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 490 of 533Janssen Vaccines & Prevention B.V.
The purposes of this study are to demonstrate the non-inferiority (NI) of the neutralizing antibody response to the original strain 14 days after booster vaccination with Ad26.COV2.S at the different dose levels, administered greater than or equal to (>=) 6 months after single-dose primary vaccination with Ad26.COV2.S, compared to the neutralizing antibody response to the original strain induced by single-dose primary vaccination with Ad26.COV2.S; To demonstrate the NI of the neutralizing antibody response to the leading variant of high consequence or concern 14 days after booster vaccination with Ad26.COV2.S at the 5*10^10 virus particle (vp) dose level, administered >= 6 months after single-dose primary vaccination with Ad26.COV2.S (5*10^10 vp dose level), compared to the neutralizing antibody response to the leading variant of high consequence or concern induced by single-dose primary vaccination with Ad26.COV2.S at the 5*10^10 vp dose level, if feasible; To demonstrate the NI of the neutralizing antibody response to the original strain 14 days after booster vaccination with Ad26.COV2.S at the different dose levels administered >=6 months after completing a 2-dose primary vaccination with Pfizer BNT162b2, compared to the neutralizing antibody response to the original strain induced by 2-dose primary vaccination with Pfizer BNT162b2; To demonstrate the NI of neutralizing antibody response to the leading variant of high consequence or concern 14 days after booster vaccination with Ad26.COV2.S at the 5*10^10 vp dose level, administered >= 6 months after completing a 2-dose primary vaccination with Pfizer BNT162b2, compared to the neutralizing antibody response to the leading variant of high consequence or concern induced by 2-dose primary vaccination with Pfizer BNT162b2, if feasible.
Royal College of Surgeons in Ireland - Medical University of Bahrain
Coronavirus disease 2019 (COVID-19) is potentially a deadly disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that targets the lung mainly, resulting in respiratory tract infections in humans. It has developed into a pandemic with serious global public health problems. Recent research has shown that the new SARS-CoV-2 variants reduces the efficacy of the vaccinations and are predominantly more transmissible or infective. A few countries namely Bahrain, United Arab Emirates, and Turkey have recently started introducing a booster dose following primary two doses of the COVID-19 immunization series. This study aims to identify which booster dose is more effective; taking a booster dose from the same vaccine initially taken or a booster dose from a different vaccine than initially taken.
Japan Agency for Medical Research and Development
This study will assess the safety and immunogenicity of AG0302-COVID19 in healthy volunteers.
Sinovac Research and Development Co., Ltd.
This study is a randomized and controlled phase Ⅳ clinical trial of the COVID-19 vaccine (Vero cell), Inactivated manufactured by Sinovac Research & Development Co., Ltd. The purpose of this study is to evaluate the immunogenicity and safety of COVID-19 vaccine (Vero cell), Inactivated co-administration with EV71 vaccine
Sinovac Life Sciences Co., Ltd.
This study is a multi-center and open design, phase Ⅳ clinical trial of an inactivated SARS-CoV-2 vaccine (CoronaVac) manufactured by Sinovac Research and Development Co., Ltd.The purpose of this study is to evaluate the safety of the SARS-CoV-2 Inactivated vaccine in population aged 3~17 years and in people with pre-existing disease to provide reference for improving the immunization strategy of COVID-19 vaccine.
Russian Direct Investment Fund
Randomized, open, multicenter, collaborative and adaptive non-inferiority trial to evaluate the immunogenicity and reactogenicity of the heterologous vaccination schedules made up of the combination of vaccines available in Argentina (Sputnik-V, AstraZeneca, Sinopharm and Moderna); and to compare the immunogenicity and reactogenicity of heterologous and homologous vaccination schedules.
GlaxoSmithKline
This is a Phase I single-dose study to investigate the pharmacokinetics, safety, and tolerability of sotrovimab vs placebo by intravenous or intramuscular administration in healthy Japanese and Caucasian participants.
King Chulalongkorn Memorial Hospital
According to preexisting data, it has revealed the fundamental role that aerosols play in the transmission of the COVID-19 virus. Esophagogastroduodenoscopy (EGD), producing particle smaller than 5 microns, was regarded as 'aerosol-generating procedures' (AGPs) associated with an increased risk of transmission of respiratory pathogens to healthcare workers. The strategies aim to reduce spreading of aerosol during the procedure should be beneficial. Using an acrylic box to cover the head of a patient undergoing an endoscopy seems to reduce aerosol scatter and reduce the spread of respiratory pathogens. At present, there are no high-quality studies that provide quantitative data on the use of head box to reduce aerosol generation.
Weill Medical College of Cornell University
Repetitive transcranial magnetic stimulation (rTMS) is a FDA-approved treatment for depression and Obsessive Compulsive Disorder (OCD). The goal of the study is to learn how to optimize the treatment to improve symptoms of depression and OCD. This research project will test a new accelerated 5-day accelerated rTMS protocol for treating symptoms of depression and OCD. A second goal of this study is to identify biomarkers of depression and OCD in the brain using functional magnetic resonance imaging (fMRI). This approach will predict who will benefit from TMS, determine the optimal treatment target, and improve treatment outcomes. Subjects will receive a clinical assessment of symptoms and an fMRI brain scan before and after each treatment course to measure the effect of treatment on symptom severity and on fMRI measures of functional connectivity. Participants will be randomized to receive rTMS targeting either the lateral prefrontal cortex (LPFC) or the dorsomedial prefrontal cortex (DMPFC). Participants will complete a 5-day course of rTMS delivered hourly for 10 hours per day. Participants who show a partial response to treatment but not a full response will then receive a second 5-day course. Treatment non-responders will be crossed over to receive rTMS targeting the opposite brain area. The primary hypothesis is that accelerated rTMS treatment will yield rapid improvement in symptoms for patients with depression and OCD in just 5 days, and that response rates can be further improved by adding a second 5-day treatment course.
Health Institutes of Turkey
A booster dose of vaccine (Turkovac or CoronaVac) will be administered to subjects who have passed at least 90 days and at most 270 days after the second dose of the first course of CoronaVac vaccine.