Ivermectin vs. Placebo for the Treatment of Patients With... | NCT04429711

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

NCT04429711

Sponsor

Sheba Medical Center

Status

Unknown status

Last Update Posted

Jun 16, 2020Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

COVID-19

Interventions

Ivermectin Oral Product

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 12, 2020Actual

Primary Completion Date

Sep 30, 2020Estimated

Completion Date

Oct 31, 2020Estimated

First Submitted Date

May 24, 2020

First Submission Date that Met QC Criteria

Jun 11, 2020

First Posted Date

Jun 12, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 14, 2020

Last Update Posted Date

Jun 16, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Prof. Eli Schwartz MD, DTMH, Prinicipal Investigator, Sheba Medical CenterPrincipal Investigator

Lead Sponsor

Sheba Medical CenterOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
IVERMECTIN	Placebo Comparator		Drug: Ivermectin Oral Product
PLACEBO	Active Comparator		Drug: Ivermectin Oral Product

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ivermectin Oral Product	Drug	3mg Capsules, 12-15mg/ day for 3 days	IVERMECTIN PLACEBO

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Viral clearance at day 6	The primary outcome will be the viral clearance at day 6 in the intervention group compared to placebo.	Outcome will be determined till 6 days post intervention
Viral shedding duration	Secondary outcomes: viral shedding duration (time between first positive PCR to last of two consecutive negative tests)	Outcome will be determined till 14 days post intervention
Symptoms clearance time	Time between drug treatment and symptoms resolution	Outcome will be determined till 14 days post intervention

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Eli Schwartz, Prof.	Contact	972 3 5308456		Eli.schwartz@sheba.health.gov.il
Asaf Biber, Dr.	Contact	972 50 7339184		Asaf.Biber@sheba.health.gov.il

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sheba Medical Center	Recruiting	Ramat Gan			Israel

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007559	Ivermectin

Ancestor Terms

ID	Term
D018942	Macrolides
D061065	Polyketides
D007783	Lactones
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided