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 990 of 1281Assistance Publique - Hôpitaux de Paris
The purpose of this case-control study is to assess the association of the current and former consumption of tobacco and nicotine in the risk of acquisition of severe acute respiratory syndrome 2 (SARS-CoV-2). the investigators will send a structured interview by mail regarding use of tobacco and nicotine to 2500 healthcare workers (1250 cases with a positive Real Time Polymorphism Chain Reaction (RT-PCR) and 1250 controls with a negative PCR) who were tested in Paris for in March and April, 2020. OR will be estimated by conditional logistic regression modelling with matching for sex and age.
National Institute of Allergy and Infectious Diseases (NIAID)
This is a platform trial to conduct a series of randomized, double-blind, placebo-controlled trials using common assessments and endpoints in hospitalized adults diagnosed with Coronavirus Disease 2019 (COVID-19). Big Effect Trial (BET) is a proof-of-concept study with the intent of identifying promising treatments to enter a more definitive study. The study will be conducted in up to 70 domestic sites and 5 international sites. The study will compare different investigational therapeutic agents to a common control arm and determine which have relatively large effects. In order to maintain the double blind, each intervention will have a matched placebo. However, the control arm will be shared between interventions and may include participants receiving the matched placebo for a different intervention. The goal is not to determine clear statistical significance for an intervention, but rather to determine which products have clinical data suggestive of efficacy and should be moved quickly into larger studies. Estimates produced from BET will provide an improved basis for designing the larger trial, in terms of sample size and endpoint selection. Products with little indication of efficacy will be dropped on the basis of interim evaluations. In addition, some interventions may be discontinued on the basis of interim futility or efficacy analyses. One or more interventions may be started at any time. The number of interventions enrolling are programmatic decisions and will be based on the number of sites and the pace of enrollment. At the time of enrollment, subjects will be randomized to receive any one of the active arms they are eligible for or placebo. Approximately 200 (100 treatment and 100 shared placebo) subjects will be assigned to each arm entering the platform and a given site will generally have no more than 3 interventions at once. The BET-B stage will evaluate the combination of remdesivir with lenzilumab vs remdesivir with a lenzilumab placebo. The primary objective is to evaluate the clinical efficacy of different investigational therapeutics relative to the control arm in adults hospitalized with COVID-19 according to clinical status (8-point ordinal scale) at Day 8.
National Institute of Allergy and Infectious Diseases (NIAID)
This is a platform trial to conduct a series of randomized, double-blind, placebo-controlled trials using common assessments and endpoints in hospitalized adults diagnosed with Coronavirus Disease 2019 (COVID-19). Big Effect Trial (BET) is a proof-of-concept study with the intent of identifying promising treatments to enter a more definitive study. The study will be conducted in up to 70 domestic sites and 5 international sites. The study will compare different investigational therapeutic agents to a common control arm and determine which have relatively large effects. In order to maintain the double blind, each intervention will have a matched placebo. However, the control arm will be shared between interventions and may include participants receiving the matched placebo for a different intervention. The goal is not to determine clear statistical significance for an intervention, but rather to determine which products have clinical data suggestive of efficacy and should be moved quickly into larger studies. Estimates produced from BET will provide an improved basis for designing the larger trial, in terms of sample size and endpoint selection. Products with little indication of efficacy will be dropped on the basis of interim evaluations. In addition, some interventions may be discontinued on the basis of interim futility or efficacy analyses. One or more interventions may be started at any time. The number of interventions enrolling are programmatic decisions and will be based on the number of sites and the pace of enrollment. At the time of enrollment, subjects will be randomized to receive any one of the active arms they are eligible for or placebo. Approximately 200 (100 treatment and 100 shared placebo) subjects will be assigned to each arm entering the platform and a given site will generally have no more than 3 interventions at once. The BET-A stage will evaluate the combination of remdesivir with risankizumab vs remdesivir with a risankizumab placebo. The primary objective is to evaluate the clinical efficacy of different investigational therapeutics relative to the control arm in adults hospitalized with COVID-19 according to clinical status (8-point ordinal scale) at Day 8.
Hengenix Biotech Inc
A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of HLX71 in Healthy Adult Subjects
Sagent Pharmaceuticals Inc.
This is a randomized, double-blind, placebo-controlled study of camostat mesilate in ambulatory patients with confirmed COVID-19 with at least one risk factor for severe illness.
Ebru Calik Kutukcu
COVID-19 is an emergency situation which broke out from China in 2020. Health commitees and goverment set some rules and limit people's freedom to leave from their houses and it is called as 'social isolation'.Staying at home and disease bring about sedentary lifestyle, anxiety and depression and changed eating habits of all person. Hypertension is an important cardiovasculary risk factor and physical activity, stress managament are very important for disease control. In that study we aimed to assess hypertensive and healthy person's anxiety level, physical activity and qualit of life level during COVID-19 social isolation.
MiNK Therapeutics
A Phase 1/2 study of agenT-797 to treat moderate to severe acute respiratory distress syndrome (ARDS) secondary to acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or influenza.
Gilead Sciences
IMPAACT 2032 was a Phase IV prospective, open label, non-randomized opportunistic study. The objectives of this study were to describe the pharmacokinetic (PK) properties and safety of remdesivir (RDV) administered intravenously as part of clinical care among hospitalized pregnant and non-pregnant women of childbearing potential with coronavirus disease of 2019 (COVID-19). RDV was provided and managed by the participant's treating physician and was not provided as part of this study.
National Center for Complementary and Integrative Health (NCCIH)
This is a randomized clinical trial (RCT) nested within the NIH PETAL Network's COVID cohort study (BLUE CORAL [Biology and Longitudinal Epidemiology: COVID Observational Study]) of patients hospitalized for COVID-19-related illness. COVID-19 patients enrolled in BLUE CORAL with elevated distress symptoms 1 month post-discharge will be randomized to either the Lift mobile app intervention or a usual care control.
Brown University
SARS-CoV-2 vaccine, now being administered to skilled nursing facility (SNF) residents and staff, has highly variable acceptance between facilities. The investigators need to develop and disseminate effective strategies to increase vaccination immediately. For SNF residents and staff, the investigators will develop and implement a scalable multi-pronged intervention that educates, builds trust and supports the informed consent process aimed to increase SARS-CoV-2 vaccination. The investigators will conduct a cluster randomized trial to compare the effect of electronic messaging and education (i.e., usual care) versus a multi-pronged 'high touch' intervention to reduce vaccine hesitancy in skilled nursing facility staff and residents among a random sample of facilities across four SNF chains. As part of the 'high touch' intervention, the investigators will identify and train local opinion leaders. The investigators will offer these leaders assistance through real-time support for questions and provide consenting specialists. During the second wave of vaccination, the investigators will provide the intervention facilities with positive reinforcement for staff and will identify local champions to garner support and empowerment of staff. Finally, in the intervention facilities, the investigators will provide additional funds to support COVID-19 testing, in order that facilities have access to enough testing kits for patient or staff who develops symptoms following vaccination. This trial will be randomized within four SNF chains in order to evaluate the effect of a multi-pronged strategy to improve SARS-CoV-2 vaccine acceptance among direct care staff and long-stay nursing home residents. In four chains, eligible facilities will undergo randomization between usual care versus adding the 'high touch' intervention, implemented in two waves. Randomization and roll out of the intervention will occur at the facility level. The investigators hypothesize that: (1) the intervention will increase vaccination of SNF residents by at least 10 percentage points versus facilities usual care alone; (2) staff of SNFs with the intervention will have at least a 10 percentage point greater vaccine uptake of vaccine than staff in SNFs that do not participate in the high touch intervention; and (3) within intervention SNFs, improvements in vaccine uptake will be similar across staff and resident race/ethnicities.