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 110 of 379Aferetica
The outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which originated in Wuhan, China, has become a major concern all over the world. Convalescent plasma or immunoglobulins have been used as a last resort to improve the survival rate of patients with SARS whose condition continued to deteriorate despite treatment with pulsed methylprednisolone. Moreover, several studies showed a shorter hospital stay and lower mortality in patients treated with convalescent plasma than those who were not treated with convalescent plasma. Evidence shows that convalescent plasma from patients who have recovered from viral infections can be used effectively as a treatment of patients with active disease. The use of solutions enriched of antiviral antibodies has several important advantages over the convalescent plasma including the high level of neutralizing antibodies supplied. Moreover, plasma-exchange is expensive and requires large volumes of substitution fluid With either albumin or fresh frozen plasma, increasing the risk of cardiovascular instability in the plasma donor and in the recipient, which can be detrimental in a critically ill patient with COVID 19 pneumonia. The use of plasma as a substitution fluid further increases treatment costs and is associated with risk of infections, allergic reactions and citrate-induced hypocalcemia. Albumin is better tolerated and less expensive, but exchanges using albumin solutions increase the risk of bleeding because of progressive coagulation factor depletion. The aforementioned limitations of plasma therapy can be in part overcome by using selective apheresis methods, such as double-filtration plasmapheresis (DFPP)3. During DFPP, plasma is separated from cellular components by a plasma filter, and is then allowed to pass through a fractionator filter. Depending on the membrane cut-off, the fractionator filter retains larger molecules and returns fluid along with smaller molecules to the circulation. Thus, the selection of a membrane with an appropriate sieving coefficient for IgG allows to efficiently clear autoantibodies in patients with antibody-mediated diseases (e.g., macroglobulinemia, myasthenia gravis and rheumatoid arthritis) with negligible fluid losses and limited removal of albumin and coagulation factors1. In patients with severe membranous nephropathy and high titer of autoreactive, nephritogenic antibodies against the podocyte-expressed M type phospholipase A2 receptor (PLA2R), DFPP accelerated anti PLA2R depletion4. Measurement of the antibody titer in treated patient and recovered fluid showed that antibody removal was extremely effective and that large part of antibodies was removed during the first DFPP procedure. This therapeutic regimen was safe and well tolerated and easy to apply4. In an ongoing pilot study we found that the same methodological approach can be used to remove circulating antibodies from patients who recovered from COVID 19 and to infuse these antibodies in patients with active viral infection. Treatment was well tolerated and preliminary findings are encouraging. Thus, in this novel pilot study we aim to explore whether the infusion of antibodies obtained with one single DFPP procedure from voluntary convalescent donors could offer an effective and safe therapeutic option for patients with earlier stages of coronavirus (COVID-19) pneumonia requiring oxygen supply without mechanical ventilation.
Imperial College London
To determine whether the coagulopathy associated with COVID-19 infection is driven by overactivation of the renin angiotensin system (RAS)
Hellenic Institute for the Study of Sepsis
Based on findings of the interim analysis of the ACTIVATE study showing 53% decrease of the incidence of all new infections with BCG vaccination, a new trial is designed aiming to validate if BCG can protect against COVID-19 (Corona Virus Disease-19).The aim of the study is to demonstrate in a double-blind, placebo-controlled approach if vaccination of participants susceptible to COVID-19 with BCG vaccine may modulate their disease susceptibility for COVID-19. This will be validated using both clinical and immunological criteria. At the same time, a sub-study will be conducted and the mechanism of benefit from BCG vaccination by assessing its effect on vascular endothelial function and mononuclear blood cells will be studied
The Cleveland Clinic
This study intends to find out how a cloth mask may impact exercise capacity, to provide guidance for exercisers to adjust their expectations and training accordingly. The investigators plan to asses exercise capacity through estimated peak oxygen consumption (eVO2peak), oxygen saturation and level of perceived exertion during treadmill based exercise while wearing a cloth mask compared to exercising without a cloth mask. The potential significance of this study is to determine if subjects can exercise safely and if their exercise training needs to be adjusted while following the current recommendations of wearing a cloth mask in public. The degree of airflow limitation experienced will depend on the type and fit of the mask being worn, and inadequeate airflow could possibly result in CO2 re-breathing if all air was not fully discharged from the mask with each breath. This re-breathing of CO2 could potentially limit the workload leading to a detriment in performance, and increase in adverse symptoms such as dizziness, lightheadedness, chest pain or shortness of breath that does not improve with rest.
University of Sao Paulo General Hospital
The COVID-19 pandemic has been spreading continuously, and in Brazil, until May 31, 2020, there have been more than 450.000 cases with more than 28.000 deaths, with daily increases. The present study proposes to evaluate the efficacy and safety of convalescent plasma in treatment of severe cases of COVID-19 in a multicenter, randomized, open-label and controlled study
Northwell Health
The FDA has provided an emergency waiver for the use of non-invasive continuous glucose monitors (CGM) in hospitals, so frontline health care providers (in hospitals) can remotely monitor patients with diabetes thus reducing patient's discomfort, limiting exposure to COVID-19 and preserving critical personal protective equipment (PPE). The FreeStyle Libre 14-day system is a continuous glucose monitoring system consisting of a handheld reader (smart phone may be used) and a sensor applied with adhesive to back of the upper arm. In order to evaluate the reliability of the Freestyle Libre CGM for in-patient use, we propose a study which will examine the correlation between the libre CGM data and capillary blood glucose test - the current standard of care taken by the Accuchek Inform II platform.
Acellena Contract Drug Research and Development
the purpose of this study: to evaluate the safety, tolerability and immunogenicity of the drug "Gam-COVID-Vac Lyo", a lyofilizate for preparing solution for intramuscular administration, at various times after vaccination in healthy adult volunteers.
Emory University
Many patients with Coronavirus Disease 2019 (COVID-19) have atypical blood clots. These blood clots can occur in either veins or arteries and be large, like in stroke or heart attack, or very tiny, called microthrombi. Some patients with COVID-19 even have blood clots despite being on anti-clotting medications. Blood with increased viscosity does not flow through the body normally, in the same way that syrup, a highly viscous liquid, and water, a minimally viscous liquid, flow differently. The researchers believe that hyperviscosity may contribute to blood clots and organ damage seen in patients with severe COVID-19. Plasma exchange removes a patient's plasma, which contains the large sticky factors that the researchers believe are increasing viscosity, and replaces it with plasma from healthy donors. In addition to providing important information about plasma exchange as a treatment in COVID-19 for patients, this study will provide data to justify resource and staffing decisions. This study will enroll 20 participants who are critically ill from COVID-19. Participants will be randomized to receive therapeutic plasma exchange (TPE) or standard of care (SOC).
Metro Infectious Disease Consultants
This study will provide investigational convalescent plasma for patients infected with the SARS-CoV-2 with mild to moderate symptoms who meet inclusion criteria as judged by physician evaluation.
Acellena Contract Drug Research and Development
The purpose of the study is to assess safety, tolerability and immunogenicity of the drug "Gam-COVID-Vac ", a solution for intramuscular administration, with the participation of healthy volunteers Study objectives A safety and tolerability assessment of the drug "Gam-COVID-Vac ", solution for intramuscular administration, using single dose of each component (Stage 1). A safety and tolerability assessment of the drug "Gam-COVID-Vac ", solution for intramuscular administration, using prime-boost immunization according to the proposed scheme (Stage 2). Post-vaccination immunity assessment at different time points after vaccination by: - Determination of antigen-specific antibody titer in blood serum by ELISA by comparison with baseline values before the vaccine administration and at days 14, 21, 28, and 42 after vaccination (hereinafter, the countdown comes from the first time of the vaccine administration); - Determination of virus neutralizing antibody titer before and at days 14, 28, and 42 after vaccination; - Determination of antigen-specific cellular immunity (specific T-cell immunity) before the vaccine administration and at days 14 and 28 after vaccination.