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

Multicenter Retrospective Cohort Study of Ivermectin as a SARS-CoV-2 Pre-exposure Prophylactic Method in Healthcare Workers in Dominican Republic

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).

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Drug: Ivermectin 6 Mg Oral Tablet

• Study Type: Observational
• Enrollment (Actual): 713

Contacts and Locations

Study Locations

• Dominican Republic
  • Puerto Plata, Dominican Republic, 57000
    • Centro Medico Bournigal
  • Punta Cana, Dominican Republic, 23000
    • Centro Médico Punta Cana

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Workers who was part of Ivermectin prophylaxis program and signed the informed consent at CMPC and CMBO in Dominican Republic was analyzed and included in the intervention group. Those who didn't participate in the prophylaxis program but were on active duty during the 4 weeks of the study were included in the control group.

Workers excluded from Ivermectin prophylaxis program was:

• Pregnant or suspected pregnant women
• Women breastfeeding
• Patients receiving coumarin anticoagulants
• Those allergic to Ivermectin

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ivermectin Group; Healthcare personnel receiving Ivermectin weekly PrEP	Drug: Ivermectin 6 Mg Oral Tablet; Ivermectin weekly oral dose 0.2 mg/kg equivalent for 4 weeks; Other Names: Ivermectin
Control Group; Healthcare personnel not receiving Ivermectin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants RT-PCR positive for Covid-19	Workers confirmed Covid-19 through Reverse Transcription Polymerase Chain Reaction (RT-PCR) test	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of sick participants who condition deteriorated	Workers infected with Covid-19, confirmed with RT-PCR and required hospitalization and/or ICU	4 weeks
Number of sick participants who died	Workers infected with Covid-19, confirmed with RT-PCR and died.	4 weeks

Collaborators and Investigators

• Sponsor: Grupo Rescue S.A.S República Dominicana
• Investigators: Principal Investigator: Jose Morgenstern, MD, Grupo Rescue; Principal Investigator: Jose Natalio Redondo, MD, Grupo Rescue; Principal Investigator: Alvaro Olavarria, Data Analyst, Grupo Rescue

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2020
• Primary Completion (Actual): September 20, 2020
• Study Completion (Actual): April 10, 2021

Study Registration Dates

• First Submitted: April 1, 2021
• First Submitted That Met QC Criteria: April 2, 2021
• First Posted (Actual): April 6, 2021

Study Record Updates

• Last Update Posted (Actual): April 13, 2021
• Last Update Submitted That Met QC Criteria: April 10, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: SARS-CoV-2; Covid-19; Coronavirus; PrEP; Prophylaxis; Ivermectin
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Anti-Infective Agents; Antiparasitic Agents; Ivermectin
• Other Study ID Numbers: 8953

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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