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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Displaying 550 of 622National 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.
Centre Hospitalier Intercommunal Creteil
This study compares the diagnostic performance of a nasopharyngeal swab antigenic test versus the RT-PCR Covid-19 reference test performed with the AllplexTM 2019-nCoV kit (Seegene, South Korea) in symptomatic children presenting at the hospital.
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.
Hunter College of City University of New York
This is a study of validation for diagnostic techniques used on epidemiological control in the COVID-19 pandemic. It will be carried out in accredited public, private and university clinical laboratories of the collaborator institutions of the project based in Tarija, Bolivia. It is designed as a sectional validation study, using samples from specific groups of participants from the municipality of Tarija grouped according to their category with respect to symptoms and viral load of COVID-19. The sample is selected for convenience.
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.
Assistance Publique - Hôpitaux de Paris
The investigators hypothesize that detection of SARS-CoV2 on saliva samples will increase the performance of the screening program compared to the reference strategy (RT-PCR on a nasopharyngeal swab).
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.
Kafrelsheikh University
Investigating the role of 13cis retinoic acid in the treatment of COVID-19 and enhancement of Its spike protein based vaccine efficacy and safety.
University of Sheffield
The healthcare workforce is amongst the most stressed in the United Kingdom (UK). The Coronavirus (COVID-19) health pandemic has increased depression, anxiety, insomnia and distress in this population. Gratitude interventions have been shown to improve wellbeing, alongside reducing risk factors associated with the aforementioned mental health conditions. This online Randomised Control Trial of 219 healthcare staff, will investigate the effects of a gratitude intervention on wellbeing (gratitude, positive affect, happiness) and psychological distress (depression and negative affect). Means of pre- and post-outcome measures of two groups (gratitude journal and control) will be assessed for differences utilising t-tests.