TrumpLyftAlles | 9 points
Randomized Phase IIA Clinical Trial to Evaluate the Efficacy of Ivermectin to Obtain Negative PCR Results in Patients With Early Phase COVID-19 (Peru 2020-11-19) New RCT clinical trialhttps://clinicaltrials.gov/ct2/show/NCT04635943?term=ivermectin&cond=covid-19&draw=2&rank=31
[-] NoDescription2309 | 2 points
With so many being diagnosed why not put the trial number of participants at 400 or 500 people involved for the study!
[-] TrumpLyftAlles | 1 points
Excellent question. Money?
I'm retired, on the classic fixed income, and I would donate to a GoFundMe for a well-designed trial.
The US, with its new infections going through the roof, could be the site for LOTS of ivermectin trials. I emphasize the US because that's where I live, and it's where NIH / FDA are strenuously ignoring ivermectin. {angry emoji}
[-] NoDescription2309 | 2 points
I agree that if any of these treatments ignored by the Regular Funding Sources occurs then There is A need to publicly fund the clinical trials using Go Fund Me Programs and other funding efforts such as applying to get licenced to have provincial in Canada or State Lotteries to be included as a recipient in their Lotteries. Or get licenced to run & operate a specific lottery to raise funding for many trials of other such low cost effective therapies that have been ignored by Big Pharma as the profit is not there.
[-] TrumpLyftAlles | 2 points | Nov 22 2020 21:59:31
Good design except for the small N = 68: random assignment, placebo-controlled, blinded.
It's unique in looking at a lot of immune system attributes, in the secondary outcomes. Do people taking ivermectin develop antibodies? This trial will tell us!
It was registered on 2020-11-19 but the study started at the end of August, with primary completion 2020-12-28 and final completion 2021-01-28. So not too long a wait for results!
SAINT-PERI is a triple-blind, randomized phase 2a controlled trial with two parallel groups to evaluate the efficacy of one (1) daily dose of ivermectin during three (3) consecutive days, administered to non-severe COVID-19 patients in the first 96 hours after symptoms onset, to reduce the proportion of patients with detectable SARS-CoV-2 RNA by PCR from nasopharyngeal swab at day seven post-treatment. The efficacy of the drug-based strategy to reduce or block transmission involves treating during early phases of infection, when viral replication is yet limited
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Treatment: 300mcg/kg for 3 consecutive days
Control: Placebo on 3 consecutive days
Primary outcome: % patients PCR+ on day 7
Secondary outcomes:
Frequency (% over total PBMC) of innate immune cells (myeloid and plasmacytoid dendritic cells, NK cell, classical, intermediate and pro-inflammatory macrophages) measured in cryopreserved PBMC by flow cytometry
Concentration (all in pg/mL) of epidermal growth factor (EGF), fibroblast growth factor (FGF), granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF), hepatocyte growth factor (HGF), vascular endothelial growth factor (VEGF), tumour necrosis factor (TNF), interferon (IFN)-α, IFN-γ, interleukin (IL)-1RA, IL-1β, IL-2, IL-2R, IL-4, IL-5, IL-6, IL-7, IL-8, IL-10, IL-12(p40/p70), IL-13, IL-15, IL-17, IFN-γ induced protein (IP-10), monocyte chemoattractant protein (MCP-1), monokine induced by IFN-γ (MIG), macrophage inflammatory protein (MIP)-1α, MIP-1β in plasma measured by a Luminex assay using a commercially available kit (Cytokine Human Magnetic 30-Plex Panel from ThermoFisher)
Notable inclusion criteria:
Patients with COVID-19 typical symptoms (cough, fever, anosmia) present for not more than 96 hours.
Not previous administration of ivermectin before the study.
I wonder what percent of Peruvians have taken IVM?
Selected exclusion criteria:
COVID-19 pneumonia, Diagnosed by the attending physician (oxygen saturation < 95% or lung crackles)
Positive IgG against SARS-CoV-2 by rapid diagnostic test
This is a serological test, right?
I'm excited! :)
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