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 2560 of 2588Centre Hospitalier Universitaire de Nice
This is a prospective observational cohort study that will define the prevalence and incidence of CA-SARS-Cov2 infection using serological and PCR tests in a group of subjects during deconfinement. The team wishes to include approximately 1000 subjects in this study. The health crisis through containment has also created unprecedented environmental conditions with the very clear decrease in economic activities and a consequent decrease in exposure to the main air pollutants. The aim is therefore to carry out a case-control study in which each subject will be his or her own control in unexposed condition (to PM2.5, PM10, NO...) then exposed (after the recovery of economic activity and the usual levels of air pollutants) and to measure the impact of these pollutants on the immune system and epigenetic markers taking into account seasonality. The occurrence of infectious, cardiovascular, allergic and autoimmune events will then be measured according to the immunological profiles measured at inclusion.
University of Milano Bicocca
This is an observational study. The aim is to describe the natural history and clinical evolution over time of hospitalized patients affected by Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-COV-2) infection, including the genetic pathology of the disease and improve therapeutic procedures.
Celltex Therapeutics Corporation
This is a phase 2 multi-center, double-blind, randomized, placebo-control clinical trial with 200 subjects who have never been infected by COVID-19 (SARS-Cov-2 virus screen test negative, no blood SARS-Cov-2 IgM and IgG antibodies detected during enrollment) followed by a pilot study of 5 subjects to demonstrate the safety of proposed three-dose regimen of autologous AdMSCs infusions. The 100 study subjects who have previously banked their AdMSCs with Celltex, will receive three doses of autologous AdMSCs (approximately 200 million cells) intravenous infusion every three days. The 100 subjects in the control group who have previously banked their AdMSCs with Celltex will not receive any Celltex's AdMSC therapy but placebo treatments. All subjects are monitored for safety (adverse events/severe adverse events), COVID-19 symptoms, SARS-Cov-2 virus test, blood SARS-Cov-2 IgM and IgG antibodies tests, blood cytokine and inflammatory (CRP, IL_6, IL-10, TNFα) tests and disease severity evaluation for 6 months after the last dose of AdMSC infusion for the study group and 6 months after the enrollment for the control group.
Chinese University of Hong Kong
The objectives of this proposal are to: 1) determine the rate of SARS-CoV-2 seroconversion in unselected pregnant women in Hong Kong; 2) determine the rate of SARS-CoV-2 infection in women presenting with miscarriage and stillbirth; 3) follow the pregnancy course and perinatal outcome of confirmed COVID-19-infected pregnant cases; 4) determine the risk and characteristics of vertical transmission; and 5) evaluate the placental barrier, immune response and fetal damage in vertical transmission of SARS-CoV-2. A series of longitudinal and cross-sectional observational studies, and a laboratory-based study will be conducted to fulfil the 5 objectives.
University of California, Los Angeles
This study will provide access to investigational anti-SARS-CoV-2 human convalescent plasma for pediatric patients with underlying medical conditions (cardiovascular disease, lung disease, immunosuppression) who are either infected with SARS-CoV-2 or who have had a high-risk exposure. Study participants will be transfused once with compatible convalescent plasma obtained from an individual who has recovered from documented infection with SARS-CoV-2. Safety information and pharmacokinetic data will be collected.
Columbia University
The 2019-2020 COVID-19 pandemic is the largest outbreak in recent history. It is not known how long after someone gets sick with COVID-19 and recovers that they can still infect other people. It is also not known how quickly people make antibodies against the virus, which help clear infection from the body. The investigators will enroll 300 people who had COVID-19 based on lab testing or confirmed exposure to participate. An additional 25 participants who have never tested positive for COVID and have not had the vaccine will be enrolled as negative controls. Participants will complete a survey at enrollment. The investigators will also collect blood, nose swab, saliva, stool, semen, and breast milk to test for the virus. The investigators will ask participants to complete a survey and give specimens up to 12 times over 24 months. This information will be used to study how long the virus can live in different parts of the body, antibody development, and post-infectious complications. The investigators hope that this information will allow medical and public health providers to make recommendations to better care for patients in the convalescent phase of COVID-19 infection.
Universitaire Ziekenhuizen KU Leuven
We aim to understand the mechanism of olfactory dysfunction in COVID-19.
University of South Alabama
This Phase 2 Randomized Placebo Controlled Trial will determine if administering nebulized Dornase Alpha (rhDNase) to COVID-19 patients with respiratory failure is safe and will reduce 28-day mortality.
Ankara University
COVID-19 (Coronavirus disease 2019) is a new infectious disease caused by a virus named as SARS-CoV2 (Severe Acute Respiratory Syndrome Coronavirus-2). Although it can have a devastating effect on many organs, the respiratory tract is particularly affected. In the course of the disease, a wide clinical spectrum is observed, from flu-like illness to lung failure. Some of the patients who survived the disease continue to have problems such as shortness of breath, fatigue, decrease in walking distance, decrease in participation in daily life activities. These problems suggest that the effects on respiratory and cardiac functions continue even after the disease ends. This study was designed to demonstrate the effects and extent of COVID-19 on cardiopulmonary capacity.
Francis Crick Institute
The study aims to investigate SARS-CoV-2 susceptibility, transmission and disease severity in healthcare workers and patients. Residual specimens from an existing collection of samples in viral inactivating buffer and derivatives and serum from the Crick COVID-19 Consortium Testing centre (Cohort A1) and additional biological material collected prospectively (Cohorts A2 and B) will be used for research into SARS-CoV-2 transmission, evolution and immune control. This testing centre is a partnership between UCLH and The Francis Crick Institute to provide COVID 19 RT PCR testing for healthcare workers (HCWs) and patients in London Hospitals and care homes. A third group (Cohort C) of the study will allow for collaborative work with other REC approved research studies that have used the Crick COVID-19 Consortium Testing centre and will involve the use of study samples already collected from each study to be analysed under the SARS-CoV-2 Longitudinal Study end points