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 160 of 431Instituto Mexicano del Seguro Social
This study aims to identify the preference of the class modalities (classroom or online) in undergraduate and graduate students. Additionally, to explore if the presence of any mental state alterations such as depression or anxiety due to the COVID-19 pandemic can alter their perception of academic performance.
Aljazeera Hospital
Covid 19 is a pandemic infection developed in late 2019
Vielight Inc.
The objective of this study is to obtain data on the efficacy of the Vielight RX Plus in decreasing time to recovery of symptoms in subjects with COVID-19. The study will be conducted among COVID-19 positive subjects at home in self-isolation via electronic data collection (EDC). There will be no physical contact between the subjects and the Qualified Investigator (QI) or other study staff. This study aims to demonstrate that the Vielight RX Plus is a useful adjunct to standard of care (SOC). We hypothesize that the Vielight RX Plus will accelerate recovery and reduce viral infection severity.
UserWise, LLC
This is an observational, prospective, non-randomized, non-significant risk study collecting voice recordings from subjects who are being tested for COVID-19 by laboratory analysis of specimens obtained by nasal or naso-pharyngeal (NP) swab. Patients record their voices through an app on their mobile phone. Patients and health care providers will be blinded to the swab test results during Phase 2 of the study.
St George's University Hospitals NHS Foundation Trust
In December 2019, a novel coronavirus (SARS-CoV-2) emerged in Wuhan, Hubei, China, and now spreads across international borders. As of 11 April 2020, the total global number of confirmed SARS-CoV-2 cases reached 1,521,252 (92,798 deaths); with 65,081 (7,978 deaths) being reported in the United Kingdom. COVID-19 is the name of the disease associated with SARS-CoV-2 infection and includes a spectrum of illness that ranges from mild infection to severe pneumonia that can progress to respiratory failure and Acute Respiratory Distress Syndrome (ARDS) or septic shock. Between 8 to 15% (depending on geographical setting) of all SARS-CoV-2 positive cases can be classified as severe or necessitating intensive care unit (ICU) admission. In the early stages of the outbreak unfolding, several retrospective case studies and cases series carried out in China reported that those who died were more likely to be male, and more likely to have underlying comorbidities. Prevalence studies conducted in the US and Italy show similar trends in the distribution of comorbidities among SARS-CoV-2 severe cases; adding obesity (BMI>30) to the list of factors potentially associated with disease severity. However, the relative importance of different underlying health conditions remains unclear owing to inadequate adjustment for important confounding factors such as age, sex, and smoking status. We propose a cohort study to evaluate predictors, clinical evolution and excess of mortality of SARS-CoV-2 in hospitalised patients, with two main workstreams- the first looking at all patients admitted to SGHFT and the second looking at patients admitted to ITU with respiratory failure.
US Department of Veterans Affairs
The purpose of this study is to assess the safety and efficiency of an assembled modified mask in protecting health care workers against Coronavirus in case of any personal protective equipment shortage. At least 20 healthy participants will be recruited to try the modified mask. The modified masks will be made from masks that are already available as well as filters available in the pulmonary department at the Oklahoma City VA Health Care System
Gaziosmanpasa Research and Education Hospital
According to various studies Covid 19 pneumonia has a very similar clinical course to Acute Respiratory Distress Syndrome (ARDS) which has clarified by Berlin definition. Based on this similarity, extracellular fluid of lungs and diffuse alveolar damage should be observed in covid 19 pneumonia as well. Extracellular water (ECW) can be determine by using whole body bioimpedence system (NİCaS). The aim of this study is to investigate the effect of ECW on the clinical apperence of covid 19 pneumonia clinical course.
Assistance Publique - Hôpitaux de Paris
Covid-19 infection is due to SARS-CoV-2 member of the Coronavirus family represented by SARS- and MERS-CoVwith neuronal tropism capacity for the brainstem and thalami. Dexmedetomidine has(i) central antihypertensive (ii) sedative and (iii) neuroprotective properties and is often used during patient recovering after mechanical ventilation withdrawal. Dexmedetomidine administration could change the immunomodulatory profile of Covid-19 patients and reduce inflammatory response.CAM-ICU scores and Blood samples from Covid-19 ICU patients will be collected at 4 different timepoints (before Dexmedetomidine administration, at D2, D7 and M6) to analyse the inflammatory profile with different approaches:i) chromatin accessibility, ii) transcriptome analysis, iii) inflammatory cytokines and chemokines levels.
ExThera Medical Corporation
Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) has caused a global pandemic and is associated with significant morbidity and mortality. The mortality rate for COVID-19 patients admitted to an intensive care unit (ICU) who require mechanical intubation is approximately 75%. While the pathophysiology of severe COVID-19 has yet to be fully understood, it is possible that a combination of high viral loads and an overactive dysregulated inflammatory response may contribute. Therefore, the clearance of SARS-CoV-2 virus and cytokines could provide a more opportunistic environment for the innate immune system to clear the virus and establish lasting immunity. The Seraph®-100 Microbind® Affinity Blood Filter (Seraph®-100) is an extracorporeal broad-spectrum sorbent hemoperfusion filter for removing virus and cytokines from the blood. The FDA authorized an Emergency Use Authorization (EUA) for treatment of severe COVID-19 with the Seraph®-100. As part of the EUA, this registry study will collect de-identified data to assess safety and efficacy on the use of Seraph®-100 Microbind® Affinity Blood Filter in the treatment of COVID-19 patients.
Hospices Civils de Lyon
Although SARS-CoV-2 (Severe Acute Respiratory Syndrome-associated coronavirus) due to COVID-19 evolves poorly towards ARDS (Acute Respiratory Distress Syndrome) and death, there is to date no validated drug available for severe forms of COVID-19. Patients with COVID-19 undergo a drastic decrease of T lymphocytes (LT) count, while the remaining ones display an "exhausted" phenotype, due to immunosuppressive pathway activation among which the Programed cell Death 1 (PD1) receptor pathways. LT exhaustion is responsible for host anergy towards viral infection and leads to increased risk of severe forms of COVID-19. Moreover, while the number of systemic LT PD1+ correlates with poor prognosis clinical stages of COVID-19 infection, healing from COVID-19 associates with LT PD1 expression normalization. Chinese epidemiologic data identified clinical risk factors of poor clinical evolution (i.e. ARDS or death), among which is found obesity, similarly to observation previously obtained during H1N1 infection (flu virus). Obese persons display meta-inflammation and immune dysfunction, a condition similar to ageing, thus termed "Inflamm-aging", thus also used during obesity. Inflamm-aging, characterized by cytotoxic LT exhaustion and reduced NK cell (Natural Killer cell) cytotoxic function secondary to PD1 pathway activation, could contribute to the poor prognosis observed during cancer and infection in obese individuals. We hypothesize that the immunocompromised profile observed during obesity contribute to their vulnerability towards COVID-19. In cancer or certain infection diseases, NIVOLUMAB, an anti-PD1 monoclonal antibody, restores exhausted LT immunity. We thus hypothesize that NIVOLUMAB-induced immunity normalization could (i) stimulate anti-viral response also during COVID-19 infection and (ii) prevent ARDS development, which has previously been associated with low LT count concomitant with increased inflammatory cytokine production. This randomized controlled therapeutic trial, using an add-on strategy to usual standard of care, aims at demonstrating the efficacy and safety of NIVOLUMAB-induced cytotoxic LT normalization, to improve clinical outcomes in hospitalized COVID-19+ adult obese individuals with low LT, since they are at risk of poor prognosis. We postulate that NIVOLUMAB will increase the number of individuals able to stop oxygen therapy at D15