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Efficacy, Safety and Tolerability of Ivermectin in Subjects Infected With SARS-CoV-2 With or Without Symptoms (SILVERBULLET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04407507
Recruitment Status : Completed
First Posted : May 29, 2020
Results First Posted : May 21, 2021
Last Update Posted : May 21, 2021
Sponsor:
Information provided by (Responsible Party):
Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.

Brief Summary:

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

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Ivermectin

Arm Intervention/treatment
Experimental: Ivermectin
Ivermectin 12 mg / day for 3 days, in combination with paracetamol therapy (500 mg QID) for 14 days
Drug: Ivermectin
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
Drug: Placebo
Placebo of ivermectin 12 mg / day for 3 days, in combination with standard paracetamol therapy (500 mg QID) for 14 days




Primary Outcome Measures :
  1. 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:

    1. Breathing difficulty (≥30 breaths per minute);
    2. Resting oxygen saturation ≤93%;
    3. Severe complications such as: respiratory failure, need for mechanical ventilation, septic shock, non-respiratory organic failure.


Secondary Outcome Measures :
  1. 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.

  2. 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
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  1. Patients with severe disease COVID-19.
  2. Positive to proof of infection by some other virus such as influenza H1N1, SARS, etc.
  3. Recurrent urinary tract infections.
  4. Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST)> 5 times above its normal limits.
  5. Pregnant or lactating patients
  6. Patients receiving antihypertensive medication verapamil, the immunosuppressant cyclosporin A and / or the antipsychotic trifluoperazine.
  7. Patients with a known allergy or hypersensitivity to dewormers.
  8. Patients who are using an antioxidant supplement.
  9. Patients with a history of filariasis, strongyloidiasis, scabies, river blindness, or any parasitic disease in the last twelve months.

Information from the National Library of Medicine

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


Locations
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Mexico
Investigacion Biomédica para el Desarrollo de Fármacos S.A. de C.V.
Zapopan, Jalisco, Mexico
Sponsors and Collaborators
Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.
Investigators
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Principal Investigator: Alma M Perez, MD Centro de Investigación Farmacéutica Especializada de Occidente S.C.
  Study Documents (Full-Text)

Documents provided by Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.:
Study Protocol  [PDF] August 5, 2020
Statistical Analysis Plan  [PDF] August 5, 2020

Additional Information:
Publications of Results:
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Responsible Party: Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.
ClinicalTrials.gov Identifier: NCT04407507    
Other Study ID Numbers: SARS-COV-IverMX-01
First Posted: May 29, 2020    Key Record Dates
Results First Posted: May 21, 2021
Last Update Posted: May 21, 2021
Last Verified: May 2021

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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
Keywords provided by Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.:
Ivermectin
Additional relevant MeSH terms:
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Ivermectin
Antiparasitic Agents
Anti-Infective Agents