Covid19NCT04832945
SARS-CoV-2 Pre-exposure Prophylaxis With Ivermectin Retrospective Cohort Study
An observational study of Covid19, run by Grupo Rescue S.A.S República Dominicana at 2 sites in Dominican Republic.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- Ivermectin 6 Mg Oral Tablet
- Type of treatment
- Pill or oral medicine
- How many people
- 713 participants
- Where
- 2 sitesDominican Republic
- Study dates
- 29 Jun 2020to 10 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- Active workers from Centro Medico Bournigal (CMBO) and Centro Medico Punta Cana (CMPC) during the study.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Dominican Republic2 sites
Centro Medico Bournigal
Puerto Plata, 57000
Centro Médico Punta Cana
Punta Cana, 23000
About this study
Official title: 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).
- Conditions
- Covid19
- Being tested
- Ivermectin 6 Mg Oral Tablet
- Keywords
- Ivermectin, SARS-CoV-2, Coronavirus, Prophylaxis, PrEP, Covid-19
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ivermectin 6 Mg Oral TabletDrug
Also called Ivermectin
Ivermectin weekly oral dose 0.2 mg/kg equivalent for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Ivermectin Group | Healthcare personnel receiving Ivermectin weekly PrEP Receives: Drug: Ivermectin 6 Mg Oral Tablet | |
| Control Group | Healthcare personnel not receiving Ivermectin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants RT-PCR positive for Covid-19
Workers confirmed Covid-19 through Reverse Transcription Polymerase Chain Reaction (RT-PCR) test
Measured: 4 weeks
Secondary outcomes (2)
Number of sick participants who condition deteriorated
Workers infected with Covid-19, confirmed with RT-PCR and required hospitalization and/or ICU
Measured: 4 weeks
Number of sick participants who died
Workers infected with Covid-19, confirmed with RT-PCR and died.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2021
- Study start29 Jun 2020
- Primary completion20 Sep 2020
- Study completion10 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 713 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grupo Rescue S.A.S República Dominicana
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Jose Morgenstern, MD, Principal investigator, Grupo RescueJose Natalio Redondo, MD, Principal investigator, Grupo RescueAlvaro Olavarria, Data Analyst, Principal investigator, Grupo Rescue
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04832945
- Sponsor's protocol ID
- 8953
- Status last verified
- Apr 2021
- First submitted
- 1 Apr 2021
- Last updated
- 13 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Retrospective Cohort Study of Ivermectin as a SARS-CoV-2 Pre-exposure Prophylactic Method in Healthcare Workers in Dominican Republic
- ClinicalTrials.gov ID
- NCT04832945
- Acronym / sponsor ID
- 8953
- Conditions
- Covid19
- Keywords
- Ivermectin, SARS-CoV-2, Coronavirus, Prophylaxis, PrEP, Covid-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 713 participants (actual)
- Lead sponsor
- Grupo Rescue S.A.S República DominicanaResearch network
- Study start
- 29 Jun 2020 (actual)
- Primary completion
- 20 Sep 2020 (actual)
- Study completion
- 10 Apr 2021 (actual)
- First posted
- 6 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ivermectin Group | – | Drug: Ivermectin 6 Mg Oral TabletHealthcare personnel receiving Ivermectin weekly PrEP |
| Control Group | – | –Healthcare personnel not receiving Ivermectin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Active workers from Centro Medico Bournigal (CMBO) and Centro Medico Punta Cana (CMPC) during the study.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ivermectin 6 Mg Oral TabletAlso: IvermectinIvermectin weekly oral dose 0.2 mg/kg equivalent for 4 weeks | Drug | Ivermectin Group |
Primary outcome
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
2 secondary outcomes
Number of sick participants who condition deteriorated
Time frame: 4 weeks
Number of sick participants who died
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose Morgenstern, MD principal investigator
Grupo Rescue
Jose Natalio Redondo, MD principal investigator
Grupo Rescue
Alvaro Olavarria, Data Analyst principal investigator
Grupo Rescue
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Grupo Rescue S.A.S República Dominicana at 2 sites in Dominican Republic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Dominican Republic. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants RT-PCR positive for Covid-19 (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2021.