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 10 of 145Orthosera Kft.
Why is the research needed? The pandemic known as COVID-19 is now spreading across the world with currently (April 10, 2020) more than 1 115 530 active cases and 96 791 deaths. In most affected countries the current goal is to 'flatten the curve' of the epidemic since there is no health care system that is able to treat an extremely high volume of patients all at once. There is a need for immediately applicable treatments for the patients at highest risk, which gains time until targeted therapies become available. A key feature in the pathomechanism of the disease is that the virus elicits an immunological over-reaction in the human body termed 'cytokine storm'. In susceptible patients this hyper-inflammation itself is a significant burden and may even inhibit the body to generate antibodies against the virus in adequate quantities. Therefore, identifying the subset of patients with excess cytokine response and supplementing them with convalescent plasma from recovered donors may be a life-saving treatment option. What is our study about? In light of recent promising data on plasma therapy in the treatment of COVID-19 and other viral epidemics, there is a need for better understanding the cytokine response to the virus in order to better characterize the target population for convalescent plasma therapy. Our hypothesis is that convalescent plasma transfusion from healthy donors who recovered from SARS CoV-2 is able to reduce the cytokine storm in addition to replenish the patient's own antibodies in the acutely infected phase of the disease. A plasmapheresis donation of 400ml will be performed in subjects who recovered from COVID-19 and who are otherwise eligible for plasma donation. The sample will be tested for anti-SARS CoV-2 neutralizing antibody titers and those that reach the level of 1:320 will be processed for transfusion at the Hungarian National Transfusion Service. Recipients will be COVID-19 patients requiring hospitalization regardless of the severity of the disease or other co-morbidities. A blood-type matched transfusion of 200 ml convalescent plasma will be infused in a single sitting through an iv. infusion of 4 hours. Recipients will be followed up at days 1, 3,7,12, 17, 28 for clinical symptoms, antibody levels and cytokine response.
Guangzhou Institute of Respiratory Disease
Coronavirus Disease 2019 (COVID-19) is spreading worldwide and has become a public health emergency of major international concern. Currently, no specific drugs or vaccines are available. For severe cases, it was found that aberrant pathogenic T cells and inflammatory monocytes are rapidly activated and then producing a large number of cytokines and inducing an inflammatory storm.Mesenchymal stem cells (MSCs) have been shown to possess a comprehensive powerful immunomodulatory function. This study aims to investigate the safety and efficacy of intravenous infusion of mesenchymal stem cells in severe patients with COVID-19.
Humanigen, Inc.
The primary objective of this study is to assess whether the use of lenzilumab in addition to current standard of care can alleviate the immune-mediated cytokine release syndrome (CRS) and improve ventilator-free survival in hospitalized subjects with severe or critical COVID-19 pneumonia.
Ain Shams University
Phase III Placebo-controlled adaptive multi-centre randomized controlled trial Interventional (Clinical Trial). The study will include nine hundred healthcare workers in the isolation hospitals for COVID-19 cases; they will be randomly assigned to receive either BCG vaccine or normal saline.
Laboratorios Clínicos de Puebla (Laboratorios Ruiz)
COVID-19 disease has become a very serious global health problem. Treatments for severe forms are urgently needed to lower mortality. Any procedure that improves these forms should be considered, especially those devoid of serious side effects.There is not enough published information on the use of allogeneic convalescent plasma (ACP) in the treatment of severe forms of COVID-19. The use of ACP can be combined with other treatments and has very few adverse effects. It takes 10-14 days for SARS-CoV2-infected patients to produce virus-neutralizing antibodies: within that time they can develop serious complications and die. Injecting PAC into patients with severe forms of COVID-19 shortens the period of risk while the patient produces the antibodies.
Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
The present study will try to respond first in an initial phase, what is the minimum effective dose necessary of convalescent plasma for getting better in severly ill (not intubated) or very severely ill (intubated) patients. Once the dose will be determined by each type of patient group (severely ill vs. very severely ill) has been determined, phase 2 of the study will begin, where the safety and efficacy of the use of plasma will be evaluated based on clinical, imaging and laboratory criteria. So, our hypotheses are: 1. Is there a minimum effective dose to treat seriously ill patients with convalescent plasma with COVID-19? 2. the plasma dose with the minimum effective effect will improve the clinical, laboratory and clearance conditions of the presence of the virus in the severely ill patient?
The Christ Hospital
The investigatores propose to evaluate intravenous administration of convalescent plasma (CP) obtained from COVID19 survivors in patients requiring hospitalization for symptomatic "high risk" COVID19 disease as reflected by the presence of elevated hsTPN. Supportive data exist for use of convalescent plasma in the treatment of COVID19 and other overwhelming viral illness. Investigators hypothesize that treatment with COVID19 CP will demonstrate salutary effects on COVID19 disease severity/duration, with the primary objective to reduce mortality and a key secondary objective to reduce the requirement for and/or duration of mechanical ventilation. Finally, as the hospital mortality for patients requiring mechanical ventilation is very high (50 to 80%), these patients will be eligible for COVID19 CP treatment as well, even in the absence of elevated hsTPN. Although considerable overlap of these populations has been observed (elevated hsTPN and requirement for mechanical ventilation) there is not 100% redundancy and it is hopeful that COVID19 CP may provide benefit to these critically ill patients.
Assistance Publique - Hôpitaux de Paris
There is very little data so far to determine whether people living with HIV (PLWHIV) are at greater risk of COVID-19 acquisition or severe disease. HIV infection is associated with deficiencies in both humoral and cell-mediated immunity that could potentially alter the course and severity of common infections. The investigators will study the correlation between clinical and immunovirological data. The singularity of this work is to have an in-depth immunovirological approach linked to the clinical characteristics in COVID-19 HIV co-infected patients. COVIDHIV is the only study to date to offer this combined approach in PLWHIV. This protocol is a historical and prospective cohort study of PLWHIV presenting COVID-19 The primary objectives are to describe the course of COVID-19 disease in patients infected with HIV
Ain Shams University
The aim of this project is to introduce way for treatment of patients with severe COVID-19 disease with respiratory complications.
University of Roma La Sapienza
In light of its high morbidity and mortality, COronaVIrus Disease 19 (COVID-19) pandemic spread is considered an unprecedented global health challenge. Given the very limited therapeutic options available against Severe Acute Respiratory Syndrome - CoronaVirus-2 (SARS-CoV-2) epidemic at this time, the evaluation of new resources, designed in the first instance for other pathologies but potentially active against COVID-19, represents a priority in clinical research. This is an observational, retrospective, non-profit study on the adjuvant use of bacteriotherapy in the early control of disease progression in patients affected by COVID-19 and treated with the current standard of care on the basis of the interim guidelines of the Italian Society of Infectious and Tropical Diseases. The main purpose of the study is to evaluate the effectiveness of bacteriotherapy in reducing the clinical impact of acute diarrhea, containing the progression of COVID-19 and preventing the need for hospitalization in intensive care units.