Please ensure Javascript is enabled for purposes of website accessibility
Coronavirus Patients Rush to Join Studies of Gilead Drug
gvw_ap_news
By Associated Press
Published 5 years ago on
April 6, 2020

Share

The new coronavirus made Dr. Jag Singh a patient at his own hospital. His alarm grew as he saw an X-ray of his pneumonia-choked lungs and colleagues asked his wishes about life support while wheeling him into Massachusetts General’s intensive care unit.

When they offered him a chance to help test remdesivir, an experimental drug that’s shown promise against some other coronaviruses, “it did not even cross my mind once to say ‘no,’” said Singh, a heart specialist.

Coronavirus patients around the world have been rushing to join remdesivir studies that opened in hospitals in the last few weeks.

Interest has been so great that the U.S. National Institutes of Health is expanding its study, which has nearly reached its initial goal of 440 patients. The drug’s maker, California-based Gilead Sciences, is quickly ramping up its own studies, too.

“I would enroll my family in a heartbeat” if the need arose, said Dr. Libby Hohmann, who placed Singh and nearly 30 others in the NIH one at Mass General. To have no approved medicines for COVID-19 now is “kind of terrifying,” she said.

For most people, the new coronavirus causes mild or moderate symptoms, which can include fever and cough but sometimes pneumonia requiring hospitalization. The risk of death is greater for older adults and people with other health problems.

Gilead Has Given Remdesivir to More Than 1,700 Patients on a Case-By-Case Emergency Basis

Remdesivir is given through an IV. It’s designed to interfere with an enzyme that reproduces viral genetic material.

In animal tests against SARS and MERS, diseases caused by similar coronaviruses, the drug helped prevent infection and reduced the severity of symptoms when given early enough in the course of illness. It’s farther along in testing than many other potential therapies and the current studies could lead to regulatory approval.

Gilead has given remdesivir to more than 1,700 patients on a case-by-case emergency basis, but more people ultimately will be helped if the company does the needed studies to prove safety and effectiveness, chief executive Dan O’Day wrote in a recent letter to the public.

“Many people have reached out to Gilead to advocate for access to remdesivir on behalf of friends and loved ones. I can only imagine how it must feel to be in that situation,” he wrote. “We are taking the ethical, responsible approach.”

In another letter on Saturday, O’Day said the company has 1.5 million doses, which could mean more than 140,000 treatment courses, depending on how long treatment needs to last. The company is providing the drug for free for now and has set a goal of making 500,000 treatment courses by October and more than a million by the end of the year.

Photo of rubber stoppers placed onto vials
In this March 2020 photo provided by Gilead Sciences, rubber stoppers are placed onto filled vials of the investigational drug remdesivir at a Gilead manufacturing site in the United States. Given through an IV, the medication is designed to interfere with an enzyme that reproduces viral genetic material. (Gilead Sciences via AP)

The NIH Study Is the Most Rigorous Test

Gilead supplied remdesivir for two studies in China expected to give results by the end of the month. It also launched two studies for hospitalized patients in the U.S., Asia, Europe and elsewhere. One in severely ill patients tests five versus 10 days of treatment. Another in moderately sick patients compares those two options to standard care alone.

“There’s so much anxiety about the disease that the patients are quite interested” and no one offered the chance has refused, said Dr. Arun Sanyal, the study leader at Virginia Commonwealth University in Richmond.

The first patient he enrolled was a previously healthy middle-aged man who had an out-of-state visitor a few days before his symptoms began. What started as mild illness escalated to profound shortness of breath requiring supplemental oxygen.

At University Hospitals Cleveland Medical Center, Dr. Grace McComsey has enrolled roughly half a dozen patients.

“We’re seeing more and more younger people, like 30, really sick,” she said.

The NIH study is the most rigorous test. It compares remdesivir to placebo infusions, and neither patients nor doctors know who is getting what until the end of the study. Besides the U.S., it’s open in Japan, Korea and Singapore.

Rigorous Testing Is Needed to Avoid Giving False Hope or Using Something Unsafe

In Chicago, an 89-year-old man was Northwestern Memorial Hospital’s first participant and “the family was very excited” to have him included, said infectious diseases chief Dr. Babafemi Taiwo.

At the University of California, Irvine, Dr. Alpesh Amin has enrolled several patients. All are getting standard care even if they wind up getting a placebo rather than remdesivir, Amin said.

The Boston cardiologist, Singh, said he was willing to take that chance to advance science even if he personally winds up not benefiting. He’s now recovering at home after spending a week in the hospital.

“The word ‘placebo’ freaks some people out,” but rigorous testing is needed to avoid giving false hope or using something unsafe. Still, it’s tough to face patients with no proven therapy now, Hohmann said.

“The worst thing is seeing some really young people who are really, really sick,” such as a 49-year-old man with three young children on life support, she said. “That’s pretty awful.”

RELATED TOPICS:

DON'T MISS

President Trump Blames DEI and Biden for Crash Under Trump’s Watch

DON'T MISS

Reds Acquire Left-Handed Reliever Taylor Rogers From Giants

DON'T MISS

Driver Vanishes After Crash on Highway 41. CHP Says Hit-and-Runs on the Rise.

DON'T MISS

Gilgeous-Alexander Scores 52 but Curry and Wiggins Lead Balanced Warriors Past Thunder 116-109

DON'T MISS

Tulsi Gabbard, Trump’s Pick to Oversee US Spy Agencies, Grilled on Snowden, Syria and Russia

DON'T MISS

Rihanna Appears at Trial of A$AP Rocky and Outshines Key Testimony on Alleged Shooting

DON'T MISS

FireAid, a Benefit for LA Wildfire Relief, Is Almost Here. Here’s How to Watch and Donate

DON'T MISS

Here Are Some of the Deadliest Plane Crashes in US History

DON'T MISS

With Sweeping Executive Orders, Trump Tests Local Control of Schools

DON'T MISS

NASA’s 2 Stuck Astronauts Take Their First Spacewalk Together

UP NEXT

Trump Set to Sign Order Deporting Pro-Palestinian Exchange Students

UP NEXT

Trump White House Rescinds Order Freezing Federal Grants After Widespread Confusion

UP NEXT

Federal Judge Temporarily Blocks Trump Administration Freeze on Federal Grants and Loans

UP NEXT

‘Doomsday Clock’ Moves Closer to Midnight Amid Global Threats

UP NEXT

CNN’s Jim Acosta, an Irritant to Trump, Says He’s Quitting

UP NEXT

Man Pardoned in Jan. 6 Riot Is Fatally Shot by Sheriff’s Deputy During Traffic Stop

UP NEXT

California Projected to Lose Congressional Seats While Texas, Florida Gain

UP NEXT

3.8 Magnitude Earthquake Felt in Boston and Maine

UP NEXT

Secret Service Agents Seeking Student Over Trump Video Blocked From School

UP NEXT

CNN Announces Layoffs as Part of a Further Shift to Digital Business

Gilgeous-Alexander Scores 52 but Curry and Wiggins Lead Balanced Warriors Past Thunder 116-109

22 minutes ago

Tulsi Gabbard, Trump’s Pick to Oversee US Spy Agencies, Grilled on Snowden, Syria and Russia

46 minutes ago

Rihanna Appears at Trial of A$AP Rocky and Outshines Key Testimony on Alleged Shooting

2 hours ago

FireAid, a Benefit for LA Wildfire Relief, Is Almost Here. Here’s How to Watch and Donate

2 hours ago

Here Are Some of the Deadliest Plane Crashes in US History

2 hours ago

With Sweeping Executive Orders, Trump Tests Local Control of Schools

2 hours ago

NASA’s 2 Stuck Astronauts Take Their First Spacewalk Together

2 hours ago

Valley Crime Stoppers’ Most Wanted Person of the Day: Bousen Chanthalangsy

2 hours ago

Baked-in-Profits Send PG&E and SCE Bills Soaring. Are They Excessive?

2 hours ago

Merced Officer Saves Choking Toddler. Brings Her a Stuffed Animal as She Recovers.

3 hours ago

President Trump Blames DEI and Biden for Crash Under Trump’s Watch

WASHINGTON — President Donald Trump blamed diversity requirements at the Federal Aviation Administration and his two Democratic predecessors...

8 minutes ago

President Donald Trump speaks to reporters aboard Air Force One en route from Miami to Joint Base Andrews, Md., Monday, Jan. 27, 2025. (AP/Mark Schiefelbein)
8 minutes ago

President Trump Blames DEI and Biden for Crash Under Trump’s Watch

16 minutes ago

Reds Acquire Left-Handed Reliever Taylor Rogers From Giants

A driver vanished after rolling a car on Freeway 41, highlighting growing concerns over hit-and-run incidents and their consequences. (CHP)
18 minutes ago

Driver Vanishes After Crash on Highway 41. CHP Says Hit-and-Runs on the Rise.

22 minutes ago

Gilgeous-Alexander Scores 52 but Curry and Wiggins Lead Balanced Warriors Past Thunder 116-109

46 minutes ago

Tulsi Gabbard, Trump’s Pick to Oversee US Spy Agencies, Grilled on Snowden, Syria and Russia

2 hours ago

Rihanna Appears at Trial of A$AP Rocky and Outshines Key Testimony on Alleged Shooting

2 hours ago

FireAid, a Benefit for LA Wildfire Relief, Is Almost Here. Here’s How to Watch and Donate

2 hours ago

Here Are Some of the Deadliest Plane Crashes in US History

Help continue the work that gets you the news that matters most.

Search

Send this to a friend