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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.
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 143Columbia University
Conditions: COVID-19, Corona Virus Infection, SARS-CoV 2
The 2019-2020 COVID-19 pandemic is the largest outbreak in recent history. It is notknown how long after someone gets sick with COVID-19 and recovers that they can stillinfect other people. It is also not known how quickly people make antibodies against thevirus, which help clear infection from the body. The investigators will enroll 300 peoplewho had COVID-19 based on lab testing or confirmed exposure to participate. An additional25 participants who have never tested positive for COVID and have not had the vaccinewill be enrolled as negative controls. Participants will complete a survey at enrollment.The investigators will also collect blood, nose swab, saliva, stool, semen, and breastmilk to test for the virus. The investigators will ask participants to complete a surveyand give specimens up to 12 times over 24 months. This information will be used to studyhow long the virus can live in different parts of the body, antibody development, andpost-infectious complications. The investigators hope that this information will allowmedical and public health providers to make recommendations to better care for patientsin the convalescent phase of COVID-19 infection.
Imagine Institute
Conditions: Covid-19 Infection
To perform comprehensive cardiac and thoracic non invasive imaging assessment by MRIand/or CT scan including cardiac functional evaluation and myocardial tissuecharacterization of COVID_19 related disease in pediatric patients with cardiacinvolvement.
Chinese University of Hong Kong
Conditions: COVID-19
The objectives of this proposal are to: 1) determine the rate of SARS-CoV-2seroconversion in unselected pregnant women in Hong Kong; 2) determine the rate ofSARS-CoV-2 infection in women presenting with miscarriage and stillbirth; 3) follow thepregnancy course and perinatal outcome of confirmed COVID-19-infected pregnant cases; 4)determine the risk and characteristics of vertical transmission; and 5) evaluate theplacental barrier, immune response and fetal damage in vertical transmission ofSARS-CoV-2. A series of longitudinal and cross-sectional observational studies, and alaboratory-based study will be conducted to fulfil the 5 objectives.
Ohio State University Comprehensive Cancer Center
Conditions: COVID-19
Low doses of radiation in the form of chest X-rays have been used to treat people withpneumonia. This treatment was found to be effective by reducing inflammation and withminimal side effects. However, it was an expensive treatment and was eventually replacedwith less costly treatments such as antibiotics. Radiation has also been shown in someanimal experiments to reduce some types of inflammation.Some patients diagnosed with COVID-19 pneumonia will experience worsening disease, whichcan become very serious, requiring the use of a ventilator. This is caused byinflammation in the lung from the virus and the immune system. For this study, the x-raygiven is called radiation therapy. Radiation therapy uses high-energy X-ray beams from alarge machine to target the lungs and reduce inflammation. Usually, it is given at muchhigher doses to treat cancers.The purpose of this study is to find out if adding a single treatment of low-dose x-raysto the lungs might reduce the amount of inflammation in the lungs from a COVID-19infection, which could help a patient to breathe without use of a ventilator.
Centre Hospitalier Universitaire de Nice
Conditions: Coronavirus Infections
This is a prospective observational cohort study that will define the prevalence andincidence of CA-SARS-Cov2 infection using serological and PCR tests in a group ofsubjects during deconfinement. The team wishes to include approximately 1000 subjects inthis study.The health crisis through containment has also created unprecedented environmentalconditions with the very clear decrease in economic activities and a consequent decreasein exposure to the main air pollutants. The aim is therefore to carry out a case-controlstudy in which each subject will be his or her own control in unexposed condition (toPM2.5, PM10, NO...) then exposed (after the recovery of economic activity and the usuallevels of air pollutants) and to measure the impact of these pollutants on the immunesystem and epigenetic markers taking into account seasonality.The occurrence of infectious, cardiovascular, allergic and autoimmune events will then bemeasured according to the immunological profiles measured at inclusion.
Nordsjaellands Hospital
Conditions: COVID-19, Health Personnel, Personnel, Hospital
The aim of this study is to apply serology testing methods for SARS-CoV2 antibodies insamples collected from HCWs in an acute hospital. This will enable the identification ofthose who are protected and non-infectious for SARS-CoV2 and those who are seronegativeand therefore potentially susceptible and infectious on patient contact. Prospectivetesting will provide data on the acquisition of SARS-CoV2 infections among HCWs andassociated risk factors for transmission during a pandemic at an acute care hospitalfacility in the capital region of Denmark.Hypothesis: Serial seroconversion measurements in hospital employees improve theorganization of the clinical treatment and care during the COVID-19 pandemic atNordsjællands Hospital and Nykøbing Falster County Hospital.
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.
Cambridge University Hospitals NHS Foundation Trust
Conditions: Lower Respiratory Tract Infection, Ventilator Associated Pneumonia, COVID19
Lower Respiratory Tract infections are a common cause of admission to the intensive careunit. Children routinely receive antibiotics until the tests confirm whether theinfection is bacterial or viral. The exclusion of bacterial infection may take 48 hoursor longer for culture tests on biological samples to be completed. In many cases, theresults may be inconclusive or negative if the patient has already received antibioticsprior to the sample being taken.A rapid assay to detect the most likely cause of infection could improve the speed withwhich antibiotic therapy is rationalised or curtailed.This study aims to assess whether a new genetic testing kit which can identify thepresence of bacteria and viruses within hours rather than days is a feasible tool inimproving antibiotic prescribing and rationalisation of therapy in critically illchildren with suspected lower respiratory tract infection.
Sunnybrook Health Sciences Centre
Conditions: COVID19, Hypoxic Respiratory Failure
Patients suffering lung failure, possibly from COVID-19 or hypoxic lung failure, willneed life-saving support from a breathing machine. Any patient needing this supportrequires drugs to keep them sleepy, or "sedated" to be comfortable on this machine.Sedation is made possible by using drugs given through a vein. Unfortunately, these drugsare in short supply worldwide due to the high number of COVID-19 patients needing thesemachines.Another way to provide sleep is by using gases that are breathed in. These are used everyday in operating rooms to perform surgery. These gases, also called "inhaled agents" canalso be used in intensive care units and may have several important benefits for patientsand the hospital. Research shows they may reduce swelling in the lung and increase oxygenlevels, which allows patients to recover faster and reduce the time spent on a breathingmachine. In turn, this allows the breathing machine to be used again for the next sickpatient. These drugs may also increase the number of patients who live through theirillness. Inhaled agents are widely available and their use could dramatically lesson thepressure on limited drug supplies.This research is a study being carried out in a number of hospitals that will compare howwell patients recover from these illnesses depending on which type of sedation drug theyreceive. The plan is to evaluate the number who survive, their time spent on a breathingmachine and time in the hospital. This study may show immediate benefits and may providea cost effective and practical solution to the current challenges caring for patients andthe hospital space, equipment and drugs to the greatest benefit. Furthermore, the studywill be investigating inflammatory profile and neuro-cognitive profiles in ventilatedpatients. Finally, this trial will be a team of experts in sedation drugs who care forpatients with proven or suspected COVID-19 who need lifesaving treatments.
Instituto Brasileiro de Osteopatia
Conditions: COVID19, SARS-CoV-2 Infection
Background: Fatigue is among the most common symptoms of the long-term effects ofcoronavirus (long COVID). This study aims to compare the effectiveness of osteopathicmanipulative treatment (OMT) combined with physiotherapy treatment (PT) compared to PTalone on fatigue and functional limitations after two months post randomization in adultswith long COVID.Methods: This is a study protocol for a two-arm, assessor-blinded, pragmatic randomizedcontrolled superiority trial. Seventy-six participants will be randomly allocated toOMT+PT or PT. The PT includes usual care interventions including motor and respiratoryexercises targeting cardiorespiratory and skeletal muscle functions. The OMT entailsdirect, indirect, visceral, and cranial techniques. Patients will be evaluated before andafter a 2-month intervention program, and at 3-month follow-up session. Primaryobjectives comprise fatigue and functional limitations at 2-month post randomization asassessed by the fatigue severity scale and the Post-COVID Functional State scale.Secondary objectives comprise fatigue and functional limitations at 3 months, and theperceived change post-treatment as assessed by the Perceived Change Scale (PCS-patient).