Baptist Health has been chosen by AstraZeneca to run a third-phase clinical trial into a drug it’s developed to prevent infection by the SARS-CoV-2 coronavirus. The trial, run by Dr. Richard Pellegrino, who also heads Baptist’s Moderna vaccine trial, opens enrollment tomorrow.
The drug, AZD7442, contains two monoclonal antibodies — each one targeting a specific coronavirus-produced antigen — to kill the virus. Unlike a vaccine, which prompts the body to manufacture its own antibodies against the virus, AZD7442 introduces synthetic antibodies into the body. If effective, it will act more quickly than a vaccine and should be protective for six months to a year. The government’s Operation Warp Speed is funding the clinical trial and if the FDA authorizes its emergency use it will be distributed at no cost, though there could be a doctor’s fee for administering the shot.
AstraZeneca plans to enroll 5,000 volunteers in the U.S. and elsewhere for the study. The drug has shown sufficient efficacy and safety to proceed into the final, phase 3 trial.
Unlike the vaccine trial (which is no longer enrolling), in which half the volunteers got the vaccine and half got a placebo, for the antibody trial, two-third of the enrollees will get the drug and one-third will get placebo (it will be double-blind; neither enrollees nor those running the trial will know who got what). There will be two cohorts: healthy individuals 18 and older and persons working jobs that put them at high risk for contracting the virus. The trial will last a year; participants will keep a diary and Baptist will contact them weekly to check on them.
In theory, Pelligrino said, the shot — which because of the volume of the medicine will be given as two shots back-to-back — should act quickly to protect the patient, but that is something the trial should determine, along with how long the shot works. Pelligrino said the phase 2 trials indicated as much. As with the vaccines, efficacy will be determined by comparing infections among those who received placebo and those who received the drug.
Pellegrino said he and others in clinical research at Baptist have gotten good feedback from volunteers. “Part of what we do is try to make the patient experience positive,” he said.
Persons interested in enrolling should go to arkansascovidvaccine.com and fill out a contact form. (Filling out the form does not commit you to the trial.) Persons will be compensated for time and travel if they qualify and enroll.