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 517University 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.
Bristol-Myers Squibb
The purpose of this study is to evaluate the efficacy and safety of intravenous abatacept administered to hospitalized COVID-19 participants with respiratory compromise.
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.
The Scripps Research Institute
Clinical specimens are collected from individuals either recovered from or with active SARS-CoV-2 infection to support process and analytical development for a potential cell-based immunotherapy in preclinical research, SRPH-CVD-01. SRPH-CVD-01 is an allogeneic cell-based immunotherapy candidate to be investigated in a subsequent clinical trial under a future FDA IND to treat people suffering from COVID-19. Enrolled participants provide a venous blood specimen (up to 40mL) to be used in preclinical studies and research and development of SRPH-CVD-01. Subjects may eventually be asked to undergo leukapheresis for peripheral blood mononuclear cell (PBMC) collection and their specimens will be used to further develop the SRPH-CVD-01 cell product, including a cGMP compliant process to be applied under the future FDA IND.
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.
Alan Bryce
To determine if the reduction in TMPRSS2 activity via direct inhibition with Camostat mesilate combined with standard of care (SOC) treatment will increase the proportion of patients alive and free from respiratory failure at Day 28 in SARS-CoV-2 as compared to SOC treatment with placebo.
State University of New York at Buffalo
This study is a pilot randomized, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of melatonin in adult outpatients suspected to be afflicted with COVID-19.
Hamad Medical Corporation
SARS-CoV-2 is the novel coronavirus responsible for COVID-19, coronavirus disease 2019. This new coronavirus was first detected in Wuhan, China in late December 2019. According to WHO, the incidence rate of COVID-19 is prominent among adults and elderly people, reaching so far >2 million cases globally. Meanwhile, confirmed death cases reached >126 thousands of reported cases in 185 countries and still increasing. We anticipate that immunological differences among COVID19-infected patients might be a reason behind the variation of patient outcomes. Therefore, we intend to investigate cellular and humoral immune responses of COVID19-positive patients, and we claim to discover new indicators of patients' prognosis. Our target population includes three categories of patients staying at ICU, HMC (COVID19-positive vs. COVID19-negative vs. healthy control). Throughout their ICU stay, multiple blood samples will be screened for leukocytes surface markers, leukocytes' production of certain molecules, and circulating cytokines/chemokines/checkpoint inhibitors. Their plasma/serum will be used as well for immune proteomics, metabolomics, and other serological tests. Such parameters can provide the more comprehensive status of COVID19-infected patients at infection onset, during treatment intake, and at recovery or relapse stage. Following analysis, the main prospective outcome of this study is to identify the most reflective markers of COVID19-positive patients' outcomes.
Hadassah Medical Organization
This is a multi-center study comparing clinical outcomes in patients with COVID-19 in subjects hospitalized at Hadassah and other hospitals for PCR or serology confirmed COVID-19 and compare the outcomes to the presence of different degrees of a cytokine storm. The patients will be subdivided into a mild, moderate, and severe course according to NEWS2.