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 340 of 347Pfizer
This retrospective study will evaluate characteristics, vaccine utilization and outcomes among subjects with immunocompromising conditions that received COVID-19 vaccination.
Arcturus Therapeutics, Inc.
This is a Phase 1/2/3, randomized, placebo-controlled, observer-blind study designed to evaluate the safety, immunogenicity and efficacy of ARCT-154 in adult participants to be enrolled in Vietnam. This study consists of four parts: Part 1 (Phase 1) will evaluate the safety of the study vaccines in 100 healthy individuals. Part 2 (Phase 2) will evaluate the safety and immunogenicity of the study vaccines in 300 healthy individuals. Part 3 (Phase 3a) will evaluate the safety, immunogenicity, and efficacy of the study vaccines in 600 individuals with and without underlying medical conditions. Part 4 (Phase 3b) will evaluate the safety and efficacy of the study vaccines in 16,000 individuals with and without underlying medical conditions. Part 5 (Phase 3c) will evaluate the safety and non-inferiority in immunogenicity of ARCT-154 vaccine vs. Astra Zeneca COVID-19 vaccine (ChAdOx1 nCoV-19) in 2400 individuals with and without underlying medical conditions. In Phase 1, healthy individuals 18 to < 60 years of age will be enrolled. In Phase 2, 3a, and 3b, individuals 18 years of age and older will be enrolled including individuals with underlying medical conditions that put them at higher risk of complications of COVID-19 disease. Phase 1, Phase 2, Phase 3a and Phase 3b participants will be randomly assigned to a study group that will receive up to 2 vaccination series. Each vaccination series comprises two vaccinations at 28-day intervals: an initial vaccination series with vaccinations on Day 1 and Day 29 and an additional vaccination series around 2 months after the first series (on Day 92 and 120). Participants of Phase 2, 3a who received 2 doses of ARCT-154 vaccine will be rerandomized to receive either dose 3 of ARCT-154 on Day 92 plus placebo on Day 120 or placebo on Day 92 plus placebo on Day 120. For Phase 1, Phase 3b and participants in Phase 2 and 3a that received placebo in the first vaccination series, the participants will be switched over to the opposite vaccine in the second series. There is no second vaccination series for Phase 3c as all participants receive active vaccine in the initial series.
People's Hospital of Hunyuan County, Shanxi Province
The COVID-19 pandemic is causing unprecedented morbidity and mortality.The safe and effective Novel coronavirus vaccine is an effective means to block the transmission of the virus by building up the immune barrier of the population.Clinical studies have shown that elderly people are at high risk of severe COVID-19 infection and have poor clinical prognosis.Considering the current situation of aging population in China, the elderly people should be given priority to vaccinate to obtain protection and reduce the risk of novel coronavirus infection.However, the current data on vaccines are mostly from young and middle-aged healthy people, while there is little research data on COVID-19 vaccination in the elderly.This study mainly studied the safety and effectiveness of COVID-19 vaccine in the elderly population and explored its potential immune mechanism.
Medigen Vaccine Biologics Corp.
The purpose of this study is to assess the immunogenicity and safety of MVC-COV1901 vaccine compared to AZD1222 in heathy adults.
Laboratorios Hipra, S.A.
This is a first-in-human, phase I/IIa, randomized, controlled, observer-blinded, dose-escalation, multicentre clinical trial to evaluate safety and immunogenicity of COVID-19 HIPRA vaccine in adult healthy volunteers.
Vaxine Pty Ltd
This is a phase III, randomized, two-armed, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of a candidate adjuvanted recombinant SARS-CoV-2 spike (S) protein subunit vaccine (SpikoGen) produced by CinnaGen Co. 16,876 adult individuals receive either SARS-CoV-2 recombinant spike protein (25 µg) with Advax-SM adjuvant (15 mg) or saline placebo in a 3:1 ratio. The randomization is stratified by age (from 18 to under 40 years of age or from 40 to under 50 years of age). The injection is given in two doses with a 21-day interval in the deltoid muscle of the non-dominant arm. Participants will be followed up for six months after the second dose of the study intervention. Study hypotheses include: 1. The adjuvanted COVID-19 vaccine candidate significantly reduces the risk of symptomatic COVID-19 in adult subjects. 2. The adjuvanted COVID-19 vaccine candidate significantly reduces the risk of severe COVID-19 in adult subjects. 3. The adjuvanted COVID-19 vaccine candidate is safe and tolerable in adult subjects.
Janssen 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