Clinical Trials Find No Increase in Mortality Among COVID-19 Patients Treated with Remdesivir, Contrary to Viral Claim

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Remdesivir is the only antiviral medication approved by the Food and Drug Administration to treat COVID-19. But a retired chiropractor misleadingly claims on a viral clip on social media that the drug is “killing people.” Studies have shown that remdesivir can lead to faster recovery times for hospitalized patients.

There are no cures for COVID-19, but an increasing number of evidence-based treatments have been identified. Most of these have emergency use authorization, rather than full approval, from the Food and Drug Administration.

At the end of December 2021, the FDA authorized for emergency use the first oral antivirals for COVID-19, Pfizer’s Paxlovid and Merck’s molnupiravir. Both drugs are authorized for patients with mild-to-moderate COVID-19 who are at high risk of severe disease. The pills should be given as early as possible and no later than five days after symptoms begin.

Paxlovid consists of nirmatrelvir, a protease inhibitor that prevents replication of the coronavirus, or SARS-CoV-2; and ritonavir, a drug that slows breakdown of nirmatrelvir. Paxlovid was found in a randomized, double-blind, placebo-controlled clinical trial to reduce COVID-19-related hospitalization or death from any cause by 88% compared with a placebo after 28 days of follow-up.

Molnupiravir also prevents viral replication of SARS-CoV-2, but works in a different way, by introducing errors into the virus’s genetic code. It was shown in a randomized, double-blind, placebo-controlled clinical trial to reduce hospitalization or death from any cause by 30% compared with a placebo after 29 days.

While potentially revolutionary for COVID-19 treatment, the pills are not a substitute for vaccination and come with some risks. Paxlovid, for example, may not be suitable in people with kidney disease or those taking certain other drugs, while molnupiravir is not recommended for pregnant people.

One FDA-approved treatment for COVID-19 is remdesivir, an intravenous antiviral drug. It was approved in October 2020 for hospitalized patients 12 years and older based on randomized, controlled clinical trials that found faster recovery times and statistically significant odds of improving conditions among hospitalized patients with mild to severe COVID-19 who received the drug, compared with those who got a placebo plus standard care. Approval has since been extended to children as young as a month old and to nonhospitalized patients with mild to moderate COVID-19 who are at high risk of developing severe disease.

Two other FDA-approved drugs for COVID-19 are baricitinib and tocilizumab, immunomodulators traditionally used to treat diseases such as rheumatoid arthritis. For COVID-19, they’re approved for use in certain hospitalized patients, such as those needing ventilation, and are thought to help by tamping down overactive immune responses that can be harmful later in the disease progression.

Other therapies include monoclonal antibodies that target SARS-CoV-2, which the FDA has authorized for patients with mild to moderate disease who are at high risk for developing severe COVID-19. These drugs are synthetic antibodies that are designed to prevent the virus from entering cells, although some may not be effective against all variants of the coronavirus. As of Nov. 30, 2022, no antibodies are FDA-authorized because none are expected to work against the particular viral strains circulating.

Another key drug in the arsenal is the steroid dexamethasone, which was found in a large randomized controlled trial in the U.K. to provide a mortality benefit in hospitalized COVID-19 patients who were ventilated or receiving supplemental oxygen. The finding was announced in June 2020. Dexamethasone, however, did not help patients who weren’t receiving respiratory support, and may have harmed them.

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Doug Mastriano — a Republican state senator in Pennsylvania who chartered buses to the Jan. 6 rally and has been subpoenaed by the committee investigating the riot that followed — hosted a panel on March 4 billed as a “Discussion on COVID-19 and Medical Freedom.”

A clip from that panel has spread widely on partisan social media accounts, showing up on platforms that cater to conservative audiences, such as Rumble, GETTR and BitChute, as well as mainstream platforms such as TikTok, Facebook and Twitter.

The clip features Bryan Ardis, a retired chiropractor who sells purported acne treatments online and hosts a show that frequently makes dubious claims about the pandemic. He used his appearance at Mastriano’s forum to spread a claim that he’s made before.

Referring to the only antiviral drug that has, so far, been approved by the Food and Drug Administration for COVID-19 patients, Ardis said, “remdesivir is killing people… remdesivir is proven to kill lives.”

The only support that Ardis offered for his claim, though, was a reference to data he said he’d received from Thomas Renz — a lawyer who was also on Mastriano’s panel. That data, he said, showed that among “Medicare-aged” patients in New York hospitals who received a five-day course of remdesivir, “26.9% of them died.”

We asked Ardis by email for a copy of that data and for evidence that the drug had caused those deaths, but we didn’t hear back.

Remdesivir was first approved in October 2020 for use in hospitalized COVID-19 patients. As we’ve explained before, randomized, controlled clinical trials found that the drug led to faster recovery times and statistically significant odds of improving conditions among hospitalized patients with mild to severe COVID-19 as compared with those who received a placebo plus standard care.

On Jan. 21, the FDA expanded the approved use of remdesivir for high-risk patients who weren’t hospitalized as part of the agency’s response to the omicron variant of the virus that causes COVID-19. That decision was based on a clinical trial that demonstrated that patients with mild to moderate COVID-19 could benefit from early treatment with the drug. High-risk patients who received three days of remdesivir within a week of onset were 87% less likely to be hospitalized or die compared with those receiving a placebo.

We don’t know what timeframe Ardis’ data covered or how sick those patients were to begin with, but he provided no evidence in the clips on social media or at the panel to support the claim that the drug itself caused any deaths.

Some patients who have had severe COVID-19 and were treated with remdesivir have died, but there’s no evidence that remdesivir caused those deaths. In fact, clinical trials found no increase in mortality among patients who were treated with the drug.

It could be true that 26.9% of “Medicare-aged” patients who took remdesivir in New York died at some point. After all, the patients were likely very sick with COVID-19. But on its own, the statistic is meaningless because it doesn’t tell you the mortality rate of similar patients who didn’t take the drug.

This isn’t the first time that Ardis has made this claim. As a guest last year on conspiracy theorist Alex Jones’ show, InfoWars, Ardis referred to remdesivir and claimed, “They’re driving a narrative to kill as many Americans as possible.”

Other fact-checkers, including MedPage Today, First Draft, and Health Feedback have addressed this claim when he’s made it in some other forums.

It’s also worth noting that, although remdesivir is the only antiviral drug that’s gotten full approval from the FDA for treatment of COVID-19, it’s not the only drug that’s available. Other treatment options have been authorized for emergency use, including an oral antiviral called Paxlovid, which has been the preferred treatment for COVID-19 patients who aren’t hospitalized.

Editor’s note: SciCheck’s COVID-19/Vaccination Project is made possible by a grant from the Robert Wood Johnson Foundation. The foundation has no control over FactCheck.org’s editorial decisions, and the views expressed in our articles do not necessarily reflect the views of the foundation. The goal of the project is to increase exposure to accurate information about COVID-19 and vaccines, while decreasing the impact of misinformation.

Sources

Meyer, Katie, Miles Bryan and Ryan Briggs. “Mastriano campaign spent thousands on buses ahead of D.C. insurrection.” WHYY. 12 Jan 2021.

Mastriano, Douglas. Subpoena. 15 Feb 2022.

Mastriano, Douglas. “Expert Panel Discussion on COVID-19 and Medical Freedom.” 4 Mar 2022.

Ardis, Bryan. Licensure verification. Tennessee Department of Health. Accessed 4 Apr 2022.

National Institutes of Health. Characteristics of Antiviral Agents. Updated 24 Feb 2022.

U.S. Food and Drug Administration. Frequently Asked Questions for Veklury (remdesivir). Updated 21 Jan 2022.

FactCheck.org. “What treatments are available for COVID-19?” Updated 28 Mar 2022.

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Gottlieb, Robert, et al. “Early Remdesivir to Prevent Progression to Severe Covid-19 in Outpatients.” New England Journal of Medicine. 27 Jan 2022.

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Ferreira, Fernanda. “Claim that the antiviral drug remdesivir is killing people is baseless.” Health Feedback. 5 Apr 2022.