Skip to main content
Home
  • facebook
  • twitter
  • linkedin
  • youtube
Home
  • Clinical Trials
  • Companies
  • Evidence Accelerator
  • Resources
    • Diagnostics
    • Medical News
    • Food
    • Veterinary

Clinical Trials and Expanded Access

Breadcrumb

  1. Home

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 64

Saint Francis Care

Convalescent Plasma in the Treatment of COVID 19

Conditions: SARS-CoV-2, COVID, Coronavirus

The purpose of this study is to collect blood from previously COVID-19 infected persons who have recovered and use it as a treatment for those who are currently sick with a severe or life-threatening COVID-19 infection.

The Cleveland Clinic

Coronavirus 2019 (COVID-19)- Using Ascorbic Acid and Zinc Supplementation

Conditions: COVID, Corona Virus Infection

The purpose of this study is to examine the impact of ascorbic acid (vitamin c) and zinc gluconate in reducing duration of symptoms in patients diagnosed with coronavirus disease 2019 (COVID-19). Patients above the age of 18 who present to the Cleveland Clinic outpatient testing and receive a positive test for COVID-19 will be invited to participate.

Stony Brook University

Convalescent Plasma vs. Standard Plasma for COVID-19

Conditions: COVID

The purpose of this study is to find out if transfusion of blood plasma containing antibodies against COVID-19 (anti-SARS-CoV-2), which were donated from a patient who recovered from COVID-19 infection, is safe and can treat COVID-19 in hospitalized patients. Antibodies are blood proteins produced by the body in response to a virus and can remain in the person's bloodstream (plasma) for a long time after they recover. Transferring plasma from a person who recovered from COVID-19 may help neutralize the virus in sick patients' blood, and/or reduce the chances of the infection getting worse.

Boston University

Awake Prone Position for Early Hypoxemia in COVID-19

Conditions: COVID-19

Prone positioning is a well studied and validated treatment for severe acute respiratory distress syndrome (ARDS), however there are no randomized studies on the use of prone positioning in the non-intubated patient. It is unknown if this intervention would be helpful in preventing further respiratory deterioration in terms of increasing supplemental oxygen requirements, endotracheal intubation, and ICU admission. The Awake Prone Position for Early hypoxemia in COVID-19 (APPEX-19) Study is a pragmatic adaptive randomized controlled unblinded trial. APPEX-19 randomizes non-ICU patients with COVID-19 or who are under evaluation for COVID-19 to lie in a prone position (i.e, with their stomach and chest facing down) or to usual care.

University of Rome Tor Vergata

Surgery During Covid-19: The Role of Asymptomatic Patients, a Survey

Conditions: Surgery, COVID, Asymptomatic Patient, COVID-19, Preventive Measures

a brief questionnaire to get a clearer picture of the situation regarding surgical patients with special emphasis on asymptomatic Covid-19 patients.

Stanford University

Oral Favipiravir Compared to Placebo in Subjects With Mild COVID-19

Conditions: SARS-COV2, COVID-19

The objective of this study is to evaluate the efficacy of oral favipiravir plus standard of care treatment (SOC) compared with placebo plus SOC in reducing the duration of shedding of SARS-CoV2 virus in patients with mild or asymptomatic COVID-19.

University of Alberta

IMPACT: IMPact of Antimalarials on Covid-19 Infections in RAPPORT

Conditions: Covid-19 Infection, Rheumatoid Arthritis, Psoriatic Arthritis, Hydroxychloroquine

This study aims to evaluate the experience of Alberta patients with inflammatory arthritis who participate in the the RAPPORT-ONTRAAC registry during the COVID-19 pandemic, specifically comparing the experience of those taking anti-malarial medications compared to those who do not. This registry includes approximately 2500 northern Alberta patients with inflammatory arthritis who receive highly complex therapies which may be associated with side effects. This program of data collection and research has been evaluating the effectiveness and safety as well as associated health care costs of rheumatoid and psoriatic arthritis patients since 2004. The principle investigators are based at the University of Alberta while the co-investigators are academic rheumatologists at the University of Alberta. The registry has approximately 900 patients taking anti-malarials combined with their complex therapies and ~ 1500 not on anti-malarials in combination with their complex therapies. We aim to perform a case control study evaluating the impact of anti-malarial drugs (eg. hydroxychloroquine and chloroquine) on the development of COVID-19 compared to those patients who are not on anti-malarial drugs over the next 6-12 months. In addition to frequent e-mail surveys screening for the clinical symptoms of COVID-19 and understanding their concomitant arthritis medication use, we will compare the healthcare outcomes of both groups of arthritis patients with and without COVID-19 for the duration of the pandemic. This information will provide critical information beyond an anecdotal level on whether or not anti-malarials truly provide a protective benefit against COVID-19 or reduce the severity of infection. A blood sample from all participants (Covid-19 positive and negative) will be drawn approximately six months into the study for measurement of antibodies to Covid-19 and possible blood types and HLA alleles. Additionally, this study will be linked to another study "Persistence of SARS-Cov2 in immunocompromised patients" which will specifically evaluate COVID-19 serology and nasopharyngeal swab findings in the subset of patients who develop COVID-19.

Duke University

Assessing the System for High-Intensity Evaluation During Radiotherapy During Changes in Response to COVID-19

Conditions: COVID-19, Cancer

The primary objective of this research study is to assess Radiation Oncology healthcare providers (i.e. faculty, residents and advanced practice providers (APPs) implementation and perception of telehealth for on treatment patients in lieu of in person on treatment visits during standard of care radiotherapy during COVID-19.

Stanford University, National Heart, Lung, and Blood Institute (NHLBI), Strategies to Innovate EmeRgENcy Care Clinical Trials Network (SIREN) - Network, University of Pittsburgh, Medical University of South Carolina

Convalescent Plasma in Outpatients With COVID-19

Conditions: COVID19

The overarching goal of this project is to confirm or refute the role of passive immunization as a safe and efficacious therapy in preventing the progression from mild to severe/critical COVID-19 illness and to understand the immunologic kinetics of anti-SARS-CoV-2 antibodies after passive immunization.The primary objective is to determine the efficacy and safety of a single dose of convalescent plasma (CP) for preventing the progression from mild to severe COVID-19 illness. The secondary objective is to characterize the immunologic response to CP administration. This study will adults presenting to the emergency department (ED) with mild, symptomatic, laboratory-confirmed COVID-19 illness, who are at high risk for progression to severe/critical illness, but who are clinically stable for outpatient management at randomization.

Michael Runyon, MD

Atrium COVID-19 Syndromic and Serologic Surveillance

Conditions: Coronavirus, COVID

The purpose of this research is to collect information about coronavirus exposures, symptoms, and health care visits due to the among Atrium Health clients and health care workers. Participation in this study will involve completing a daily questionnaire which covers participants coronavirus illness history or symptoms, health care seeking behaviors and treatments, contact with other sick people, and for health care workers, their use of personal protective equipment.

Pagination

  • Current page 1
  • Page 2
  • Page 3
  • Page 4
  • Page 5
  • Page 6
  • Page 7
  • Next page ››
  • Last page Last »

Status

  • Recruiting (994)
  • Not yet recruiting (421)
  • Active, not recruiting (201)
  • (-) Enrolling by invitation (64)
  • Expanded Access (14)
  • Completed (12)
  • Suspended (2)
  • Terminated (1)

Intervention Type

  • (-) Other (48)
  • Drug (28)
  • Behavioral (21)
  • Diagnostic Test (21)
  • (-) Biological (15)
  • Device (10)
  • Procedure (5)
  • (-) Dietary Supplement (4)
  • Combination Product (3)
  • Genetic (1)
  • Radiation (1)

Subscribe for updates from the Reagan-Udall Foundation for the FDA

Subscribe
(202) 849 - 2075
1900 L Street NW, Suite 835
Washington, DC 20036
admin@reaganudall.org
  • facebook
  • twitter
  • linkedin
  • youtube

© Reagan-Udall Foundation for the FDA
© Reagan-Udall Foundation for the FDA