAR is an international initiative to monitor the occurrence of arrhythmic events in the context of the SARS-CoV2 infection, to identify potential modifiable predisposing factors to reduce their incidence and to inform the best arrhythmia management options in this patient population. MAIN OBJECTIVE: To describe the incidence and type of arrhythmic events in the context of the SARS-CoV2 infection. STUDY DESIGN: patient registry (observational). Patients will not undergo any additional investigations. Only data that is generated during routine clinical care will be collected. STUDY POPULATION: Patients admitted to the hospital highly suspected of or with confirmed COVID-19.
Miro Health
This is a nationwide research program to study the neurological effects of COVID-19. It is open to the public. Healthy individuals and individuals who are or have been infected with COVID-19 are encouraged to join the effort. The study can be done at home with internet access and an iPad or iPhone. Participation takes about one hour. To learn more, go to https://www.mirohealth.com/consent/
Azienda Ospedaliera Universitaria Integrata Verona
The aim of the project is to evaluate the immunological features of COVID-19 patients. Patients are recruited without any pharmacological treatments restriction. The number of samples is estimated on the basis of feasibility, that means on the maximum number of patients with COVID-19, who are expected to be able to be enrolled by the units involved. Based on the investigators' experience, gained in the onco-immunological field, considering the time and economic resources available, the investigators expect to enroll at least 80 patients.