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

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: NCT04832945
Recruitment Status : Completed
First Posted : April 6, 2021
Last Update Posted : April 13, 2021
Sponsor:
Information provided by (Responsible Party):
Grupo Rescue S.A.S República Dominicana

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment
Covid19 Drug: Ivermectin 6 Mg Oral Tablet

Study Design
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Study Type : Observational
Actual Enrollment : 713 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Multicenter Retrospective Cohort Study of Ivermectin as a SARS-CoV-2 Pre-exposure Prophylactic Method in Healthcare Workers in Dominican Republic
Actual Study Start Date : June 29, 2020
Actual Primary Completion Date : September 20, 2020
Actual Study Completion Date : April 10, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Ivermectin

Groups and Cohorts
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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 Name: Ivermectin
Control Group
Healthcare personnel not receiving Ivermectin


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants RT-PCR positive for Covid-19 [ Time Frame: 4 weeks ]
    Workers confirmed Covid-19 through Reverse Transcription Polymerase Chain Reaction (RT-PCR) test


Secondary Outcome Measures :
  1. Number of sick participants who condition deteriorated [ Time Frame: 4 weeks ]
    Workers infected with Covid-19, confirmed with RT-PCR and required hospitalization and/or ICU

  2. Number of sick participants who died [ Time Frame: 4 weeks ]
    Workers infected with Covid-19, confirmed with RT-PCR and died.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Criteria

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
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): NCT04832945


Locations
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Dominican Republic
Centro Medico Bournigal
Puerto Plata, Dominican Republic, 57000
Centro Médico Punta Cana
Punta Cana, Dominican Republic, 23000
Sponsors and Collaborators
Grupo Rescue S.A.S República Dominicana
Investigators
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Principal Investigator: Jose Morgenstern, MD Grupo Rescue
Principal Investigator: Jose Natalio Redondo, MD Grupo Rescue
Principal Investigator: Alvaro Olavarria, Data Analyst Grupo Rescue
More Information
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Responsible Party: Grupo Rescue S.A.S República Dominicana
ClinicalTrials.gov Identifier: NCT04832945    
Other Study ID Numbers: 8953
First Posted: April 6, 2021    Key Record Dates
Last Update Posted: April 13, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Grupo Rescue S.A.S República Dominicana:
Ivermectin
SARS-CoV-2
Coronavirus
 Prophylaxis
PrEP
Covid-19
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
 Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Ivermectin
Antiparasitic Agents
Anti-Infective Agents