- 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 240 of 530University of Oxford
Conditions: Coronavirus
A phase 2/3 study to determine the efficacy, safety and immunogenicity of the candidateCoronavirus Disease (COVID-19) vaccine ChAdOx1 nCoV-19 in healthy UK volunteers.
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions: Coronavirus Disease 2019
Background:COVID-19 is an acute respiratory syndrome. One symptom of COVID-19 is a reduction in thenumber of cells called lymphocytes in the blood. Lymphocytes are a type of white bloodcell that fights infections. With fewer lymphocytes, the body cannot effectively fightback against SARS CoV-2, the virus that causes COVID-19. Researchers want to betterunderstand how SARS-CoV-2 affects these blood cells. This information may give them ideasfor new treatments.Objective:To learn more about how SARS-CoV-2 affects lymphocytes, the immune, and the bloodclotting system.Eligibility:Adults age 18 and older who either currently have COVID-19 or have recently recoveredfrom itDesign:Participants will give a blood sample. For this, a needle is used to collect blood froman arm vein. For participants who have a central line, blood will be collected throughthat instead.Participants medical records related to COVID-19 will be reviewed.Participants who have recovered from COVID-19 will be asked to undergo leukapheresis tocollect white blood cells. For this, blood is taken from a needle placed in one arm. Amachine separates out the white blood cells. The rest of the blood is returned to theparticipant through a needle placed in the other arm. This takes about 2-3 hours.Recovered participants may have material collected from inside the nostrils and/orrectum. This is done by gently rubbing the area with a sterile cotton swab.Recovered participants may have an echocardiogram to look at their heart. For this, asmall probe is held against the chest to get pictures of the heart from different angles.This takes less than 30 minutes.Participation lasts 1-2 days on most cases and may be split in a few visits for recoveredpatients if leukapheresis and echocardiogram are done....
Centre Hospitalier Universitaire de Nice
Conditions: COVID, ARDS, Quality of Life
Many of the patients hospitalized for a severe form of SARSCoV-2 respiratory impairmentrequire prolonged intensive care that can be complicated in the short term, In the mediumand long term, physical and psychological sequelae can affect patients' quality of lifeand prevent a return to normal working life.To date, there is little data on the fate of patients treated in Resuscitation for asevere form of COVID-19, both in terms of respiratory sequelae, as well as in terms ofpsychological sequelae and their quality of life. The objective of this study is to beable to describe and evaluate the possible physical and psychological sequelae andquality of life of patients hospitalized in Resuscitation for a severe form of COVID-19in the short (3 and 6 months), medium (1 year) and long (5 years) End of their stay inICU. To do this, we want to carry out a prospective, observational and monocentric studyin the consultation department of the Nice CHU. All patients admitted to Resuscitationfor a severe form of COVID-19 who have accepted the longitudinal medical follow-upproposed by the Nice CHU will be included in the study and data from the computerizedmedical record will be analyzed.
Sanofi
Conditions: Neoplasm Malignant
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
Medical University of Graz
Conditions: COVID
We hypothesize that the intake of Omni-Biotic® 10 AAD can reduce intestinal inflammationand improves dysbiosis in Covid-19 disease. We further hypothesize that Omni-Biotic® 10AAD can reduce the duration of diarrhea, stool frequency, improve stool consistency,improve other gastrointestinal symptoms of Covid-19, reduce disease duration andseverity.The investigators aim to perform a randomized, double blind, placebo-controlled studyusing telemedicine in patients with Covid-19 disease.
Farmoquimica S.A.
Conditions: COVID19
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.
Canadian Cancer Trials Group
Conditions: Cancer, COVID-19
The purpose of this study is to find out if immunization with IMM-101 will reduce theincidence of severe respiratory and COVID-19 infections in cancer patients.
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Conditions: COVID 19, Inflammatory Status
During the current pandemic, in Italy the majority of asymptomatic or pauci-symptomaticCOVID-19 cases were not identified nor diagnosed and this fact caused a decrease in theeffectiveness of the various containment measures implemented. Therefore, in a futurescenario where a new viral swarm is expected, the early identification of all infectedcases becomes essential to plan and activate a containment strategy for the spread of thevirus, given the current absence of vaccines.The typical radiological finding of COVID-19 is an interstitial pneumonia, which can beresponsible, in a significant portion of patients, of an acute respiratory distresssyndrome (ARDS).Low-dose chest CT and simple blood tests could identify sub-solid pulmonary nodules(SSNs) indicative of COVID-19 infection in asymptomatic subjects.Objectives of this observational study are the early detection of COVID-19 markersindicative of prior exposure or persisting viral infection in asymptomatic subjects andthe assessment of the frequency and outcome of COVID-19-related SSNs in asymptomaticsubjects by time, domicile, and other individual risk factors.SMILE lung CT screening program cohort has been considered, based on 960 subjects at highlung cancer risk for tobacco smoking (≥20 pack/year) and age (50-75 years), together withinflammatory and respiratory profile. SMILE utilizes a top technology dual-source CTscanner (Somatom Force) with the lowest radiation dose ever applied to lung screening.All chest CT images from screening subjects will be re-evaluated by two additional CADprograms, specifically designed for the analysis of SSNs and quantification of the totalvolume of lung parenchyma showing an increased density. This re-evaluation will improvethe sensitivity and specificity of radiomic assessment.This study cohort, enriched by the already established longitudinal biobank of frozenplasma samples, represent an ideal opportunity to assess the frequency of SSNs inasymptomatic subjects, due to the effect of COVID-19, particularly among subjects livingin areas at high risk of viral exposure. It will also be possible to evaluate ifCOVID-19-related SSNs are associated with chronic co-morbidity, other individual riskfactors, inflammatory (CRP) / immunomodulatory (25(OH)D) blood profile, and/or can betraced by immune markers such as IgM/IgG and other cytokines.Clinical data will be integrated with an analysis of the IgG-IgM profile specific forcovid-19, on the plasma samples taken at the time of the CT scan, or subsequently, incollaboration with University of Milan, Luigi Devoto Work Clinic.The lasting collaboration with the Radiological Science Department of the University ofParma in lung screening also offers the opportunity to validate the results obtained inthis cohort on chest CT performed at the University Parma Hospital during the last twomonths in symptomatic subjects for suspected covid-19 pneumonia.In collaboration with University of Milano Bicocca, Machine Learning (ML) tools will beapplied to predict the clinical relevance, severity and ultimate outcome of SSNs, basedon radiomic CT features, epidemiologic risk, co-morbidity and inflammatory/immune bloodbiomarkers. ML analysis will generate a predictive algorithm for clinical outcome ofSSNs, and specifically the risk of COV-I9 infection and unfavorable disease prognosis.
Sheba Medical Center
Conditions: COVID 19
The aim of this preliminary study is to describe the potential decline in forcedexpiratory volume in 1 second (FEV1) or forced vital capacity (FVC) as measured by homespirometry in high-risk subjects infected with COVID-19. We hypothesize that themagnitude of such a decline in FEV1 and/or FVC may be associated with clinicaldeterioration and hospitalization. The study will ultimately inform a larger subsequentRCT that will evaluate the efficacy of home spirometry in the early detection (prerespiratory symptoms) of respiratory complications and therefore prompt early medicalattention which is a key for improving outcome.
National Cancer Institute (NCI)
Conditions: Pneumonia, Severe Acute Respiratory Syndrome, Symptomatic COVID-19 Infection Laboratory-Confirmed
This phase III trial compares low dose whole lung radiation therapy to best supportivecare plus physicians choice in treating patients with COVID-19 infection. Low dose wholelung radiation therapy may work better than the current best supportive care andphysician's choice in improving patients' clinical status, the radiographic appearance oftheir lungs, or their laboratory blood tests.