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 440 of 521Meharry 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.
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.
Boston University
Many countries in sub-Saharan Africa are implementing a policy of six-month dispensing of antiretroviral (ARV) medications for HIV. Under the new guidelines, stable patients can receive a six-month supply of ARV medications at once, reducing the number of clinic visits required for medication refills. South Africa is considering this policy but has not yet adopted it and has requested evidence of its feasibility, effectiveness, and costs to the healthcare system and to patients. The decision on whether to implement a six-month dispensing policy has become urgent due to the SARS-Cov-2 epidemic, as clinic visits to refill prescriptions pose COVID-19 transmission risks to both patients and providers. To generate the required evidence, South Africa is implementing a pilot program that will allow for a cluster-randomized evaluation of 6-month dispensing. This protocol is for that evaluation. It aims to provide supporting evidence to inform future policy and procurement decisions by the National Department of Health (NDOH). All interventions will be conducted as part of routine care by Department of Health staff. In the pilot program, the NDOH will randomize 28 clinics in two provinces 1:1 to receive the six month dispensing intervention or continue standard of care, which currently allows for 2-3 month dispensing. The researchers will assess the patient outcomes of six month dispensing, administer a cross-sectional patient questionnaire, conduct semi-structured in-depth interviews with care providers and implementers, and estimate the costs to NDOH and to patients of six month dispensing. A maximum of 150,545 patients will be followed through their medical records and 400 patients and providers will be consented to be interviewed at baseline and after 6 months (total maximum sample size = 150,945).
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.
Hospices Civils de Lyon
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a new coronavirus responsible for the pandemic called coronavirus disease 2019 (COVID-19), which appeared in China in December 2019 and which has spread rapidly around the world. Even if in the vast majority of viral infection results in a mild illness, it can also progress to a severe form with sometimes fatal consequences. Indeed, clinical worsening, between the 7th and 10th days of the onset of symptoms, has been widely described since the start of the pandemic. This manifests itself at the biological level by hyperinflammation (VS, CRP, ferritin), coagulopathy (elevation of D-dimers, sometimes disseminated intravascular coagulation) and cell lysis (CPK, LDH). At the same time, it was observed high levels of pro-inflammatory cytokines (IL-1β, IL-6, TNF-α, IL-18), suggestive of a cytokine storm, and the first studies on therapeutic management targeting these cytokines are currently underway in COVID-19. Such a profile strongly recalls on the one hand the cytokine release syndrome (CRS, observed in CAR-T cell therapy in malignant hematology), and on the other hand the lymphohistiocytic activation syndrome (SALH). Systemic diseases, such as adult Still's disease and its pediatric side, can also be complicated by a cytokine storm, known as macrophagic activation syndrome (SAM, equivalent to secondary SALH). Under all these conditions, IL-1β, IL-18, IFN-γ and IL-6 seem to be key mediators of hyperinflammation. Plasma ferritin is a biological marker of inflammation, long known, associated with various infectious, hematological and immunological conditions. An increase in ferritin levels has in particular been associated with an unfavorable development in certain infections such as influenza and certain authors have moreover shown an association between plasma ferritin and the evolution towards ARDS or death in patients. Its dosage is also used as a diagnostic tool for SAM, and could make it possible to differentiate the latter from severe sepsis in intensive care. Some authors have also noted it as a prognostic factor in Kawasaki disease or CRS. The plasma dosage of ferritin, associated with that of its glycosylated fraction, could therefore be a diagnostic (difference between SAM and severe sepsis in intensive care), prognostic (evolution towards ARDS, mutation in intensive care, mortality) and therapeutic (indication of preemptive treatment with an inhibitor of IL-1 or IL6) in patients infected with SARS-CoV-2. The objective of this study is to retrospectively assess the prognostic value of ferritin and glycosylated ferritin in SARS-CoV-2 infection in hospitalized.