The National Institute of Health (NIH) announced Tuesday it is accepting volunteers who wish to enroll in a clinical trial to help test the safety and efficacy of a potential new treatment for COVID-19.
The trial, titled ACTIV-3, is asking for patients who are currently being treated for the novel coronavirus at select hospitals around the world, according to an NIH news release.
The trial is currently in its third phase and is designed to expand its testing to multiple kinds of synthetic antibody treatments. If the treatment shows promise, additional volunteers can enroll in the middle of testing, the news release said.
Approximately 300 volunteers who have been hospitalized with mild to moderate COVID-19 symptoms with fewer than 13 days of symptoms will be initially enrolled into the study.
The trial is one of the four ongoing studies being conducted by the NIH with assistance from Operation Warp Speed, a U.S. government initiative, announced in May to help develop, manufacture and distribute medical countermeasures against COVID-19, as well as accelerate the development of potential coronavirus vaccines.
The hospitals that are eligible for patients to volunteer must already be part of existing trial networks, according to the NIH.
The networks include:
-International Network of Strategic Initiatives in Global HIV Trials (INSIGHT), operated by the National Institute of Allergy and Infectious Diseases (NIAID), a part of the National Institutes of Health
-Prevention and Early Treatment of Acute Lung Injury network (PETAL)
-Cardiothoracic Surgical Trials Network (CTSN), supported by the NIH’s National Heart, Lung and Blood Institute through the Collaborating Network of Networks for Evaluating COVID-19 and Therapeutic Strategies (CONNECTS) program, and the U.S. Department of Veterans Affairs Medical Centers.
“Under Operation Warp Speed, the U.S. Government has brought together multiple agencies to accelerate the development, manufacture and distribution of medical countermeasures for COVID-19,” said NIH Director Dr. Francis S. Collins. “The ACTIV studies are just a few examples of this critical activity, which emphasizes flexibility and minimizes delays to generate scientifically sound results.”
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This is how the ACTIV-3 trial will run:
-The study will begin by observing the investigational monoclonal antibody LY-CoV555, which was identified in a blood sample from a recovered COVID-19 patient. A monoclonal antibody is a synthetic antibody created in a lab, according to the NIH.
-Once patients have confirmed they are COVID-19 positive and consent to participate in the study, they will be randomly assigned to receive either an intravenous (IV) infusion of LY-CoV555 or a saline placebo infusion. Participants will also receive standard care for COVID-19, including treatments of the antiviral drug remdesivir.
-After five days, participants’ symptoms will be assessed, as will their need for supplemental oxygen, mechanical ventilation or other supportive care.
-Data collected on the fifth day of the volunteers’ participation will determine whether the investigational therapeutic will be administered to a larger group of volunteers.
-Volunteers will be followed for 90 days after enrollment and will receive regular examinations and have blood samples taken periodically during this time to analyze their response.
If the data collected after the study’s fifth day shows promise, an additional 700 participants will be enrolled into the trial. Those new participants will be patients with more severe symptoms, such as infected individuals who are on a respirator or have other organ failure.
The intended goal of the study is for patients who are administered the synthetic antibody to sustain their recovery 14 days after being discharged from the hospital, according to the NIH.
“Studying the impact of this investigational therapeutic on multiple patient populations at the same time is critical to determining whether it can help COVID-19 patients with differing levels of disease severity,” said NIAID Director Dr. Anthony S. Fauci. “These concurrent trials have the potential to yield significant and comprehensive clinical data.”