- 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 159Nordsjaellands 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.
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.
University of Milano Bicocca
Conditions: SARS-COV2
This is an observational study. The aim is to describe the natural history and clinicalevolution over time of hospitalized patients affected by Severe Acute RespiratorySyndrome-Coronavirus-2 (SARS-COV-2) infection, including the genetic pathology of thedisease and improve therapeutic procedures.
Poudre Valley Health System
Conditions: COVID-19
A pilot study to investigate the effects of the prone positioning (PP) on hospitalpatients diagnosed with COVID-19 pneumonia.Investigators that early self-proning may prevent intubation and improve mortality inpatients with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2).Up to 100 participants with a primary diagnosis of confirmed COVID-19 pneumonia will beenrolled to the study.All participants will be screened and those that meet inclusion and exclusion criteriawill be enrolled to one of two groups: one with prone positioning (on the belly) and theother with standard supine positioning (on the back). The patient and nursing staff willmonitor times spent in various positions.Outcome measures include incidence of intubation, max oxygen requirements, length ofhospital stay, ventilator-free days, worsening of oxygenation saturation, and mortality.
Karolinska Institutet
Conditions: COVID-19
In this study we cross-reference several nationwide high-quality Swedish registers inorder to study risk factors for severe Covid-19 outcomes.
University Hospital, Grenoble
Conditions: COVID-19
The current project is a prospective, multicentric cohort study aiming at amultidisciplinary assessment (pulmonary, cardiometabolic, sleep and mental health) of theconsequences of infection by SARS-CoV-2, 3 months after the diagnosis in order to bettercharacterize these complications. 400 patients with a positive diagnosis of SARS-CoV-2will be included in the study 3 months after their diagnosis: They will be followed at 6months, 1 year, 3 years, and 5 years, as function of their after-effects discovered at 3months and their evolution.
University of Toronto
Conditions: COVID
The Açaí trial will be testing if the açaí berry extract, a safe natural product withanti-inflammatory properties, can be used as a treatment option in adult patients withCOVID-19 in the community.
Hellenic Cooperative Oncology Group
Conditions: Head and Neck Cancer, COVID19
To develop an International registry on head and neck cancer patients infected withCOVID-19
Longeveron Inc.
Conditions: ARDS, Human, COVID19
A Phase I, double- blinded, randomized, placebo- controlled study to test the safety ofLomecel-B in Adults suffering from mild to severe acute respiratory distress syndrome(ARDS) due to COVID-19 resultant from 2019-nCoV coronavirus infection, or resultant frominfluenza virus infection.
VA Office of Research and Development
Conditions: COVID-19, Chronic Lung Diseases
This is study is comprised of three approaches. First, the investigators will conduct aretrospective cohort study to determine factors associated with COVID-19 severity andcomplications and understand COVID-19 outcomes, including all-cause mortality,post-discharge events, and impacts of rehabilitation services (third aim). The second aimis a mixed-method study and follows COVID-19 patients with repeated surveys to determinepatient-reported functional outcomes, health recovery, and rehabilitation needs afterCOVID-19. The investigators will recruit patients and their informal caregivers forinterviews to assess their function and rehabilitation needs.