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 170 of 314University of Manitoba
The main objective of this pilot study is to evaluate the effect of a remote interdisciplinary PR program that is delivered using two exercise approaches on the recovery of long-term post-COVD-19 outcomes. The specific aims are i) to evaluate the effect of the program and ii) each of the approaches on patients': 1) lung capacity, 2) dyspnea and fatigue, 3) exercise capacity, 4) physical function, 5) participation, and 5) HRQoL.
Istanbul Gelisim University
Aerobic Versus Anaerobic Exercise on Immune Functions and Disease Severity in Patients With COVID-19
Participants were assigned randomly into two groups, aerobic exercise and resistance exercise groups. All participants in both groups followed the WHO guidelines of quarantine and used standardized medications given by the physician according to the Turkish Ministry of Health guidelines, including the Hydroxyclorocin Sulphate 200 Mg Film Tablet (Plaquenil 200 Mg Film Tablet). The dose was 2 times/ day, 200Mg/time, for 5 days. Besides, the aerobic exercise group performed moderate-intensity aerobic exercises for 40 min/ 3 sessions/week, 40 minute/session, and the resistance exercise groups 40 min/ 3 sessions/week, 40 minute/session.
Jacobs University Bremen gGmbH
Aim of the study is to investigate possible predictors and factors that may be associated with the development and maintenance of mental and physical health constrains including depression and anxiety symptomatology as well as loneliness in hospitalized post-COVID patients and non-COVID patients in Germany. Furthermore, it will be investigated whether psychological interventions have an effect on anxiety and depression symptomatology, on loneliness values, self-efficacy and perceived social support values. Specifically, the research aim is to examine the relationships between loneliness, self-efficacy, and social support and to address the question of what factors increase the risk of post covid depression/anxiety, and to test the buffering effect of physical and social activities. For this purpose an experimental group comparison will be applied, in which two interventions will be performed on post-COVID patients and non-COVID patients in the unit of Physical Medicine and Geriatrics in Medical Rehabilitation. (PhD Project by Annika Roskoschinski, M.Sc., Psychology, Principal Investigator)
Saglik Bilimleri Universitesi
The primary aim of our study is to understand the effects of Covid-19 disease on vascular inflammation and coagulation cascade, and secondarily, to investigate its utility in predicting disease prognosis by analyzing serum PAI-1 levels in patients with different severity. The study is planned as a prospective, cross-sectional study that will include patients admitted to Covid-19 services between January 18, 2021, and August 30, 2021. A total of 80 volunteers will be enrolled in the trial whose age, gender, and BMI are planned to be matched.The study will be conducted on four groups. Group 1 (n=20; with mild symptoms), Group 2 (n=20; with moderate symptoms), Group 3 (n=20; with severe symptoms) and Group 4 (n=20; Control group). All participants who accepted the study will have their sociodemographic data, medical history, and vital signs (respiratory rate, saturation, temperature, and blood pressure values) recorded at the start of the study. The pulmonologist in the study will also classify the patient group's chest X-ray and chest tomography findings and the thymus gland dimensions. After all four groups of patients have given their consent for the study, a sample of 5cc blood will be obtained once for the PAI-1 analysis.
Butantan Institute
NDV-HXP-S is an inactivated COVID-19 vectored-vaccine virus using the Newcastle Disease Virus as basis and expressing S protein from SARS-CoV-2 stabilized in pre-fusion form with Hexapro technology. This vaccine was successfully tested in non-clinical study with a good safety profile and eliciting neutralizing antibodies against SARS-CoV-2. Clinical testing is conducted by an international consortium including three different manufacturers. Butantan, in Brazil, is one of them.
Charles Drew University of Medicine and Science
African Americans (AA)/People of Color (POC) are disproportionately impacted by COVID-19 to an extent not observed in other racial/ethnic subgroups. People of color are uniquely affected because keeping diabetes under control - the best defense against COVID-19 - has become more difficult as the pandemic has disrupted medical care, exercise and healthy eating routines which are already well-known challenges for the African American community. Diabetes Self-Management Education and Support (DSMS/S) facilitates the knowledge, skills, and ability necessary for diabetes self-care as well as activities that assist a person in implementing and sustaining the behaviors needed to manage their condition on an ongoing basis. Now, given the implications of COVID-19 on the AA/POC diabetes community, it is imperative to enhance DSME/S with education about protection and prevention of COVID-19. To begin to solve this problem we will adapt and implement the "emPOWERed to Change" DSME/S program to provide enhanced type 2 diabetes mellitus (T2DM) education with an additional emphasis on COVID-19 protection and prevention. This study will employ Community Based Participatory Research methods and will be conducted virtually in the community setting. The proposed hypothesis, based on the Health Belief Model (HBM) and the Theory of Planned Behavior (TPB), is: African Americans (AA)/People of Color (POC) in Los Angeles County with type 2 diabetes mellitus (T2DM) randomized to participate in the "emPOWERed to Change" program (N=48) are more likely to demonstrate sustained glycemic control, increase in knowledge and skills related behaviors, and risk factors associated with T2DM and SARS-CoV-2 (COVID-19) and increased compliance with prevention, and vaccination as compared to those who are randomized to usual care (N=48) in this 12 week program. We propose a randomized control study design among 96 participants with 48 assigned to an intervention group and 48 assigned to a control group. This study will also explore the experience of the participants' appraisal of knowledge and skills acquisition for DSME/S to maintain T2DM control, reduce complications, and SARS-CoV-2 (COVID-19) prevention and protection. The ultimate goal is to design prospective larger behavioral studies (SuRe first or R21) with a multi-centered intervention with other RTRN institutions to demonstrate the applicability of this approach specifically focusing on the AA/POC community.
Universita di Verona
This randomized controlled trial will evaluate the implementation and (cost-)effectiveness of the culturally and contextually adapted Doing What Matters in times of stress (DWM) and Problem Management Plus (PM+) stepped-care programs amongst asylum seekers, refugees, and/or migrants living in Italy. Outcomes include mental health, resilience, wellbeing, health inequalities, and costs to health systems.
National Institute of Mental Health (NIMH)
For caregivers in the Bronx, the pandemic has caused unprecedented psychological distress; in addition to combating social determinants of health (SDOH), these families now face greater financial insecurity and challenges related to their school-aged children. Furthermore, social distancing requirements and limited telehealth resources for Bronx families have posed greater barriers to healthcare. Such parental distress contributes to heightened risk of transgenerational cycles of psychological stress, trauma and maltreatment. The social and economic impacts of the COVID-19 pandemic have had significant consequences for family well-being, putting parents at higher risk of experiencing distress and potentially impairing their ability to provide supportive care to their children. Although children may be less susceptible to the most damaging physical consequences of COVID-19, there are growing concerns regarding the short-and long-term impacts of pandemic-related stressors on children. The marked upheaval of family life over an extended period may make children vulnerable to mental health consequences associated with the public health crisis and infection mitigation efforts. School and childcare closures, unstable financial circumstances, social isolation and lack of support have a disproportionate, cumulative impact on parents and may undermine their capacities to provide support for their children. Importantly, a large body of evidence suggests that parental stress during times of disasters induces psychopathologies in family members including children. Further, high anxiety and depressive symptoms in parents during the pandemic have been associated with higher child abuse potential, whereas greater parental support was associated with lower perceived stress and child abuse potential. In addition to psychological impacts, stress associated with caregiving can interfere with parents' ability to maintain their own health. This multimodal study addresses key strategies to mitigate the psychological and health impact of COVID-19 in parents.
Diagnósticos da América S/A (DASA)
This is a Phase 2/3, randomized, multicenter, double-blind, dose-response study to evaluate the safety, immunogenicity, and efficacy of UB 612 in 2 age groups, adults 18 to 59 and ≥60 years of age with or without comorbidities.
University Hospital Schleswig-Holstein
COVID-19 is a novel disease caused by SARS-CoV-2 that primarily affects the lungs but also various other organs of the body already in early stages of the disease. Due to the multiple organ involvements in the acute phase, it is conceivable that - in a significant proportion of patients - longterm sequels in various organ systems might occur, thereby impacting the individual's health status and quality of life; and posing a relevant burden to the resources of the health care system Assessment of SARS-CoV-2-longterm morbidity and sequels on the population level: In order to identify and treat these sequels in a timely fashion and to get a sense of the prevalence of such SARS-CoV-2 sequels on the population level, it is important to collect follow-up data and to comprehensively re-examine a population-representative sample of SARS-CoV-2 infected individuals. Within the COVIDOM study we will conduct deep clinical and biochemical phenotyping in population-representative samples in Germany. This will allow novel insights into disease pathogenesis and chronicity of virus infections.