Skip to main content
Home
  • facebook
  • twitter
  • linkedin
  • youtube
Home
  • Clinical Trials
  • Evidence Accelerator
  • Lessons Learned
  • Vaccines

COVID-19 Clinical Trials and Expanded Access

  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.

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 50 of 129

University Hospitals, Leicester

Novel Face Mask Sampling for COVID-19: A Diagnostic and Public Health Tool

Conditions: COVID19

COVID-19 has become a global problem. There is an urgent need to improve the diagnosisand screening of patients and healthcare workers for COVID-19 in the UK. Mask basedsampling is a method of detecting SARS-COV-2 (the virus responsible for COVID-19) in thebreath of suspected COVID-19 patients or healthcare workers in the mask that they wouldwear in hospital. The investigators have previously demonstrated the utility of thismethod in other respiratory infections, such as tuberculosis.This project aims to investigate the utility of mask-based sampling is a tool for thediagnosis and quantification of COVID-19 in breath and the implications in a healthcaresetting using three cohorts of participants. Initially we will compare the amount ofCOVID-19 detected by mask sampling compared with standard nasopharyngeal swab, which isthe current gold standard test, in patients who present to hospital with COVID-19symptoms.We will address the length of time COVID-19 is breathed out by people affected by thevirus and the how infectious the virus is over time in a cohort of symptomatic healthcareworkers who are isolating at home. This will allow us to understand how long someonestays infectious for and may have the potential to inform public health measures, forinstance when healthcare workers can return to work or duration of isolation. Finally wewill investigate asymptomatic carriage of COVID-19 by different healthcare workers indifferent areas of the hospital during a screening study. This will allow us tounderstand the extent of infection amongst healthcare workers and allow us to addresshospital acquired transmission.

Chinese University of Hong Kong

Coronavirus Disease 2019 (COVID-19) During Pregnancy: Prevalence of Seroconversion, Effect on Maternal and Perinatal Outcomes and Risk of Vertical Transmission (COVID-MAP)

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.

Imagine Institute

Cardiac and Thoracic Imaging in Pediatric Patients With Evidence of Systemic Inflammation COVID19 Linked

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.

Wuhan Union Hospital, China

Study on the Recovery of Pulmonary Function, Chest CT, Airway Microbiota, Hematologic, and Immune & Inflammatory Conditions in COVID-19 Rehabilitation Patients

Conditions: COVID-19

The intent of this study was to examine the health status of individuals who had beenconfirmed with COVID-19 in the year after their recovery. Parameters studied includedserum levels of SARS coronavirus 2 (SARS-CoV 2) IgG antibody, SARS-CoV-2 nucleic acidtest, hematology indicators (blood routine, liver function, kidney function, myocardialenzymes, coagulation function, etc), lung function test, imaging data and airwaymicrobiota data. In addition, we explored the systematic Immune & Inflammation in some ofthe individuals recovering from COVID-19.

Columbia University

Determinants of SARS (Severe Acute Respiratory Syndrome)-COV2 (COVID-19) Persistence After Convalescence

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.

University of Liege

Mesenchymal Stromal Cell Therapy for Severe Covid-19 Infection

Conditions: Coronavirus Infection

The overall objective of the study is to evaluate the safety and efficacy of MSC therapycombined with best supportive care in hospitalized patients with COVID-19.

Universitaire Ziekenhuizen KU Leuven

ANalyzing Olfactory Dysfunction Mechanisms In COVID-19

Conditions: SARS-CoV-2

We aim to understand the mechanism of olfactory dysfunction in COVID-19.

University of South Alabama

Phase 2 Trial Using rhDNase to Reduce Mortality in COVID-19 Patients With Respiratory Failure

Conditions: COVID19

This Phase 2 Randomized Placebo Controlled Trial will determine if administeringnebulized Dornase Alpha (rhDNase) to COVID-19 patients with respiratory failure is safeand will reduce 28-day mortality.

Centre Hospitalier Universitaire, Amiens

Screening for Postpartum Depression and Associated Risk Factors Among Women Who Deliver in Four Hospital in France During the COVID-19 Epidemic

Conditions: Postpartum Depression, COVID19, Prevalence, Social Distance

Postpartum depression (PPD) represent around 15% of birth in developed countries. Thecontext of the COVID-19 epidemy represents a possible source of additional emotionaldistress. The objective of this study is to determine the screening prevalence and riskfactors of postpartum depression, among women who deliver in fourth hospital in the Northof France in the context of the COVID epidemy.

Laval University

MAVIPAN: My Life and the COVID-19 Pandemic

Conditions: Psychosocial Impacts of the COVID-19 Pandemic

The health crisis imposed by COVID-19 is forcing major worldwide social reorganizationthat will have profound consequences on our society. Currently, one-third of the world'spopulation (~3 billion individuals) is living under some kind of isolation or quarantinemeasures, causing an unprecedented and rapidly evolving psychosocial crisis.The psychosocial consequences of this health crisis will persist long after restrictionmeasures are lifted and the pandemic is over. This impact will be significant forindividuals facing unique contexts or challenges (e.g., older adults, individuals livingwith a disability, underprivileged families) and will most likely exacerbate existingsocial and gender inequalities in health and human development.There is an urgent need for information on the evolution of the psychosocial dimensionsof health and coping strategies used by our population and our health and social servicesstructures. Thus, this study is designed to accelerate the availability of high-quality,real-time evidence within health and social services structures to address, support andminimize psychosocial consequences of the COVID-19 pandemic. Through constantly evolvingresearch questions responsive to the course of the pandemic evolution, the rapid systemtransformations and adaptation of services, and knowledge users (KUs) needs, MAVIPAN aimsto address, document, monitor, and evaluate the following: 1. Individuals and families' adjustments and mitigation strategies, especially for those considered vulnerable and in high-risk contexts. 2. Healthcare and social services workers and managers' adjustments and mitigation strategies. 3. The organization of service structures. 4. The social and economic response.To achieve these objectives, we use a mixed methods study design that combinesquantitative questionnaires and qualitative interviews to deepen our understanding ofelements such as the coping strategies used during the pandemic. A first measure wastaken during lock-down as well as a follow-up at 3 months. Another follow-up will be madeat 7 months. At least one per year follow-up will be made over the course of the study (5years). Additional measures may be taken depending on the evolution of the pandemic andthe sanitary measures put in place by the authorities.

Pagination

  • First page « First
  • Previous page ‹‹
  • Page 1
  • Page 2
  • Page 3
  • Page 4
  • Current page 5
  • Page 6
  • Page 7
  • Page 8
  • Page 9
  • …
  • Next page ››
  • Last page Last »

Status

  • (-) Recruiting (129)

Intervention Type

  • Other (48)
  • Drug (19)
  • Biological (14)
  • Behavioral (8)
  • Diagnostic Test (8)
  • Device (4)
  • Dietary Supplement (2)
  • Radiation (2)
  • Genetic (1)

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

Subscribe
(202) 849 - 2075
1333 New Hampshire Ave, NW
Suite 420
Washington, DC 20036
admin@reaganudall.org
  • facebook
  • twitter
  • linkedin
  • youtube

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