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 160 of 290Deborah O'Connor
This will be a prospective observational study of lactating mothers who are planning to, have scheduled or have received vaccination against SARS-COV-2 (COVID-19 vaccine). Mothers may have delivered at Mount Sinai Hospital or may be from the general public recruited by social media or word of mouth. As the study participants will be lactating mothers, they will not be under the care of the investigators. Due to lack of information, we are unsure of an appropriate sample size but envision we will recruit at least 10 women each immunized with the approved mRNA vaccines (e.g. Pfizer-BioNTech and Moderna COVID-19 vaccines) and in the future at least two other vaccines (e.g. Oxford-AstraZeneca) as they are approved and become available. Milk samples will be analyzed for the presence of antibody to SARS-CoV-2 using the Anti-SARS-CoV-2 ELISA (IgG and IgA). These analyses will be conducted in the Department of Microbiology at Sinai Health following validation of the procedures in human milk.
University of Manitoba
The main objective of this pilot study is to evaluate the effect of a remote interdisciplinary PR program that is delivered using two exercise approaches on the recovery of long-term post-COVD-19 outcomes. The specific aims are i) to evaluate the effect of the program and ii) each of the approaches on patients': 1) lung capacity, 2) dyspnea and fatigue, 3) exercise capacity, 4) physical function, 5) participation, and 5) HRQoL.
Asociacion Instituto Biodonostia
Randomized, open, single-center, controlled clinical trial, with 2 treatment arms that seeks to demonstrate the effectiveness of tocilizumab against systemic corticosteroids, both treatments added to supportive treatment in patients admitted for COVID-19 with bilateral pneumonia and poor evolution
International AIDS Vaccine Initiative
A Phase 1, Randomized, First-in-human, Open-label Study to Evaluate the Safety and Immunogenicity of eOD-GT8 60mer mRNA Vaccine (mRNA-1644) and Core-g28v2 60mer mRNA Vaccine (mRNA-1644v2-Core) in HIV-1 Uninfected Adults in Good General Health
National Institute of Allergy and Infectious Diseases (NIAID)
This is a randomized, multi-site, adaptive, open-label clinical trial comparing the immune response to different additional doses of COVID-19 vaccine in participants with autoimmune disease requiring IS medications. All study participants will have negative serologic or suboptimal responses (defined as a Roche Elecsys® Anti-SARS-CoV-2 S result ≤200 U/mL) or a low immune response (defined as a Roche Elecsys® Anti-SARS-CoV-2 S result >200 U/ml and ≤2500 U/mL) to their previous doses of COVID-19 vaccine. The study will focus on 5 autoimmune diseases in adults: - Systemic Lupus Erythematosus (SLE) - Rheumatoid Arthritis (RA) - Multiple Sclerosis (MS) - Systemic Sclerosis (SSc), and - Pemphigus. This study will focus on 4 autoimmune diseases in pediatric participants: - Systemic Lupus Erythematosus (SLE) - Juvenile Idiopathic Arthritis (JIA) - Pediatric-Onset Multiple Sclerosis (POMS) - Juvenile Dermatomyositis (JDM)
International Vaccine Institute
This is an observer-blind, randomized study which aims to assess the immune response and the safety of two different approved vaccines for first and second dose in healthy adults.
Assiut University
To measure the frequency of persistent liver dysfunction (raised liver enzymes, serum albumin, prothrombin time, etc) in recovered COVID -19 patients. To compare the hepatic manifestations in post COVID -19 patients with and without liver disease
Asociacion Instituto Biodonostia
EC CORONACOLCHI is a multicenter, double-blind and randomized clinical trial with two branches. Patients who meet all the inclusion criteria and none of the exclusion criteria will be randomized 1: 1 to be included in one of the following groups: - Experimental group: colchicine for 2 weeks orally at the doses described, added to the standard treatment of COVID-19. - Control group: placebo for 2 weeks orally added to standard COVID-19 treatment.
Butantan Institute
NDV-HXP-S is an inactivated COVID-19 vectored-vaccine virus using the Newcastle Disease Virus as basis and expressing S protein from SARS-CoV-2 stabilized in pre-fusion form with Hexapro technology. This vaccine was successfully tested in non-clinical study with a good safety profile and eliciting neutralizing antibodies against SARS-CoV-2. Clinical testing is conducted by an international consortium including three different manufacturers. Butantan, in Brazil, is one of them.
Universidad del Desarrollo
Preliminary data suggest that inactivated vaccine-induced neutralizing antibodies against SARS-CoV-2 decrease at six months after vaccination. Observational, unpublished data also indicate that vaccine effectiveness against Covid-19 wanes over time. Thus, the investigators aimed to determine the reactogenicity, safety, and immunogenicity of a homologous or heterologous booster of SARS-CoV-2 vaccines among people already immunized with an inactivated SARS-CoV-2 vaccine. The study focuses on the elderly population and healthcare workers.