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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To search this directory, simply type a drug name, condition, company name, location, or other term of your choice into the search bar and click SEARCH. For broadest results, type the terms without quotation marks; to narrow your search to an exact match, put your terms in quotation marks (e.g., “acute respiratory distress syndrome” or “ARDS”). You may opt to further streamline your search by using the Status of the study and Intervention Type options. Simply click one or more of those boxes to refine your search.
Displaying 119 of 119Ottawa Heart Institute Research Corporation
This study is being conducted to study the use and application of a point-of-care (POC)Covid-19 test developed by Spartan BioSciences and recently approved for clinical use byHealth Canada. Phase I of this study will determine the best route for the swabs (nasal,throat, or both), and to determine if this POC test results are comparable to thestandard core-lab test results.
University of Giessen
Acute kidney injury (AKI) has been identified as an independent risk factor forin-hospital mortality. The present study aims to investigate the incidence of AKI andrenal recovery of inpatients diagnosed with COVID-19.
Vanderbilt-Ingram Cancer Center
In this study we will collect granular information on cancer patients infected withCOVID-19, as rapidly as possible. The mechanism for collection of this information is ade-identified centralized registry housed at Vanderbilt University Medical Center, withdata donations from internal and external health care professionals.
Hospices Civils de Lyon
Covid-SER is a prospective multi-center study for the evaluation of diagnosticperformance of available serological tests
Institut National de la Santé Et de la Recherche Médicale, France
Infectious disease is the single biggest cause of death worldwide. New infectious agents,such as the SARS, MERS and other novel coronavirus, novel influenza viruses, virusescausing viral haemorrhagic fever (e.g. Ebola), and viruses that affect the centralnervous system (CNS) such as TBEV & Nipah require investigation to understand pathogenbiology and pathogenesis in the host. Even for known infections, resistance toantimicrobial therapies is widespread, and treatments to control potentially deleterioushost responses are lacking.In order to develop a mechanistic understanding of disease processes, such that riskfactors for severe illness can be identified and treatments can be developed, it isnecessary to understand pathogen characteristics associated with virulence, thereplication dynamics and in-host evolution of the pathogen, the dynamics of the hostresponse, the pharmacology of antimicrobial or host-directed therapies, the transmissiondynamics, and factors underlying individual susceptibility.The work proposed here may require sampling that will not immediately benefit theparticipants. It may also require analysis of the host genome, which may reveal otherinformation about disease susceptibility or other aspects of health status.
Sanofi
Primary Objectives: - Safety run-in Part: To confirm the recommended dose of isatuximab when combined with lenalidomide and dexamethasone in participants with high-risk smoldering multiple myeloma (SMM) - Randomized Phase 3 Part: To demonstrate the clinical benefit of isatuximab in combination with lenalidomide and dexamethasone in the prolongation of progression-free survival when compared to lenalidomide and dexamethasone in subjects with high-risk SMMSecondary Objectives:Safety run-in Part: - To assess overall response rate (ORR) - To assess duration of response (DOR) - To assess minimal residual disease (MRD) negativity in participants achieving very good partial response (VGPR) or complete response (CR) - To assess time to diagnostic (SLiM CRAB) progression or death - To assess time to first-line treatment for multiple myeloma (MM) - To assess the potential immunogenicity of isatuximab - Impact of abnormal chromosomal subtype on participant outcomeRandomized Phase 3 Part:Key Secondary Objectives:To compare between the arms - MRD negativity - Sustained MRD negativity - Second progression-free survival (PFS2) - Overall survivalOther Secondary Objectives:To evaluate in both arms - CR rate - ORR - DOR - Time to diagnostic (SLiM CRAB) progression - Time to biochemical progression - Time to first-line treatment for MM - Impact of abnormal chromosomal subtype on participant outcome - Safety and tolerability - Pharmacokinetics (PK) - Potential of isatuximab immunogenicity - Clinical outcome assessments (COAs)
University of Alabama at Birmingham
The scientific community is in search for novel therapies that can help to face theongoing epidemics of novel Coronavirus (SARS-Cov-2) originated in China in December 2019.At present, there are no proven interventions to prevent progression of the disease. Somepreliminary data on SARS pneumonia suggest that inhaled Nitric Oxide (NO) could havebeneficial effects on SARS-CoV-2 due to the genomic similarities between this twocoronaviruses. In this study we will test whether inhaled NO therapy prevents progressionin patients with mild to moderate COVID-19 disease.
National Cancer Institute, Naples
This study project includes a single-arm phase 2 study and a parallel cohort study,enrolling patients with COVID-19 pneumonia.
University Hospital, Akershus
In the current proposal, the investigators aim to investigate the virological andclinical effects of chloroquine treatment in patients with established COVID-19 in needof hospital admission. Patients will be randomized in a 1:1 fashion to standard of careor standard of care with the addition of therapy with chloroquine.