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 100 of 233Hoxworth Blood Center
The purpose of this research study is to learn more about the use of viral specific T-lymphocytes (VSTs) when given in the presence of COVID-19 signs and symptoms, caused by the virus SARS-CoV-2. VSTs are cells specially designed to fight viral infections. These cells are created from a blood sample collected from a donor who has recovered from COVID-19 infection. VSTs are investigational meaning that they are not approved by the Food and Drug Administration (FDA). COVID-19 is a new virus and treatment options are evolving rapidly. VSTs have been successfully used to treat many different viral infections and may be beneficial in treating COVID-19 in the absence of other treatments.
Dhaka Medical College
As of March 18, 2020, COVID-19 cases were reported in approximately 195 countries. No specific therapeutic agents or vaccines for COVID-19 are available. Several therapies, such as remdesivir and favipiravir, are under investigation, but the antiviral efficacy of these drugs is not yet known. The use of convalescent plasma (CP) was recommended as an empirical treatment during outbreaks of Ebola virus in 2014. A protocol for treatment of Middle East respiratory syndrome coronavirus (MERS-CoV) with CP was established in 2015. This approach with other viral infections such as SARS-CoV, H5N1 avian influenza, and H1N1 influenza also suggested that transfusion of CP was effective. In previous reports, most of the patients received the CP by single transfusion. In a study involving patients with pandemic influenza A(H1N1) 2009 virus infection, treatment of severe infection with CP (n = 20 patients) was associated with reduced respiratory tract viral load, serum cytokine response, and mortality. In another study involving 80 patients with SARS, the administration of CP was associated with a higher rate of hospital discharge at day 22 from symptom onset compared with patients who did not receive CP. Accordingly, these findings raise the hypothesis that use of CP transfusion could be beneficial in patients infected with SARS-CoV-2. The objective of this study is to describe the initial clinical experience with CP transfusion administered to severe COVID-19 patients. The primary endpoint of this trial would be to assess the tolerability, efficacy, and dose-response of CP in severe COVID-19 patients. The secondary endpoint would be to assess the clinical and laboratory parameters after therapy, in-hospital mortality, length of hospital stay, reduction in the proportion of deaths, length of ICU stay, requirement of ventilator and duration of ventilator support. All RT-PCR positive cases with features of severe infection will be enrolled in this study. Apheretic CP will be collected from a recovered patient (consecutive two RT-PCR samples negative) between day 22 to 35 days of recovery and those with the antibody titre above 1:320. This RCT will consist of three arms, a. standard care, b. standard care and 200 ml CP and c. standard care and 400 ml CP as a single transfusion. Twenty (20) patients will be enrolled for each arm. Randomization will be done by someone not associated with the care or assessment of the patients by means of a random number table. Allocations will be concealed in sequentially numbered, opaque, sealed envelopes. Clinical parameters [fever, cough, dyspnea, respiratory rate, PaO2/ FiO2 level, pulse, BP, the requirement of O2, and others] will be recorded before and after CP. Laboratory parameters such as complete blood count, CRP, chest X-ray, SGPT, SGOT, S. Ferritin, and serum antibody titre will be measured before and after transfusion. Allergic or serum sickness-like reactions will be noted and adjusted with outcome. Laboratory tests including RT-PCR will be done at BSMMU virology and laboratory medicine department. Apheretic plasma will be collected at the transfusion medicine department of SHNIBPS hospital, ELISA, antibody titre will be done at CMBT, and patients will be enrolled at DMC and MuMCH. All necessary screening tests will be done before transfusion. Graphpad Prism v 7.0 will be used for analysis. One way ANOVA test, a non-parametric Mann-Whitney test, and a Kruskal-Wallis test will be performed to compare the arms. For parametric outcomes, the investigators will compare the odds ratios across the pairs.
Baylor College of Medicine
This is a dose-finding safety trial followed by a randomized pilot trial comparing administration of SARS-CoV2-specific T cells (SARS-CoVSTs) to standard of care treatment in hospitalized patients with COVID19 who are at high risk of requiring mechanical ventilation. The SARS-CoVSTs lines have been made at Baylor College of Medicine from healthy donors who have made a full recovery from COVID19. These cell lines were frozen for later use and will be thawed and used to treat patients who meet the eligibility criteria.
Inova Health Care Services
The investigators hypothesize that use of convalescent plasma donated from individuals recovered from Coronavirus Disease 2019 (COVID-19) will help expedite recovery of individuals with active, severe COVID-19 infection.
Merck Sharp & Dohme LLC
The primary objective of this early Phase 1/2 study is to identify the V591 dose that achieves the target immune response in humans based on preclinical or early clinical data.
University of Utah
The purpose of this study is to explore the effectiveness of processed human amniotic fluid as a treatment for COVID-19.
Maimonides Medical Center
This study is a prospective randomized controlled, double blind clinical trial performed on laboratory confirmed COVID-19 infection admitted patients in the Shamir Medical Center. The trial will include 30 patients who will undergo either hyperbaric oxygen therapy (HBOT) or Normobaric oxygen therapy (NBOT), randomized on a 2:1 ratio, within 4 days in addition to the standard treatment including oxygen, drugs, steroids, bronchodilators, antibiotics and others. The evaluation procedure includes symptom monitoring, room air saturation, vital signs monitoring, pulmonary function and blood tests at baseline, one day and one week after the last session. In addition, one hour prior to and post session saturation and vitals will be monitored.
Centre Hospitalier Universitaire Dijon
To date, nearly 2 million people, including at least 100,000 in France, have been infected with SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2). This infection is very heterogeneous in nature, ranging from asymptomatic forms to acute respiratory distress syndrome patterns in 6.1% of cases, leading to an estimated overall mortality of 5.2%. Apart from age, few risk factors for a pejorative evolution have been identified: arterial hypertension, diabetes, cardiovascular history, obesity and chronic respiratory pathology in particular. The median incubation period is 5 days and the median time between the appearance of the first symptoms and the onset of hypoxia requiring admission to intensive care is 7 to 12 days. The mechanisms involved in the occurrence of these secondary worsening patterns are unclear. One hypothesis is that it is related to an inappropriate inflammatory response rather than a direct cytopathic effect of the virus. The objective of this study is to measure the intensity of the T lymphocyte response in patients hospitalized for Cov2 SARS infection in order to determine whether the intensity of the response is associated with worsening of symptoms.
Northside Hospital, Inc.
The plan is to transfuse COVID-19 infected patients with convalescent plasma and observe whether this will result in a significant improvement in clinical outcome in comparison to historical experience.
Assistance Publique Hopitaux De Marseille
COVID/Homeless is a prospective observational cohort study of homeless people to determine the impact of the SARS-CoV-2 epidemic on this population. The cohort aims for exhaustiveness for the city of Marseille, being based on the active files of the partner teams, namely the four emergency shelters of Marseille and 12 outreach teams (including one specialized in psychiatry, three specialized in addictions, and three working in squats and shantytowns). Aims of this cohort include to identify of the prognostic factors of morbi-mortality of homeless people by COVID-19, and therefore to propose appropriate management strategies.