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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 19

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.

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.

Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus, Belarusian State Medical University

Treatment of Covid-19 Associated Pneumonia With Allogenic Pooled Olfactory Mucosa-derived Mesenchymal Stem Cells

Conditions: COVID, COVID-19, Coronavirus, Pneumonia, Pneumonia, Viral, Pneumonia, Interstitial, SARS-COV2

Treatment of patients with Covid-19 associated pneumonia using intravenous injection of allogenic pooled olfactory mucosa-derived mesenchymal stem cells

Providence Health & Services, Center for Outcomes Research and Education, Providence Cancer Center, Earle A. Chiles Research Institute

Hydroxychloroquine in Patients With Newly Diagnosed COVID-19 Compared to Standard of Care

Conditions: COVID-19, Corona Virus Infection, SARS-CoV-2, 2019-nCoV, 2019 Novel Coronavirus

This study will assess the efficacy of hydroxychloroquine in reducing the severity of symptoms in patients with COVID-19

Mazandaran University of Medical Sciences

Investigating Effect of Convalescent Plasma on COVID-19 Patients Outcome: A Clinical Trial

Conditions: Coronavirus Infections

Coronavirus disease 2019 (COVID-19) was recognized as a pandemic on March 11, 2020 by the World Health Organization. The virus that causes COVID-19 (SARS-CoV-2) is easily transmitted through person to person and there is still no specific approach against the disease and mortality rate in severe cases is also significant. Therefore, finding effective treatment for the mortality of these patients is very important. In this study the investigators aim to determine the effect of Convalescent Plasma on COVID-19 patients Outcome through a Clinical Trial

Bursa City Hospital

Do Vitamin D Levels Really Correlated With Disease Severity in COVID-19 Patients?

Conditions: COVID

Blood vitamin D levels may be associated with COVID-19 disease severity, we aimed to find out whether blood 25-hydroxy vitamin D (25(OH)D) levels were correlated with COVID-19 disease severity or noy.

Bandim Health Project

OPV as Potential Protection Against COVID-19

Conditions: Poliovirus Vaccine, Oral, COVID, Mortality, Morbidity, Non-specific Effects of Vaccines

Since the 1960s, studies have shown that oral polio vaccine (OPV) may have beneficial non-specific effects, reducing morbidity and mortality from other infections than polio. Such beneficial non-specific effect have been observed for other live vaccines, including measles, smallpox and BCG vaccine. For BCG, the vaccine for which the mechanism has been studied the most, the effects appear to be mediated through the innate immune system. The COVID-19 pandemic caused by the novel coronavirus SARS-CoV-2 has now caused over 7.1 million cases and >400,000 deaths worldwide. As everywhere else, it is anticipated that in Africa the older part of the population will be at risk of severe COVID-19. OPV is widely used in Africa, but for children. Both polio and coronavirus are positive-strand RNA viruses, therefore it is likely that they may induce and be affected by common innate immune mechanisms. In a randomised trial at the Bandim Health Project in Guinea-Bissau, the investigators will assess the effect of providing OPV vs no vaccine to 3400 persons above 50 years of age. The trial will have the power to test the hypothesis that OPV reduces the combined risk of morbidity admission or death (composite outcome) by at least 28% over the subsequent 6 months.

Chinese Academy of Medical Sciences, West China Second University Hospital, Yunnan Center for Disease Control and Prevention

Safety and Immunogenicity Study of an Inactivated SARS-CoV-2 Vaccine for Preventing Against COVID-19 in People Aged ⩾60 Years

Conditions: COVID-19

This study is a randomized, double-blinded, and placebo-controlled phase Ib/IIb clinical trial of the Inactivated SARS-CoV-2 Vaccine to evaluate the safety and immunogenicity of the vaccine in healthy people aged ⩾60 Years.

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Status

  • Recruiting (356)
  • Not yet recruiting (157)
  • Active, not recruiting (90)
  • (-) Enrolling by invitation (19)
  • Expanded Access (13)
  • Completed (2)
  • Suspended (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)

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