Efficacy, Safety and Tolerability of Ivermectin in Subjects Infected With SARS-CoV-2 With or Without Symptoms (SILVERBULLET)
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|ClinicalTrials.gov Identifier: NCT04407507|
Recruitment Status : Not yet recruiting
First Posted : May 29, 2020
Last Update Posted : May 29, 2020
This study aims to evaluate the efficacy, safety and tolerability of Ivermectin in patients with mild SARS-CoV-2 infection, in the rate of progression to severe 2019 novel coronavirus disease (COVID-19).
The primary efficacy endpoint is the proportion of participants with a disease control status defined as no progression of severe disease Hypothesis (H0): There is no difference between group A (ivermectin + paracetamol) and group B (ivermectin + paracetamol) in terms of the primary endpoint on day 14.
|Condition or disease||Intervention/treatment||Phase|
|COVID-19||Drug: Ivermectin Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||66 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Care Provider)|
|Official Title:||Multicenter, Double-blind, Randomized, Placebo-controlled Study to Assess the Efficacy, Safety and Tolerability of Ivermectin in Mild Virus-positive Subjects (SARS-CoV)-2 With or Without Symptoms|
|Estimated Study Start Date :||June 2020|
|Estimated Primary Completion Date :||August 2020|
|Estimated Study Completion Date :||October 2020|
Ivermectin 12 mg / day for 3 days, in combination with paracetamol therapy (500 mg QID) for 14 days
ivermectin 12 mg / day for 3 days, in combination with standard paracetamol therapy (500 mg QID) for 14 days
Placebo Comparator: Placebo
Ivermectin placebo 12 mg / day for 3 days, in combination with paracetamol therapy (500 mg QID) for 14 days
Placebo of ivermectin 12 mg / day for 3 days, in combination with standard paracetamol therapy (500 mg QID) for 14 days
- Participants with a disease control status defined as no disease progression to severe. [ Time Frame: 14 days ]
The subject is considered to have progressed to severe illness when one or more of the following criteria are present:
- Breathing difficulty (≥30 breaths per minute);
- Resting oxygen saturation ≤93%;
- Severe complications such as: respiratory failure, need for mechanical ventilation, septic shock, non-respiratory organic failure.
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): NCT04407507
|Contact: Carmen de la Rocha, PhD||+52 (33) 1522 email@example.com|
|Contact: Marco A Cidfirstname.lastname@example.org|
|Principal Investigator:||Alma M Perez, MD||Centro de Investigación Farmacéutica Especializada de Occidente S.C.|