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 90 of 134Sinocelltech Ltd.
The study is a multicenter, adaptive, randomized, double-blinded and placebo-controlledPhase II/III clinical trial. It will be conducted at selected investigational sitesglobally. The study is comprised of 2 parts.
Cold Spring Harbor Laboratory
The overall objective of this study is to evaluate the clinical efficacy of oralfamotidine in symptomatic non-hospitalized patients with confirmed COVID-19. This studyis expected to enroll up to 84 patients with mild to moderate symptoms divided into eachof the two study arms. Clinical outcomes of the two treatment arms will be compared. Thisstudy will be conducted virtually/remotely.
Cardresearch
The COVID-19 pandemic has been characterized by high morbidity and mortality, especiallyin certain subgroups of patients. To date, no treatment has been shown to be effective inpatients with early-onset disease and mild symptoms. Experimental studies havedemonstrated a potential anti-inflammatory role of Fluvoxamine, Fluoxetine, Budesonideand Spirulin Platensis in SARS-CoV-2 infections and observational studies have suggesteda reduced complications in patients with COVID-19 disease.
University of Liverpool
The AGILE platform master protocol allows incorporation of a range of identified andyet-to-be-identified candidates as potential treatments for adults with COVID-19 into thetrial. Candidates will be added into the trial via candidate-specific trial (CST)protocols of this master protocol as appendices. Having one master protocol ensuresdifferent candidates are evaluated in the same consistent manor and opening up new trialsfor new candidates is more efficient. Inclusion of new candidates will be based onpre-clinical data, evidence in the clinical setting and GMP capabilities.
Oslo University Hospital
None of the vaccines approved, or in clinical trials, have so far been tested ontransplanted patients. If they produce an immune response to the Spike protein ofSARS-CoV-2 it is unknown how long the protective immunity will last.Not all immune responses are equal. The investigators will quantify immune cell subsetswith flow and mass cytometry analyses to describe the phenotype of responding immunecells, including specific T cells. If not already established, patient human Leukocyteantigen (HLA) genotypes will be typed.In order to compare the immune responses with healthy individuals a control group ofhospital employees will be included and sampled before and after vaccination according tothe same time schedules as the kidney transplanted patients.
National Institute on Aging (NIA)
The proposed trial will obtain preliminary data on the feasibility of studying RTB101 ascompared to placebo for COVID-19 post-exposure prophylaxis in adults age ≥ 65 years toinform the design of a subsequent pivotal trial.
GeneOne Life Science, Inc.
This clinical trial will evaluate the safety, tolerability and efficacy of GLS-1027 inthe prevention of severe pneumonitis caused by SARS-CoV-2 infection
Pregistry
The objective of the COVID-19 International Drug Pregnancy Registry (COVID-PR) is toevaluate obstetric, neonatal, and infant outcomes among women treated with monoclonalantibodies or antiviral drugs indicated for mild, moderate, or severe COVID-19 from thefirst day of the last menstrual period (LMP) to end of pregnancy. For monoclonalantibodies, the exposure period also includes 90 days prior to the first day of the LMP.
Farmoquimica S.A.
This is a pivotal phase III study to evaluate the efficacy of nitazoxanide 600 mg BIDcompared to placebo to treat hospitalized patients with non-critical COVID-19.
Sanofi
Primary Objective:To determine the maximum tolerated dose (MTD) of SAR442257 administered as a single agentin patients with relapsed and refractory multiple myeloma (RRMM) and relapsed andrefractory non-Hodgkin lymphoma (RR-NHL), and determine the recommended Phase 2 dose(RP2D)Secondary Objectives: - To characterize the safety profile of SAR442257 - To characterize the pharmacokinetics (PK) profile of SAR442257 - To assess preliminary evidence of antitumor activity