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 760 of 805Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
This is a phase II, randomized, placebo-controlled, observer-blinded study of the safety and immunogenicity of SARS-CoV-2 messenger RNA (mRNA) vaccine (BNT162b2) in Chinese healthy population. After randomization, the trial for each participant will last for approximately 13 months. Screening period is 2 weeks prior to randomization (Day -14 to Day 0), and two doses of either SARS-CoV-2 vaccine (BNT162b2) or placebo will be given intramuscularly (IM) separated by 21 days.
National Heart, Lung, and Blood Institute (NHLBI)
A multicenter, adaptive, randomized platform trial evaluating the efficacy and safety of antithrombotic strategies in patients with COVID-19 following hospital discharge
AbbVie
Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Lung failure is the main cause of death related to COVID-19 infection. The main objective of this study is to evaluate the safety and tolerability of ABBV-47D11 and ABBV-2B04 given alone and in combination to participants with COVID-19 infection. In addition, this study will evaluate the pharmacokinetics (how the body handles the study drug) and anti-viral activity of the study drug. ABBV-47D11 and ABBV-2B04 are investigational anti-SARS-CoV-2 monoclonal antibodies being developed for the treatment of COVID-19. Study will be conducted in two parts. In part A, participants will receive ABBV-47D11 or placebo. There is a 1 in 4 chance that participants will be assigned to placebo. In part B, participants will receive ABBV-2B04 alone or in combination with ABBV-47D11 or placebo. There is a 1 in 5 chance that participants will be assigned to placebo. Around 54 adult participants with COVID-19 will be enrolled in approximately 10 to 30 sites globally. In part A participants will receive single intravenous (into the veins) infusion of ABBV-47D11 or placebo on Day 1. In part B participants will receive single intravenous (into the veins) infusion of ABBV-2B04 alone or in combination with ABBV-47D11 or placebo on Day 1. Participants will be followed up for 106 days. There may be higher treatment burden for participants in this trial compared to their standard of care. The effect of the treatment will be checked by medical assessments, blood tests, nasal swabs and presence of side effects.
Hamad Medical Corporation
Coronavirus Disease 2019 (COVID-19) was first isolated in Wuhan, China in December 2019. It is rapidly spreading worldwide, posing a severe threat to global health. Many therapeutics have been investigated for the treatment of this disease with inconclusive outcomes. Anakinra - an interleukin (IL)-1 receptor antagonist - had showed survival benefits in patients with macrophage activation syndrome (MAS) and sepsis and was investigated for the use in COVID-19 infection with promising outcomes.
Nobelpharma
This is a randomized, placebo-controlled, double-blind, group comparison, multicenter study to evaluate the efficacy and safety of inhalation administration of sargramostim for 5 days, in principle (up to 10 days) as Add-on treatment to the standard treatment in COVID-19 patients.
University of the Philippines
This study is an adaptive, randomized, open-label, controlled clinical trial utilizing an adaptive design to compare effects of repurposed drugs with local standard of care alone on major inpatient hospital outcomes. This is performed worldwide in collaboration with WHO.
Pfizer
This retrospective study will evaluate characteristics, vaccine utilization and outcomes among subjects with immunocompromising conditions that received COVID-19 vaccination.
Celltrion
This is a Phase I study that randomized, double-blind, Placebo-controlled, Parallel Group, Single Ascending Dose Study to evaluate Safety, Tolerability and Pharmacokinetics of CT-P63 in Healthy Subjects.
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.
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.