- About
-
Projects
-
Column 1
- Advancing Regulatory Science
- Animal Health & Veterinary Medicine
- Expanded Access
- FDA Patient Listening Sessions
-
Column 2
- Food & Nutrition
- Improving Access to FDA Information
- Research
- Substance Use Disorders
-
Column 1
- News and Events
- Expanded Access eRequest
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.
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.
Search Tips
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 80 of 134Regeneron Pharmaceuticals
Conditions: Chronic Obstructive Pulmonary Disease
Primary Objective:Primary population (former smokers cohort): - Evaluate the efficacy of itepekimab compared with placebo on the annualized rate of acute moderate-or-severe COPD exacerbations in former smokers with moderate-to-severe COPDSecondary Objectives:Primary population (former smokers cohort): - Evaluate the efficacy of itepekimab compared with placebo on pulmonary function in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on occurrence of acute exacerbation of COPD (AECOPD) in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on severe AECOPD in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on corticosteroid-treated AECOPD in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on respiratory symptoms in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on Forced Expiratory Volume in 1 second (FEV1) slope in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on health-related quality of life (HRQoL) as assessed by St. George's Respiratory Questionnaire (SGRQ) in former smokers with moderate-to-severe COPD - Evaluate the safety and tolerability of itepekimab in former smokers with moderate-to-severe COPD - Evaluate the pharmacokinetic (PK) profile of itepekimab in former smokers with moderate-to-severe COPD - Evaluate immunogenicity to itepekimab in former smokers with moderate-to-severe COPDSecondary population (current smokers cohort) - Estimate the efficacy of itepekimab compared with placebo on the annualized rate of acute moderate or severe COPD exacerbations in current smokers with moderate-to-severe COPD - Estimate the efficacy of itepekimab compared with placebo on pulmonary function in current smokers with moderate-to-severe COPD - Estimate the safety and tolerability of itepekimab in current smokers with moderate-to-severe COPD - Estimate the PK profile of itepekimab in current smokers with moderate to severe COPD - Estimate immunogenicity to itepekimab in current smokers with moderate-to-severe COPD
Oslo University Hospital
Conditions: Kidney Transplant Infection, SARS-CoV Infection
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.
University of Liverpool
Conditions: COVID19
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.
Kafrelsheikh University
Conditions: Covid19 Vaccine
Investigating the role of 13cis retinoic acid in the treatment of COVID-19 andenhancement of Its spike protein based vaccine efficacy and safety.
Cardresearch
Conditions: COVID19, SARS-Associated Coronavirus
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 Minnesota
Conditions: COVID19, SARS-CoV Infection, ARDS, ARDS, Human
Acute treatment of COVID-ARDS with direct topical lung instilled T3 therapy for patientson mechanical ventilation.
Cold Spring Harbor Laboratory
Conditions: COVID-19
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.
Bahçeşehir University
Conditions: COVID-19, SARS-CoV-2
Small molecule inhibitors have previously been investigated in different studies aspossible therapeutics in the treatment of SARS-CoV-2. In the current drug repurposingstudy, the investigators identified the leukotriene (D4) receptor antagonist Montelukastas a novel agent that simultaneously targets two important drug targets of SARS-CoV-2.The investigators initially demonstrated the dual inhibition (main protease andSpike/ACE2) profile of Montelukast through multiscale molecular modeling studies. Next,the investigators characterized its effect on both targets by different in vitroexperiments including the Fluorescent Resonance Energy Transfer (FRET)-based mainprotease enzyme inhibition assay, surface plasmon resonance (SPR) spectroscopy,pseudovirus neutralization on HEK293T / hACE2, and virus neutralization assay usingxCELLigence MP real time cell analyzer.
Genexine, Inc.
Conditions: SARS-CoV-2
The objective of our study is to evaluate safety, tolerability, and immunogenicity ofCOVID-19 preventive DNA vaccine in healthy volunteers.
Sinocelltech Ltd.
Conditions: COVID-19, SARS-CoV-2
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.