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 60 of 69Maimonides Medical Center
This study is a prospective randomized controlled, double blind clinical trial performed on laboratory confirmed COVID-19 infection admitted patients in the Shamir Medical Center. The trial will include 30 patients who will undergo either hyperbaric oxygen therapy (HBOT) or Normobaric oxygen therapy (NBOT), randomized on a 2:1 ratio, within 4 days in addition to the standard treatment including oxygen, drugs, steroids, bronchodilators, antibiotics and others. The evaluation procedure includes symptom monitoring, room air saturation, vital signs monitoring, pulmonary function and blood tests at baseline, one day and one week after the last session. In addition, one hour prior to and post session saturation and vitals will be monitored.
Boehringer Ingelheim
This is a study in adults with severe breathing problems because of COVID-19. People who are in hospital on breathing support can participate in the study. The purpose of the study is to find out whether a medicine called alteplase helps people get better faster. The study has 2 parts. In the first part, participants are put into 3 groups by chance. Participants in 2 of the groups get 2 different doses of alteplase, in addition to standard treatment. Participants in the third group get standard treatment. In the second part of the study, participants are put into 2 groups by chance. One group gets alteplase and standard treatment. The other group gets only standard treatment. Alteplase is given as an infusion into a vein. In both study parts, treatments are given for 5 days. Doctors monitor patients and check whether their breathing problems improve. They compare results between the groups after 1 month. Participants are in the study for 3 months.
CSL Behring
CSL760 is a human hyperimmune product of the purified gamma immunoglobulin (IgG) fraction of human plasma containing polyvalent neutralizing antibodies to SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2). CSL is evaluating CSL760 as a passive immunotherapy for COVID-19 (Coronavirus Disease 2019).
University Hospital Bispebjerg and Frederiksberg
The purpose of this study is to evaluate the effect of the ganglion sphenopalatine block (SPG block) on persistent headache following acute COVID-19 infection.
Carilion Clinic
A comparison of a direct antigen test for SARS-CoV-2 obtained by mid-turbinate swab with the reference standard rt-PCR test obtained by nasopharyngeal swab in outpatients with symptoms compatible with COVID-19.
Medical University of Graz
Background: Coronavirus disease 2019 (COVID-19) has affected almost every country in the world, especially in terms of health system capacity and economic burden. People from sub-Saharan Africa (SSA) often face interaction between human immunodeficiency virus (HIV) infection and non-communicable diseases such as cardiovascular disease. Role of HIV infection and anti-retroviral treatment (ART) in altered cardiovascular risk is questionable and there is still need to further carry out research in this field. However, thus far it is unclear, what impact the COVID-19 co-infection in people living with HIV (PLHIV), with or without therapy will have. The ENDOCOVID project aims to investigate whether and how HIV-infection in COVID-19 patients modulates the time course of the disease, alters cardiovascular risk, and changes vascular endothelial function and coagulation parameters/ thrombosis risk. Methods: In this long-term study, cardiovascular research on PLHIV with or without ART with COVID-19 and HIV-negative with COVID-19 will be carried out via clinical and biochemical measurements for cardiovascular risk factors and biomarkers of cardiovascular disease (CVD). Vascular and endothelial function will be measured by brachial artery flow-mediated dilatation (FMD), carotid intima-media thickness (IMT) assessments, and retinal blood vessel analyses, along with vascular endothelial biomarkers and coagualation markers. The correlation between HIV-infection in COVID-19 PLHIV with or without ART and its role in enhancement of cardiovascular risk and endothelial dysfunction will be assessed. Potential changes in these endpoints by COVID-19 will be followed for 4 weeks across the three groups (PLHIVwith or without ART and HIV negatives). Impact of project: The ENDOCOVID project aims to evaluate in the long-term the cardiovascular risk and vascular endothelial function in PLHIV thus revealing an important transitional cardiovascular phenotype in COVID-19.
CMC Ambroise Paré
The Covid-19 pandemic requires a reliable diagnosis of patients in order to take care of them in the best conditions and in the appropriate services. Moreover, the current diagnostic reference is reverse transcription by polymerase chain reaction (RT-PCR) on a nasopharyngeal sample taken by swab. This technique is expensive (54€) and its production time is several hours. Alternative methods are in progress, including, rapid diagnostic tests. The MEMS microfluids and nanostructures (MMN) laboratory, in partnership with the Institut Chimie Biologie Innovation (CBI) (Paris, 75005), have developed a portable test "COVIDISC", low-cost (10 €), fast (1 hour), including extraction, elution and amplification in solid medium isothermal, reverse amplification loop mediated transcription (RT-LAMP). The "lab" version has received an analytical validation on human nasopharyngeal samples with performance comparable to classic RT-PCR (sensitivity of 7 copies per μl, specificity 100%). The objective of this study is to validate the in vitro diagnostic medical device, COVIDISC, with the standard nasopharyngeal RT-PCR test.
Drägerwerk AG & Co. KGaA
The study is designed to demonstrate suitability of the Dräger Antigen Test for SARS-CoV-2 detection in clinical nasal specimens. Real-time polymerase chain reaction (RT-PCR) on specimens collected by pharyngeal swabs serves as a reference method.
The Cleveland Clinic
This study evaluates operative and non-operative management of acute appendicitis (infection or inflammation of the appendix) and acute cholecystitis (inflammation/infection of the gallbladder) in patients with active mild to moderate COVID-19 infection. The hypothesis is that COVID+ patients with uncomplicated acute appendicitis or acute cholecystitis amendable to a laparoscopic procedure can have safe operative outcomes compared to those managed non-operatively.
Meyer Children's Hospital IRCCS
The new coronavirus (SARS-CoV-2) causing COVID-19 is an RNA virus coated with a capsid and a peri-capsid crossed by glycoprotein structures. The external proteic structure, which attacks human cells, is a potential target to therapeutic interventions against virus replication in airways. Since high temperature can cause irreversible denaturation of proteins and loss of SARS CoV and SARS CoV-2 infectivity was obtained after heating at 56 ◦C for 15 and 30 min in liquid environments respectively, we designed a protocol aimed at damaging SARS-CoV-2 capsid through steam inhalation cycles. Although the ominous consequences of COVID 19 infections has directed medical attention toward solidly established medical approaches, the European Pharmacopoeia VI edition also quotes steam inhalations as a procedure to treat of respiratory diseases. Based on these suggestions we established a quasi-randomized clinical trial enrolling 200 asymptomatic or paucisymptomatic patients in whom rhino-pharyngeal-swab revealed a SARS-CoV-2 infection. The study protocol consisted of exposure of airway mucosae to humidified steam (pH 8 per NaHCO3 and hypertonic 15 g/L NaCl) through steam inhalation for at least 20 min (4 cycles of 5 min) daily, for 10 days. The objective of the study is to reduce the viral shedding using steam inhalations.