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Completed

NCT Number: NCT04832945

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

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).

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centro Medico Bournigal, Puerto Plata, Dominican Republic

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ivermectin 6 Mg Oral Tablet

Drug

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

Other names: Ivermectin

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Grupo Rescue S.A.S República Dominicana

Network

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Apr 6, 2021
Registry last updated
Apr 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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