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 1190 of 1242Assistance 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
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.
University Hospital Tuebingen
This is a prospective, longitudinal study to determine the incidence of SARS-COV-2 infection in children and adolescents by measuring specific antibodies in non-invasive saliva sampled in kindergartens and schools in a defined city area. The study includes an additional arm to validate the ELISA for anti-SARS-COV-2 reactive antibody measurements in saliva compared against blood collected in adult volunteers in a bimonthly follow-up period for 12 months.
Patient-Centered Outcomes Research Institute
The clinical guidance for 90 percent of infected COVID-19 adult patients who do not meet eligibility for inpatient admission is to self-isolate. To support these patients, alternatives to in-person care are needed to manage an unpredictable clinical course; identify and intercept patients rapidly deteriorating at home, prevent viral spread during in-person visits; and minimize future surges in emergency departments (EDs). In addition, fingertip pulse oximeters have been proposed to improve in-home early detection of respiratory deteriorations but are untested and the operational infrastructure to support large-scale monitoring is limited. While telemedicine has been widely adopted during the pandemic as an alternative to conventional outpatient care, limited telemedicine access may be exacerbating observed disparities for Black and Latino patients. In our health system, Black and Latino patients used video-visits 15 percent less often than white patients. Text messaging and phone calls may improve healthcare access for communities of color, but the evidence for these telecommunication modalities to be effective and improve equity are limited. The University of Pennsylvania Health System (UPHS) developed and deployed COVID Watch to improve access to health care for COVID-19 patients who are self-isolating at home. COVID Watch sends twice-daily, scheduled text messages to assess patients for shortness of breath using a clinical algorithm to determine whether patients need an urgent escalation to a team of dedicated, on-call nurses within one hour. These nurses are supported by an on-call team of clinicians who can conduct urgent phone or video assessments. Patients can also trigger the algorithmic assessment independent of the scheduled messages. As of May 21, 2020, COVID Watch has managed 3,628 COVID-19 patients at home, of which 1,295 are confirmed COVID-19 positive; of these, 61 percent are Black or Latino, higher than the proportion of all UPHS COVID-19 positive patients that are Black or Latino (55 percent).
University of Valencia
One of the major problems in suppressing the spreading of an epidemic resides in understanding and monitoring its propagation patterns, and in evaluating how these are modified by enforced policies. The standard solution requires detailed information at the microscopic scales, e.g. how infected people have moved and whom they came in contact with, which is hardly ever available. The researchers propose a novel approach to the study of the propagation of COVID-19, in which a proxy of this information is derived at macroscopic scales. This will be based on two ingredients: the spatiotemporal study in shiny with mathematical models with aggregated or non aggregated data and the reconstruction of functional networks of spreading patterns, and the development of a supporting software.
Health Institutes of Turkey
This study is a randomized, double-blinded, and placebo controlled phase III clinical trial of the SARS-CoV-2 inactivated vaccine manufactured by Sinovac Research & Development Co., Ltd. The purpose of this study is to evaluate the efficacy, safety and immunogenicity of the experimental vaccine in healthy adults aged 18~59 Years.
Imperial College London
The Multi-arm trial of Inflammatory Signal Inhibitors for COVID-19 (MATIS) study is a two-stage, open-label, randomised controlled trial assessing the efficacy of ruxolitinib (RUX) and fostamatinib (FOS) individually, compared to standard of care in the treatment of COVID-19 pneumonia. The primary outcome is the proportion of hospitalised patients progressing from mild or moderate to severe COVID-19 pneumonia. Patients are treated for 14 days and will receive follow-up assessment at 7, 14 and 28 days after the first study dose. Patients with mild or moderate COVID-19 pneumonia will be recruited. Initially, n=171 (57 per arm) patients will be recruited in Stage 1. Following interim analysis to assess the efficacy and safety of the treatments, approximately n=285 (95 per arm) will be recruited during Stage 2.