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SLHS Participates in Operation Warp Speed

Media Contact: Pam Klosowski
December 9, 2020

SLHS Participates in Operation Warp Speed

POTSDAM, NY – The Clinical and Rural Health Research Department with St. Lawrence Health (SLHS) has been selected to take part in the National Operation Warp Speed COVID-19 clinical trials, which are currently at the forefront of the research community.

“Operation Warp Speed is aiming to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics. Because there are so few treatment options for COVID-19, being part of these programs brings treatment options to the North Country, and equips the St. Lawrence Health COVID-19 treatment team with additional tools to combat the pandemic in our community,” stated Clinical Research Manager Carly Lovelett, CCRP, MS.

SLHS’s Clinical Research Department is involved in the ACTIV-2 portion of Operation Warp Speed, which will include outpatients with COVID-19. The clinical trial Principal Investigator is Rheumatologist Eyal Kedar, MD; and the Sub-Investigators are Infectious Diseases providers Daniel Soule, DO; and Kylie Broughal, PA-C; and Hospitalist Sara Mohaddes, PA-C.

Ms. Lovelett explained that for patients to be considered for the clinical trial, they must meet certain criteria.

“Outpatients must have a laboratory-confirmed positive COVID-19 test, and symptom onset within 10 days of enrolling in the trial (such as fever, cough, shortness of breath, sore throat, fatigue, body aches, headache, nasal congestion, nausea/vomiting/diarrhea, loss of taste or smell),” she said.

“Each patient considering participation in the ACTIV-2 clinical trial will be presented with the informed consent form, which describes what would happen if they did participate in the trial; the risks and benefits, and the rights they have,” Ms. Lovelett said. “Participation in the trial is completely voluntary. For patients who decide to participate, they are still able to withdraw from the trial at any time, for any reason.”

Dr. Soule pointed out that early treatment of COVID-19 is vital to helping healthcare personnel prevent advanced illness of the disease, hospitalization, and transmission.

“ACTIV-2 is designed to help us rapidly identify treatments that have the potential to radically alter the current pandemic, and make a profound difference in the lives of people who have, or are at risk for, the disease,” he said.

“This trial aims to study treatments that may help prevent people with COVID-19 from developing advanced disease that requires hospitalization,” Dr. Kedar said. “While people with COVID-19 may start off with just a few minor symptoms, they can rapidly become very ill, and this is true of both young and older people. North Country residents who have recently been diagnosed with the coronavirus have the opportunity to make a significant contribution by participating in this study.”

ACTIV-2 is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), which also funds the ACTG. ACTIV-2 is part of NIH’s Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV), a public-private partnership program to create a coordinated research strategy that prioritizes and speeds development of the most promising treatments and vaccines. It is also receiving support from Operation Warp Speed, the U.S. government’s multi-agency effort to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics.

Learn more about SLHS’s Clinical and Rural Health Research Department.