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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04832945
• Other study ID #: 8953
• Status: Completed
• Start date: June 29, 2020
• Est. completion date: April 10, 2021

Study information

• Verified date: April 2021
• Source: Grupo Rescue S.A.S República Dominicana
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 713
• Est. completion date: April 10, 2021
• Est. primary completion date: September 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Covid19

Intervention

Drug:
• Ivermectin 6 Mg Oral Tablet
Ivermectin weekly oral dose 0.2 mg/kg equivalent for 4 weeks

Locations

Country	Name	City	State
Dominican Republic	Centro Medico Bournigal	Puerto Plata
Dominican Republic	Centro Médico Punta Cana	Punta Cana

Sponsors (1)

Lead Sponsor	Collaborator
Grupo Rescue S.A.S República Dominicana

Country where clinical trial is conducted

Dominican Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of sick participants who condition deteriorated	Workers infected with Covid-19, confirmed with RT-PCR and required hospitalization and/or ICU	4 weeks
Secondary	Number of sick participants who died	Workers infected with Covid-19, confirmed with RT-PCR and died.	4 weeks