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

NCT04832945 | Completed

• 1 other identifier: 8953
• Study Type: observational
• Target: 713
• Locations: 1 country
• Sites: 2

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).

Conditions

Covid19

Keywords

Ivermectin; SARS-CoV-2; Coronavirus; Prophylaxis; PrEP; Covid-19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of sick participants who condition deteriorated

  4 weeks

• Number of sick participants who died

  4 weeks

Study Arms (2)

Ivermectin Group

Healthcare personnel receiving Ivermectin weekly PrEP

Drug: Ivermectin 6 Mg Oral Tablet

Control Group

Healthcare personnel not receiving Ivermectin

Interventions

Ivermectin 6 Mg Oral Tablet DRUG

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

Also known as: Ivermectin

Ivermectin Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Grupo Rescue S.A.S República Dominicana: lead

Study Sites (2)

Centro Medico Bournigal

Puerto Plata, 57000, Dominican Republic

Location

Centro Médico Punta Cana

Punta Cana, 23000, Dominican Republic

Location

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Interventions

Ivermectin

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Jose Morgenstern, MD

  Grupo Rescue

  PRINCIPAL INVESTIGATOR

• Jose Natalio Redondo, MD

  Grupo Rescue

  PRINCIPAL INVESTIGATOR

• Alvaro Olavarria, Data Analyst

  Grupo Rescue

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2021
• First Posted: April 6, 2021
• Study Start: June 29, 2020
• Primary Completion: September 20, 2020
• Study Completion: April 10, 2021
• Last Updated: April 13, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

DO (2)