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 310 of 364Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
In this trial, a total of 50 subjects were recruited; the test vaccines were divided into 3 groups, low-dose vaccine groups, high-dose vaccine groups, and placebo groups. The first-stage randomized participants in the low-dose group (20 cases) and the placebo group (5 cases) were evaluated for 7 days. After the 7-day safety data was evaluated and agreed by the DSMB, the second-stage study was conducted. Into the high-dose group (20 cases) and placebo group (5 cases) subjects; follow-up to 30 days, after the safety assessment by the investigator and consent, then inoculate the second dose. Observation was performed for 1.0 hour after the second dose. The researchers conducted a safety evaluation and agreed to follow-up after discharge.
Sentien Biotechnologies, Inc.
The purpose of this study is to assess the safety and tolerability of the investigational product, SBI-101, in subjects with an infectious etiology of Acute Kidney Injury (AKI). SBI-101 is a biologic/device combination product designed to regulate inflammation and promote repair of injured tissue using allogeneic human mesenchymal stromal cells. SBI-101 will be integrated into the renal replacement circuit and patients will be treated for up to 24 hours.
Bandim Health Project
Since the 1960s, studies have shown that oral polio vaccine (OPV) may have beneficial non-specific effects, reducing morbidity and mortality from other infections than polio. Such beneficial non-specific effect have been observed for other live vaccines, including measles, smallpox and BCG vaccine. For BCG, the vaccine for which the mechanism has been studied the most, the effects appear to be mediated through the innate immune system. The COVID-19 pandemic caused by the novel coronavirus SARS-CoV-2 has now caused over 7.1 million cases and >400,000 deaths worldwide. As everywhere else, it is anticipated that in Africa the older part of the population will be at risk of severe COVID-19. OPV is widely used in Africa, but for children. Both polio and coronavirus are positive-strand RNA viruses, therefore it is likely that they may induce and be affected by common innate immune mechanisms. In a randomised trial at the Bandim Health Project in Guinea-Bissau, the investigators will assess the effect of providing OPV vs no vaccine to 3400 persons above 50 years of age. The trial will have the power to test the hypothesis that OPV reduces the combined risk of morbidity admission or death (composite outcome) by at least 28% over the subsequent 6 months.
University of Oxford
A Phase I/II, double-blinded, placebo-controlled, individually randomized trial to assess safety, immunogenicity and efficacy of the candidate Coronavirus disease (COVID-19) vaccine ChAdOx1 nCoV-19 in adults aged 18-65 years living with and without HIV in South Africa. The vaccine or placebo will be administered via an intramuscular injection into the deltoid muscle of the non-dominant arm.
Nanose Medical Ltd.
The study aim is to collect and analyze data of potential Volatile Organic Compounds (VOCs) that could be used for discriminating between patients with and without COVID-19 or with high-risk for COVID-19 by DiaNose breath test. up to 300 subjects will be enrolled to the study ( 200 COVID-19 suspected and 100 healthy volunteers in two clinical sites (1 in Israel and 1 in US). DiaNose system is an electronic nose device that can "smell" diseases in the exhaled breath of patients in real time. This approach is non-invasive, simple and save. The DiaNose prototype system consists the following elements: A Soft Tube connected to a Sensors Chamber - The soft tube is made of medical grade silicon. The subject blows air into the tube for a few seconds and the exhaled air is directed through the sensors chamber. This unit is for single use. • Sensors Reading Unit- a multi used unit for sensors signals measurement. The Sensor Reading Unit is connected to a Laptop that is used to activate and save the test measurements.
Royal Centre for Defence Medicine
This study is intended to address the association between vitamin D status and seroconversion to SARS-CoV-2 in healthy young adults. The primary aim of the study is to determine the rates of 'silent' seroconversion rates, consistent with asymptomatic transmission of SARS-CoV-2, in a young healthy adult population with a wide spread of vitamin D concentrations. The secondary aims of this study are to explore: 1. Any effect of vitamin D status on symptomatic illness. 2. The background 'point' prevalence and subsequent rate of increase in seropositivity for SARS-CoV-2 in healthy young adults. 3. The individual reductions in seropositivity to SARS-CoV-2 over time, and changes in seropositivity in a defined young adult population over time. 4. Where salivary Immunoglobulin A (IgA) may be used to provide an alternative/ complementary serological method 5. The effect (if any) of vitamin D supplementation on seroconversion rates stratified by: i) level of baseline vitamin D 'deficiency/ insufficiency/ sufficiency' status; ii) extent of BMI-defined normal/overweight/obesity cut-offs and iii) gender.
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
This study is a randomized, double-blinded, and placebo-controlled phase Ib/IIb clinical trial of the Inactivated SARS-CoV-2 Vaccine to evaluate the safety and immunogenicity of the vaccine in healthy people aged ⩾60 Years.
SAb Biotherapeutics, Inc.
: Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). SAB Biotherapeutics has developed SAB-185, an Anti-SARS-CoV-2 Human Immunoglobulin Intravenous (transchromosomic [Tc] bovine-derived), as a potential therapeutic to treat COVID-19. This study will evaluate the safety, immunogenicity, and pharmacokinetics of SAB-185 in ambulatory participants with COVID-19.
Hackensack Meridian Health
This expanded access program will provide access to investigational convalescent plasma for patients at Hackensack University Medical Center infected with SARS-CoV-2 who have severe or life-threatening COVID-19, or who are judged by a healthcare provider to be at high risk of progression to severe or life-threatening disease.
Ministry of Health, Saudi Arabia
There are currently no antiviral drugs with proven efficacy nor are there vaccines for its prevention. Unfortunately, the scientific community has little knowledge of the molecular details of SARS-CoV-2 infection. The drugs we are chosen are used as clinical trials for antiviral and there is no proven guide for specificity and effectiveness against the virus so the results are different Now the clinical trials and research authorities are work speedily to target the most proven treatment for the virus so anything is infantile until now. the covid-19 with time be more explained by scientists it is steroid response disease and cause thromosis and cytokine storm , the aim of the study to inhibit viral replication and decrease the severity of the disease as antiviral and anticytokine storm , antithrombosis Zinc is a mineral element needed to regulate adaptive immune cells' functions. Higher level of intracellular zinc showed to increase intracellular pH; which affect on RNA-dependent RNA polymerase and decrease replication mechanism of RNA viruses. Therefore, drugs that described as zinc ionophores could be used with zinc supplement to act as antiviral against many RNA viruses including SARS-CoV-2 Quercetin is natural compound act as zinc ionophore to cause zinc influx intracellular. Quercetin is a safe natural anti-oxidant and anti-inflammatory polyphenolic compound that found in various natural sources include onion, red grapes, honey and citrus fruits. It was shown that quercetin has the ability to chelate zinc ions and act as zinc ionophore. Therefore, quercetin could have antiviral activity against many RNA viruses . Quercetin, a flavonoid found in fruits and vegetables, has unique biological properties that may improve mental/physical performance and reduce infection risk ; These properties form the basis for potential benefits to overall health and disease resistance, including anti-carcinogenic, anti-inflammatory, antiviral, antioxidant, and psychostimulant activities, as well as the ability to inhibit lipid peroxidation, platelet aggregation and capillary permeability, and to stimulate mitochondrial biogenesis .There are various studies that report the immunomodulatory effect of bromelain . Bromelain activates natural killer cells and augments the production of granulocyte-macrophage-colony stimulating factor, IL-2, IL-6 and decreases the activation of Thelper cells. Thus, bromelain decreases the majority of inflammatory mediators and has demonstrated a significant role as an anti-inflammatory agent in various conditions Vitamin C is known as an essential anti-oxidant.,and enzymatic co-factor for physiological reactions such as hormone production, collagen synthesis and immune potentiation . Naturally, an insufficiency of vitamin C leads to severe injuries to multiple organs, especially to the heart and brain, since they are both highly aerobic organs that produce more oxygen radicals. In fact, studies of in vivo effect on vitamin C are difficult since most animals, except human and some primate, are capable of synthesizing vitamin C endogenously