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Mountain Valley MD $MVMD $MVMDF Proceeding with FDA Pathway Application for Novel Ivectosol™ $CTLT $MRNA $NVAX

Posted by AGORACOM at 9:54 AM on Wednesday, March 3rd, 2021
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Mountain Valley MD Holdings Inc. (the “Company” or “MVMD“) (CSE: MVMD) (FRA: 20MP) (OTCQB: MVMDF) is pleased to announce it has contracted Camargo Pharmaceutical Services, LLC (“Camargo”) to provide regulatory consulting services to support MVMD’s pursuit of U.S. Food and Drug Administration (FDA) approval of its novel Ivectosol™ rapid dissolve oral format.

Camargo is recognized as one of the most experienced global organizations who specialize in drug and combination device product development and approval utilizing the regulatory pathway provided for in Section 505(b)(2) of the US Federal Food, Drug, and Cosmetic Act.  Over the last decade, Camargo has established a leading track record with 505(b)(2) investigational new drug (“IND”) and new drug applications (“NDA” preparations and submissions, including participation in more than 1100 Agency meetings and more than 200 FDA NDA and ANDA (Abbreviated New Drug Applications) approvals.

“After successful pre-clinical studies of our novel solubilized Ivectosol™ sublingual in our pre-clinical trials, this is a critical next step in the approval process to support our human application objectives,” stated Mike Farber, Director of Life Sciences at Mountain Valley MD.   “Camargo will be a great partner to accelerate our efforts for the initial pre-IND presentation to the FDA outlining Ivermectin’s prior usage history and extensive safety record for the FDA’s assessment and approval pathway.”

The 505(b)(2) new drug application is one of three U.S. Food and Drug Administration drug approval pathways and represents an appealing regulatory strategy by way of helping to avoid unnecessary duplication of studies already performed on a previously approved drug.  The Company believes the 505(b)(2) pathway will result in a much less expensive and much faster route to approval, compared with a traditional development pathway, while creating a new, differentiated Ivermectin product with tremendous commercial value.

“Camargo is proud to partner with Mountain Valley MD to advance their novel solubilized Ivermectin sublingual wafer,” said Catherine Gatza, PhD, Vice President, Regulatory and Strategy at Camargo. “This program delivers important advantages to the parasitic infection treatment landscape by providing an alternative dosage form.”

As previously communicated, MVMD’s solubility technology applied to the Ivermectin drug is the only form in the world that uses strictly excipients that are currently approved by the US Food and Drug Administration (FDA), making it a leading candidate for human injection and sublingual applications as well as significantly broader husbandry and companion animal treatments based on its low viscosity.

“The U.S. FDA approval would prove the efficacy and safety of MVMD’s Ivectosol™ wafer at one of the highest standards in the world and would assist in facilitating greater access to key global markets in an accelerated capacity,” stated Dennis Hancock, President & CEO of Mountain Valley MD.  “The human approval pathway timed with our aggressive pursuit of husbandry applications, is core to making our Ivectosol™ products the number one commercial form of Ivermectin in the world.”

Read More: https://agoracom.com/ir/MountainValleyMD/forums/discussion/topics/756473-mountain-valley-md-proceeding-with-fda-505-b-2-pathway-application-for-novel-ivectosol/messages/2306213#message

Mountain Valley MD $MVMD $MVMDF Commencing Husbandry Animal Trials, Appoints Seasoned Doctor of Veterinary Medicine to Advisory Board $CTLT $MRNA $NVAX

Posted by AGORACOM at 9:23 AM on Monday, March 1st, 2021
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Mountain Valley MD Holdings Inc. (the “Company” or “MVMD“) (CSE: MVMD) (FRA: 20MP) (OTCQB: MVMDF) is pleased to announce it is commencing husbandry animal trials with a third-party preclinical contract research organization (“CRO”) to validate the superiority of the Company’s injectable solubilized Ivermectin technology, Ivectosol™ 1%, versus current commercially available forms to treat a broad category of animal parasites.

MVMD’s Ivectosol 1% will be tested in swine and poultry by way of advanced intra-muscular needleless injection to prove superior pharmacokinetics in terms of CMAX (peak serum concentration that a drug achieves) and AUC (area under the curve) with targeted drug withdrawal times within 10 days of administration.  Additionally, the study is anticipated to demonstrate superior ease of administration with elimination of typically heavy restraint requirements, elimination of injection pain for the animal, while dramatically reducing the risk of potentially fatal clostridial infection common with traditional injection site penetration from large gauge needles.

“This is a very significant project that will move very quickly and will form the basis for our submissions in new animal drug applications to the Food and Drug Administration,” stated Dennis Hancock, President and CEO of Mountain Valley MD.  “With our solubilized Ivectosol™1% solution, we will be able to pursue new injectable markets for Ivermectin such as game and poultry that doesn’t exist today, opening up tens-of-billions of animal applications globally per year.”

The Company’s Ivectosol 1% solution uses no harmful organic solvents and is the viscosity of water, which enables novel needleless injector applications.  The Company believes the use of needle-free injection systems with a solubilized Ivermectin will deliver significant benefits to livestock and poultry producers, including increased efficacy and elimination of needles that transfer disease and risk of breaking into food supply, improved administration simplicity with reduced labour and safer handling protocols, minimized tissue damage that traditionally negatively impacts yields, and precision dosing that helps to eliminate human error.

Proceeding with the animal trial is part of the Company’s plan to pursue the broad husbandry and companion animal markets with its Ivectosol™ 1% technology, focused immediately on cattle, swine and poultry industries with a combined annual consumption market size of more than 67 billion animals.

Additionally, the Company is pleased to announce the introduction of Michel Rondeau, Doctor of Veterinary Medicine, as an advisor who will be overseeing the study and driving global pharmaceutical husbandry applications as part of the ongoing business commercialization of MVMD’s technology.

Dr. Rondeau has extensive experience in veterinary research having worked with numerous pharmaceutical companies in animal drug field trials and is credited with co-inventing a global award winning sprayable vaccination device that was acquired by Rhone Poulenc.  Dr. Rondeau has completed an extensive range of research and development projects across a diverse range of husbandry animals including porcine industrial medicine across preventative and curative medicine, nutrition and animal health products and automated feed systems.

Read More: https://agoracom.com/ir/MountainValleyMD/forums/discussion/topics/756293-mountain-valley-md-commencing-husbandry-animal-trials-appoints-seasoned-doctor-of-veterinary-medicine-to-advisory-board/messages/2305890#message

Mountain Valley MD $MVMD $MVMDF Confirms Quicksome™ License Agreement, First Revenues $CTLT $MRNA $NVAX

Posted by AGORACOM at 9:18 AM on Thursday, February 25th, 2021
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  • Entered a commercial license agreement with that is focused on the rapidly emerging global mushroom space.
  • Based on applying MVMD’s Quicksome™ technology to mushroom nutraceutical products
  • Initial payment in the amount of $250,000 CAD

Mountain Valley MD Holdings Inc. (the “Company” or “MVMD“) (CSE: MVMD) (FRA: 20MP) (OTCQB: MVMDF) is pleased to announce that Mountain Valley MD Inc. (“Mountain Valley“) has finalized and entered into a commercial license agreement with Circadian Wellness Corp. (“Circadian“), a privately held Ontario corporation that is focused on the rapidly emerging global mushroom space.

The license agreement with Circadian is based on applying MVMD’s Quicksome™ technology to mushroom nutraceutical products in consideration of ongoing product royalties and an initial payment in the amount of $250,000 CAD, made up of $200,000 CAD cash and $50,000 CAD of equity shares in Circadian.  The initial payment monies will be applied to formulation, product development and sample development work and represents the Company’s first revenues.

MVMD has been working closely with Circadian on proprietary formulations for mushroom-infused products that achieved a significant increase in overall molecule efficacy with the Company’s Quicksome™ desiccated liposome technology applied across a variety of rapid dissolve oral products.  Circadian is finalizing its product plans and go-to-market strategy for a broad line of naturally derived mushroom products that will be distributed initially in North America and expanded globally in future phases.

“Embedding Mountain Valley MD’s Quicksome™ technology into our unique mushroom product formulations has allowed us to create a product line that we believe will be unmatched in its efficacy in the marketplace,” stated Dr. Sanjeev Goel, Chief Medical Officer at Circadian Wellness and founder of Peak Human Labs. “The initial consumer testing with our energy and sleep products has been very well received.  The precision of this delivery technology allows us to build the functional mushroom business out while simultaneously pursuing a leadership position in the rapidly emerging psychedelic space.”

Circadian is a privately held Ontario corporation in the business of mushroom cultivation, extraction, clinical research and development, and end-user consumer health and wellness products and retreats (www.circadianwellness.com).

“With our focus on providing our global nutraceutical, vaccine and pharmaceutical partners with unprecedented product and market advantages, we believe our partnership with Circadian Wellness is a perfect bullseye for our value proposition across the health and wellness space,” stated Dennis Hancock, President and CEO of Mountain Valley MD.  “This inroad into the rapidly growing mushroom industry timed with the broadening analyst coverage of the numerous scientific benefits of mushrooms on human health are expected to be significant for our business plan at Mountain Valley MD.”

“Our ability to drive an increase in bioavailability across convenient and easy-to-use rapid dissolve oral delivery formats provides numerous product advantages that we believe will position Circadian Wellness products as the preeminent choice for consumers in the rapidly growing mushroom marketplace,” stated Mike Farber, Director of Life Sciences at Mountain Valley MD.

Read More: https://agoracom.com/ir/MountainValleyMD/forums/discussion/topics/756066-mountain-valley-md-confirms-quicksome-license-agreement-first-revenues/messages/2305344#message

Mountain Valley MD $MVMD $MVDMF to Include Testing of South African Mutation in Upcoming COVID-19 BSL-4 Clearance Work $CTLT $MRNA $NVAX

Posted by AGORACOM at 9:29 AM on Monday, February 22nd, 2021
  • Testing South African COVID-19 variant with the Company’s new solubilized Ivermectin technology.
  • Mutation is now the most dominant form of the COVID-19 virus in South Africa

Mountain Valley MD Holdings Inc. (the “Company” or “MVMD”) (CSE: MVMD) (FRA: 20MP) (OTCQB: MVMDF) is pleased to announce that it will be testing the new B.1.351 South African COVID-19 variant in its upcoming Bio Safety Level 4 (“BSL-4”) lab study, which is analyzing viral clearance efficacy with the Company’s new solubilized Ivermectin technology.

According to the World Health Organization*, the mutated B.1.351 COVID-19 variant is now the most dominant form of the COVID-19 virus in South Africa and is believed to be more infectious and thus easier to spread. As the COVID-19 virus continually mutates, researchers are assessing the impact of the current vaccines that are in distribution to understand if they may be rendered less effective or even noneffective**.

“We felt it was critical to look at this new South African COVID-19 variant given the immediate complexities we are seeing with the pace of vaccine rollout and the high probability that current vaccines will not be as effective, if at all, against these emerging mutations,” stated Dennis Hancock, President and CEO of Mountain Valley MD. “It is important to us across our broad human health objectives that our solubilized Ivermectin technology can be confidently applied as the broadest COVID-19 therapeutic and number one choice in the world when a vaccine falls short.”

The Company has previously communicated that it believes its solubilized Ivermectin would be suitable for a broad therapeutic across a wide range of viruses in the future, not just limited to COVID-19.

“It is not clear if the current vaccines will protect you from the new variants and early information is that vaccines are not as effective on the mutations. We are attempting in our work with the BSL-4 lab to target novel COVID-19 variants that would prove Ivermectin’s broad activity in interfering with the replication of the virus and thus broadly applies across multiple variants versus being specific to a variant the way a vaccine would be,” stated Mike Farber, Director of Life Sciences at MVMD.

As communicated in the Company’s news release on January 27, 2021, the BSL-4 trial will be the first of its kind ever conducted with human grade solubilized Ivermectin anywhere in the world and its design was led by the Company’s key scientific advisor, Dr. John Clements. Dr. Clements is Emeritus Professor of Microbiology and Immunology at Tulane University School of Medicine and has over 35 years of experience in vaccine, immunology and infectious diseases research and development, with a distinguished scientific career focused on developing and evaluating vaccines for a wide range of infectious diseases globally.

Read More: https://agoracom.com/ir/MountainValleyMD/forums/discussion/topics/755796-mountain-valley-md-to-include-testing-of-south-african-mutation-in-upcoming-covid-19-bsl-4-clearance-work/messages/2304707#message

Mountain Valley MD $MVMD.ca to Commence Trading on OTCQB Market Under Ticker MVMDF $CTLT $MRNA $NVAX

Posted by AGORACOM at 1:33 PM on Friday, February 12th, 2021

Mountain Valley MD Holdings Inc. (the “Company” or “MVMD“) (CSE: MVMD) (FRA: 20MP) is pleased to announce that effective February 16, 2021, it will graduate from the OTC Pink Sheets (“OTCPK”) and commence trading on the OTCQB Venture Marketplace (“OTCQB”) under the symbol “MVMDF”. 

The OTCQB is operated by OTC Markets Group Inc. (“OTC”) out of New York City, NY.  The OTC operates the world’s largest electronic interdealer quotation system for US broker dealers and offers multiple media channels to increase the visibility of OTC-listed companies.  Trading on the OTCQB Market enables companies to efficiently build broader investor awareness and provide U.S. investors with a seamless trading facility to more easily trade through the broker of their choice.

Investors can find Real-Time quotes and market information for MVMD on www.otcmarkets.com.  The Company continues to trade on the Canadian Securities Exchange under the ticker symbol “MVMD” and the Frankfurt Stock Exchange under the ticker symbol “20MP”.

“Trading on the OTCQB is an excellent advancement that will provide a large U.S. investor base with the opportunity to participate directly in Mountain Valley MD’s growth,” stated Dennis Hancock, President and CEO of Mountain Valley MD Holdings.  “The OTC listing will contribute to our strategy to continue to enhance our share liquidity and broaden the reach and awareness of our global health and wellness innovations.”

Read More: https://agoracom.com/ir/MountainValleyMD/forums/discussion/topics/755263-mountain-valley-md-holdings-to-commence-trading-on-otcqb-market-under-ticker-mvmdf/messages/2303455#message

Mountain Valley MD $MVMD.ca $MVMDF Contracts Tulane University for Adjuvant IPV Study $CTLT $MRNA $NVAX

Posted by AGORACOM at 8:53 AM on Tuesday, February 2nd, 2021
  • Tulane University contracted as Research Organization to conduct its adjuvant Inactivated Polio Vaccine (“IPV“) study
  • Study will evaluate the ability of MVMD to promote dose-sparing, and therefore lower costs

Mountain Valley MD Holdings Inc. (the “Company” or “MVMD“) (CSE: MVMD) (FRA: 20MP) is pleased to announce it has contracted Tulane University School of Medicine in New Orleans, Louisiana, United States, as its Contract Research Organization (“CRO“) to conduct its adjuvant Inactivated Polio Vaccine (“IPV“) study, commencing in February, 2021.

As announced in its recent news release on January 20, 2021, the Company filed a POROUS ALUMINUM NANO-STRUCTURED ADJUVANT (“PANA“) patent to support its advanced vaccine dose sparing work and began immediately to undertake the study development and contracting of a qualified CRO.  The study will compare existing Alhydrogel adjuvant to the Company’s recently invented stable nano-particulate adjuvant by both intramuscular injection and intradermal injection immunization, evaluating the antibody responses following vaccination with fractional doses of IPV comparing delivery types with IPV alone or adjuvanted.

The study is anticipated to take sixty-days and will be led by Dr. Elizabeth Norton, PhD, Assistant Professor, Department of Microbiology and Immunology at Tulane University School of Medicine.  Dr. Norton’s research focus is mucosal immunity and immunologic mechanisms of vaccination, with a particular concentration on how infection or vaccination can target specific cell populations involved in antigen transport and processing, enhance Th17 cell development and induce IgA production.

Dr. Norton was supported by the Company’s key scientific advisor, Dr. John Clements in the development and design of the adjuvant IPV study that would effectively determine the exact dose sparing achievement of its patent-pending approach.  Dr. Clements is Emeritus Professor of Microbiology and Immunology at Tulane University School of Medicine and has over 35 years of experience in vaccine, immunology and infectious diseases research and development, with a distinguished scientific career focused on developing and evaluating vaccines for a wide range of infectious diseases globally.

“Our study will evaluate the ability of MVMD’s new porous aluminum nanostructures to adjuvant injected IPV, promote dose-sparing, and therefore lower costs, and facilitate mucosal and herd immunity when compared to IPV,” stated Dr. John Clements, MVMD scientific advisor and Emeritus Professor of Microbiology and Immunology at Tulane University School of Medicine. “Successful completion of these studies and subsequent human clinical studies could further demonstrate the potential of Mountain Valley MD’s porous aluminum nanostructures as an adjuvant in a modified IPV vaccine strategy and thereby take a major step toward achieving the global eradication of polio.”

Read More:https://agoracom.com/ir/MountainValleyMD/forums/discussion/topics/754427-mountain-valley-md-contracts-tulane-university-for-adjuvant-ipv-study/messages/2301571#message

Mountain Valley MD $MVMD.ca Proceeding With COVID-19 Clearance Trial in Level 4 Biohazard Facility $CTLT $MRNA $NVAX

Posted by AGORACOM at 9:11 AM on Wednesday, January 27th, 2021
  • Lab study to demonstrate solubility technology applied to the Ivermectin drug can be applied as a broad therapeutic to immediately treat COVID-19
  • Commencing lab trial in late February 2021, with results anticipated in April 2021.

Mountain Valley MD Holdings Inc. (the “Company” or “MVMD“) (CSE: MVMD) (FRA: 20MP) is pleased to announce it has executed an agreement to conduct its Bio Safety Level 4 (“BSL-4”) lab study of COVID-19 viral clearance in transgenic mice designed to prove the superiority of the Company’s solubilized Ivermectin technology versus commercially available oral form in speed and efficacy of viral clearance.  The agreement was signed January 26, 2021.

“This is a very significant project for MVMD and it will clearly demonstrate how our solubility technology applied to the Ivermectin drug can be applied as a broad therapeutic to immediately treat COVID-19, as well as its role in stopping the deadly spread of future pandemics that are certain to follow,” stated Dennis Hancock, President and CEO of Mountain Valley MD.  “Quicksol™ allows us to imagine a world’s first as an injectable Ivermectin format for emergency front line usage as well as a rapid dissolve tablet that is administered for prevention like vitamin C around the world.”

There are less than thirty BSL-4 facilities in the world capable of performing this study and it is not unusual for projects to take up to three years to schedule.  The Company was able to demonstrate the significance of its patented solubilized Ivermectin technology through its presentation of the superior pharmacokinetic data documented from two previously completed pre-clinical trials and was granted approval by the BSL-4 facility to commence this trial in late February 2021.  The study results are anticipated in April 2021.

This study will be the first of its kind ever conducted with human grade solubilized Ivermectin anywhere in the world and its design was led by the Company’s key scientific advisor, Dr. John Clements.  Dr. Clements is Emeritus Professor of Microbiology and Immunology at Tulane University School of Medicine and has over 35 years of experience in vaccine, immunology and infectious diseases research and development, with a distinguished scientific career focused on developing and evaluating vaccines for a wide range of infectious diseases globally.

Read More: https://agoracom.com/ir/MountainValleyMD/forums/discussion/topics/754031-mountain-valley-md-proceeding-with-covid-19-clearance-trial-in-level-4-biohazard-facility/messages/2300498#message

VIDEO – Mountain Valley MD $MVMD.ca Patent Filing Creates New Global Delivery And Patient Delivery Model That Can Eradicate Polio From The World …. Then Other Viruses $CTLT $MRNA $NVAX

Posted by AGORACOM-JC at 6:55 PM on Wednesday, January 20th, 2021
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Let us start off by saying this interview may be the best one we’ve done in the last 10 years.  Here is why.

When Mountain Valley MD issued this press release today, you wouldn’t be alone if you declared “I really don’t know what that means”.  The fact of the matter is that MVMD is a double-edged sword that puts it in a position to quite potentially change the way the world delivers drugs and vaccines via physical transport and into the body of patients who need them most.  The flip-side of creating something so cutting edge is that it makes it very difficult to understand for anybody without a Life Sciences PhD.

Fortunately, this is where AGORACOM comes in to bridge the worlds between MVMD and the investment community.  To do that, the first thing you have to understand is the following:

MVMD Takes Existing Vaccines and Drugs – And Delivers Them Better.  Both Into The Body and By Transportation To The World. Way Better.

For the purposes of introducing you to MVMD, we’ll use vaccines as an example given the state of the world since COVID-19 arrived.  Specifically, we’ve all heard more about vaccines in 12 months than we have in the last 12 years.  One thing we all know about vaccines is that vaccination is the safest way to protect people against infectious diseases.

BUT 

One thing we don’t know or understand about vaccinations is that they are only as good as:

1.  The global physical delivery system that actually gets them from the manufacturer to the hands of nurse who injects the vaccine;

2.  The delivery system into your body (i.e. injection)

If either parts of these delivery systems are weak, or even fail, a vaccine loses some or even all of its potency – and that’s not good.

This is where MVMD comes in.  They don’t make vaccines, drugs or pharmaceuticals.

What they do is make their delivery better.  Their physical delivery until their ultimate delivery into your body – and that is very good.

By doing so, they help save lives and they help manufacturers be more profitable – and that is very good for humanity and shareholders.

CAN MVMD CREATE A WORLD WITHOUT POLIO … AND THEN OTHER VIRUSES? THEY JUST MIGHT

With the information above in mind, you can now start to get a sense of the power of this quote from MVMD CEO, Dennis Hancock:

“Using a fraction of the Inactivated Polio Vaccine, applying advanced Quicksome™ thin film inside a vial that can be distributed completely outside of the cold chain, and administering through needleless applications is the formula to help us achieve our vision of a world without Polio“. 

If you want to find out what is possible, watch this powerful, eye-opening and sometimes emotional interview with CEO Dennis Hancock and Director of Life Sciences Mike Farber.

The COVID-19 Treatment Guidelines Panel’s Statement on the Use of Ivermectin for the Treatment of COVID-19 SPONSOR: Mountain Valley MD $MVMD.ca $CTLT $MRNA $NVAX

Posted by AGORACOM at 12:53 PM on Friday, January 15th, 2021

SPONSOR: Mountain Valley MD has confirmed the ability to make the drug ivermectin water-soluble without the use of organic solvents, greatly increasing the potential applications for treatment. MVMD has Improved ivermectin’s water solubility by nearly 5000 times more than current solubility  Click Here for More Info

  • The NIH has upgraded their recommendation and now consider IVERMECTIN an option for use! The national Institute of Health

Recommendation

  • The COVID-19 Treatment Guidelines Panel (the Panel) has determined that currently there are insufficient data to recommend either for or against the use of ivermectin for the treatment of COVID-19. Results from adequately powered, well-designed, and well-conducted clinical trials are needed to provide more specific, evidence-based guidance on the role of ivermectin for the treatment of COVID-19.

Rationale

Ivermectin is an antiparasitic drug that is approved by the Food and Drug Administration (FDA) for the treatment of onchocerciasis and strongyloidiasis. Ivermectin is not FDA-approved for the treatment of any viral infection. In general, the drug is well tolerated. It is currently being evaluated as a potential treatment for COVID-19.

Antiviral and Anti-Inflammatory Effects of Ivermectin

Reports from in vitro studies suggest that ivermectin acts by inhibiting the host importin alfa/beta-1 nuclear transport proteins, which are part of a key intracellular transport process that viruses hijack to enhance infection by suppressing the host antiviral response.1,2 In addition, ivermectin docking in vitro may interfere with the attachment of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein to the human cell membrane.3

Ivermectin has been shown to inhibit the replication of SARS-CoV-2 in cell culture. However, pharmacokinetic and pharmacodynamic studies suggest that ivermectin doses up to 100-fold higher than those approved for use in humans would be required to achieve the plasma concentrations necessary to duplicate the drug’s antiviral efficacy in vitro.4,5 Even though ivermectin appears to accumulate in lung tissue, with the doses used in most clinical trials, predicted systemic plasma and lung tissue concentrations are much lower than 2 µM, the half-maximal inhibitory concentration (IC50) against SARS-CoV-2 in vitro.6,7

Ivermectin demonstrates potential anti-inflammatory properties in some in vitro studies,8,9 properties which have been postulated to be beneficial in the treatment of COVID-19.10

Clinical Data

Since the last revision of the Ivermectin section of the Guidelines, the results of several randomized trials and retrospective cohort studies of ivermectin use in patients with COVID-19 have been published in peer-reviewed journals or made available as preliminary, non-peer-reviewed reports. Some clinical studies showed no benefits or worsening of disease after ivermectin use,11-14 whereas others reported shorter time to resolution of disease manifestations attributed to COVID-19,15-18 greater reduction in inflammatory markers,16,17 shorter time to viral clearance,11,16 or lower mortality rates in patients who received ivermectin than in patients who received comparator drugs or placebo.11,16,18

However, most of the studies reported to date had incomplete information and significant methodological limitations, which make it difficult to exclude common causes of bias. The missing information and limitations include the following:

  • The sample size of most of the trials was small.
  • Various doses and schedules of ivermectin were used.
  • Some of the randomized controlled trials were open-label studies in which neither the participants nor the investigators were blinded to the treatment arms.
  • In addition to ivermectin or the comparator drug, patients also received various concomitant medications (e.g., doxycycline, hydroxychloroquine, azithromycin, zinc, corticosteroids), confounding assessment of the true efficacy or safety of ivermectin.
  • The severity of COVID-19 in the study participants was not always well described.
  • The study outcome measures were not always clearly defined.

Because of these limitations, the Panel cannot draw definitive conclusions about the clinical efficacy or safety of ivermectin for the treatment of COVID-19. Results from adequately powered, well-designed, and well-conducted clinical trials are needed to provide more specific, evidence-based guidance on the role of ivermectin for the treatment of COVID-19.

SOURCE: https://www.covid19treatmentguidelines.nih.gov/statement-on-ivermectin/