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 160 of 225DR. JASSIM ALGHAITH
This study aims to evaluate the effectiveness of respiratory muscle training with COVID-19 patient, who has underlying health conditions, in order to delay or prevent them from admitting to ICU.
San Bortolo Hospital - Vicenza
The novel coronavirus disease (COVID-19) is posing a serious challenge to the health-care systems worldwide, with an enormous impact on health conditions and loss of lives. More than 30 millions of recoveries worldwide were registered at the end of October 2020 with more than 1 million of deaths. As the disease continues to spread, strategies aimed to reduce hospitalization time in sub intensive unit care, thus reducing pressure on health system, but also to reduce some of the pathological features of COVID-19 such as inflammation and the "cytokines storm". The ketogenic diet is a high fat, low carbohydrate, adequate-protein diet that promotes a physiological ketosis (due to an increase of liver ketone bodies production). High fat, low carbohydrate diets have been shown to reduce duration of ventilator support and partial pressure carbon dioxide in patients with acute respiratory failure. Moreover, the physiological increase in plasma levels of ketone bodies exerts important anti-inflammatory and immunomodulating effects, which may reveal as precious tools to reduce potential adverse outcomes of COVID-19 disease. The hypothesis of this study is that the administration of a ketogenic diet will improve gas exchange, reduce inflammation, and the duration of hospitalization. The plan is to enrol 28 patients with diagnosis of COVID-19 hospitalized but not in ICU with SPO2 higher than 88%.
University of Zurich
Randomized controlled trial to analyse adjuvant therapeutic plasma exchange (TPE) in severe Covid-19 associated coagulopathy and systemic inflammation compared to current standard of care (SOC). A total of three TPEs (d1, 3, 5) will be performed in the intervention group. Primary endpoint is the reversibility of relative ADAMTS13 deficiency (indicated by the change in ADAMTS13 / VWF:Ag ratio from day 1 to 7).
Instituto de Terapia Celular: ITC
The propose of this study is implement adjuvant therapy with adipose tissue derived-mesenchymal stem cells (MSCs) for critical COVID-19 patients admitted to the intensive care unit of the Regional Hospital Lic. Adolfo López Mateos of the Institute for Social Security and Services for State Workers to reduce cytokine storm and contribute to the favorable resolution of respiratory insufficiency and multiple organic failure.
Israel Institute for Biological Research (IIBR)
The SARS-CoV-2 virus is responsible for the COVID-19 pandemic. The pandemic emerged from Wuhan Province in China in December 2019 and was declared by the WHO Director-General a Public Health Emergency of International Concern on 30 January 2020. In this study, a vaccine developed by IIBR for SARS-CoV-2 virus will be assessed for its safety and potential efficacy in volunteers. The study is comprised of two phases, a dose-escalation phase (phase I) during which subjects (18-55 years old) will be randomly allocated to receive a single administration of IIBR-100 100 at low, mid or high dose or saline or two administrations of IIBR-100 at low dose, or saline, 28 days apart. Based on results obtained during phase I, and cumulative phase I data review, the expansion phase (phase II) has begun, during which larger cohorts as well as elderly age subjects will be randomly allocated to receive a single administration of IIBR-100 at low, mid or high dose or saline, or two administrations of IIBR-100 at low, mid or high dose (prime-boost) or saline, 28 days apart. Additional top-dose (prime-boost) may be implemented when immunogenicity of any prime-boost arm is considered insufficient. Based on immunogenicity preliminary data and DSMB recommendations, the two administrations of mid, high and top dose (prime-boost) or saline will continue. The subjects will be followed for a period of up to 12 months post last vaccine administration to assess the safety and efficacy of the vaccine.
Skane University Hospital
One hundred patients hospitalized and in need of oxygen treatment due to Covid-19 should be randomized and 50% treated with 200 ml convalescent plasma x 3 and 50% given ordinary treatment. Primary outcome is number of days the patients need oxygen within 28 days from inclusion. Secondary outcome is number of days in hospital, number of days in respirator and mortality. Side effects of treatment is monitored.
University Hospital, Clermont-Ferrand
The hypothesis is that from a cluster defined by a confirmed positive case of COVID-19 and its contact cases, it is possible to study the different expressions and clinical evolutions of COVID-19 infection and to explore the biological profiles related to the observed clinical history. Certain biological determinants (virological, immunological, microbological or gentic) could indeed be correlated with the clinical presentation and/or be useful for personalized care. The main objective is to study the relationship between the biological profiles observed and the clinical evolutions within the same cluster of transmission of the coronavirus SARS-CoV-2 (positive COVID-19 cases and contact subjects).
University Hospital, Grenoble
Phase 1: 25 patients with a PCR-based diagnosis of Covid-19 will be be included to give 500 microliters of saliva and a 3 ml sample of blood for proteomic analysis; a drop of blood will also be put in a device connected to a silica matrix to perform spectrometric analyses. 25 patients with a non-Covid-19 respiratory infection will be included for the same samples. The proteomic analyses will be performed from classicaly draught blood, blood drop on silica, and saliva, to search for discriminating profiles between Covid-19 and non-Covid-19. Phase 2: 150 patients with a suspected Covid-19 will be included at the same time than the Covid-19PCR is performed ; they will have a sample of saliva and of a drop of blood for proteomic analysis, whose results will be matched with PCR results.
Guangzhou Institute of Respiratory Disease
This study is a multicenter, randomized, open, parallel-controlled study. Qualified subjects will randomly be assigned to the experimental arm or the control arm according to the ratio of 1:1, with age (> 60 years or ≤ 60 years), smoking status (yes/no) and forced expiratory volume in one second/prediction (FEV1 %pred > 60% or ≤ 60%) as the random stratification factors.
Hadassah Medical Organization
This is a multi-center, open-label study evaluating the safety of Allocetra-OTS, in up to 24 subjects with severe COVID-19 and respiratory dysfunction. Subjects, who will be identified as suffering from COVID-19, will be recruited. After signing an informed consent by the patient and, within 24+6 hours following the time of eligibility (time 0), on Day 1, eligible recipient subjects will receive single intravenous (IV) administration of investigational product as described below. Subjects will be hospitalized for COVID-19, and later as medically indicated. Following the investigational product (IP) administration (Day 1), subjects will be followed for efficacy and safety assessments through 28 days.