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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This study aims to investigate the association between the use different information sources to obtain information about the COVID-19 pandemic and symptoms of psychopathology (i.e., depression and anxiety). Research Question: How central are different sources of information used to obtain knowledge about the COVID-19 pandemic in network along with depressive and anxiety symptoms? Which sources of information are most strongly connected to different symptoms of depression and anxiety? Staying away from information will be measured in the present study. As avoidance is a type of safety behavior in anxiety disorders, we are further eager to investigate the centrality of this behavior in the network. Furthermore, multiple studies using latent-variable paradigms have established a relationship between sum-scores of depression and social anxiety use in general. We are further interested in examining this potential link more thoroughly and detailed in the present network study. The findings of this study, although they will be cross-sectional and require further examination in studies with temporal data structure, will be an important and interesting starting point giving initial ideas about potential mechanisms that may be involved in use of information sources in pandemics and mental health
Meharry Medical College
Newborns and infants receive passive natural immunity through maternal antibodies present in breastmilk to fight infections caused by viruses such as the COVID-19, until they develop active immunity by illness or vaccination. Such immunity will become the main stay for preventing future waves of COVID-19 epidemics. The high COVID-19 mortality among African Americans is ascribed partly to compromised immune status associated with comorbidity. Exclusive breastfeeding (EBF) is the effective low-cost natural strategy for building immunity right from birth. African Americans record the lowest EBF rates and also lack workplace support. This intervention includes a 10-hour course extracted from 90-hour CLC online program, sufficient to prepare physicians to partner with certified lactation consultant (CLC) to provide their patients comprehensive COVID-19 breastfeeding guidelines, training, and support to afford their babies the benefits of breastmilk antibodies, the best line of defense against COVID-19, until availability of safe vaccines. The Breastfeeding Report Card indicates slow improvements in overall breastfeeding rates with persisting disparities. Improving EBF rates can contribute to increased COVID-19 immunity among infants. Preliminary data in Nashville indicates excellent breastfeeding benefit knowledge and intent, but limited training to succeed. Hospital staff encourage breastfeeding but routinely offer formula at birth. Most physicians who provide prenatal care do not actively promote breastfeeding nor routinely offer CLC referral. This single action by physicians can halt routines that compromise successful EBF. The program long-term goal is to prepare obstetricians to actively promote comprehensive breastfeeding among African American mothers. The immediate objective is to develop and evaluate feasibility and effectiveness of an intervention designed to increase COVID-19 breastfeeding guideline adherence and improve EBF skills and rates among African American mothers. The rationale is that mothers who receive physician prenatal encouragement and CLC referral will make confident informed decisions, adopt COVID-19 breastfeeding guidelines, safely meet their EBF goals, and provide their infants with appropriate antibodies. The expected outcome is that patient participants will adhere to COVID-19 breastfeeding guidelines and record 3-month EBF rate 60 percent or greater.
Hospices Civils de Lyon
The coronavirus outbreak is a stressful event for the whole population. Confinement measures are protective against the risk of dissemination of the virus, but they can also lead to several psychological symptoms. In children, a study in China has reported about 20% of depressive or anxious troubles in school-age children after a 4-week period of confinement. In France, confinement lasted about 8 weeks. School resumed on May 11th for primary school children and on June 2nd for secondary school children. In this survey, we aim at exploring the psychological status of these children and the impact on their schooling, for better understanding, support and prevention. Through this online questionnaire, we also aim at giving some psycho-education advices. Finally, we could identify some subgroups of children particularly vulnerable, and organise some specific support for them in coming months.
Royal Centre for Defence Medicine
This study is intended to address the association between vitamin D status and seroconversion to SARS-CoV-2 in healthy young adults. The primary aim of the study is to determine the rates of 'silent' seroconversion rates, consistent with asymptomatic transmission of SARS-CoV-2, in a young healthy adult population with a wide spread of vitamin D concentrations. The secondary aims of this study are to explore: 1. Any effect of vitamin D status on symptomatic illness. 2. The background 'point' prevalence and subsequent rate of increase in seropositivity for SARS-CoV-2 in healthy young adults. 3. The individual reductions in seropositivity to SARS-CoV-2 over time, and changes in seropositivity in a defined young adult population over time. 4. Where salivary Immunoglobulin A (IgA) may be used to provide an alternative/ complementary serological method 5. The effect (if any) of vitamin D supplementation on seroconversion rates stratified by: i) level of baseline vitamin D 'deficiency/ insufficiency/ sufficiency' status; ii) extent of BMI-defined normal/overweight/obesity cut-offs and iii) gender.
Medical University Innsbruck
The aim of this questionnaire survey is to evaluate the improvement in vision-related quality of life before and after cataract surgery using the National Eye Institute Visual Function Questionnaire 25 and the delay of improvement in the COVID-19 pandemic.
University of Lincoln
The Primary objective is to explore ambulance service attendance at incidents involving alcohol and/or substance use over the period of the pandemic lockdown, and the following months. This will be to determine prevalence and explore factors such as patient gender, age, ethnicity or location. Analysis will examine the calls over the course of the year prior to the lockdown, and then compare this to the period of lockdown and following months.
Sohaib Ashraf
To measure the effect of Ivermectin (sub-cutaneous) with or without zinc in treating the COVID-19 patients to clear viral load of SARS-CoV-2 along with reduction in severity of symptoms and length of hospitalization of patients with COVID-19.
University of Sao Paulo
The aim of this work is to conduct a randomized, double-blind, placebo-controlled clinical trial to assess the efficacy and safety of cannabidiol (CBD - 300 mg a day) in patients infected with SARS-CoV-2. The specific objectives are to assess whether, in patients with mild and moderate forms of SARS-CoV-2, daily use of CBD 300 mg for fourteen days is capable of: i) decrease viral load; ii) modify inflammatory parameters, such as cytokines, measured from serum; iii) reduce clinical and emotional symptoms through daily clinical evaluation; iv) improve sleep; v) reduce hospitalization and worsen the severity of the disease; v) Monitor the possible adverse effects of CBD use in these patients.
University of Lagos, Nigeria
Background: Coronavirus (CoViD-19) positive stroke survivors (SSv) with comorbidities faces possibility for mortality. Study reports success of physiotherapy in CoViD-19 positive SSv with multiple comorbidities. Methods: This clinical controlled study involve a minimum of 30 SSv and 30 age and sex-matched non-stroke individuals with multiple comorbidities with CoViD-19 status confirmed using Real-Time Quantitative-Polymerase Chain Reaction. The Cycle Threshold (CT) and nucleic acid content in the test sample (NA) will be recorded from the virology test results. Their exercise endurance, exercise capacities and quality of life will be assessed using 3-minutes' walk test and 3-meters test and Stroke Specific Quality of Life Questionnaire. Measurements will be taken at every three days intervals from admission to discharge from hospital-isolation. They will receive their normal treatments for CoViD-19 in addition to daily Physiotherapy for the SSv delivered through E-Platform. the Zoom and the WhatsApp video platforms will be used for the interactions between the physiotherapists and the participants. A pre-tested exercise protocol for stroke patients developed by the Stroke and Nervous System Disorders research group of the University of Lagos, Nigeria will be used for the E-exercises. The exercise package will be loaded into the phones of the participants at hospital admission. The Physiotherapists will lead in the exercises through video interaction will the participants watches the video programme. Their risks for respiratory complications (RC), ventilation (RV) and death (RD) will be analysed. Data will be analysed using independent t-test, Analysis of Co-Variance, and multivariate retrogression, survival analyses, Friedman Analysis of Variance and MannWithney U test (95% Confident Interval). Anticipated Outcomes: It is anticipated that the outcome of this study will provide evidence for inclusion of Physiotherapy in the acute management of individuals tested positive for CoViD-19 most important for the stroke survivors tested positive for CoViD-19 at acute stage to reduce the odds of developing complications expedite discharge and reduce odd of death.
SAb Biotherapeutics, Inc.
: Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). SAB Biotherapeutics has developed SAB-185, an Anti-SARS-CoV-2 Human Immunoglobulin Intravenous (transchromosomic [Tc] bovine-derived), as a potential therapeutic to treat COVID-19. This study will evaluate the safety, immunogenicity, and pharmacokinetics of SAB-185 in ambulatory participants with COVID-19.