COVID-19 --- Treatments versus Vaccines, Gilead’s Remdesivir

[sharoncrayn]

Please note: These observations are conclusions of my own and are either drawn from my extensive experience with CTs or from conversations with individuals who actually have research expertise in this field. I am sure other medical scientists and non-medical types will have different opinions.

By way of explanation, Treatments are considered pharmaceutical to assist individuals to recover from COVID-19; vaccines will presumably help “prevent’ people from ever getting the virus.

Remdesivir (antiviral drug, not a vaccine) is a treatment drug and many are suggesting it as a "first off the line" drug that might be available soon for widespread use. It was developed by Gilead (USA). It presumably was able to block previous viruses, specifically SARS and Mers (which are somewhat similar to COVID-19 depending on who you talk to). However, previously it was only tested on mice and earlier on a cell basis, in vivo and in vitro. It also had a clinical trial related to Ebola for “safety”. Gilead will “ramp up” development by launching 2 Phase III clinical trials at the same time. Random, “open label”, IV administration (2 different protocols for the 2 CTs), up to 1,000 Asian participants primarily from Asia (split by CT into 2 different groups, one with COVID-19, one without), March-April, 2020 Kick off. These parameters can obviously change.

My understanding is that Remdeisvir would be used as a "universal" treatment if clinical trial results meet some minimal requirements. What those requirements might be is apparently still being discussed, especially for the CT using COVID-19 volunteers.

In contrast to treatment drugs, Vaccines are unlikely to be available before the virus peaks this year or early next year depending on the validity of future data (which is still very questionable IMO). Moderna will begin a Clinical trial (phase 1) at Kaiser’s VTEU sometime this spring to test for safety. It will run 13 months and include 45 virus free participants. It will NOT test for effectiveness. So, next year a the earliest would we see a full blown, combined Phase II/III. It all depends on the course of the virus to some respect and detection of the percentage of abnormal, adverse events.

Sharon

[pvw2]

Thanks, I'm seeing reports that few people under 40 are getting COVID-19. That's good news for my children and grandchildren. However, is anyone considering if people exposed to COVID-19 and not showing any symptoms, might be carriers?

[enjoysalud in reply to pvw2]

If you read the papers (I get the L.A. Times as I live in Los Angeles). Yes, people who show little or no symptoms will still be able to pass it on. In addition, 80% or more that test positive for the virus will have NO symptoms or very mild.

If you don't get a paper, since you have a computer, GOOGLE your questions. You will get answers.

I think there is much to do over nothing....mostly because it's a BRAND NEW VIRUS and little is known about it.

LosAngeles, CA, USA

[Parkinsonjisung in reply to enjoysalud]

The current number today had the world death rate at 3.4%. I know this is higher due to high rate at the start in china but it really is a concern. You are on a parkinson forum where the vast majority of people in here are in the high risk age category with pre existing conditions. People dont need to panic but people should be concerned and take the correct precautions.

[Parkinsonjisung]

Sharon, why are they running it for 13 months? What's the rationale for that kind of duration for a vaccine? How do they verify the vaccine works?

[sharoncrayn]

For those who want to dig a little deeper into the true significance of COVID-19, I suggest reading and studying the Lancet article --- "Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China: a single-centered, retrospective, observational study." Small study, but all we have right now.

What will blow your mind is the 61% mortality rate of those critically ill patients after 28 days. 61% is completely frightening IMO. The "median" duration from ICU entry to death was a very, very short 7 days. A single week.

These statistics, if proven reliable over a much larger sample size, should give even those who dismiss COVID-19 as nothing more than a strain of seasonal flu a lot to think about.

Sharon

[MarionP in reply to sharoncrayn]

Bang. To say nothing of how real epidemiology is not even being practiced worldwide yet <and diagnostic tests not even valid in the U.S. yet and even those used are just barely used now> , so there is no basis to determine actual incidence or prevalence, lethality, true transmission nor transmissabilty, treatment or prevention efficacy or effectiveness of anything really...this virus is likely different enough, however, from other viruses, meaning novel to immune systems, to probably have few current impediments (save perhaps warm weather regions\seasons), to eventual full herd infection prior to vaccination unless mass vaccination occurs within a year or two.

[BUSHPILOTS]

Gilead Sciences

Approach: Treatment

Stage: Phase 3

Gilead’s remdesivir, an intravenous treatment, has already been used to treat one infected patient in the U.S. and will soon be deployed in a pair of large, late-stage studies in Asia. Later this month, Gilead will recruit about 1,000 patients diagnosed with the coronavirus to determine whether multiple doses of remdesivir can reverse the infection. The primary goals are reducing fever and helping patients get out of the hospital within two weeks. The drug, which previously failed in a study on Ebola virus, is also being studied in smaller trials in China and the U.S.