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 370 of 1397Stanford University
The primary objective of Part 1 (Single Ascending Dose) is to assess the safety and tolerability of anti-SARS-CoV-2 IgY when given as single-ascending doses administered intranasally to healthy participants. The primary objective of Part 2 (Multiple Dose) is to assess the safety and tolerability of anti-SARS-CoV-2 IgY when given as multiple doses administered intranasally to healthy participants. A secondary objective is to assess the pharmacokinetics of anti-SARS-CoV-2 IgY when given as multiple doses administered intranasally to healthy participants. Safety will be evaluated using adverse event (AE), physical examination (including vital signs), electrocardiogram, and clinical laboratory data. Pharmacokinetics will be evaluated by serum anti-SARS-CoV-2 IgY concentration.
Pharmamel S.L.
There is an urgent need to evaluate effective treatments for COVID-19 patients. Melatonin has significant anti-inflammatory and antioxidant properties and it lacks of side-effects. This randomized controlled trial seeks to evaluate the efficacy of intravenous melatonin in reducing mortality in Covid-19 patients in the ICUs.
Universitätsklinikum Hamburg-Eppendorf
In this phase I first-in-human clinical trial, healthy volunteers in two different dose cohorts will be vaccinated twice with the candidate vaccine MVA-SARS-2-S. A subgroup will receive a heterologous booster vaccination with a licensed COVID-19 vaccine. The aim of the study is to assess the safety and tolerability of the candidate vaccine and to characterize its immunogenicity.
Iqvia Pty Ltd
The COVID-19 pandemic has caused major disruption to healthcare systems with significant socioeconomic impacts. Currently, there are no licensed preventions available against COVID-19 and accelerated vaccine development is urgently needed. A safe and effective vaccine for COVID 19 prevention would have significant global public health impact.
Harvard University
The goal of this project is to help the state of Minnesota understand why individuals are not getting tested and potentially identify trusted individuals or organizations that could be used in follow-up work to send messages. Investigators focus on the first two issues of unit and item nonresponse, which is not random across the population and thus could lead to nonresponse bias. To do so, investigators are deploying flyers through 10 Twin City area food shelves and potentially through public housing units with information on how to answer an online questionnaire.
Imperial College London
The proposed study is designed to investigate if and how pregnant women infected with Coronavirus Disease-19 (COVID-19) infection go on to develop long-term immunity. In December 2019, a group of people in Wuhan, China presented with symptoms of a pneumonia of an unknown cause that led to the discovery of a new coronavirus called COVID-19. COVID-19 has caused a global pandemic with 7,140,000 confirmed cases and 418,000 deaths as of 13th June 2020. In the United Kingdom (UK), there have been 294,000 cases and 41,662 deaths as of 13th June 2020. In humans, this infection primarily involves the upper part of the lungs, but it can also affect other organs. It causes mild symptoms in the majority of people affected but some people can have severe infections, with some even requiring critical care in hospital. During Severe acute respiratory syndrome (SARS), a previous coronavirus epidemic, pregnant women were disproportionately affected with severe illness. Understanding how the immune system responds long-term to this infection may hold the key to developing better vaccines and efficient treatment plans. Specialised immunity develops when individuals are infected by this and other viruses. The investigators of this study propose that, in pregnancy, this specialised immunity may not behave effectively. This may affect their ability to develop long lasting immunity and make them more vulnerable to re-infection. In this study, the investigators aim to recruit patients across 6 groups including COVID-19 newly infected pregnant women, and people with differing illness severity, mild to moderate, severe/critical, no infection (controls), as well as pregnant women with influenza and those receiving influenza vaccine. The study team will compare COVID-19 in pregnancy with non-pregnant infected and with influenza infected and vaccinated pregnant women. The study team will consent patients in all of these groups to provide a series of blood samples at different time points in a 12-month period.
Sociedad Argentina de Reumatologia
SAR-COVID is a national, multicenter, prospective, observational longitudinal registry of consecutive patients with diagnosis of rheumatic diseases treated or not with immunomodulatory and/or immunosuppressive drugs and SARS-CoV-2 infection (asymptomatic or COVID-19). Hypothesis: Patients with rheumatic diseases who are under chronic treatment with immunomodulatory and/or immunosuppressive drugs more frequently have an asymptomatic infection, a milder COVID-19 and lower mortality than patients with rheumatic diseases without immunomodulatory and/or immunosuppressive treatments.
CanSino Biologics Inc.
This study is a randomized, double-blind, placebo -controlled IIb clinical trial, in order to evaluate the safety and immunogenicity of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) in people 6 years old and above and .
Chulalongkorn University
This study will be conducted in 2 phases. Phase 1 of this study will be a single-centre, open label, dose escalation first in human (FIH) study conducted in 2 groups of healthy participants. Group 1 will enrol adults aged 18-55 years (inclusive); Group 2 will enroll elderly adults (elderly) aged 56-75 years (inclusive). Phase 2 of this study will be a single centre, the proposed design will be observer-blind, placebo-controlled study to assess the safety, reactogenicity, and immunogenicity of ChulaCov19 vaccine in healthy adults (18-75 years of age inclusive).
Shaperon
A randomized, double blind, placebo-controlled, phase 2 clinical trial to investigate the efficacy and safety of 2 doses of NuSepin® intravenous infusion in COVID-19 pneumonia patients