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 : Completed
First Posted : May 29, 2020
Results First Posted : May 21, 2021
Last Update Posted : May 21, 2021
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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)|
|Actual 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|
|Actual Study Start Date :||July 1, 2020|
|Actual Primary Completion Date :||January 29, 2021|
|Actual Study Completion Date :||January 29, 2021|
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.
- SARS-CoV-2 Viral Load, at 5 and 14 Days [ Time Frame: days 1, 5 and 14 ]To determine viral load indirectly, the Ct value of the SARS-COV-2 gene N was used on days 1, 5 and 14 of treatment, considering values greater than 37.5 as negative.
- Presence and Frequency of Symptoms Associated With the COVID-19 Disease [ Time Frame: 14 days ]
Subjects were asked to answer a symptoms dairy during 14 days, where they recorded the presence of the following symptoms; fever, cough, muscular pain, fatigue, breath difficulty, headache, diarrhea, palpitations, expectoration and "Other", in the other question several subjects answer hypogeusia/ageusia, hyposmia/anosmia and backpain.
The total of days anaylized were considered as 100%; 364 days for placebo patients(26 subjects x 14 days), and 420 for ivermectin subjects (30 subjects x 14 days), then the number of days reported correspond to de % of days when symptom was present.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Diagnosis of acute severe respiratory syndrome due to SARS-CoV-12 coronavirus infection defined by RT-PCR.
- Asymptomatic, or with mild symptoms who are taking outpatient treatment of the disease.
- Signed Informed Consent.
- Patients with severe disease COVID-19.
- Positive to proof of infection by some other virus such as influenza H1N1, SARS, etc.
- Recurrent urinary tract infections.
- Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST)> 5 times above its normal limits.
- Pregnant or lactating patients
- Patients receiving antihypertensive medication verapamil, the immunosuppressant cyclosporin A and / or the antipsychotic trifluoperazine.
- Patients with a known allergy or hypersensitivity to dewormers.
- Patients who are using an antioxidant supplement.
- Patients with a history of filariasis, strongyloidiasis, scabies, river blindness, or any parasitic disease in the last twelve months.
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
|Investigacion Biomédica para el Desarrollo de Fármacos S.A. de C.V.|
|Zapopan, Jalisco, Mexico|
|Principal Investigator:||Alma M Perez, MD||Centro de Investigación Farmacéutica Especializada de Occidente S.C.|
Documents provided by Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.:
Publications of Results:
|Responsible Party:||Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.|
|Other Study ID Numbers:||
|First Posted:||May 29, 2020 Key Record Dates|
|Results First Posted:||May 21, 2021|
|Last Update Posted:||May 21, 2021|
|Last Verified:||May 2021|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
|Product Manufactured in and Exported from the U.S.:||No|