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 750 of 1911Rockefeller University
This study is 'A Randomized Phase 1 Double Blind Placebo Controlled, Single-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Orally Inhaled Aerosolized Hydroxychloroquine Sulfate in Healthy Adult Volunteers.' The primary objectives are as follows: - To assess the safety and tolerability of AHCQ administered as a single dose by oral inhalation in healthy individuals at escalating doses until either the maximum tolerated dose (MTD) is identified or 1 mL of a 50 mg/mL solution is administered. - To determine the recommended Phase 2a dose (RP2D). Secondary objectives: • To characterize pharmacokinetics (PK) of single dose AHCQ in healthy individuals.
Hanane EL KENZ
When the COVID-19 virus infects a person, it enters the lung epithelial cells of its host and uses its genetic material to replicate. The pulmonary epithelial cells of a part of the population, known as "secretors", are capable of expressing the antigens of the "ABO" system on their surface. This secretory status can be established by determining the antigens of the Lewis blood group system. When the virus replicates in an "secreting" individual, the antigens of the "ABO" system of the infected individual will be present on the surface of the viruses formed in his/her lungs. It was shown in 2003 that the response of a given individual to the transmission of a virus depends on his/her blood group and on the antigens of the "ABO" system carried by the virus. A patient of group "O" would thus defend himself much better against a virus carrying antigens of blood group "A", the natural antibodies "anti-A" of the patient reducing the ability of the virus to bind to its specific receptor on pulmonary epithelial cells, to penetrate them to replicate itself. The first data collected in Wuhan (China) seems to confirm this hypothesis. A COVID-19 virus transmission model can therefore be established on the basis of blood groups. In order to reduce the spread of the virus among nursing staff, it is possible to establish a preferential algorithm for patient management based on the "ABO" and "Lewis" blood groups of patients and "ABO" of nursing staff in health care units, if operational and human conditions allow.
GCS Ramsay Santé pour l'Enseignement et la Recherche
The objective of this study is to look for the presence of SARS-CoV-2 in the semen of patients diagnosed with COVID+ based on RT-PCR analysis of nasopharyngeal swabs.
AO GENERIUM
It is a multicenter, open-label, randomized, parallel-group study of the efficacy and safety of Tigerase® (GENERIUM JSC, Russia) with standard therapy versus standard therapy in patients with COVID-19.
Cairo University
This observational study aims at Assessment of the prevalence and types Psychiatric disturbances that affects patients with COVID-19 infection with and without previous psychiatric diseases. in addition to, Assessment of the types of Psychiatric disturbances in patients with COVID-19 infection in correlation to age, disease severity, co-morbid conditions and treatments applied
University of Wisconsin, Madison
The purpose of this research study is to evaluate and improve a rapid COVID-19 test. The test is designed to identify people who are most contagious and likely to spread the virus to others. This test will be performed at various locations in the Madison area using a mobile laboratory or standard lab space for processing. Saliva samples can be collected and processed at these locations or participants can self-collect at home and drop their samples off at designated locations for same day processing. Results of potential findings of clinical significance will be communicated to the participants by a physician with appropriate expertise on the study team. Individuals with a potential finding of clinical significance will be encouraged to self-isolate and obtain a diagnostic test at their earliest convenience. No results will be given if the test is negative. If the participant consents, advanced molecular testing such as PCR or viral sequencing can be done and results can be shared via online databases, presentations and publications along with the date, site and county of collection to help facilitate tracking the spread of the virus.
Emory University
COVID-19 is increasingly affecting children but convalescent plasma (CP) has not been adequately studied in children to date. The study will determine safety of convalescent plasma for pediatric patients with severe, or at high risk for severe, COVID-19 disease.
Amarin Pharma Inc.
The PREPARE-IT investigator-initiated trial program is a simple, pragmatic, therapeutic strategy evaluating pure icosapent ethyl (IPE) at initially higher doses intended to reduce infection rates and subsequent morbidity and mortality among subjects at high risk of infection due to COVID-19 (prevention arm), and to reduce the hospitalization rate and complications in patients with a positive diagnosis of COVID-19 (treatment arm).
Alexandria University
This research is planned to illustrate the efficacy of Therapeutic Plasma Exchange (TPE) treatment in COVID-19 patients with resistant cytokine storm state.
Postgraduate Institute of Medical Education and Research
Coronavirus-2019 (COVID-19) caused by severe acute respiratory syndrome-associated coronavirus-2 (SARS-CoV-2) has affected the lives of millions of individuals globally and severely strained the medical community. Pre-symptomatic and asymptomatic SARS-CoV-2 positive individuals far outnumber the symptomatic ones or those with severe disease. The transmission potential of SARS CoV-2 is potentially greator than earlier viral outbreaks of SARS-CoV and MERS-CoV. Identification of asymptomatic carriers of SARS-CoV-2 infection is paramount to contain viral infection because of high transmission potential Routine measures of social distancing, personal hand hygiene and limited outdoor contact activities have shown benefits to limit corona virus infection. However, the role of vitamin D in SARS-CoV-2 infection is not explored despite the knowledge of an immunomodulatory role and protective effect of vitamin D against viral infections. It has been found that mortality from COVID-19 is more in countries with vitamin D deficiency. The role of therapeutic vitamin D supplementation in asymptomatic individuals with vitamin-D deficiency and COVID-19 is not known. Immune-modulatory effect of vitamin D is likely to be observed at 25(OH)D levels which are considered higher than that required for normal bone metabolism.An earlier SARS-CoV-2 negativity may have significant public health benefits in limiting the spread of the disease. Therefore, we hypothesise that high dose vitamin D supplementation in patients with COVID-19 and vitamin D deficiency may lead to SARS-CoV-2 negativity in greater proportions of patients associated with decrease in serological markers of inflammation.