Posted on 04/10/2020 5:35:24 PM PDT by SeekAndFind
Study Type : | Interventional (Clinical Trial)
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Estimated Enrollment : | 3000 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Safety And Efficacy Of Hydroxychloroquine As COVID-19 Prophylaxis For At-Risk Population (SHARP): A Cluster Randomized Controlled Trial |
Estimated Study Start Date : | April 2020 |
Estimated Primary Completion Date : | August 2020 |
Estimated Study Completion Date : | October 2020 |
Outcome Measures Eligibility Criteria Contacts and Locations More Information
Arm | Intervention/treatment |
---|---|
Experimental: Hydroxychloroquine post exposure prophylaxis Treatment arm will be given Hydroxychloroquine sulfate. Dose: 800 milligrams (mg) (4 pills of 200mg) as single dose on day 1 followed by 400mg (2 pills of 200mg) single dose on day 2, 3,4, 5. Mode of administration: Oral pills of 200mg of HCQ; has to be given in the form of single daily dose. Supply: The total supply of all the pills (12 pills of 200mg per subject in the study group) will be given to the recruited subject from day 1. |
Drug: Hydroxychloroquine Sulfate 200 milligram (mg) Tab Oral tablet of Hydroxychloroquine sulfate
|
Standard Preventive Measures No intervention. Standard recommended preventive measures by the ministry of health ( MOH), Singapore. under which the subjects under control arm will be following the standard measures recommended by Ministry of Health (temperature monitoring 3 times per day, three times video calls by MOH, no mask, advice to close the lid and flush toilet, hand hygiene)
|
Drug: Hydroxychloroquine Sulfate 200 milligram (mg) Tab Oral tablet of Hydroxychloroquine sulfate
|
Outcome Measures Eligibility Criteria Contacts and Locations More Information
Outcome Measures Eligibility Criteria Contacts and Locations More Information
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Outcome Measures Eligibility Criteria Contacts and Locations More Information
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04342156
Contact: Rupesh Agrawal, MD | 6357100 ext 7726 | rupesh_agrawal@ttsh.com.sg |
Principal Investigator: | Rupesh Agrawal, MD | Tan Tock Seng Hospital |
Responsible Party: | Tan Tock Seng Hospital |
ClinicalTrials.gov Identifier: | NCT04342156
|
Other Study ID Numbers: | 2020/00402 |
First Posted: | April 10, 2020 Key Record Dates |
Last Update Posted: | April 10, 2020 |
Last Verified: | April 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Post Exposure Prophylaxis (PEP) Hydroxychloroquine Singapore COVID-19 |
Coronavirus Infections Severe Acute Respiratory Syndrome Coronaviridae Infections Nidovirales Infections RNA Virus Infections Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases |
Hydroxychloroquine Antimalarials Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antirheumatic Agents |
Anecdotal
Study won’t complete until October, which makes it not that useful right now.
I am beginning to see a pattern in these CARES funded clinical trials.
Very few of them are missing a critical study arm, HCQ in combination with Zinc.
Unless the diet is rich in Zinc, these studies will likely show mixed results. That’s a temporary win for the Vaccine Lobby.
Good news is POTUS mentioned HCQ with Zinv at yesterday’s task force press conference.
Good news is POTUS is in contact with Dr. Zev Zelenko via Rudy G.
Chances are when POTUS hears previews of results of these clinical trials, that is paid for by the American people, he’s going to ask his military MDs and others to check it out.
Chances are these studies are going to include the combination arm with Zinc.
I, for one, won’t be satisfied until all 27 types of clinical trials are completed and the drug proven safe and efficacious beyond a shadow of a doubt. Then the drug has to be tested again with Azithromycin and no zinc then again with Azithromycin AND zinc. Only then will we be able to finally BEGIN answering the questions about safety and efficacy.
1) Clinical Trial
2) Open Clinical Trial
3) Single-Blind Clinical Trial
4) Double-Blind Clinical Trial
5) Triple-Blind Clinical Trial
6) Crossover Clinical Trial
7) N-Of-1 Clinical Trial
8) Explanatory Clinical Trial
9) Unicenter Clinical Trial
10) Multicenter Clinical Trial
11) Parallel Clinical Trial
12) Sequential Clinical Trial
13) Community Trial
14) Classification Of The Types Of Design
15) Pilot Study
16) Descriptive Study
17) Observational Study
18) Experimental Study
19) Cross-Sectional Studies
20) Longitudinal Studies
21) Feasibility Study
22) Crossover Study
23) Analytical Study
24) Prospective Study
25) Retrospective Study
26) Case-Control Study
27) Cohort Study
So this is just starting? Why wasnt it done at the beginning of the outbreak, we would already have the answer.
RE: Very few of them are missing a critical study arm, HCQ in combination with Zinc.
This study is not about treating Covid-19 patients, it’s about determining whether or not Hydroxychloroquine, which already acts as prophylaxis for Malaria, can likewise act as a prophylaxis (protective) for Covid-19.
In other words, can taking it PROTECT against getting the disease?
Why would they add Zinc into the picture? This is not a treatment study.
Study ranking:
-Scientific reliability
Blinded random controlled trial > Observational study > Anecdotal
-Effectiveness at discovering new therapies
Anecdotal > Observational study > Blinded RCT
Indeed. But, there is already a means to ascertain the prophylactic effectiveness of HCQ.
Dr. Wallace, Rheumatologist, Cedar-Sinai, has more than 2000 Lupus patients under his care. They take HCQ continually. His practice is 35 years old and he has not had a single patient to date come down with the Wuhan Virus.
He wrote a letter to the Head of the FDA detailing this and sent copies to other prominent physicians.
For some reason, likely TDS, the MSM refuses to cover this at all.
Don’t forget impeachment trial.
The drug is being prescribed already. Nothing is lost by having clinical trials. If it weren’t being prescribed, you’d have a point. You don’t.
To put the duration of this trial (5 months until preliminary results) in perspective; consider that the average time for approval of a new drug is 12 years. Twelve years — accelerated to 5 months!
Western medicine cannot be separated from clinical trials. There is an infinite number of molecules or blends of molecules that might be medicinal. Most of them are useless. Many of them are harmful. Only a tiny fraction actually works. That’s why there are clinical trials.
In the case of HCQ — it seems to be working & it should be prescribed to anyone who wants it. However, without trials we don’t know the best dose, we don’t know when to give it, we don’t know how well it performs compared to other drugs — we don’t know a whole lot of things.
Let the trials proceed — there’s no harm in that, and much that might be gained. If conservatives continue to complain about conducting clinical trials, expect the leftists to renew claims that conservatives are anti-science, as they have been with regard to the climate hoax. The difference is — this time they’d be right. If conservatives go all-in for HCQ, and we later discover a problem — that will be the end for Trump. Why take that chance? Why not just be satisfied that the drug is being prescribed, and support the clinical trials?
Do you think the end of the five month trial will immediately result in FDA approval?
Ive got 50,000 face masks to sell you.
That’s what I said in Post #7 above.
I note also that the sponsor of this study is a SINGAPOREAN HOSPITAL!
Mechanism of action,
HCQ is not to be taken as a prophylactic. It’s not setup that way.
Zinc, IF IT CAN GET IN THE LUNG CELLS, will stop the SARS-COV-2 virus from replicating (multiplying).
So Zinc as a natural nutrient the body needs, can act as a prophylactic, why?
Because if the virus enters the body, then with Zinc loaded up in the cells, the virus is neutered and flushed out with the cytokine immune response, then eliminated in the urine.
HCQ can cover the ACE2 receptacle in pneumocytes and act as a prophylactic that way but it can’t be used long tern like a vitamin or nutrient, But Zinc is a nutrient. It can be used long term. But still needs a doctor’s care because we can overdose on too much Zinc.
Now how is Zinc pushed into cells?
HCQ.
Read more here:
HYDROXYCHLOROQUINE + ZINC — MECHANISM OF ACTION
(Zev’s Tx Regimen)
http://freerepublic.com/focus/f-chat/3831654/posts
and death within 14 days! They had better speed up their timetable.
Exactly Hostage. Expect a number of misleading studies of HCQ without Zinc, to marginalize its effectiveness. Have seen a few this week already.
No animal tests?
Clearly fast tracking.
In vitro studies suggested HCQ would be useful for prophylaxis of corona virus back in the SARS era. Adding zinc wasn't discussed therein. Multiple mechanisms have been suggested for how HCQ affects the virus. Zinc is needed for one of them. Having more than one mechanism is good (less chance of developing resistance) and not unusual. Probably many people get enough zinc via their diet for the zinc mechanism to work without additional zinc. Severe zinc deficiency is rare and very noticeable (look up acrodermatitis enteropathica). How common milder deficiencymild enough to avoid symptoms, but enough so the suggested antiviral method wouldn't workI don't know. As it's cheap and seems safe at the suggested doses it's reasonable to add zinc now. But it would be nice to do some studies, so that we eventually understand whether or not it is really needed. HCQ±Zinc theoretically might work on additional viruses; the better knowledge may prove useful. I wouldn't deny zinc to anyone who wants to add it, but with so much clinical material there ought to be enough zinc agnostics around for an uncoerced trial.
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