Using the main ACTIV protocol, the study will focus on potential interventions for mild to moderate disease.
The National Institutes of Health will fund a large, randomized, placebo-controlled phase 3 clinical trial to test several existing prescription and over-the-counter drugs for humans that can be used alone in the treatment of COVID-19 symptoms. Part of a public-private partnership to accelerate COVID 19 therapeutic interventions and vaccines (ACTIV), ACTIV-6 aims to provide evidence-based treatment options for most adult patients with COVID-19 who have mild to moderate symptoms and are not ill enough to be hospitalized. . The NIH will provide an initial investment of $ 155 million in financing the trial.
“While we are doing a good job of treating hospitalized patients with severe illness, we currently do not have an approved drug that can be administered alone to alleviate the symptoms of people suffering from mild illness at home and reduce the risk of their needing hospitalization,” the NIH director said. Francis S. Collins, Ph.D. med., dr. sc. “ACTIV-6 will assess whether certain drugs that show promise in small trials can pass the rigor of a larger trial.”
Several drugs are currently recommended for the treatment of hospitalized patients with moderate to severe COVID-19, including the antiviral drug remdesivir, the anti-inflammatory baricitinib, and corticosteroids. In addition, the U.S. Food and Drug Administration has approved the emergency use of intravenous monoclonal antibodies in non-hospitalized patients with mild to moderate COVID-19 who are at high risk for severe disease. However, self-administering medications at home are critically needed to reduce the symptoms of COVID-19.
The ACTIV-6 protocol will investigate a group of up to seven FDA-approved drugs for other conditions – an approach called drug reassignment – and test their safety and effectiveness in treating mild to moderate COVID-19. Because the drugs under consideration have already been tested in humans, re-use could provide treatment options for COVID-19 sooner. The drugs will be administered orally or by inhaler, and participants will be able to take them easily at home. Participants will be randomly assigned to receive either a placebo or one of the treatments to be mailed to them.
Up to 13,500 participants aged at least 30, who tested positive for SARS-CoV-2 infection and who experienced two or more mild to moderate symptoms of COVID-19 in no more than seven days are expected to open in a few weeks. The researchers plan to assess changes in patients’ symptoms over a 14-day period, as well as hospitalizations and deaths over a 28-day period. They will also evaluate the long-term symptoms associated with COVID-19 90 days after starting treatment. The list of drugs to be added to the hands of the study is still being finalized. All drugs will have established safety records and early indications from smaller or less controlled efficacy studies against COVID-19.
The trial will focus on the enrollment of people within minority, rural and other communities that are significantly affected by COVID-19 but do not have access to major academic medical centers, where large clinical trials usually take place.
In addition to funding provided by the U.S. Rescue Act, the trial will be overseen by the NIH National Center for the Advancement of Translational Sciences (NCATS). The Duke Institute for Clinical Research, Durham, North Carolina, the hub of the Clinical and Translational Science (CTSA) program funded by NCATS, will serve as the clinical coordination center, and the Vanderbilt Center for Clinical and Translational Research, the CTSA program center at Vanderbilt University School of Medicine, Nashville, Tennessee, will serve as a trial data coordination center.
To expedite enrollment in ACTIV-6, NCATS and its Duke-Vanderbilt Experimental Innovation Center will partner with the Patient Outcome Research Institute (PCORI), an independent nonprofit research funding organization. PCORnet, the PCORI-funded National Patient-Focused Clinical Research Network, will support the management and operations of ACTIV-6. In addition, PCORnet sites will enroll participants from a wide range of communities.
“Obtaining approval for a new drug to enter the market usually takes years,” said Dr. Joni Rutter, Acting Director of NCATS. “Using drug repurpose and existing national clinical trial networks, ACTIV-6 aims to accelerate the delivery of definitive responses to available drugs that could help people manage COVID-19 symptoms at home.”
NIH / National Center for the Advancement of Translational Sciences (NCATS)