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 390 of 481Medicago
The study will be a randomized, partially-blinded, prime-boost, staggered dose-escalation Phase 1 study intended to assess the safety, tolerability, and immunogenicity of the Coronavirus-Like Particle COVID-19 Vaccine at three dose levels (3.75 µg, 7.5 µg, and 15 µg VLP) unadjuvanted or adjuvanted with either CpG 1018 or AS03 in healthy adults 18 to 55 years of age, who have been tested for the absence of SARS-CoV-2 antibodies. At each dose level, the vaccine will initially be administered to a small number of subjects. Vaccinations of the first 6 subjects at the lowest dose level will be staggered so that each vaccination must be performed at least 30 minutes apart. Vaccination of the remaining subjects at the same dose level and the next higher vaccine dose level will be administered with approval of the Independent Data Monitoring Committee (IDMC). The same process will be followed for the second vaccine administration. All subjects will be followed for a period of 12 months after the second administration of the vaccine for safety and immunogenicity testing at the end of the follow-up period.
Federal Research Clinical Center of Federal Medical & Biological Agency, Russia
As coronavirus disease 2019 (COVID-19) spreads across the world, the intensive care unit (ICU) community must prepare for the challenges associated with this pandemic. Providing an efficient care to the patients of the most severely affected category - intensive care unit (ICU) patients - has become one of the serious problems appearing in the COVID-19 pandemics. A typical patient's clinical portrait in ICU of COVID centers is very similar in different countries, however, the key to improve the treatment results for critically ill patients has not yet been found. Data on predictors of severe course in COVID-19 is limited. Knowledge of predictors of severe course of disease can lead to different selection of therapeutic strategy, determine the group of risk of patients for severe course of disease, and improve outcomes.
Central Hospital, Nancy, France
In order to inform the public decision on the containment strategy and knowledge of the intensity of the epidemic during post-containment, estimates of the share of the population infected with the SARS-CoV-2 virus responsible for COVID-19 disease at the territorial level are needed as soon as possible. The aim of the study is to estimate the prevalence of positive anti-SARS-CoV-2 serologies by detection of IgT-total antibodies (IgM/IgA/IgG) in the general population of the Grand Nancy Metropolitan area. A study of seroprevalence and symptom collection, or absence of symptoms, on a cluster (household) sample of the Grand Nancy Metropolitan population randomly selected will be conducted. The target population consists of all the inhabitants of the Grand Nancy Metropolitan area, from which a sample is drawn from the electoral lists (households) in a random manner to ensure representativeness. In order to ultimately include 2000 people in the study
Coalition for Epidemic Preparedness Innovations
This study aims to evaluate the safety and reactogenicity profile after 1 and 2 dose administrations of CVnCoV at different dose levels.
Corporacion Parc Tauli
Prospective observational trial in patients admitted to ICU diagnosed with COVID-19 requiring invasive mechanical ventilation. Characterization of Reverse Triggering asynchrony during the first 5 days of invasive mechanical ventilation and other asynchronies, and its correlation with different outcomes.
International 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.
Medical College of Wisconsin
This study will evaluate the feasibility of self-sampling with the iAMP® COVID-19 Detection Kit (Atila BioSystems, Mountain View, CA), a new, low-cost SARS-CoV-2 test that does not require RNA extraction. The investigators will compare the sensitivity and specificity of the iAMP® assay on self-sampled mid-turbinate, anterior nares, and saliva swabs against the gold standard, a nucleic acid amplification testing assay on a clinician-collected nasopharyngeal swab.
I.M. Sechenov First Moscow State Medical University
Data on respiratory mechanics and gas exchange in acute respiratory failure in COVID-19 patients is limited. Knowledge of respiratory mechanics and gas exchange in COVID-19 can lead to different selection of mechanical ventilation strategy, reduce ventilator-associated lung injury and improve outcomes. The objective of the study is to evaluate the respiratory mechanics, lung recruitability and gas exchange in COVID-19 -associated acute respiratory failure during the whole course of mechanical ventilation - invasive or non-invasive.
Azienda Ospedaliero-Universitaria Careggi
This study is part of the current global emergency scenario due to infection with Coronavirus, SARS-CoV-2 as indicated by the international taxonomy. Study aim is to investigate the possibility of the presence of the virus within the seminal fluid and in the urine of infected patients, both during the acute phase and remotely. Current evidences show that Coronaviruses can be present inside the testicle and sperm in other species, such as in feline and avian models. In human beings, current researches have mixed results regarding the presence of SARSCoV-2 in urine, as several studies with a large sample found no traces of the same with Real-Time Reverse method Transcriptase - Polymerase Chain Reaction or with method of nucleic acid amplification. By contrast, in just over 6% of 58 patients with Real Time Polymerase Chain Reaction method have found the presence of SARS-CoV-2 in the urine, even at a distance from the last negative nasopharyngeal swab. Given the topicality of the problem, our study has the objective of specifically researching the presence and possible persistence over time of SARS-CoV-2 in seminal fluid and urine. A saliva sample will also be collected as a control. At the moment there are no studies in literature that tested this possibility. If confirmed, it would lead to find out another potential method of transmission, the sexual one, in asymptomatic patients or apparently no longer infectious with negative buffer. The rationale for our study is the evidence that in other species this type of transmission by coronaviruses is possible and that at present it has not been verified in mankind. The relevance of the study would be both in the case of a negative result, as the first study in its generally, both in the case of a positive result, due to the possibility of introducing new prevention measures in the long run.
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
By applying polymerase chain reaction (PCR) test for Covid-19 to preeclampsia patients who applied to our hospital during the Covid-19 pandemic period, we investigated the frequency of Covid-19 related preeclampsia-like syndrome in this patient group.