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 130 of 211University of Manchester
The response to COVID-19 means social isolation/distancing for the majority of the UK. This has the potential to negatively affect all domains of quality of life (QoL). QoL can be improved by giving feedback on gaps between someone's perceived QoL in a domain and how important it is to them (plus prompting reflective questions). However, interventions that are designed to improve QoL may increase the effectiveness of this as optimised behaviour change techniques can be used. This study aims to develop and test a quality of life intervention during social isolation/distancing.
Federal University of Rio Grande do Sul
Skin Picking Disorder (SPD) affects up to 10% of the general population, causing significant socioeconomic damage in 75% of affected individuals. It is characterized by the repeated habit of touching the skin itself, causing or aggravating wounds, with difficulty in controlling the habit. It is associated with anxiety disorders in about 20% of cases and with depressive disorder in about 50%. Patients with SPD have difficulties in regulating emotions, being more vulnerable to having their mental symptoms aggravated in face of stressful situations, such as the current coronavirus-19 pandemia. Among the treatments available to SPD, cognitive behavioral therapy is the only intervention superior to placebo, and there is still no medication approved by the FDA indicated specifically to SPD. The effectiveness of cognitive behavioral therapy was assessed in a randomized clinical trial with Brazilian patients with SPD, but its long-term benefit has not yet been evaluated. Additionally, telemedicine interventions can be effective and used during pandemia, but the effectiveness of internet delivered cognitive behavioral therapy for SPD is not clear yet.
University of California, Davis
This project will establish that pediatric and family medicine residents who complete a hybrid breastfeeding medicine curriculum that includes an asynchronous unfolding case scenario along with telesimulation with a standardized patient (SP) will provide timely, skilled lactation support more frequently than residents randomized to an asynchronous unfolding case scenario followed by videoconference group discussion regarding care for the breastfeeding dyad.
AB Biotics, SA
Clinical research focused to evaluate the effect as coadyuvant of a combination of L. plantarum and P. acidilactici in adults positive for SARS-CoV-2 with mild clinical COVID-19 symptoms. Main objective is to evaluate how this combination of probiotics reduce the risk to progress to moderate or severe COVID and associated advantages such as reduce the risk of death. Adittionnally this RCT is launching to explore the benefits of this combination of strains to modulate fecal microbiome and explore how this correlate with clinical improvement.
Direction Centrale du Service de Santé des Armées
Stress is underpinned by a biological reaction of the organism allowing the production of energy to respond to a change in the environment (or stressor). Stress reaction is expressed in behavioural, cognitive, emotional and physiological terms. This biological response is non-specific because it is the same regardless of the stressor. Its evolution over time has been conceptualised by Hans Selye (1956) in the General Adaptation Syndrome (GAS) which comprises three successive phases. (i) The first phase, known as the alarm phase, corresponds to the activation of all biological mechanisms according to a trend regulation, allowing a rapid response to the stressor. (ii) The second phase of resistance which adjusts the stress response to the intensity of the perceived aggression according to a constant regulation. (iii) When the aggression disappears, a recovery phase dominated by the return of the parasympathetic brake allows a return to homeostasis (eustress). The "primum movens" of all pathologies is therefore the inability of the individual to adapt his stress response in duration and/or intensity to the course of the phases of the GAS (distress). The perception of not being in control of the situation contributes to the perceived stress and constitutes a well-established risk of distress. It is a risk factor for the emergence of burnout. It induces a biological cost called allostatic cost. Allostasis is a concept that characterizes the process of restoring homeostasis in the presence of a physiological challenge. The term "allostasis" means "achieving stability through change", and refers in part to the process of increasing sympathetic activity and corticotropic axis to promote adaptation and restore homeostasis. Allostasis works well when allostasis systems are initiated when needed and turned off when they are no longer required. Restoring homeostasis involves effective functioning of the parasympathetic system. However, when the allostasis systems remain active, such as during chronic stress, they can cause tissue burnout and accelerate pathophysiological processes. The perception of uncontrollability depends on the stress situation, the psychological and physiological characteristics of the subject and his or her technical skills in responding to the stressors of the situation. In particular, subjects with a high level of mindfulness are more accepting of uncontrollability and less likely to activate the stress response. The COVID-19 pandemic situation is a situation characterized by many uncertainties about the individual, family and work environment and the risk of COVID infection. Healthcare workers, like the military, are high-risk occupations that are particularly exposed to these uncertainties in the course of their work and continue to work in an uncertain situation. These professionals are described as a population at risk of occupational/operational burnout that the level of burnout operationalises. This ancillary study in a population of civilian and military non-healthcare workers will complement the study conducted among military health care workers. It will make it possible to isolate the specificity of each profession (civilian or military, healthcare personnel or not) with regard to the risk of burnout in the COVID context. The objective of this project is to evaluate the impact of the perception of non-control in the operational burnout of experts in their field of practice and to study the psychological and physiological mechanisms mediating the relationship between the subject's characteristics, perceived non-control and burnout.
University of Toronto
The COVID-19 pandemic and the accompanying lockdown measures have made mental health a pressing public health concern. Acts that focus on benefiting others-known as prosocial behaviors-offer one promising intervention that is both flexible and low cost. However, neither the range of emotional states prosocial acts impact nor the size of those effects is currently clear, both of which directly influence its attractiveness as a treatment option. Using a large online sample from Canada and the United States, the investigators will examine the effect of a three-week prosocial intervention on two indicators of emotional well-being (happiness and the belief that one's life is valuable) and mental health (anxiety and depression). Respondents will be randomly assigned to perform prosocial, self-focused, or neutral behaviors each week. Two weeks after the intervention, a final survey will assess whether the intervention has a lasting effect on mental health and emotional well-being. The results will illuminate whether prosocial interventions are a viable approach to addressing mental health needs during the current COVID-19 pandemic, as well for those who face emotional challenges during normal times.
University of South Carolina
The current pilot study will explore the optimal cost-effective treatment configuration for online group-based weight control by focusing on two aspects of our existing treatment program which have significant associated cost and determine which contribute meaningfully to weight loss outcomes. Specifically, we will explore whether adding synchronous group social support (weekly group video chat sessions facilitated by a trained weight loss counselor) to on demand (asynchronous) social support provided through the program discussion board significantly increases weight losses achieved. We will also examine whether detailed feedback on dietary and physical activity self-monitoring records from a counselor enhances weight loss outcomes in comparison with basic feedback. Finally, we will examine the cost efficiency of the treatment constellations. Further, this pilot study will also explore the feasibility of recruiting participants nationally (rather than just locally) and the capture of data electronically (including body weight measurements) without any in-person contact.
Makerere University
Introduction: During pandemics like the COVID-19, a significant number of the populace suffer from psychological distress (PD) that often abates naturally over time in the majority of people but persists in others to become pervasive and severe enough to trigger the onset of common mental disorders (CMD) like major depressive disorders (MDD), generalized anxiety disorders (GAD), post-traumatic stress disorders (PTSD) and substance misuse disorders (SUD). Once identified, psychological distress as well as CMD can be managed using psychotherapy or pharmacotherapy. However, low levels of mental health literacy (MHL) manifested by the individual's unawareness of CMD symptoms, limited human and mental health infrastructure resources and high levels of mental illness stigma (MIS), are barriers to integration of mental health care in general health care during pandemics and epidemics such as the COVID-19. The study objectives will include: (a) Documenting MHL, PD, MDD, GAD, PTSD and SUD levels in the study population, (b) Determining the effectiveness of a psycho-education intervention delivered by village health team (VHT) members on study outcomes Methods: We shall employ an open label cluster-randomized trial design, with each village as a cluster, to conduct the study in 24 villages (12 intervention and 12 control villages) in Kampala (n= 15), Wakiso (n= 3), Masaka (n= 2) and Mukono (n= 4) districts. To ensure balance between the two study arms, villages underwent stratified randomization on the basis of rural vs urban population. The second level of stratification will be achieved by a separate randomization procedure performed within each stratum to ensure gender balance within each cluster We will develop information education and communication materials (IEC) aimed at improving MHL and reducing MIS. In the intervention arm (n=12 villages), VHTs will distribute the IEC materials in every 12th household till they accrue 420 individuals (adults ≥ 18 years old) who express interest in participating in the study. In the control arm (n=12 villages), VHTs will distribute MOH COVID-19 information leaflets in every 12th household till they accrue 420 individuals who express interest in participating in the study. Within 7days after distribution of the materials, trained research assistants will schedule and assess participants (through a phone interview) for MHL, PD, MDD, GAD, PTSD and SUD. Individuals who don't have phones will be asked to provide a phone number of a friend or relative through which the interviews can be conducted; interviews could also be conducted using the VHTs' phone. Cost data will be collected using available implementation data. We will document the number of individuals from both arms who will contact the investigators Data analysis plans: We will (a) report frequencies and percentages and their 95% confidence intervals for the first objective, (b) use an intention to treat analysis to analyze the second objective, Conclusion: Findings from this research will guide policy and practice regarding the integration of mental health services in the community in the context of epidemic preparedness and response.
George Washington University
This is a pilot feasibility study of remotely delivered Problem Management Plus, a low-intensity psychological intervention, delivered in five sessions to adults affected by crisis. The current study will evaluate the feasibility and acceptability of the intervention when delivered remotely via Zoom to community members in New York City impacted by the COVID-19 pandemic. The investigator's goal is to use qualitative and quantitative approaches to inform procedures for a subsequent cluster randomized control trial of Problem Management Plus versus enhanced usual care. A mixed-methods design will be used to evaluate the feasibility, acceptability, perceived utility, and impact of the remotely delivered PM+ intervention, to determine recruitment and retention rates, to assess ethics and safety of trial procedures. Additionally, the study will evaluate the acceptability, feasibility and fidelity of the remote training and supervision of helpers trained to deliver the intervention.
University of Michigan
This study is an open trial designed specifically to address the need for evidence-based treatment delivered via telehealth to individuals that are currently struggling with mental health issues during the COVID-19 pandemic, with the overarching goal of helping residents of New York adversely impacted by the pandemic to effectively manage their anxiety, stress, and depression during this unprecedented time in human history.