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Coronavirus Remdesavir Study Started
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https://www.genengnews.com/news/coronavirus-gileads-remdesivir-begins-trials-as-researchers-publish-positive-in-vitro-results/
Remdesivir, chloroquine "highly effective"
The trials were announced as having begun a day after the experimental drug and a marketed anti-malarial, chloroquine, showed promising preclinical results.
"Our findings reveal that remdesivir and chloroquine are highly effective in the control of 2019-nCoV infection in vitro," the researchers reported in
"Remdesivir and chloroquine effectively inhibit the recently emerged novel coronavirus (2019-nCoV) in vitro," a study published as a letter to the editor of the Nature-owned journal Cell Research.
"Since these compounds have been used in human patients with a safety track record and shown to be effective against various ailments, we suggest that they should be assessed in human patients suffering from the novel coronavirus disease," the researchers added.
The research team consisted of investigators from the Wuhan Institute of Virology, Chinese Academy of Sciences / National Center for Biosafety and the National Academy of Military Medical Research Institute of Emergency Medicine for Prevention and Control of Drugs.
The researchers published their recommendation Tuesday, the same day that China's Ministry of Science and Technology first said it would launch human clinical trials of remdesivir after a batch of the drug arrived in the country, Xinhua reported.
In their study, the researchers assessed remdesivir and chloroquine and five other drugs against a clinical isolate of 2019-nCoV in vitro. The five were: ribavirin, penciclovir, nitazoxanide, nafamostat, and favipiravir (T-705 or Avigan).
"Notably, Remdesivir (EC50 = 0.77 μM; CC50 > 100 μM; SI > 129.87) and chloroquine (EC50 = 1.13 μM; CC50 > 100 μM, SI > 88.50) potently blocked virus infection at low-micromolar concentration and showed high SI [selectivity index]," the researchers reported.
A time-of-addition assay showed remdesivir to function at a stage post virus entry, which according to the scientists appeared to reflect its putative anti-viral mechanism as a nucleotide analogue.
"Our data showed that EC90 value of remdesivir against 2019-nCoV in Vero E6 cells was 1.76 μM, suggesting its working concentration is likely to be achieved in NHP," the researchers added. "Our preliminary data showed that remdesivir also inhibited virus infection efficiently in a human cell line (human liver cancer Huh-7 cells), which is sensitive to 2019-nCoV."
1) U.S. patient recovered
https://seekingalpha.com/article/4322933-gilead-sciences-5-reasons-remdesivr-is-likely-to-be-effective-against-wuhan-coronavirus?mail_subject=gild-5-reasons-remdesivr-is-likely-to-be-effective-against-the-wuhan-coronavirus&utm_campaign=rta-stock-article&utm_content=link-0&utm_medium=email&utm_source=seeking_alpha
Jan 26, a 35-year-old Wuhan coronavirus patient, within the U.S. received remdesivir. This happened on a compassionate use basis a week after he was hospitalized. Within 24 hours his fever went down from 39.4 degrees Celsius to 37.3 degrees Celsius. His oxygen saturation values improved to 94% to 96%. Bilateral lower-lobe rales (I think those are crackles in your lungs the doctors listen for with a stethoscope).
Five days later the fever and all other symptoms except his cough were gone.
Note that one recovered patient is meaningless on its own.
2) How remdesivir works
In case you haven't picked up on it I'm definitely not an expert on anything biotech. But I view the Wuhan coronavirus as a great risk and spent a lot of time researching it. Doing that I came across a podcast by the American Society for Microbiology. In this particular podcast here. Biologist Timothy Sheahan talks about a compound (he has worked on) that can inhibit all coronaviruses tested (which does not include the Wuhan variant).
Here's some things I picked up on; Coronavirus diseases in mice play out in a compressed timeframe.
• Could protect mice when giving it one day after getting SARS.
• Could diminish replication giving it after two days.
• Remdesivir has been used in humans for Ebola. remdesivir has gone through phase 1. Safety testing and phase 2 testing for Ebola in West-Africa.
• Bio informatically the target of remdesivir is very similar to SARS. 99% similar and 96% identical.
• Interestingly, the target of remdesivir is what the researchers found very attractive about the compound because it is common to all Coronaviruses.
• So far it works against every coronavirus they tested against.
• It worked even against the most divergent coronavirus called Porcine deltacoronavirus.
3) It is relatively safe
As Sheahan puts it on the podcast:
"Remdesivir has been used in humans but for Ebola, so there's a lot of information about it. If you have an experimental drug treatment, you can do experiments in cell culture or in mice, but you still don't know if it's safe in people. Remdesiver has already gone through Phase I, so they already know it's safe in people. It's undergone safety testing and I think there's potential for this to be used in China."
4) Study on Remdesivir and Chloroquine
Study showing the effectiveness of remdesivir and chloroquine (in a lab outside of humans):
Remdesivir and chloroquine effectively inhibit the recently emerged novel coronavirus (2019-nCoV) in vitro
In this study, we evaluated the antiviral efficiency of five FAD-approved drugs including ribavirin, penciclovir, nitazoxanide, nafamostat, chloroquine and two well-known broad-spectrum antiviral drugs remdesivir (GS-5734) and favipiravir (T-705) against a clinical isolate of 2019-nCoV in vitro.
Chloroquine is a cheap and a safe drug that has been used for more than 70 years and, therefore, it is potentially clinically applicable against the 2019-nCoV.
Our findings reveal that remdesivir and chloroquine are highly effective in the control of 2019-nCoV infection in vitro. Since these compounds have been used in human patients with a safety track record and shown to be effective against various ailments, we suggest that they should be assessed in human patients suffering from the novel coronavirus disease.
This all adds up to facts that remdesivir seems to work against other coronaviruses in humans. It is also safe enough. In the lab it works on the Wuhan coronavirus. The Wuhan coronavirus is very similar and 96% identical to SARS (against which remdesivir works).
Again, I'm not a biotech expert but it seems very unlikely this treatment is not effective.
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CDC MMWR-
Initial Public Health Response and Interim Clinical Guidance for the 2019 Novel Coronavirus Outbreak - United States, December 31, 2019-February 4, 2020:
https://www.cdc.gov/mmwr/volumes/69/wr/mm6905e1.htm?s_cid=mm6905e1_w
News from the FDA/CDC
CDC begins coronavirus diagnostic test kit distribution; new case confirmed in Wisconsin:
https://www.mdedge.com/internalmedicine/article/216779/coronavirus-updates/cdc-begins-coronavirus-diagnostic-test-kit
Updates: https://www.mdedge.com/internalmedicine/coronavirus-updates
Publish date: February 5, 2020
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Remdesivir under study as treatment for novel coronavirus
Publish date: February 7, 2020
By
Doug Brunk
https://www.mdedge.com/internalmedicine/article/216929/coronavirus-updates/remdesivir-under-study-treatment-novel?channel=63993
A randomized, controlled trial of Gilead's antiviral drug remdesivir is currently underway in China in hopes that it will be an effective treatment for the 2019 Novel Coronavirus (2019-nCoV).
"What they're looking at is the effect of this drug -- either the drug plus standard of care versus standard of care alone," Anthony S. Fauci, MD, reported Feb. 7 during a press briefing held by members of President Trump's Coronavirus Task Force. "I think pretty soon we are going to get a definitive answer, whether one of these among several drugs works."
Dr. Fauci, director of the National Institute of Allergy and Infectious Diseases, added that several organizations and individual investigators are developing vaccines for 2019-nCoV. In one such effort, the National Institutes of Health is working with Moderna Inc. to develop a vaccine built on a messenger RNA platform. "One of the first steps is to successfully get that [novel coronavirus] gene and insert it into the messenger RNA platform successfully and allow it to express proteins," Dr. Fauci explained. "We've succeeded in that. The next [step] is to put it in a mouse animal model to induce immunogenicity, and to get the company to make [gold nanoparticle] products. All of those have been successfully implemented. There have been no glitches so far. If that continues, we will be in Phase 1 trials in people within the next two-and-a-half months."
In another development on the same day, Robert R. Redfield, MD, director of the Centers for Disease Control and Prevention, announced that Heath & Human Services issued an interim final rule to amend foreign quarantine regulations in the wake of the public health threat posed by the 2019-nCoV. "This will enable CDC to collect certain contact information data regarding airline passengers and crew when they arrive from other countries. . .and may be exposed to communicable disease," Dr. Redfield said. "This action is part of our multi-layered approach to the U.S. response and demonstrates our commitment to take all necessary actions to protect the American people."
According to Alex Azar, secretary of Health and Human Services, and chair of President Trump's Coronavirus Task Force, there are 12 confirmed cases of the novel coronavirus in the United States, including two cases of transmission to people who had not recently been in China. "Although the virus represents a potentially very serious public health threat, and we expect to continue seeing more cases here, the immediate risk to the American public is low at this time," Mr. Azar said. "We are working as quickly as possible on the many unanswered questions about this virus. That includes exactly how it spreads, how deadly it is, whether it's commonly transmitted by patients who are not yet displaying symptoms, and other issues."
dbrunk@mdedge.com
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