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 20 of 58Emory University
The purpose of this pilot study is to measure the impact of non-invasive pneumatic manipulation of transthoracic pressure on oxygenation in patients with Acute Respiratory Distress Syndrome (ARDS) due to Coronavirus Disease 2019 (COVID 19) who are on mechanical ventilator support. This will be achieved by a pneumatic Vest placed around the chest wall of consenting patients who meet inclusion criteria. The Vest is essentially a non-invasive segmental device placed upon the anterior and posterior right and left aspects of the chest wall. The researchers have the ability to inflate and deflate the chambers of the Vest to achieve preset pressures as determined by the protocol and observe the patient's physiological response. Participants will have up to four hours of intervention with the study intervention, followed by 1 hour of post-intervention observation.
Jessa Hospital
Rationale In a very short time corona virus disease 2019 (COVID-19) has become a pandemic with high morbidity and mortality. The main cause of death is respiratory failure including acute respiratory distress syndrome, however the exact mechanisms and other underlying pathology is currently not yet known. In the current setting of the COVID-19 pandemic complete autopsies seem too risky due to the risk of SARS CoV-2 transmission. Yet, as so little is known, additional histopathological, microbiological and virologic study of tissue of deceased COVID-19 patients will provide important clinical and pathophysiological information. Minimal invasive autopsy combined with postmortem imaging seems therefore an optimal method combining safety on the one hand yet proving significant information on the other. This study aims to determine the cause of death and attributable conditions in deceased COVID-19 patients. This will be performed using post-mortem CT-scanning plus CT-guided MIA to obtain tissue for further histological, microbiological and pathological diagnostics. In addition, the pathophysiology of COVID-19 will be examined by further tissue analysis.
Robert W. Alexander, MD
COVID-19 Viral Global Pandemic resulting in post-infection pulmonary damage, including Fibrotic Lung Disease due to inflammatory and reactive protein secretions damaging pulmonary alveolar structure and functionality. A short review includes: - Early December, 2019 - A pneumonia of unknown cause was detected in Wuhan, China, and was reported to the World Health Organization (WHO) Country Office. - January 30th, 2020 - The outbreak was declared a Public Health Emergency of International Concern. - February 7th, 2020 - 34-year-old Ophthalmologist who first identified a SARS-like coronavirus) dies from the same virus. - February 11th, 2020 - WHO announces a name for the new coronavirus disease: COVID-19. - February 19th, 2020 - The U.S. has its first outbreak in a Seattle nursing home which were complicated with loss of lives.. - March 11th, 2020 - WHO declares the virus a pandemic and in less than three months, from the time when this virus was first detected, the virus has spread across the entire planet with cases identified in every country including Greenland. - March 21st, 2020 - Emerging Infectious Disease estimates the risk for death in Wuhan reached values as high as 12% in the epicenter of the epidemic and ≈1% in other, more mildly affected areas. The elevated death risk estimates are probably associated with a breakdown of the healthcare system, indicating that enhanced public health interventions, including social distancing and movement restrictions, should be implemented to bring the COVID-19 epidemic under control." March 21st 2020 -Much of the United States is currently under some form of self- or mandatory quarantine as testing abilities ramp up.. March 24th, 2020 - Hot spots are evolving and identified, particularly in the areas of New York-New Jersey, Washington, and California. Immediate attention is turned to testing, diagnosis, epidemiological containment, clinical trials for drug testing started, and work on a long-term vaccine started. The recovering patients are presenting with mild to severe lung impairment as a result of the viral attack on the alveolar and lung tissues. Clinically significant impairment of pulmonary function appears to be a permanent finding as a direct result of the interstitial lung damage and inflammatory changes that accompanied. This Phase 0, first-in-kind for humans, is use of autologous, cellular stromal vascular fraction (cSVF) deployed intravenously to examine the anti-inflammatory and structural potential to improve the residual, permanent damaged alveolar tissues of the lungs.
Insel Gruppe AG, University Hospital Bern
COVID-19 patients with a severely symptomatic progression with development of an Acute respiratory distress syndrome (ARDS) due to SARS-CoV-2 need prolonged intensive care treatment involving pharmacological immobilization, sedation and mechanical ventilation, leaving them at a very high risk for developing Critical illness myopathy (CIM). CIM is associated with increased mortality and significant consequences for recovery and the ability to return to normal daily life. Up to date, there are no studies investigating the mid- or long-term course of the novel COVID-19 disease. The present study therefore aims to evaluate the clinical outcome of patients with ARDS due to SARS-CoV-2 with special attention to the development of CIM and its underlying causes. To provide the possibility of early diagnosis of CIM, critically ill patients will be regularly screened for muscle membrane alterations using (Muscle velocity recovery cycles) MRVC measurements. The primary endpoint is the incidence of CIM in patients with ARDS due to SARS-CoV-2, diagnosed according to the current diagnostic criteria.
Shirley Ryan AbilityLab
1. Develop a wearable sensor package to gather data on COVID-19-like signs and symptoms such as elevated body temperature, respiratory parameters, heart rate ,cough and gait. 2. Create algorithms to monitor and track changes to COVID19-like signs and symptoms for developing a better care and isolation strategies for COVID-19 pandemic.
National Cancer Institute (NCI)
This study collects blood samples, medical information, and medical images from patients who are being treated for cancer and have a positive test for SARS CoV-2, the new coronavirus that causes the disease called COVID-19. Collecting blood samples, medical information, and medical images may help researchers determine how COVID-19 affects the outcomes of patients undergoing cancer treatment and how having cancer affects COVID-19.
ElectroCore INC
The study is a prospective, randomized, controlled investigation designed for comparison of two groups for the reduction of respiratory distress in a CoViD-19 population, using gammaCore Sapphire (nVNS) plus standard of care (active) vs. standard of care alone (SoC), the control group. The gammaCore® (nVNS) treatments will be used acutely and prophylactically. The aims of this study are to summarize and compare the incidence of clinical events and pro-inflammatory cytokine levels in patients randomized to use of gammaCore Sapphire plus standard of care vs standard of care alone in patients hospitalized for CoViD-19. Secondary objectives are demonstrate the safety of gammaCore Sapphire use in patients hospitalized for CoViD-19.
Cairo University
Until now there is no vaccine or reliable treatment for the COVID-19 pandemic. The fundamental mechanisms of non-invasive low-level laser in photobiomodulation (PBM) and photodynamic therapy is to stimulate the mitochondrial respiratory chain where a transient release of non-cytotoxic levels of reactive oxygen species (ROS) will lead to positive modulation of the immune response. As previous studies mentioned that the most important strategy for COVID-19 management is oxygenation and faster rehabilitation of the damaged tissue, antiviral effects, and, finally, reduction or controlling the cytokine storm by reducing inflammatory agents. PBM may be used as adjuvant therapy or even an alternative therapy in all these mechanisms without side effects and drug interactions. Objectives The objective of this clinical trial is to use the photobiomodulation therapy (PBMT), and photodynamic therapy as adjuvant therapy or even an alternative therapy for Covide-19. Patients and methods A randomized controlled study will be conducted on 60 patients of positive COVID 19. The patients will be divided into 3 equal groups. Group, I will receive a low-level laser (diode laser 980nm) from laser watch for 30 minutes, 20 J for 3 to 5 days, and laser acupuncture. Group 2 will be treated with photodynamic therapy by injecting the methylene blue as a photosensitizer and irradiated with laser watch (diode laser 670 nm). Group 3 will serve as a control. Evaluation methods will include laboratory investigations and CT chest.
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.
National Cancer Institute (NCI)
This phase III trial compares low dose whole lung radiation therapy to best supportive care plus physicians choice in treating patients with COVID-19 infection. Low dose whole lung radiation therapy may work better than the current best supportive care and physician's choice in improving patients' clinical status, the radiographic appearance of their lungs, or their laboratory blood tests.