SARS-CoV-2 Pre-exposure Prophylaxis With Ivermectin Retrospective Cohort Study

NCT ID: NCT04832945

Last Updated: 2021-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

713 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-29

Study Completion Date

2021-04-10

Brief Summary

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This observational study, a multicenter retrospective cohort database study, carried out in two medical centers, Centro Medico Bournigal (CMBO) in Puerto Plata and Centro Medico Punta Cana (CMPC) in Punta Cana, Dominican Republic, sought to determine whether Ivermectin, at a weekly orally dose of 0.2 mg/kg, is an effective pre-exposure prophylactic method (PrEP) for the spread of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), in the healthcare workers. The study began on June 29, 2020 and ended on July 26, 2020 (4 weeks).

Detailed Description

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Conditions

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Covid19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Ivermectin Group

Healthcare personnel receiving Ivermectin weekly PrEP

Ivermectin 6 Mg Oral Tablet

Intervention Type DRUG

Ivermectin weekly oral dose 0.2 mg/kg equivalent for 4 weeks

Control Group

Healthcare personnel not receiving Ivermectin

No interventions assigned to this group

Interventions

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Ivermectin 6 Mg Oral Tablet

Ivermectin weekly oral dose 0.2 mg/kg equivalent for 4 weeks

Intervention Type DRUG

Other Intervention Names

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Ivermectin

Eligibility Criteria

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Inclusion Criteria

* Active workers from Centro Medico Bournigal (CMBO) and Centro Medico Punta Cana (CMPC) during the study.

Exclusion Criteria

* Workers with positive Covid-19 RT-PCR prior to the start of the study
* Those that did not take the first dose of Ivermectin the first week at the start of the study
* Those that did not complied with at least 2 out of 4 weekly doses
* Those that had greater than 14 days difference in days between two intakes Ivermectin
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Grupo Rescue S.A.S República Dominicana

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jose Morgenstern, MD

Role: PRINCIPAL_INVESTIGATOR

Grupo Rescue

Jose Natalio Redondo, MD

Role: PRINCIPAL_INVESTIGATOR

Grupo Rescue

Alvaro Olavarria, Data Analyst

Role: PRINCIPAL_INVESTIGATOR

Grupo Rescue

Locations

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Centro Medico Bournigal

Puerto Plata, , Dominican Republic

Site Status

Centro Médico Punta Cana

Punta Cana, , Dominican Republic

Site Status

Countries

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Dominican Republic

Other Identifiers

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8953

Identifier Type: -

Identifier Source: org_study_id

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