Pitt researchers begin new drug trial to test covid-19 treatments

Emily Evans was looking for a clinical trial to enroll in.

The 28-year-old internal medicine resident at UPMC contracted covid-19 in early September after visiting family. She began experiencing headaches, dehydration, body aches and a lingering cough – as well as the loss of taste and smell that’s come to define the illness.

When she learned she received positive test results, she immediately began searching for nearby trials. She has a professional interest in clinical research, and she also felt it was important to help researchers gather data and information, to help remedy the health crisis.

“I don’t think you need to be in medicine to realize and acknowledge the value that research has,” she said.

It didn’t take long to find a national program called ACTIV-2, which is testing covid-19 treatments at 28 sites nationwide, including one in Pittsburgh. Evans signed up, and soon found herself a study subject at her own medical school.

The University of Pittsburgh School of Medicine announced this week that it’s operating a test site as part of a national clinical trial. This newest trial is aimed at treating early-stage covid-19 in patients who aren’t sick enough to be hospitalized.

“The goal is to see if these experimental medications are able to decrease the duration of symptoms and/or prevent hospitalization and death,” said Dr. Madhu Choudhary, associate professor in Pitt’s Division of Infectious Diseases and the principal investigator for the Pittsburgh trial site.

The trial is an initiative by the National Institute of Health, called Accelerating Covid-19 Therapeutic Interventions and Vaccines (ACTIV). Choudhary said that all drugs that enter this study have passed “phase one” evaluations, meaning they have passed basic safety standards. The study will include both phase two and three of evaluations for multiple treatments in development.

ACTIV-2 allows researchers to test multiple treatments in a single trial, according to a news release. The first drug being studied will be an antibody treatment developed by Lilly, the pharmaceutical company that in September announced one of the first antibodies in development to treat covid-19.

Health professionals and scientists have studied several antibodies throughout the course of the pandemic – two weeks ago, UPMC announced the development of its own antibody-based drug, Ab8. Choudhary said that promising drugs can be added or removed to the ACTIV-2 platform during the course of the study. More test sites will also be added as drugs move through the phases of evaluation.

“It’s a seamless transition on the same platform, designed to save time,” Choudhary said.

Phase two is underway now. There will be 110 participants nationwide to receive the antibody infusion and 110 to receive a placebo. The participants and their doctors won’t know which they’ve received. If the medication produces positive results, it will advance to phase three.

Evans said she went through an initial visit in a negative pressure room, where she was given an IV infusion of either the drug or the saline placebo – she doesn’t know which. For the next few weeks, she kept a daily symptom log, checking her temperature and taking daily mouth swabs to monitor her improvement. There were also regular check-ins with doctors over the phone and in person.

So far, she said she’s feeling much better than earlier in the month.

Choudhary said phase two is specifically testing to see if a drug lowers a patients “viral load,” or the amount of the virus in their body.

In phase three, researchers will evaluate the ability of the medication to prevent hospitalization and death. Including the participants from phase two, 1,000 people will receive the medication and 1,000 will receive a placebo.

The entire process will be repeated for multiple medications as they become available, according to the news release. Still early in the trial process, Choudhary said it’s too soon to guess how quickly a drug could successfully move through the phases and receive FDA approval.

The announcement of the new drug trial comes just days after UPMC officials said a covid vaccine is “not going to happen this year.” Medical professionals worldwide have been racing to develop a successful vaccine for distribution; in the U.S., there has been much conflict over whether a safe vaccine would be available by next year or sooner.

Creating a safe and effective vaccine that works for everyone and can be available to everyone is a momentous task. Even after a vaccine is developed Choudhary said, people could still contract the virus and need treatment.

“We still have a lot of questions with vaccines,” Evans added. “It’s still a new pandemic…I think this will be a very useful intervention.”