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 60 of 130Australian National University
The Can nebulised HepArin Reduce morTality and time to Extubation in Patients withCOVID-19 Requiring mechanical ventilation Meta-Trial (CHARTER-MT) is a prospectivecollaborative individual patient data analysis of randomised controlled trials and earlyphase studies. Individual studies are being conducted in multiple countries, includingAustralia, Ireland, the USA, and the UK.Mechanically ventilated patients with confirmed or strongly suspected SARS-CoV-2infection, hypoxaemia and an acute pulmonary opacity in at least one lung quadrant onchest X-ray, will be randomised to nebulised heparin 25,000 Units every 6 hours orstandard care (open label studies) or placebo (blinded placebo controlled studies) for upto 10 days while mechanically ventilated. All trials will collect a minimum core dataset.The primary outcome for the meta-trial is ventilator-free days during the first 28 days,defined as being alive and free from mechanical ventilation. Individual studies may haveadditional outcomes.
Quadram Institute Bioscience
This is a longitudinal study in which participants that have been confirmed by a NationalHealth Service (NHS) swab test as COVID-19 positive will be asked to provide faecal andsaliva samples, and complete short health/lifestyle questionnaires at the time ofsampling (referred to as a sample set). The number of sample sets collected from anyparticipant will be dependent on how long the SARS-CoV-2 virus persists within the stool.The investigators aim to collect a minimum of 4 and a maximum of 8 sample sets, and willtarget all COVID-19-positive subjects, with the exception of those severally ill (e.g. inthe intensive care unit (ICU)). The investigators aim to recruit a minimum of 100 and upto 200 participants. To obtain the desired numbers, it may be necessary to continuerecruitment during any further United Kingdom (UK) COVID-19 infection peaks.
LumiraDx UK Limited
Performance of the LumiraDx SARS-CoV-2 Ag assay will be assessed by comparison to areference method.
National Institute on Aging (NIA)
Background:The higher death rate from COVID-19 in the older population is associated with low CD8 Tcell counts in the blood. Researchers want to learn the status of CD8 T cells specific toSARS-CoV-2 and their changes with aging and in COVID-19. This may help to identify whyCOVID-19 is particularly lethal in the elderly and help to create an effective vaccineagainst SARS-CoV-2 in the elderly.Objective:To identify SARS-CoV-2 specific CD8 T cells in humans, and to determine their quantityand quality in people who have recovered from COVID-19.Eligibility:Maryland residents age 18 and older who have tested positive for and recovered fromCOVID-19.Design:Participants will be screened by phone. They must be able to provide a copy of theirpositive COVID-19 test result.Participants will visit the NIA/Clinical Research Unit. The visit will take about 1 hour.Laboratory tests showing a positive COVID-19 result will be verified.Participants vital signs will be checked. This will include blood pressure, temperature,pulse, and respiration. Height and weight will be measured.Participants will have a medical history and medicine review. They will complete aCOVID-19 questionnaire.Participants will have blood drawn. They will give a urine sample.Participants will give a saliva sample. They will rinse their mouth with water. Afterabout 3 minutes, they will let saliva pool in the base of their mouth and then spit intoa sterile container.Participants may be asked if they would be willing to return for optional visits at about4 months and 1 year later. They will repeat the same laboratory sampling performed at thefirst visit....
Castilla-La Mancha Health Service
Clinical Characteristics and Prognostic Factors of Patients With COVID-19 (Coronavirus Disease 2019)
This is a multicenter, non-interventional, retrospective study using data captured in theEHRs (Electronic Health Records) of the participating hospital sites to determine factorsthat predict disease prognosis and outcomes in COVID-19 patients, specifically:Hospitalization/Off-site monitoring, transfer to ICU and/or need for medical mechanicalventilation (both invasive and non- invasive), length of ICU stay, and outcome (cure/hospital discharge, in-hospital death)
University of Chicago
Tocilizumab is an effective treatment for severe coronavirus disease 2019 (Covid-19)pneumonia and related inflammation. Given limited global supplies, clarification of theoptimal tocilizumab dose is critical. We conducted an open-label, randomized, controlledtrial evaluating two different dose levels of tocilizumab in Covid-19 (40mg and 120mg).Randomization was stratified on remdesivir and corticosteroid at enrollment. The primaryoutcome was the time to recovery. The key secondary outcome was 28-day mortality.
Sound Pharmaceuticals, Incorporated
The study is a randomized, double-blind, placebo-controlled, dose escalation,multi-center clinical trial (RCT) of SPI-1005 in adult subjects with positive PCR testfor novel SARS-CoV-2 (nCoV2) and moderate symptoms of COVID-19 disease.
Johns Hopkins University
This is a a randomized double blind placebo controlled Phase 2 trial with a 12 patientlead-in to evaluate safety, prior to full enrollment to an additional 28 patients (for atotal of 40 patients) to assess efficacy of decitabine in the treatment of critically illpatients with COVID-ARDS. The patients will be randomized in a 1:1 ratio to receivestandard of care plus Decitabine or standard of care plus saline based placebo. Theprimary objective is to determine safety and efficacy of decitabine for COVID-19 ARDSbased on clinical improvement on a 6-point clinical scale.
University of Melbourne
An International Multi-Centre Randomised Adaptive Platform Clinical Trial to Assess theClinical, Virological and Immunological Outcomes in Patients with SARS-CoV-2 Infection(COVID-19).
Sound Pharmaceuticals, Incorporated
The study is a randomized, double-blind, placebo-controlled, dose escalation,multi-center clinical trial (RCT) of SPI-1005 in adult subjects with positive PCR testfor novel SARS-CoV-2 (nCoV2) and severe symptoms of COVID-19 disease.