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A phase 3 trial of Merck and Ridgeback Biotherapeutics’ oral antiviral treatment molnupiravir showed it reduced the risk of hospitalization or death by around 50% in Covid patients.

Merck plans to seek emergency use authorization in the U.S. and submit marketing applications to other global drug regulators.

If authorized by regulatory bodies, molnupiravir could be thefirst oral antiviral medicine for Covid.

“The company, when they briefed us last night, had mentioned that they will be submitting their data to the FDA imminently,” White House chief medical advisor Dr. Anthony Fauci said at a Covid briefing Friday.

https://www.cnbc.com/2021/10/01/merck-to-seek-emergency-authorization-for-oral-covid-19-treatment.html

DIRTY SCUMBAGS

Wait til you see WHO IS INVOLVED in a paper supporting this drug.....

next post.

>>97628

Molnupiravir, an Oral Antiviral Treatment for COVID-19

posted June 17, 2021

William Fischer, Joseph J. Eron, Wayne Holman, Myron S. Cohen, Lei Fang, Laura J. Szewczyk, Timothy P Sheahan,Ralph Baric, Katie R. Mollan, Cameron R. Wolfe, Elizabeth R. Duke, Masoud M. Azizad, Katyna Borroto-Esoda, David A. Wohl, Amy James Loftis, Paul Alabanza, Felicia Lipansky, and Wendy P. Painter

Background

Easily distributed oral antivirals are urgently needed to treat coronavirus disease-2019 (COVID-19), prevent progression to severe illness, and block transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). We report the results of a Phase 2a trial evaluating the safety, tolerability, and antiviral efficacy of molnupiravir in the treatment of COVID-19 ( ClinicalTrials.gov NCT04405570 ).

Methods

Eligible participants included outpatients with confirmed SARS-CoV-2 infection and symptom onset within 7 days. Participants were randomized 1:1 to 200 mg molnupiravir or placebo, or 3:1 to molnupiravir (400 or 800 mg) or placebo, twice-daily for 5 days. Antiviral activity was assessed as time to undetectable levels of viral RNA by reverse transcriptase polymerase chain reaction and time to elimination of infectious virus isolation from nasopharyngeal swabs.

Results

Among 202 treated participants, virus isolation was significantly lower in participants receiving 800 mg molnupiravir (1.9%) versus placebo (16.7%) at Day 3 (p = 0.02). At Day 5, virus was not isolated from any participants receiving 400 or 800 mg molnupiravir, versus 11.1% of those receiving placebo (p = 0.03). Time to viral RNA clearance was decreased and a greater proportion overall achieved clearance in participants administered 800 mg molnupiravir versus placebo (p = 0.01). Molnupiravir was generally well tolerated, with similar numbers of adverse events across all groups.

Conclusions

Molnupiravir is the first oral, direct-acting antiviral shown to be highly effective at reducing nasopharyngeal SARS-CoV-2 infectious virus and viral RNA and has a favorable safety and tolerability profile. <<<<< LIARS LIARS PANTS ON FIRE

Competing Interest Statement <<<<<< NOTHING TO SEE HERE FOLKS

All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare the following: PA, FL, WP, LS, and WH were employed by Ridgeback Biotherapeutics in direct support of the work reported in this manuscript. MA, WF, KM, and RB were contracted by Ridgeback Biotherapeutics in direct support of the work reported in this manuscript. JE, WP, TS, DW, CW, and WF are independent contractors who were topically related to this study within the past 36 months. MC was employed by UNC at Chapel Hill and received a grant from the National Institute of Health in direct support of the work presented in this manuscript. KM has stocks or stock options in ICON Plc. WP and WH received royalties from patents, trademarks, copyrights or other intellectual property. WH has stock or stock options and is a fiduciary offer or member of another board. LF, KB-E, AJL and ED declared no conflicts of interest. The initial draft of this manuscript was prepared by Mark Stead of Covance Clinical Research Unit Limited, UK.

Clinical Trial

NCT04405570

Funding Statement

Molnupiravir wasinventedat Drug Innovations at Emory (DRIVE) LLC, a not for profit biotechnology company wholly owned by Emory University, and with partial funding support from the US government. Since licensed by Ridgeback Biotherapeutics, all funds used for the development of molnupiravir by Ridgeback Biotherapeutics have been provided by Wayne and Wendy Holman and Merck.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.
The details of the IRB/oversight body that provided approval or exemption for the research described are given below:
The protocol was approved by: WCG IRB 1019 39th Ave SE, Suite 120 Puyallup, WA 98374
All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived.
I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).
I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.