Why Women Are Essential in COVID-19 Numerous Studies

 

Redefining Lupus Clinical Trials Amid COVID-19 and Beyond

Video taken from the channel: Lupus Research Alliance


 

Get yourself Up-To-Date on COVID-19 Clinical trials at www.clinicaltrials.gov

Video taken from the channel: ICU REACH


 

Coronavirus Cure: How UC Davis researchers are participating in clinical trials | COVID-19 in contex

Video taken from the channel: ABC10


 

‘Robust immune responses’ found in Covid-19 vaccine clinical trials point to 2021 release

Video taken from the channel: South China Morning Post


 

COVID-19: Drug Therapies and Clinical Trials

Video taken from the channel: NYU Langone Health


 

FDA Clinical Trial Guidance During COVID-19

Video taken from the channel: Alliance for Regenerative Medicine


 

Clinical trial evaluating antiviral drug remdesivir for treatment of COVID-19 Dr. Catharine Paules

Video taken from the channel: Penn State Health


Why it’s critical that women join the COVID-19 trials “Lack of enough women, particularly minority women, participating in clinical trials can skew research data towards men,” Mallampalli said. “Essentially, not being able to analyze data by sex, age and race/ethnicity will not ensure adequate treatment for a given population, and this can lead. “There is currently no standard of care for anticoagulation in hospitalized COVID-19 patients, and there is a desperate need for clinical evidence to guide practice,” said NIH Director Francis S. Collins, M.D., Ph.D. “Conducting trials using multiple existing networks of research sites provides the scale and speed that will get us answers. 2 days ago · Oxford and AstraZeneca resume COVID-19 vaccine trial the university confirmed the restart across all of its U.K. clinical trial sites after regulators gave the go-ahead following the pause on. This is needed to catch more rare side effects. Many clinical trials have a data and safety monitoring board This has shifted with COVID-19 trials.

Leaders of the Latino community, hit hard by the coronavirus pandemic, roll up their sleeves for vaccine trials. Volunteers point to startling inequities exposed by COVID-19. Some potential COVID-19 vaccines are already in the third stage of clinical trials. It’s taken a lot of effort and money to squeeze a process that can normally take five years into about 10.

Running a large clinical trial is complex and finding the right mix of volunteers is often challenging and can take months, but Hiatt thinks the COVID-19 trials will be different. “The altruistic. Early-stage clinical trials show that three COVID-19 vaccines are generally safe and induce an immune response in healthy people. The results of two of these studies were published online. Per the New York Times’ Covid-19 vaccine tracker, 3 out of the 9 companies in late stage trials have declared an annual capacity totaling to about 3.5 billion doses.

The second is a regulatory issue. One principle is that the manufactured and sold product has to be “identical” in key aspects to the product used during clinical trials. AstraZeneca paused its COVID-19 vaccine trials after a volunteer developed a potentially serious side effect.

Why that’s actually good news.

List of related literature:

Is Because of the long duration of preinvasive detectable disease in women of reproductive age, annual screening in the absence of specific risk factors is unnecessary for most women.

“Primary Care Medicine: Office Evaluation and Management of the Adult Patient” by Allan H. Goroll, Albert G. Mulley
from Primary Care Medicine: Office Evaluation and Management of the Adult Patient
by Allan H. Goroll, Albert G. Mulley
Wolters Kluwer Health/Lippincott Williams & Wilkins, 2009

These trials have significantly increased the overall number of women in clinical trials.

“Sex Differences in Cardiovascular Physiology and Pathophysiology” by Babbette LaMarca, Ph.D., Barbara T. Alexander, PhD, FAHA, FAPS
from Sex Differences in Cardiovascular Physiology and Pathophysiology
by Babbette LaMarca, Ph.D., Barbara T. Alexander, PhD, FAHA, FAPS
Elsevier Science, 2019

Because these women are at increased risk for adverse events, further diagnostic evaluation, as well as interventions to modify risk factors, relieve symptoms, and improve microvascular and macrovascular function, should be considered.

“Mayo Clinic Internal Medicine Board Review” by Amit K. Ghosh
from Mayo Clinic Internal Medicine Board Review
by Amit K. Ghosh
OUP USA, 2010

Because LMWHs are not routinely monitored the possibility that women could be at risk for higher anti-Xa levels and subsequently at greater risk for bleeding when these agents are used may occur.

“Principles of Gender-specific Medicine” by Marianne J. Legato, John P. Bilezikian
from Principles of Gender-specific Medicine
by Marianne J. Legato, John P. Bilezikian
Elsevier Academic Press, 2004

Because most infections in males and females are asymptomatic, screening atrisk individuals is a cornerstone of secondary prevention.

“Conn's Current Therapy 2020, E-Book” by Rick D. Kellerman, KUSM-W Medical Practice Association, David Rakel
from Conn’s Current Therapy 2020, E-Book
by Rick D. Kellerman, KUSM-W Medical Practice Association, David Rakel
Elsevier Health Sciences, 2019

Because this is a modifiable risk factor, education of women about the dangers of hypertension and intensive screening becomes important.

“Netter's Cardiology E-Book” by George Stouffer, Marschall S. Runge, Cam Patterson, Joseph S. Rossi
from Netter’s Cardiology E-Book
by George Stouffer, Marschall S. Runge, et. al.
Elsevier Health Sciences, 2018

Large-scale clinical trials of new treatment options for cardiovascular conditions need to enroll women, and the results of such studies need to be analyzed by sex in order to inform individualized care that will lead to improved outcomes.

“Sex-Specific Analysis of Cardiovascular Function” by Peter L. M. Kerkhof, Virginia M. Miller
from Sex-Specific Analysis of Cardiovascular Function
by Peter L. M. Kerkhof, Virginia M. Miller
Springer International Publishing, 2018

In this case, because of test sensitivity of 84% for MammaPrint versus 98% for NIH criteria, some women who will progress will be categorized as low risk and not recommended for chemotherapy.

“Genomic and Personalized Medicine: V1-2” by Geoffrey S. Ginsburg, Huntington F Willard
from Genomic and Personalized Medicine: V1-2
by Geoffrey S. Ginsburg, Huntington F Willard
Elsevier Science, 2008

They make no recommendation for or against screening asymptomatic, low-risk women and found insufficient evidence to recommend for or against routine screening of men.

“Textbook of Family Medicine E-Book” by Robert E. Rakel
from Textbook of Family Medicine E-Book
by Robert E. Rakel
Elsevier Health Sciences, 2007

Because women often experience greaterdisability after MI, it isimperative that future research efforts includewomeninsufficient numbersto examine gender differences in symptom presentation, risk factors, and treatment options.

“Handbook of Psychology, Health Psychology” by Irving B. Weiner, Arthur M. Nezu, Christine M. Nezu, Pamela A. Geller
from Handbook of Psychology, Health Psychology
by Irving B. Weiner, Arthur M. Nezu, et. al.
Wiley, 2012

Oktay Kutluk

Kutluk Oktay, MD, FACOG is one of the world's foremost experts in fertility preservation as well as ovarian stimulation and in vitro fertilization for infertility treatments. He developed and performed the world's first ovarian transplantation procedures as well as pioneered new ovarian stimulation protocols for embryo and oocyte freezing for breast and endometrial cancer patients.

Mail: [email protected]
Telephone: +1 (877) 492-3666

Biography: https://medicine.yale.edu/profile/kutluk_oktay/
Bibliography: oktay_bibliography

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21 comments

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  • I’m not a Dr just curious. Has there been any attempt on covid 19 patients to use surfactant to try to open the lungs up or use of hyperbaric chambers with hi pressure o2

  • Coronavirus Studies

    There are 202 clinical studies on Coronavirus (CV) listed on the site clinicaltrials.gov. A few of these are observational studies, some are studies on an offbeat treatment and are available at only one or two institutions, most are for the treatment of the critically ill, and the majority are being done in countries outside the United State. I will admit, upon looking at the study offerings, I am disappointed in what little is being done in the United States. Of that 202 studies there are only a dozen or so treatment studies here in the United States.

    At this time, almost all for the studies are for patients who are critically ill, at a time when it I probably too late for antiviral to help much. (But I hope that I am wrong). In the setting of critical illness, the potent anti-inflammatories such as the IL-6 inhibitors still make sense.

    What we needs are studies offered to CV patients before they are so ill that they are in the intensive care unit. Actually, we needs studies on CV patients who have just been diagnosed with the disease. It is in this setting where antiviral treatment should do the most good. It is also in this setting where a lot of people will not advance to critical illness.

    We need studies to offered at 100 or more medical centers, not just 20 or 30.

    We need large studies that randomize patients to one of many possible combinations of treatment. There is only one place in the world where just a study is offered, at that is in Bangkok, Thailand

    The approach researchers are taking is painstakingly slow. This might be fine for testing new treatments for colon cancer but it is grossly inadequate for this epidemic. The FDA and researchers are thinking “we will have some information on several drug treatments in 5 or 6 weeks, then we will start another study, combining promising treatments and that will take another 5 or 6 weeks. It will probably be around July or August when we will optimize treatment.

    In other words, less than one tenth of one percent of CV patients area being put on study.

    This is totally inadequate.

    In my opinion, we need multi-armed studies, aimed at enrolling 1,000 patients a week, and testing treatments early in the disease processes.

    Here is a study that I suggest. Have a seven armed study for early diagnosed patients. People are randomized to get a) no treatment, b) Remdesivir, c) Favipiravir, d) a combination of Remdesivir and Favipiravir, e) Hydroxychlroroquine plus Remdesivir, f) Hydroxychloroquine plus Favirpiravir, g) Hydroxycholoroquine plus Remdesivir plus Favipiravir.

    You could have the same study offered to hospitalized patients who are not yet critically ill.

    You could have the same 7-arm study, but replace Favipiravir with EIDD-2801 (another oral anti-viral RNA polymerase inhibitor.

    And offer this one to both early diagnosed patients and those that need hospitalization.

    Or you could offer the same 7-arm study but instead of giving oral Hydroxychloroquine offer the anti IL-6 antibody Tocilizumab (Actemra) which is a shot in the arm given once a week for two weeks.

    Or the anti IL-6 antibody Sarilumab (Kevzara)

    Or the anti IL-6 antibody Siltuximab (Sylvant).

    Keep in mind, Actemra, Kezara and Sylvant are drugs that are FDA approved to arthritic conditions. These drugs should be readily available with an ample supply

    And, of course, there will be other potential drugs, coming in short order.

    There is a challenge, of course, in offering studies to those newly diagnosed. If you included a lot of young and healthy in these early case studies, you might find that almost everyone does well and you might now be able to detect an improvement in survival (although you might be able to see the virus clear faster). You could restrict enrollment to individuals over age 35 or individuals who have diabetes or other chronic conditions. Furthermore, you would be recruiting people who would ordinarily be staying at home in isolation. Getting them to come in to the office for an intravenous infusion (for those getting Remdesivir) might be difficult (but this can be accomplished). A special infusion center would have to set up and staffed by brave nurses who are willing to gown up and risk the disease. This would be a ideal setting for nurses who have caught and recovered from CV, for they should have ample antibodies to prevent re-infeciton.

    For any of these seven-armed studies you would need to recruit probably 100 subjects per arm. Those who get on Placebo and progressively get worse, may then be offered a new study. In fact, anyone who progresses regardless of what treatment they have been given may be offered another study, if that study is not a repeat of what they have just failed. You might end up needing 200 individuals per treatment arm, if you want good confirmation of which treatment or combination is the best.

    To run all of these studies you need a great deal of cooperation. You need to have physician groups or hospitals experienced with performing clinical studies. But they are out there. There certainly is more than 100 groups who could participate in enrolling and treating study patients. (probably more like 500). You need training. You need a protocol. You need reliable shipment and containment of drug. These medical groups are accustomed to this. Conducting studies is not rocket science

    The FDA needs to act on this now. Come out of the stone age of research. We hare in an international emergency and they have to act like it is an emergency. The United States was slow on the draw in getting people isolated and now we have well over 100,000 with CV. In another week it may be 200,000 to 300,000 and our health system is overloaded. Look, there is no shortage of individuals who can and are willing to participate in clinical studies Why is the FDA slow on the draw here?

    There needs to be very large studies, with rapid enrollment, done at over 100 institutions, both inpatient and outpatient with multi-armed studies comparing combination treatment.

    Hydroxychloroquine should be available, since there are three manufacturers, increasing production.

    Gilead should be making Remdesivir in large quantities and I would think would soon have 10,000 doses. (not an easy drug to make)

    Favipiravir is made in Japan, but they should have a lot of it. Favipiravir is a simple chemical compound and should be easy to manufacture.

    EIDD-2801, made by Ridgeway Pharmaceuticals may not be entirely ready yet. The drug may not be well characterized as to absorption and side effect profile. I am less sure about this one.

  • They’re WASTING THEIR TIME!!! A Covid-19 VACCINE was developed at the same time that BILL GATES financed the development of the TWEAKED CORONA VIRUS from where COVID-19 was created in a USA Lab and then transported to the Lab in Wuhan for those Immunologists to MASS PRODUCE!!! Bill Gates has a PATENT on COVID-19 VACCINE and all CORONA related stuff too!!!
    WAKE UP ALLLLLLLLLL OF YOU DEVELOPING VACCINES, because they won’t contain the lethal components that BILL’s does and IS THE ONE THAT WILLLLLLLL BE USED!!!
    Yes! Sorry guys, but you are wasting your time and a LOT of money which could be spent on other WORTHY research and immunological developments! You’re farting against thunder and DREAMING!!!
    BTW… Dr Rashid Buttar has copies of those CORONA and COVID-19 patents owned by Bill Gates… fortunately before all proof of their existence was WIPED OFF THE NET! ������ The ONLY 2 trustworthy TRUTHERS in my opinion, are Dr Rashid BUTTAR on his own channel and website, and DEL BIGTREE on �� The Highwire Channel.
    I also take direction from my MOST TRUSTED Heavenly mentor, Matthew Ward, who has NEVER ONCE been incorrect since I first encountered his existence in 2004.
    �� https://www.matthewbooks.com/july-2-2020/
    Do read previous FREE monthly messages pertaining to this LAB CREATED VIRUS intended to CULL BILLIONS… YES! You read that correctly… BILLIONS!
    �� South Africa ����������

  • https://www.globenewswire.com/news-release/2020/07/07/2058547/0/en/In-Vitro-Testing-of-Innovation-Pharmaceuticals-Brilacidin-for-COVID-19-Shows-Consistent-Anti-SARS-CoV-2-Efficacy-Manufacturing-Preparation-Underway-for-COVID-19-Clinical-Trial.html

  • We are looking for #PIs for #compassionate use or #emergency trial for #COVID-19 with severe #ARDS patients with our #Olinvacimab + standard of care +/low dose #dexamethasone.

    Olinvacimab is anti-VEGFR2 neutralizing human IgG with clear safety profile. https://www.medrxiv.org/content/10.1101/2020.07.26.20159756v1.full.pdf?fbclid=IwAR3Pv566LQ8IyIe5yQ_l-o-Go1gFa4_mS44zHH3u60JjXG67J4sBq4MeIRw

  • I’ve seen The Fantastic Fungi and it suggested that our defenses for pandemic viruses could be found in these mushrooms and other fungi. We really need to take care of our forests and environment, and I hope governments across the globe start thinking and enforce more stringent measures in protecting our only home.

  • https://aapsonline.org/coronavirus-victims-die-while-government-hoards-medication/ This is written by the National Board of Drs. and Surgeons, It is not partisan and look at what they say! Many state governments are hoarding more than 100 million doses of hydroxychloroquine (HCQ) while victims of COVID-19 are dying from lack of early treatment, which an increasing number of physicians and scientists believe is crucial to save lives!  Reports to date of results in more than 2,300 persons who received HCQ show that more than 90 percent experienced clinical improvement or did not become ill. HCQ is also being used successfully as a prophylaxis in other countries, including India, to protect medical workers, first responders, household contacts, and other persons at risk of exposure. The COVID-19 mortality rate in India is only one per million in population, compared with more than 200 per million in the U.S.! But in the USA the politics have halted treatment of COVID patients because these state politicians are stopping DRS from prescribing HCQ and locking it away in govt warehouses to Rot! This because Pres Trump pushed for it! https://justthenews.com/politics-policy/coronavirus/pa-forced-nursing-homes-take-covid-patients-health-secretarys-mother These same left Governors and their people have made nursing homes accept COVID patients and the result is more than half of all deaths in nearly every state is in Nursing Homes!  In NYC it was just exposed 5200 died in Nursing homes. Pennsylvania made nursing homes accept COVID patients, but the Penn State Health Secratary’s Mom was moved out and into a Hotel! That tells me they Knew it would be deadly and it was!

  • Its could have this side effect it could have that side effect blah blah blah.
    IN THE MEAN TIME Dr Seigels NINETY SIX YEAR OLD father took it and was better the next day.
    PS I know of a couple of guys who took this drug in Vietnam for malaria protection FOR Months at a Time With NO Side effects

  • Why is the study using vitamin c as the placebo vs chloroquine? Will it not have confounding effects as vitamin c has effects on reducing inflammation?

  • We are looking for #PIs for #compassionate use or #emergency trial for #COVID-19 with severe #ARDS patients with our #Olinvacimab + standard of care +/low dose #dexamethasone.

    Olinvacimab is anti-VEGFR2 neutralizing human IgG with clear safety profile. https://www.medrxiv.org/content/10.1101/2020.07.26.20159756v1.full.pdf?fbclid=IwAR3Pv566LQ8IyIe5yQ_l-o-Go1gFa4_mS44zHH3u60JjXG67J4sBq4MeIRw

  • I saw they used this medication back in 2003 in Africa to treat meningitis. Lies… It has been used for many applications and ailments in humans… With a bit of web digging any 12 year year old kid could find what I found just looking for the info…. The truth is they don’t want a cure they want a treatment or therapy. There is more money in therapies in treatments than there is in a cure.

  • Wow Really guys? Really?
    Covid is a short term illness in that you are either way better or way worse 14 or 15 days after onset.
    And these trial are going on about 14 days now maybe 20 days.
    In another week anyone that tells you that they dont have large enough sample size data is Lying PLAIN AND SIMPLE!

  • Have you looked into aminaphtone as possible support treatment for ARDS patients or maybe even to avoid it developing at all? It down-regulates gene transcription for several citokines including TNF-ß e IL-6. It reduces the secretion of VCAM-1,ICAM-1 and ELAM-1. So, theoretically, it could reduce citokine release, capillary permeability and reduce lung fibrosis all at once. Too good to be truth? Maybe, but it might be worth the shot, especially in such times. What is your thought on that?

  • https://www.breitbart.com/politics/2020/07/28/watch-live-silenced-frontline-doctors-hold-capitol-hill-press-conference-to-challenge-big-tech/

  • This drug had been around for more then 60 years and they claim not to know side effects, if the meaning is side effects in conjunction with this virus that that needs to be made clear. Professionals need to be clear when they speak to the common man, most people have absolutely no understanding of this terminology or viruses & microorganisms. By the I’m a metallurgical technician

  • Back in May this vaccine failed the tests on monkeys:

    Doubts over Oxford vaccine as it fails to stop coronavirus in animal trials

    Experts warn that vaccine may only be ‘partially effective’ after results of a trial in rhesus macaque monkeys

    https://www.telegraph.co.uk/global-health/science-and-disease/doubts-oxford-vaccine-fails-stop-coronavirus-animal-trials/

    Potential Oxford vaccine fails to prevent coronavirus spread in monkeys, but protects from pneumonia

    https://www.thehindu.com/news/national/potential-oxford-vaccine-fails-to-prevent-virus-spread-in-monkeys/article31617852.ece

    Maybe they got it right today? Who wants to be a Guinee pig? Volunteers? Anyone?

  • https://www.globenewswire.com/news-release/2020/07/07/2058547/0/en/In-Vitro-Testing-of-Innovation-Pharmaceuticals-Brilacidin-for-COVID-19-Shows-Consistent-Anti-SARS-CoV-2-Efficacy-Manufacturing-Preparation-Underway-for-COVID-19-Clinical-Trial.html

  • A vaccine for a virus that hasn’t been isolated and sequenced???
    How do you do that?
    Dr Judy Mikovits would tie this Clown in knots!
    COVID1984

  • Since March, Dr. Richard Bartlett from Midland, Texas has been using an inexpensive safe drug to effectively treat 100% of his COVID-19 patients quickly and easily. The treatment is inhaling a steroid called budesonide using a nebulizer. Dr. Bartlett says many patients experience rapid relief from Covid symptoms after the first treatment. It’s the same treatment that worked in crowded countries like Taiwan, Singapore and Japan who’ve had very few deaths compared to countries that locked down. Therefore, Bartlett questions the effectiveness of mandatory masks, social distancing or a vaccine.

    He explained that a vaccine is unnecessary because the mortality rate is so low and effective treatments already exist. And he emphasized that vaccines would be ineffective because of constant mutations to the coronavirus. “The beautiful thing about the treatment that I’m using is that no matter how many times it mutates it’s universally going to work because it decreases the inflammation. It’s a respiratory anti-inflammatory solution to a respiratory inflammatory problem.”

    Bartlett does have a channel: @UCHBiz5wMLRiQwBoMdzYbLVw
    and there is an one hour audio interview on Joel Evan channel. Very informative. Let me know what you think: @

  • Also I took the horse paste ivermectin 1.87 percent upped the dose to a 1500 pound horse and no side effects beside a bad aftertaste.

  • This was an outstanding discussion with a high-powered panel, balanced by respected specialists and professionals on one end, and lupus patients with clinical trials experience, on the other. As a medical writer for LRA I watched this webinar with pride, and appreciated everyone’s contribution to better inform the public about the brighter future envisioned for clinical trials, especially as it pertains to increasing diversity of participants. Thank you!