TrumpLyftAlles | 3 points | Aug 26 2020 21:00:39

Effectiveness and Safety of Ivermectin for the Prevention of Covid-19 Infection in Colombian Health Personnel (Colombia 2020-08-26 ClinicalTrials)

https://clinicaltrials.gov/ct2/show/study/NCT04527211?term=ivermectin&cond=COVID&draw=2&rank=19

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[-] TrumpLyftAlles | 2 points | Aug 26 2020 21:11:54

There are now 35 ivermectin trials registered at ClinicalTrials!

Title: Effectiveness and Safety of Ivermectin for the Prevention of Covid-19 Infection in Colombian Health Personnel (IveprofCovid19)

Prophylaxis! Yay! :) :) :)

Looks like a really well-designed study: placebo-controlled, randomly-assigned, triply-masked (!!) blind study with N = 550. That's the biggest N so far, IIRC.

Treatment: 200cmg/kg every week for 7 weeks

Primary completion: 2020-11-30 Final completion: 2020-12-16

Primary outcome measure:
Clinical development of covid-19 disease during the intervention period [ Time Frame: 8 weeks ] Development of of the disease according to the definitions of cases found in the guidelines from the Colombian National Institute of Health

Don't know what that means. TLATODO look up the guidelines

Objective: To determine the effectiveness and safety of the administration of ivermectin at a dose of 200 mcg/kg once a week for 7 weeks in a prophylactic treatment against SARS COV-2 infection in Colombian health workers during the COVID-19 pandemic.

Methods: It will be performed a randomized, multicenter, triple-masked, placebo-controlled clinical experiment to determine the relative risk of SARS COV-2 infection, seroconversion, and clinically presenting disease. In addition, the relative risk of requiring hospitalization or entering the intensive care unit was evaluated in doctors, nurses, respiratory therapists and assistants who have direct contact with patients with COVID-19. After being exposed to ivermectin prophylaxis or placebo for seven weeks, the results will be measured at eight weeks, with interim analyses to monitor the safety of the participating subjects.

Masking description:
Simple randomization will be done with a random number generator and masking will be maintained by concealing the allocation with opaque envelopes. The active medicine as the control will have the same presentation, color and taste, it will be differentiated by a pre-established code from the maker. This will maintain the concealment of patients, caregivers and evaluators. At the central level, only an intervention safety coordinator will know the assignment of each patient in case serious adverse events occur and the concealment needs to be lifted. The outcomes of interest will be obtained from the clinical history of the patients and through direct measurement in the follow-up visits.

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[-] TrumpLyftAlles | 1 points | Aug 26 2020 21:12:02

I can't tell if this one is the trial referenced in this 2020-06-11 TrialSiteNews article.. It's being done in Cali, same as the TSN article's study.

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