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 330 of 646International Vaccine Institute
This is a phase I/IIa trial to evaluate the safety, tolerability and immunological profile of INO-4800 administered by intradermal (ID) injection followed by electroporation (EP) using the CELLECTRA® 2000 device in healthy adults aged 19 to 64 years in Republic of Korea. INO- 4800 contains the plasmid pGX9501, which encodes for the full length of the Spike glycoprotein of SARS-CoV-2. The primary objective of this trial is to evaluate the tolerability, safety, and immunogenicity of INO-4800 administered by ID injection followed by EP in healthy adults in the Part A and Part B. Enrollment into Part A, and Part B will proceed sequentially.
Jonathan Gerber
The purpose of this program is to see if giving convalescent plasma to individuals who test positive for COVID-19 may reduce their symptoms and help minimize complications from the illness.
Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
In this trial, a total of 50 subjects were recruited; the test vaccines were divided into 3 groups, low-dose vaccine groups, high-dose vaccine groups, and placebo groups. The first-stage randomized participants in the low-dose group (20 cases) and the placebo group (5 cases) were evaluated for 7 days. After the 7-day safety data was evaluated and agreed by the DSMB, the second-stage study was conducted. Into the high-dose group (20 cases) and placebo group (5 cases) subjects; follow-up to 30 days, after the safety assessment by the investigator and consent, then inoculate the second dose. Observation was performed for 1.0 hour after the second dose. The researchers conducted a safety evaluation and agreed to follow-up after discharge.
University of Nebraska
This study will establish the safety and efficacy of using stellate ganglion blocks in patients with ARDS due to COVID-19 disease.
Makerere University
Currently there are no proven treatments or vaccines for COVID-19 and care of the COVID patients is largely supportive involving treatment of symptoms such as fever with antipyretics, secondary bacterial chest infection with antibiotics and meticulous management of comorbid conditions. Several repurposed and new drugs have been investigated for treatment of COVID-19, however, none have been confirmed to be efficacious. These drugs include the antimalarials (chloroquine and hydroxychloroquine), antivirals such as remdesivir and favipiravir and antiretroviral combination therapies such lopinavir/ritonavir. There is emerging evidence to support the use of COVID convalescent plasma for the treatment of COVID-19. There is need to leverage the blood transfusion services in countries and this is beginning to happen on the continent.
Bandim Health Project
Background: The virus SARS-CoV-2 has spread rapidly throughout the world. Seniors are at high risk of severe COVID-19 when infected. Bacille Calmette-Guérin (BCG) is a vaccine against tuberculosis, with protective non-specific effects against other infections; significant reductions in morbidity and mortality have been reported, and a plausible immunological mechanism has been identified: "trained innate immunity". The investigators hypothesize that BCG vaccination can reduce the risk of COVID-19 and other infections among senior citizens during the COVID-19 pandemic. Objectives: Primary objective: To reduce senior citizens' risk of acute infection during the COVID-19 pandemic. Secondary objectives: To reduce senior citizens' risk of SARS-CoV-2 infection during the COVID-19 pandemic. To reduce senior citizens' risk of self-reported respiratory illness during the COVID-19 pandemic. Study design: A placebo-controlled randomized trial. Study population: 1900 seniors 65 years of age or above. Intervention: Participants will be randomized 1:1 to intradermal administration of a standard dose of BCG vaccine or placebo (saline). Outcomes: Primary outcome: "Acute infection" identified either by a doctor, antibiotics use, hospitalization, or death due to infection. Secondary outcomes: Verified SARS-CoV-2 infection and self-reported respiratory illness. With an expected incidence of "acute infection" of 20%, the trial can show a 25% risk reduction in the the intervention group versus the placebo group by including a total of 1900 individuals, 950 individuals in each group. Risk for participants and impact: Based on previous experience and randomized controlled trials in adult and elderly individuals, the risks of BCG vaccination are considered low. If BCG can reduce the risk of acute infection in seniors by 25% it has tremendous public health importance, both during the COVID-19 pandemic and overall.
CanSino Biologics Inc.
This study is a phase III clinical trial to evaluate efficacy, reactogenicity and safety of the vaccine Ad5-nCoV compared with placebo in volunteers at the age from 18 to 85 years,with the randomized, double-blind design
Biomed Industries, Inc.
In this randomized double blind Phase 3 clinical trial we will study the efficacy and safety of oral polio vaccine with and without NA-831 versus placebo.
AstraZeneca
The purpose of this study is to evaluate safety and immunogenicity of AZD1222 for COVID-19 prevention in the Russian Federation
Biontech SE
Originally, the study was planned to include two parts, i.e., Part A and Part B, however Part B was skipped due to changes in the overall clinical development plan. The conducted Part A was a dose-finding part to investigate the optimal dose, allowing dose adjustments upwards and downwards in younger participants. Doses tested in older participants were chosen based on acceptability of dosing in younger participants.