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Clinical Trials and Expanded Access

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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 10 of 258

Northwestern Medicine

Non-contact ECG Sensor System for COVID19

Conditions: COVID-19

The purpose of this study is two-fold. First we would like to confirm that non-contact ECG provides equivalency to current contact methods of obtaining ECG data. Second we would like to investigate whether non-contact ECG can detect ECG changes prior to the onset symptoms from COVID19.

Peking Union Medical College Hospital

Safety and Effectiveness of Low-flow ECMO Driving by CVVH Machine in Severe NCP

Conditions: COVID-19, ECMO

assess the safety and effectiveness of using low-flow extracorporeal membrane oxygenation(CO2 removal) driving by CVVH machine in the severe NCP patients

The University of Hong Kong

Using Biovitals® Sentinel to Monitor Disease Progression in Subjects Quarantined for Suspected COVID-19

Conditions: COVID19

The novel coronavirus (COVID-19) emerged in December 2019, and in mere months has spread to more than 104 countries, resulting in an outbreak of viral pneumonia worldwide. Current local quarantine policy in Hong Kong for individuals suspected for COVID-19 requires daily self-reported symptomatology and body temperature, given the intermittent nature and the high dependency of self-discipline undermine the practicality of the approach. To date, the advance in sensor technology has made possible to continuously monitor individual physiological parameters using a simple wearable device. Together with the mobile wearable technology that allowing instantaneous, multi-directional, and massive data transfer, remote continuous physiological monitoring is made possible. The Cardiology division, the Univeristy of Hong Kong has been in collaboration with Biofourmis to implement such technology for remote heart failure management. Similar digital therapeutic system can be applied to remotely monitor physiological parameters of large number of quarantined or suspected COVID-19 at home or in quarantine facility. It is purposed to allow the monitoring team to effectively and remotely monitor COVID-19 quarantined and patients, manage and evaluate the disease progression.

Ochsner Health System

Hyperbaric Oxygen Therapy (HBOT) as a Treatment for COVID-19 (COVID-19) Infection

Conditions: COVID-19

Patients who meet inclusion criteria will be randomized into treatment vs control group. Treatment groups will undergo Hyperbaric Oxygen Therapy (HBOT) and compared to the control group.

Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori, AUSL Romagna

Correlative Study on Cancer Patients and Healthcare Professionals Exposed to Infection by Severe Acute Respiratory Syndrome-Corona Virus-2 (SARS-Cov-2), COVID-19 Causative Agent.

Conditions: COVID-19, SARS-CoV-2

Translational, prospective / retrospective, non-profit, non-pharmacological study, with cohort characteristics. The study consists of two parts: the first to study epidemiological aspects of the spread of the disease and the second one to identify infection-related genetic factors.

William Beaumont Hospitals

Beaumont Quantitative Lung Function Imaging to Characterize Patients With SARS-COV 2

Conditions: SARS-COV2, Severe Acute Respiratory Syndrome, COVID-19

The goal of this study is to evaluate if CT (Computerized Tomography) can effectively and accurately predict disease progression in patients with SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2). You may be eligible if you have been diagnosed with SARS-CoV-2, are an inpatient at Beaumont Hospital-Royal Oak and meet eligibility criteria. After consent and determination of eligibility, enrolled patients will have a CT scanning session. After the CT scan, patients are followed for 30 days by reviewing their medical records and by phone after discharge from hospital.

Laval University

Closed-Loop Oxygen to Verify That Healthcare Workers Interventions Decrease During SARS-CoV-2 Pneumonia (COVID-19)

Conditions: Coronavirus, Pneumonia, Oxygen Toxicity

There is a high risk of transmission of COVID-19 to healthcare workers. In a recent cohort, 29% of the patients hospitalized were healthcare workers. Among the WHO's primary strategic objectives for the response to COVID-19, the first was to limit human-to-human transmission, including reducing secondary infections among close contacts and health care workers. Automated oxygen titration, weaning and monitoring (FreeO2 device) may be a solution to reduce the number of interventions of healthcare workers related to oxygen therapy, to reduce complications related to oxygen and to improve monitoring.

Centro Studi Internazionali, Italy, VivaChek Laboratories, Inc.

Clinical Performance of the VivaDiag ™ COVID-19 lgM / IgG Rapid Test in Early Detecting the Infection of COVID-19

Conditions: Coronavirus Infections

This study aim to evaluate the immune response of negative patients during a COVID-19 outbreak. Patients are serially tested with a VivaDiag ™ COVID-19 lgM / IgG Rapid Test to evaluate the immune response in negative patients and the reliability of the test in those patients who develop clinical signs of COVID-19 during the trial.

McMaster University, University of Alberta

Medical Masks vs N95 Respirators for COVID-19

Conditions: Coronavirus, N95, Medical Mask

A randomized controlled trial in which nurses will be randomized to either medical masks or N95 respirators when providing care to patients with COVID-19.

MedStar Georgetown University Hospital, Medstar Health Research Institute

Home Blood Pressure Study for Recent Stroke Survivors With High Blood Pressure *Due to COVID-19 Outbreak in United States the Investigators Have Paused All In-person Enrollment and Will Re-evaluate on May 1st*

Conditions: Ischemic Stroke, Hypertension

The purpose of this pilot study is to assess the feasibility of implementing a home blood pressure self-management program in a population of recent stroke survivors in the Washington, D.C. area. The investigators hypothesize that hypertensive stroke survivors in the Washington, DC area who participate in the Home Blood Pressure Monitoring program will have a greater reduction in mean systolic blood pressure (SBP) from baseline to 3 months, as measured by automated office blood pressure (AOBP), as compared to usual care.

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Status

  • Recruiting (161)
  • Not yet recruiting (67)
  • Active, not recruiting (15)
  • Enrolling by invitation (11)
  • Completed (3)
  • Expanded Access (1)

Intervention Type

  • Drug (1463)
  • Other (1213)
  • Biological (535)
  • Diagnostic Test (415)
  • Behavioral (261)
  • (-) Device (244)
  • Procedure (105)
  • Dietary Supplement (103)
  • Combination Product (42)
  • Radiation (24)
  • (-) Genetic (14)

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© Reagan-Udall Foundation for the FDA