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.
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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 580 of 638Pliant Therapeutics, Inc.
Evaluation of the safety, tolerability, and pharmacokinetics of PLN-74809 in participants with acute respiratory distress syndrome (ARDS) associated with at least severe COVID-19
Washington University School of Medicine
The primary goal of this project is to identify the best messaging and implementation strategies to maximize SARS-CoV-2 testing for children with intellectual and developmental disabilities (IDD) and their teachers to help ensure a safe school environment. Additionally, we will understand nationally the perceptions of COVID-19 and identify facilitators and barriers to help with the adoption of testing in other parts of the US and the necessary strategies to address other mitigation strategies including vaccination.
Henry Ford Health System
The primary objective is to assess and validate the ability of the Beckman Coulter Access COVID-19 IgG and IgM assays to detect immunity in COVID-19 patients in the Henry Ford Hospital Health System.
Centre Hospitalier Universitaire, Amiens
This study aims to determine how long COVID-19 neutralizing antibodies can be detected in an elderly institutionalized population presenting fragility factors. This study also aims to stratify seroconversion by immunological profiles of the elderly patients residing in the EHPAD. This stratification requires the measurement of immunological marker levels already described in immunosenescence and also involved in the development of certain chronic infectious diseases more common in the elderly population. This analysis will enable the investigators to describe an immunological, clinical and biological profile representing a patient who has developed an immunity against COVID 19. It will also help the investigators to understand the different mechanisms leading to a reduced immune response after a potential administration of a vaccine. Finally, it will help describe the immune profiles of elderly residents who presented with non-severe forms of COVID-19.
KCE Belgian Healthcare Knowledge Centre
The principal objective of the CONFIDENT trial is to assess the efficacy of two units (400-500 mL in total) of convalescent plasma, as compared to Standard of Care (SoC), to reduce day-28 mortality in patients with SARS-CoV-2 pneumonia who require mechanical ventilation.
Genentech, Inc.
- There is a knowledge gap associated with the management of patients with COVID-19 lung injury and a laboratory picture compatible with disseminated intravascular coagulation (DIC). Clinical data to date support that COVID-19 is associated with a prothrombotic state that is not simply explained by an influx of more critically ill individuals. - These patients suffer from severe respiratory failure; hypoxemia and ventilator dependence are the primary concerns; ARDS with respiratory failure is frequently the cause of death. Macroscopic and probable microvascular thromboembolic events are a major concern in this population. - When DIC is associated with COVID-19, it predicts a very poor prognosis. - This study will evaluate the clinical efficacy and safety of low-dose IV bolus tenecteplase (TNK) together with anticoagulation compared with control patients on therapeutic anticoagulation alone in hospitalized adults diagnosed with COVID-19 and acute intermediate-risk PE. - Prospective, multicenter, randomized two-arm trial enrolling consecutive patients who meet enrollment criteria. - The study will generate evidence that low-dose TNK together with anticoagulation is beneficial in these patients
Sanofi
Prospective, single center, randomized, open label, parallel group, 2-arm study assessing the clinical benefit in term of enhancement of overall response rate of Isatuximab in combination with CellProtect as compared to Isatuximab for the treatment of patients with newly diagnosed multiple myeloma who are eligible for stem cell transplantation (SCT) as maintenance after SCT.
LumiraDx UK Limited
Performance of the LumiraDx SARS-CoV-2 Ag assay will be assessed by comparison to a reference method.
Jordi Alonso
The aim of the proposed project is to provide a comprehensive assessment of the mental health impact of the ongoing COVID-19 outbreak in Spain. A prospective cohort study of three groups will be conducted: (1) COVID-19 cases or close contacts recently isolated or quarantined; (2) healthcare workers; (3) adult general population. Recruitment through epidemiologic surveillance services, hospitals, primary care centers in 6 Spanish Autonomous Communities (groups 1 & 2) and a random sample of individuals using telephone numbers as the sampling frames(group 3). Web-based surveys or telephone interviews at baseline and 6-month follow-up assess: current living and employment status; COVID-19 infection status; mental health (post-traumatic stress, panic, depression, anxiety, alcohol and substance use, suicidality; services use); psychological functioning; general health status and quality of life. Specific modules focus on isolation or quarantine (group 1) and care for COVID-19 patients (group 2). Short bi-weekly brief follow-up surveys among groups 1 & 2 will provide additional assessment of main outcomes in the two months following baseline assessment.
Galera Therapeutics, Inc.
A Trial of GC4419 in Patients with Critical Illness due to COVID-19