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NIH Opens Covid-19 Clinical Trial Network

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(Gerd Altmann, Pixabay)

9 July 2020. National Institutes of Health is organizing a collection of sites for late-stage clinical trials to test Covid-19 vaccines and antibody treatments. The Covid-19 Prevention Network, or CoVPN, is operated by National Institute of Allergy and Infectious Diseases, or NIAID, the agency in NIH most responsible for Covid-19 vaccines and therapies, and Fred Hutchinson Cancer Research Center in Seattle.

CoVPN will test Covid-19 vaccines and antibody treatments in late-stage clinical trials. Late-stage trials, also called phase 3 trials, usually enroll thousands, even tens of thousands, of participants, testing experimental drugs or medical devices against a placebo, current drugs, or other experimental vaccines or therapies. As the name implies, late-stage trials are conducted after an experimental therapy or vaccine is shown to be safe, establishes safe dose levels, and demonstrates some clinical benefits in early- and mid-stage trials.

The first drug tested in CoVPN is made by Moderna Inc. in Cambridge, Massachusetts, code-named mRNA-1273, developed with NIAID. The vaccine is given as two injections, 28 days apart. As reported by Science & Enterprise in May, the company says early-stage trials among healthy volunteers show mRNA-1273 is generally well tolerated with a few severe adverse effects experienced at its highest dose level after the second injection. Also, mRNA-1273 produced neutralizing antibodies in eight recipients, age 18 to 55. The company did not report findings from older age groups.

The network is being established from four current networks already operating to test drugs for HIV and other infectious diseases: HIV Vaccine Trials Network,  HIV Prevention Trials Network, Infectious Diseases Clinical Research Consortium, and AIDS Clinical Trials Group. Together, CoVPN is expected to have about 100 sites in the U.S. and some overseas locations.

In addition, CoVPN is using standard clinical trial plans and protocols designed by Accelerating Covid-19 Therapeutic Interventions and Vaccines, or ACTIV, a consortium of federal health agencies, European Medicines Agency, not-for-profit organizations, and pharmaceutical and biotechnology companies. ACTIV aims to streamline clinical trial execution as much as possible by offering standard protocols and avoiding duplicative efforts in preclinical studies and clinical trials.

“Having a safe and effective medical countermeasure to prevent Covid-19 would enable us to not only save lives but also help end the global pandemic,” says NIAID director Anthony Fauci in an NIH statement. “Centralizing our clinical research efforts into a single trials network will expand the resources and expertise needed to efficiently identify safe and effective vaccines and other prevention strategies against Covid-19.”

A key challenge for CoVPN is recruitment of thousands of volunteers representing the diverse populations affected by Covid-19 to test vaccines and antibody treatments. NIH says CoVPN has a community engagement function for this purpose built into the process. Database systems company Oracle in Redwood Shores, California provides the data collection platform for CoVPN that includes a secure clinical trial registry for online enrollment.

“Each of the phase 3 clinical trials that the CoVPN will conduct will require thousands of volunteers,” notes NIH director Francis Collins. “Community engagement, particularly with the communities most vulnerable to Covid-19’s severe outcomes, will be critical to the success of this research endeavor.”

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