NIH clinical trial trial starts COVID-19 to treat hyperimmune intravenous immunoglobulin plus remediesvir – tech2.org

NIH clinical trial trial starts COVID-19 to treat hyperimmune intravenous immunoglobulin plus remediesvir


News release

Thursday, October 8, 2020

A clinical trial to test the safety, tolerance, and efficacy of a combination treatment for coronovirus disease 2019 (COVID-19), consisting of antiviral remedieswear and a highly concentrated solution of antibodies that neutralize SARS-CoV-2 Is, virus-19 causing COVID, has started. The study is taking place in hospitalized adults with COVID-19 in the United States, Mexico, and 16 other countries on five continents. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, is sponsoring and funding a Phase 3 trial, called anti-coronovirus immunoglobulin, or inpatient treatment with ITAC.

The antibody solution being tested in the ITAC test is anti-coronavirus hyperimmune intravenous immunoglobulin or hIVIG. Antibodies in anti-coronavirus virus come from the liquid part of the blood or plasma, donated by healthy people who have recovered from COVID-19. These antibodies are highly purified and concentrated so that anti-coronavirus hIVIG contains several consecutive more SARS-CoV-2, neutralizing antibodies commonly found in the plasma of people recovering from COVID-19.

ITAC investigators hypothesize that giving anti-coronavirus hIVIG to people at the onset of COVID-19 symptoms may increase the natural antibody response to SARS-CoV-2 before the body itself undergoes a protective immune response, The risk will be less severe illness and death.

Anthony S., director of NIAID. Fauci, MD, said “it is absolutely important to find safe and effective treatments for COVID-19″, the ITAC trial will investigate whether adding anti-coronavirus hIVIG to the Remedisvir region may provide the necessary boost to suppress the immune system . SARS-CoV-2 eliminates infection in the bud during early disease. ”

Leading Protocol Chair in the ITAC Trial Mark Paulismoto, MD, PhD, heads the therapeutic and vaccine research program at The Kirby Institute at the University of New South Wales, Sydney. The University of Minnesota is the Coordinating Center for Testing, being run by the NIAID-funded International Network for Strategic Initiatives for Global HIV Testing (INSIGHT). While INSIGHT was established to conduct clinical studies on HIV, it has also been involved in clinical trials related to influenza-like illness and anti-influenza hIVIG since 2009. The ITAC test is also known as INSIGHT 013.

Four companies are collaborating to provide anti-coronovirus HIVIG for testing: Emergent Biosolution of Gaithersburg, Maryland; Grypholes SA of Barcelona; CSL Bering of King of Prussia, Pennsylvania; And Takeda Pharmaceuticals of Tokyo. HIVIG was developed from Emergent Biosolutions and Griffols SA in collaboration with the Biomedical Advanced Research and Development Authority, part of the Office of the Assistant Secretary for Preparedness and Response in the US Department of Health and Human Services. CSL Behring and Takeda Pharmaceuticals are providing anti-coronavirus hIVIG on behalf of a partnership of plasma companies called CoVIg-19 Plasma Alliance.

Based on the analysis of currently available data from the NIAID-sponsored Adaptive COVID-19 Treatment Trial (ACTT), Remedisavir has been recommended for the treatment of some hospitalized patients with COVID-19. ACTT found that hospitalized patients with COVID-19 and low respiratory tract involvement who received rembesvir had a statistically significant shorter time to recovery than patients receiving placebo. Remedswear is an investigative broad-spectrum antiviral, discovered and developed by Gilead Sciences, Inc. of Foster City, California.

The ITAC study team will provide informed consent to 500 hospitalized adults 18 years of age or older who have COVID-19 symptoms for 12 days or less, and do not have life-threatening organ dysfunction or organ failure. . > Enrollment will take place at 58 locations across Africa, Asia, Europe, North America and South America. Study participants will be randomly assigned to receive either anti-coronovirus HIVIG and remedivir or a placebo and remedisivir infection. Neither the participants nor the study team would know who is receiving treatment.

hIVIG will be given as a single infusion of 400 mg (mg) per kilogram of current body weight. Remdesivir infusions will be administered as a 200-mg loading dose followed by a 100-mg once daily intravenous maintenance dose during hospitalization, with a total stay of 10 days.

The main goal of the ITAC trial is to compare the health status of participants in the combination treatment group with that of participants in the seventh-day remedisavir-only group. Health status will be based on a consequent outcome with seven mutually exclusive categories, with no symptoms until death due to COVID-19. These categories capture the full range of severity experienced by hospitalized patients with COVID-19, according to study investigators.

ITAC study participants will be followed for 28 days. If the test is completed, the primary analysis will be completed after all participants have finished the 28-day follow-up.

An independent data and safety monitoring board (DSMB) will review interim safety and efficacy data to ensure patient well-being and safety as well as study integrity.

The ITAC trial is associated with accelerated COVID-19 therapeutic intervention and vaccine (ACTIV) public-private partnerships. The Foundation for NIH and NIH created ACTIV to develop a coordinated research strategy to prioritize and accelerate the development of the most promising therapies and vaccines for COVID-19. Activa-associated trials are sponsored by the NIH and have one or more industry partners. Both Gilead Sciences and Takeda Pharmaceuticals are members of Activa.

More information about the ITAC trial is available at clinicaltrial.go under study identifier NCT04546581.

NIAID supports research and is conducted at the NIH, across the United States, and around the world – to study the causes of infectious and immune-mediated diseases and to develop better tools for preventing, diagnosing and treating these diseases Does. News releases, fact sheets and other NIAID related material are available on the NIAID website.

About National Institutes of Health (NIH):The NIH, the nation’s medical research agency, consists of 27 institutions and centers and is a component of the US Department of Health and Human Services. The NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

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