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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To search this directory, simply type a drug name, condition, company name, location, or other term of your choice into the search bar and click SEARCH. For broadest results, type the terms without quotation marks; to narrow your search to an exact match, put your terms in quotation marks (e.g., “acute respiratory distress syndrome” or “ARDS”). You may opt to further streamline your search by using the Status of the study and Intervention Type options. Simply click one or more of those boxes to refine your search.
Displaying 60 of 75Pregistry
The objective of the COVID-19 Vaccines International Pregnancy Exposure Registry(C-VIPER) is to evaluate obstetric, neonatal, and infant outcomes among women vaccinatedduring pregnancy with a COVID-19 vaccine.Specifically, the C-VIPER will estimate the risk of obstetric outcomes (spontaneousabortion, antenatal bleeding, gestational diabetes, gestational hypertension,intrauterine growth restriction, postpartum hemorrhage, fetal distress, uterine rupture,placenta previa, chorioamnionitis, Caesarean delivery, COVID-19), neonatal outcomes(major congenital malformations, low birth weight, neonatal death, neonatalencephalopathy, neonatal infections, neonatal acute kidney injury, preterm birth,respiratory distress in the newborn, small for gestational age, stillbirth, COVID-19),and infant outcomes (developmental milestones [motor, cognitive, language,social-emotional, and mental health skills], height, weight, failure to thrive, medicalconditions during the first 12 months of life, COVID-19) among pregnant women exposed tosingle (homologous) or mixed (heterologous) COVID-19 vaccine brand series from 30 daysprior to the first day of the last menstrual period to end of pregnancy and theiroffspring relative to a matched reference group who received no COVID-19 vaccines duringpregnancy.
Haukeland University Hospital
The ongoing Coronavirus Disease 2019 (COVID-19) pandemic has been intensified by nopopulation-based immunity to the severe acute respiratory disease coronavirus 2(SARS-CoV2) and initially lack of effective treatments or vaccines available to mitigatethe pandemic. Currently, two COVID-19 vaccines are available for vaccination in Europethrough conditional marketing authorisation granted by the European Medicines Agency andfurther vaccine will be licensed. These vaccines have shown good vaccine efficacy inphase 3 vaccine trials. We will recruit subjects who will be prioritised for vaccinationwith the primary aim of comparing the immune responses after COVID-19 vaccination andnatural SARS-CoV-2 infection. In Western Norway we have recruited cohorts of health careworkers and patients infected with SARS-CoV-2 and will extend to COVID-19 vaccinees.Demographic, clinical data and repeated blood samples will be collected to evaluate thecomplications and kinetics, duration and breadth of the immune responses comparingnatural infection to vaccination.
McGill University Health Centre/Research Institute of the McGill University Health Centre
To evaluate if omalizumab is effective in decreasing mortality in severe hospitalizedCOVID-19 cases.
Finnish Red Cross Blood Service
This study investigates the possible adverse effects and effectiveness of convalescentplasma for patients infected with SARS-CoV-2. Following provision of informed consent,patients will be randomized into three groups: High-titre convalescent plasma, low-titreconvalescent plasma or placebo. Primary outcomes of the study will cover safety andeither intubation or initiation of systemic corticosteroids. Safety information collectedwill include serious adverse events judged to be related to administration ofconvalescent plasma. Microbiological and other laboratory parameters will be followed up.
Walvax Biotechnology Co., Ltd.
The purpose of this double-blind, randomized, controlled study is to assess safety,reactogenicity, and preliminary immunogenicity of 202-CoV at multiple dose levels,administered as 2 injections (i.m) at 28 days apart in adult subjects 18 years of age andabove.
International Vaccine Institute
To expand the access and delivery of COVID-19 Vaccines in Africa (ECOVA), theinvestigators will conduct a phase 3, individually randomized, observer-blind, controlled(influenza vaccine) trial to evaluate the safety and efficacy of the BBIBP-CorV vaccineagainst any severe acute respiratory syndrome 2 (SARS-CoV- 2) infection among adults 18years and older. The BBIBP-CorV vaccine is an inactivated SARS-CoV-2 vaccine (Vero cell)manufactured by the Beijing Institute of Biological Products (BIBP), China NationalBiotec Group (CNBG), Sinopharm, Beijing, People's Republic of China and receivedemergency use authorization (EUA) from World Health Organization (WHO).
Walvax Biotechnology Co., Ltd.
The purpose of this double-blind, randomized, controlled study is to assessimmunogenicity and safety of 202-CoV at multiple dose levels, administered as 2injections (i.m) at 28 days apart in adult subjects 18 years of age and above.
International Vaccine Institute
This is an observer-blind, randomized study which aims to assess the immune response andthe safety of two different approved vaccines for first and second dose in healthyadults.
Imperial College London
This study will test the COVID-19 vaccine candidate AZD1222 to investigate its safety,tolerability and capability of boosting immune responses both in the blood and the lungwhen administered to the respiratory tract, in volunteers previously vaccinated byintramuscular COVID-19 vaccination. Using standardised methods, we will measure immuneresponses in the blood, nose and lower airway and compare with data from ongoing clinicaltrials of intramuscular vaccination. Thus, we will show the effect of the delivery methodand provide the critical information required to begin further clinical trials to showthe efficacy of this needle-free vaccination strategy for booster vaccination.
University of Oxford
A phase 2/3 study to determine the efficacy, safety and immunogenicity of the candidateCoronavirus Disease (COVID-19) vaccine ChAdOx1 nCoV-19 in healthy UK volunteers.