This is the 10th ivermectin + covid-19 trial registered at ClinicalTrials.gov.
SAINT is a double-blind, randomized controlled trial with two parallel groups that evaluates the efficacy of ivermectin in reducing nasal viral carriage at seven days after treatment in SARS-CoV-2 infected patients who are at low risk of progression to severe disease.
# Detailed Description:
SAINT is a double-blind, randomized controlled trial with two parallel groups that evaluates the efficacy of ivermectin in reducing nasal viral carriage at seven days after treatment in SARS-CoV-2 infected patients who are at low risk of progression to severe disease. The trial is currently planned at a single center in Navarra.
Participants will be randomized to receive a single dose of 400 mcg/kg ivermectin or a placebo. The randomization code will be generated by the trial statistician using blocks that ensure balance between the groups.
The allocation will be made by the investigator after obtaining informed consent, and confirmation of fulfillment of all inclusion and none of the exclusion criteria. The investigational product will be administered by a researcher not involved in patient care or participant follow up.
Participants will remain in the trial for a period of 28 days.
In the interests of public health and containing transmission of infection, trial visits will be conducted in the participant's home by a clinical trial team comprising nursing and medical members.
Subsequent visits will be to assess clinical and laboratory parameters.
A final study visit will be made for participants who withdraw prematurely from the study or are withdrawn by the investigator.
Participants on this arm will receive a single, oral dose of ivermectin 400 mcg/kg at the enrolment visit.
Primary outcome measure: Proportion of patients with a positive SARS-CoV-2 PCR [ Time Frame: 7 days post-treatment ]
The principal investigator is Carlos J Chaccour, MD PhD. The study is being dnoe in Pamplona, Navarra, Spain.
Dr. Chaccour organizes news, studies, etc on twitter. @CarlosChaccour.
Estimated completion dates:
Primary: 8/4/2020
Study: 8/30/2020
A dose of 400mcg is average; the range of the trials is 150mcg to 600mcg.
The sample size of 24 is disappointingly low but time to completing the trial is comparatively fast. IIRC, only one trial is expected to be done before this one.
[-] TrumpLyftAlles | 1 points | May 16 2020 01:54:50
This is the 10th ivermectin + covid-19 trial registered at ClinicalTrials.gov.
SAINT is a double-blind, randomized controlled trial with two parallel groups that evaluates the efficacy of ivermectin in reducing nasal viral carriage at seven days after treatment in SARS-CoV-2 infected patients who are at low risk of progression to severe disease.
# Detailed Description:
SAINT is a double-blind, randomized controlled trial with two parallel groups that evaluates the efficacy of ivermectin in reducing nasal viral carriage at seven days after treatment in SARS-CoV-2 infected patients who are at low risk of progression to severe disease. The trial is currently planned at a single center in Navarra.
Participants will be randomized to receive a single dose of 400 mcg/kg ivermectin or a placebo. The randomization code will be generated by the trial statistician using blocks that ensure balance between the groups.
The allocation will be made by the investigator after obtaining informed consent, and confirmation of fulfillment of all inclusion and none of the exclusion criteria. The investigational product will be administered by a researcher not involved in patient care or participant follow up.
Participants will remain in the trial for a period of 28 days.
In the interests of public health and containing transmission of infection, trial visits will be conducted in the participant's home by a clinical trial team comprising nursing and medical members.
Subsequent visits will be to assess clinical and laboratory parameters.
A final study visit will be made for participants who withdraw prematurely from the study or are withdrawn by the investigator.
Participants on this arm will receive a single, oral dose of ivermectin 400 mcg/kg at the enrolment visit.
Primary outcome measure: Proportion of patients with a positive SARS-CoV-2 PCR [ Time Frame: 7 days post-treatment ]
The principal investigator is Carlos J Chaccour, MD PhD. The study is being dnoe in Pamplona, Navarra, Spain.
Dr. Chaccour organizes news, studies, etc on twitter. @CarlosChaccour.
Estimated completion dates:
A dose of 400mcg is average; the range of the trials is 150mcg to 600mcg.
The sample size of 24 is disappointingly low but time to completing the trial is comparatively fast. IIRC, only one trial is expected to be done before this one.
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