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Ivermectin vs. Placebo for the Treatment of Patients With Mild to Moderate COVID-19

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: NCT04429711
Recruitment Status : Unknown
Verified June 2020 by Prof. Eli Schwartz MD, DTMH, Sheba Medical Center.
Recruitment status was:  Recruiting
First Posted : June 12, 2020
Last Update Posted : June 16, 2020
Sponsor:
Information provided by (Responsible Party):
Prof. Eli Schwartz MD, DTMH, Sheba Medical Center

Study Description
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Brief Summary:

Ivermectin which is an FDA-approved broad spectrum anti-parasitic agent, has also anti-viral activity. In vitro study have shown its activity against SARS-CoV-2, however its clinical effect on patients with COVID-19 never been tested.

In this RCT we would like to evaluate the effect of Ivermectin on reduction of viral shedding among mild to moderate COVID-19 patients, and in shortening the symptom resolution time.


Condition or disease Intervention/treatment Phase
COVID-19 Drug: Ivermectin Oral Product Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double blind randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ivermectin vs. Placebo for the Treatment of Patients With Mild to Moderate COVID-19 to Prevent Progression to Severe Infection and to Decrease Viral Shedding - A Double Blind , Randomized Controlled Trial
Actual Study Start Date : May 12, 2020
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : October 31, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Ivermectin

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: IVERMECTIN Drug: Ivermectin Oral Product
3mg Capsules, 12-15mg/ day for 3 days
Active Comparator: PLACEBO Drug: Ivermectin Oral Product
3mg Capsules, 12-15mg/ day for 3 days


Outcome Measures
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Primary Outcome Measures :
  1. Viral clearance at day 6 [ Time Frame: Outcome will be determined till 6 days post intervention ]
    The primary outcome will be the viral clearance at day 6 in the intervention group compared to placebo.

  2. Viral shedding duration [ Time Frame: Outcome will be determined till 14 days post intervention ]
    Secondary outcomes: viral shedding duration (time between first positive PCR to last of two consecutive negative tests)

  3. Symptoms clearance time [ Time Frame: Outcome will be determined till 14 days post intervention ]
    Time between drug treatment and symptoms resolution


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Participants eligible for inclusion will include non-pregnant adult (>18 years old) with molecular confirmation of COVID-19. [Participants will be eligible in a period of no longer than 72 hours after exposure].

Exclusion Criteria:

  • Severe infection ( defined as need for invasive or non-invasive ventilator support, ECMO or shock requiring vasopressor support).
  • Weight below 40Kg or above 100Kg
  • Unable to take oral medication
  • Known allergy to the drugs
  • Pregnancy or breast feeding
  • Participating in another RCT for treatment of COVID-19.
Contacts and Locations
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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): NCT04429711


Contacts
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Contact: Eli Schwartz, Prof. 972 3 5308456 Eli.schwartz@sheba.health.gov.il
Contact: Asaf Biber, Dr. 972 50 7339184 Asaf.Biber@sheba.health.gov.il

Locations
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Israel
Sheba Medical Center Recruiting
Ramat-Gan, Israel
Contact: Eli Schwartz, M.D    +972-35308456    Eli.schwartz@sheba.health.gov.il   
Sponsors and Collaborators
Sheba Medical Center
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Prof. Eli Schwartz MD, DTMH, Prinicipal Investigator, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT04429711    
Other Study ID Numbers: SHEBA-20-7156-ES-CTIL
First Posted: June 12, 2020    Key Record Dates
Last Update Posted: June 16, 2020
Last Verified: June 2020

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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
Additional relevant MeSH terms:
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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
 Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Ivermectin
Antiparasitic Agents
Anti-Infective Agents