Mymensingh Medical College Retrospective Study: Ivermectin Superior to Standard of Care for COVID-19 Patients

Sep 28, 2020 | Bangladesh, Ivermectin, Mymensingh Medical College, News, Popular Posts, Positive Results

Mymensingh Medical College Retrospective Study Ivermectin Superior to Standard of Care for COVID-19 Patients

Recently, a Japanese and Bangladeshi-led research team completed a retrospective study involving 325 consecutive patients infected with SARS-CoV-2 at the COVID-19 treatment unit at Mymensingh Medical College hospital (MMCH), Mymensingh, Bangladesh from April to June 2020. The study’s results were published online Sept. 24 in peer-reviewed Archivos de Bronconeumologia. With a total of 248 adult patients infected with SARS-CoV2 free of any pathological conditions, 115 of them received ivermectin plus standard of care while 133 of the subjects only received standard of care. The remaining patients, 77 in total who were under 18, were transferred from other facilities and received different care management approaches. The study team compared both arms of this study including ivermectin (N=115) and standard of care (N=133) in terms of 1) time to SARS-CoV-2 negativity, 2) disease progression (e.g. condition worsens from pneumonia to severe respiratory distress), 3) duration of hospital stay, and 4) mortality rate. The ivermectin treatment produced no aberrant symptoms (e.g. adverse safety events). While none of the ivermectin patients showed progressive pathology (e.g. pneumonia or cardiovascular complications), 9.8% of the standard of care group developed pneumonia and 1.5% had ischemic stroke. While only 9.6% of the ivermectin group ultimately required oxygen inhalation, 45.9% of the standard of care group fell in this category—a marked and material difference. This observation held up for the development of respiratory distress as well (2.6% ivermectin vs. 15.8% standard of care group). Moreover, of those patients needing antibiotic treatment, superiority of ivermectin was clear with 15.7% of the ivermectin groups vs. 60.2% of the standard of care group. Patients that were given ivermectin didn’t end up in the ICU nearly as much (0.9% ivermectin vs. 8.3% standard of care). Finally, those patients in the ivermectin arm got better faster. In a striking observation, those administered ivermectin became COVID-19 negative in a median of 4 days vs. 15 days for the standard of care group, at 95% CL, 8.97-10.59,P. Although the researchers acknowledge randomized, multicenter study could strengthen the evidence, they’re clear that ivermectin should be considered as a first-line therapy as part of a COVID-19 containment strategy.

Study Suggests Action in the West

Recently published by Elsevier, this study Ivermectin Treatment May Improve the Prognosis of Patients with COVID-19,” authored by Khan MSI, Debnath CR, Nath PN, Mahtab MA, Nabeka H, Matsuda S, and Akbar SMF, produced materially provocative data indicating that Western research agencies and non-government organizations seeking economical, efficient and available treatments for SARS-CoV-2 should at least commission studies to further investigate and validate the accumulating real world evidence.

FDA Embraces Real World

A retrospective study, critics can undoubtedly point to the fact that this particular study wasn’t designed as a randomized controlled trial. However, the U.S. Food and Drug Administration (FDA) established guidance around Real World Data (RWD) and Real World Evidence (RWE) for a reason. In fact, with the passage in the U.S. of the 21st Century Cures Act back in 2016 the additional focus on the use of observational data, retrospective study data and more was acknowledged and recognized as important contributors to support regulatory decision making, including approvals for new indications for approved drugs. 

Moreover, TrialSite has been accumulating volumes of case series, observational studies and the results from a couple randomized controlled trials suggesting the importance of ivermectin-based inquiry in association with COVID-19.

A Multi-faceted Strategy to Contain COVID-19

The authors convey that not only does the antiparasitic drug evidence expedite clearance of the novel coronavirus as observed in this retrospective study, but also represents a possible candidate therapy to manage the course of disease.

After all, the authors remind all, COVID-19 won’t go away. Rather, the world now experiences a marked rise in cases, especially in low and middle-income countries (LMICs) in select parts of Asia and Latin America. The authors suggest a flexible containment and patient management strategy, depending on country, economics, etc. TrialSite concurs within this point of view; these findings, which although not derived from randomized controlled studies, nonetheless represent an accumulating mountain of evidence that this drug can actually be part of a containment strategy for at least LMICs.

The authors although recognizing the importance of an additional multicenter randomized controlled study to strengthen the evidence, regardless suggests that based on the findings of this retrospective study, health authorities should consider ivermectin as a first-line therapy for containing COVID-19 to prevent disease progression and as part of a strategy to help reduce community transmission.

The Trial Site                                                            

A government medical school in Bangladesh, Mymensingh Medical College was established in 1924 by Earl of Lytton, then the governor of Bengal as The Lytton Medical School during British colonial times. Mymensingh Medical Journal, Index Medicus/MEDLINE listed, is the official journal of Mymensingh Medical College.

The postgraduate government medical college conducting MBBS, BDS and postgraduate courses across 27 disciplines is affiliated with Dhaka University and Bangabandhu Sheikh Medical University (BSMMU). More on the hospital can be read here

Lead Research/Investigator

·         Saiful Islam Khan, MD, Mymensingh Medical College and Hospital, COVID-19 Management Team

·         Sakirul Islam Khan, PhD, Ehime University Graduate School of Medicine, Dept. of Anatomy & Embryology

·         Chitto Ranjan Debnath, Mymensingh Medical College and Hospital, Dept. of Hepatology

·         Progga Nanda Nath, Mymensingh Medical College and Hospital, COVID-19 Management Team

·         Mamun AlMahtab, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

·         Hiroaki Nebeka, Ehime University Graduate School of Medicine, Dept. of Anatomy & Embryology

·         Seiji Matsuda Sheikh, Ehime University Graduate School of Medicine, Dept. of Anatomy & Embryology

·         Mohammad Fazle Akbar, Ehime University Graduate School of Medicine, Dept. of Gastroenterology

Call to Action: The study team suggests a multicenter, double-blind, drug-controlled study to strengthen the evidence. TrialSite has sent an email to NIH Director Francis Collins, recommending that the mighty research agency fund an ivermectin clinical trial, notably suggesting the effort currently underway involving Dr. Jean-Jacques Rajter and the follow-up to his ICON study in Broward County, Florida.

16 Comments

  1. Walt

    The proof keeps building. It is becoming rather obvious. Ivermectin works. The intransigence and foot dragging by the western medical authorities to at minimum give some sort of off label signal is just abhorrent. Ivermectin already has FDA approval for heavens sake, and is taken by millions annually. Keep up the great work TrialSite. Your library of articles and continued research on Ivermectin is largely responsible for the ground swell of study and useage of Ivermectin to treat COVID 19.

    • Dennis Ray Abrameit

      What if you’re a placebo person and you feel like quitting or getting the real stuff. I would just keep getting sicker and die or something

      • Peter

        Dennis,
        This is exactly the point that Prof Thomas Borody makes in an interview on Sept. 13th (You Tube) He thinks is unethical to conduct RCT’s when people die in the control group. Especially as his triple theropy is for out-patient care of non-hospitalized covid 19 patients. Also his results have been 92 – 100% effective, how can you ethically run an RCT with those results.

  2. Sam Gorvine

    There is an underground movement of medical pefessionals etc. taking Ivermectin prophylacically with observed success, i.e. we’re not getting Covid– any data on this out there?

  3. rick keizer MD

    The report does not give the treatment regimen. Was it standardized? Was it a single dose or repeated for a number of days?

    • Jon

      On page 4 it says:
      “Ivermectin was given once at dose of 12 mg within 24-h after hospital admission. SC was provided as required and included antipyretics for fever, anti-histamines for cough, and antibiotics to control secondary infection.”

      The author has clarified that the antibiotic given was Azithromycin when necessary.

  4. Dr. LaMarca

    On the most recent

    On the most recent Masschusetts General Hospital guidance for Covid 19 this is posted:
    Not recommended
    Azithromycin and ivermectin are
    not proven as treatments for COVID-19. Only use
    azithromycin or ivermectin for
    other indications.
    Version 6.2 9/23/2020 9:00AM

    • TrialSite

      Dear Dr. LaMarca
      Thank you so much for visiting and offering to share this with the network–we are grateful. I guess its sort of good news/bad news.
      Good news that perhaps a couple months ago they wouldn’t have even mentioned it and now simply ask for proof. Of course there is significant accumulation of real world data leading to RWE but there is sort of a collective response that they need randomized controlled studies. There actually have been a couple such studies but of course they’ll need to see them in the States.
      The bad news of course is there is a sort of collectivistic, sheep-like behavior and that those in the field, collecting real world evidence are discounted as not worthy of generating evidence. No rather that must come from the Ivory Tower and the feds only. Unfortunate that the FDA’s one guidance isn’t considered.
      https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence
      Thanks again Dr. LaMarca
      Publisher

    • Aaron J Courtney

      Third world countries like Pakistan (empty hospitals and shuttered COVID wards) couldn’t care less what the bozos at MGH say.

  5. Dennis Ray Abrameit

    If I had Corona I would volunteer for an ivermectin clinical trial. If I kept getting sicker I would assume it was because I got the placebo and would drop out of the study and beg borrow or steal me the real Ivermectin doxycycline zinc vitamin D3 and live. I’m a Christian I don’t steal. I was just making a point. I also probably left out some commas in my punctuation but I tried.

    • Dina Goldin

      If you want ivermectin that bad, you can stock up on it ahead of time just in case. It’s available without a prescription, supposedly as a drug for pets and livestock, but it’s THE SAME drug.

      • Walt

        You are correct Dina, Further I researched all the minimal (3 or 4)non active ingredients in the equine paste and they are all FDA approved human food preparation ingredients for products like ice cream and other paste and gel like food products. It even comes apple flavoured. The FDA is concerned that people will not dose themselves properly using this paste. Fair concern but the paste comes in an applicator based on the safe human doseage per weight as already approved by the FDA. Just dial up your body weight and you have the correct amount. People have used these products for scabies for years when their doctors hesitated to prescribe ivermectin with great success, same as prescribed Ivermectin. Ivermectin is one of the highest used vetrinary drugs, far greater than human use. They are not going to make a seperate different Ivermectin for humans, the animal medication is repurposed and packaged for human use. Knowledge is power everyone.

        • Nick Berg

          I have searched for the information the horse paste ingredients has other than ivermectin. The FDA drug sheet did list them as they were referred to as proprietary. So thank you. How did find out the unlisted ingredients?

  6. Nizam Ahmad

    What is the dose for prevention of Covid for a 27 year old weighing 65kg?

  7. Trevor Osborne

    Thanks for providing such a great service to humanity.

    I have been following and collecting information of COVID ivermectin treatments for several weeks. You can view and/or download over 20 documents and videos from my Google Drive HERE: https://drive.google.com/drive/folders/1fAcmgASWPMu-GNsxHraVb-lOqr4KWPOG?usp=sharing

    My current conclusions are as follows

    There are 3 stages of the disease:

    I suggest there should be THREE different ivermectin treatments:

    1. Prevention: For people who are in high risk areas and not tested positive, ivermectin twice weekly.

    2. Those who have just tested positive and do not have any symptoms (Stages 1 and 2) ivermectin + zinc until negative.

    3. Those who have tested positive and do have symptoms (Stage 3). For these people perhaps having the Triple Therapy as described by Professor Borody, ivermectin + Doxycycline + zinc.

    Treatments 1 & 2 would “nip the disease in the bud” so people would not have to go to hospital. This regime should empty the hospitals of Covid and allow us to get back to normal very quickly.

    Trevor

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