Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
24 participants
INTERVENTIONAL
2020-07-31
2020-10-09
Brief Summary
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Detailed Description
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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A final study visit will be made for participants who withdraw prematurely from the study or are withdrawn by the investigator.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Ivermectin
Participants on this arm will receive a single, oral dose of ivermectin 400 mcg/kg at the enrolment visit.
Ivermectin
Single dose of STROMECTOL® tablets at 400mcg/kg
Placebo
Participants on the arm will receive a single, oral dose of placebo tablets at the enrollment visit.
Placebo
Placebo tablets will not match ivermectin but they will be administered by staff not involved in the clinical care.
Interventions
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Ivermectin
Single dose of STROMECTOL® tablets at 400mcg/kg
Placebo
Placebo tablets will not match ivermectin but they will be administered by staff not involved in the clinical care.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Residents of the Pamplona basin ("Cuenca de Pamplona")
3. The patient should be aged 18 to 59 years
4. Negative pregnancy test for women of child bearing age\*
5. The patient or his/her representative, have given consent to participate in the study.
6. The patient should, in the investigator's opinion, be able to comply with all the requirements of the clinical trial (including home follow up during isolation)
* Women of child bearing age may participate if they use a safe contraceptive method for the entire period of the study and at least one month afterwards. A woman is considered to not have childbearing capacity if she is post-menopausal (minimum of 2 years without menstruation) or has undergone surgical sterilization (at least one month before the study)
Exclusion Criteria
2. Hypersensitivity to any component of Stromectol®
3. COVID-19 Pneumonia
* Diagnosed by the attending physician
* Identified in a chest X-ray
4. Fever or cough present for more than 48 hours
5. Positive IgG against SARS-CoV-2 by rapid test
6. Age under 18 or over 60 years
7. The following co-morbidities (or any other disease that might interfere with the study in the eyes of the investigator):
* Immunosuppression
* Chronic Obstructive Pulmonary Disease
* Diabetes
* Hypertension
* Obesity
* Acute or chronic renal failure
* History of coronary disease
* History of cerebrovascular disease
* Current neoplasm
8. Recent travel history to countries that are endemic for Loa loa (Angola, Cameroon, Central African Republic, Chad, Democratic Republic of Congo, Ethiopia, Equatorial, Guinea, Gabon, Republic of Congo, Nigeria and Sudan)
9. Current use of CYP 3A4 or P-gp inhibitor drugs such as quinidine, amiodarone, diltiazem, spironolactone, verapamil, clarithromycin, erythromycin, itraconazole, ketoconazole, cyclosporine, tacrolimus, indinavir, ritonavir or cobicistat. Use of critical CYP3A4 substrate drugs such as warfarin.
18 Years
59 Years
ALL
No
Sponsors
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Barcelona Institute for Global Health
OTHER
Clinica Universidad de Navarra, Universidad de Navarra
OTHER
Responsible Party
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Principal Investigators
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Carlos J Chaccour, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Clinica Universidad de Navarra and Barcelona Institute of Global Health
Locations
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Clinica Universidad de Navarra
Pamplona, Navarre, Spain
Countries
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References
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Chaccour C, Casellas A, Blanco-Di Matteo A, Pineda I, Fernandez-Montero A, Ruiz-Castillo P, Richardson MA, Rodriguez-Mateos M, Jordan-Iborra C, Brew J, Carmona-Torre F, Giraldez M, Laso E, Gabaldon-Figueira JC, Dobano C, Moncunill G, Yuste JR, Del Pozo JL, Rabinovich NR, Schoning V, Hammann F, Reina G, Sadaba B, Fernandez-Alonso M. The effect of early treatment with ivermectin on viral load, symptoms and humoral response in patients with non-severe COVID-19: A pilot, double-blind, placebo-controlled, randomized clinical trial. EClinicalMedicine. 2021 Feb;32:100720. doi: 10.1016/j.eclinm.2020.100720. Epub 2021 Jan 19.
Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Other Identifiers
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SAINT
Identifier Type: -
Identifier Source: org_study_id