Condition category
Infections and Infestations
Date applied
11/11/2020
Date assigned
17/11/2020
Last edited
13/11/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
COVID-19 is a condition caused by the coronavirus (called SARS-CoV-2) that was first identified in late 2019. This virus can infect the respiratory (breathing) system. Some people do not have symptoms but can carry the virus and pass it on to others. People who have developed the condition may develop a fever and/or a continuous cough among other symptoms. This can develop into pneumonia. Pneumonia is a chest infection where the small air pockets of the lungs, called alveoli, fill with liquid and make it more difficult to breathe.

In 2020, the virus has spread to many countries around the world and neither a vaccine against the virus or specific treatment for COVID-19 has yet been developed. As of March 2020, it is advised that people minimize travel and social contact, and regularly wash their hands to reduce the spread of the virus.

Groups who are at a higher risk from infection with the virus, and therefore of developing COVID-19, include people aged over 70 years, people who have long-term health conditions (such as asthma or diabetes), people who have a weakened immune system and people who are pregnant. People in these groups, and people who might come into contact with them, can reduce this risk by following the up-to-date advice to reduce the spread of the virus.

To date, some 12.9% of global deaths occurred in Brazil.

Ivermectin has been shown strong antiviral activity against chikungunya virus in 2016. Ivermectin is approved to treat a range of parasitic worm infections, it is a safe drug widely used in many countries and presents very few and mild side effects. The aim of this study is to test if taking ivermectin can reduce the probability of being infected by SARS-CoV-2 virus that causes COVID-19.

Who can participate?
Adult volunteers aged 18 or more who live in a local community previously chosen, who have neither developed immunity for SARS-CoV-2 or COVID-19 and are clinically asymptomatic for COVID-19.

What does the study involve?
Healthy volunteers will be randomly allocated to one of the two groups.
Those in the first group will receive a single dose of a placebo (dummy drug) and those in the second group receive a single dose of ivermectin. The follow-up period is 90 days after receiving the treatment.

Participants will be asked to provide information regarding to presence of symptoms suggestive of COVID-19 at any point during the 90 days of the trial. All participants will be interviewed before they have taken their treatment dose and after, at days 7, 14, 30 and 90, to answer if they have presented any signs and/or symptoms of COVID-19 and side effects, that will be included in the questionnaire of this trial.
They will be asked to provide fingerpick blood samples for testing immunity status for SARS-CoV-2 at time of enrollment (screening for excluding previous infected participant) and at any time of follow-up to confirm any symptom suggestive of COVID-19.

What are the possible benefits and risks of participating?
The study participants might help be diagnosed early and treated for COVID-19. Participants who do not respond to treatment and develop symptoms of COVID-19 will be referred to local health facilities for confirmatory diagnoses and receive treatment (according to WHO recommendations).
There is a low risk of side effects of ivermectin. These will be monitored throughout.

Who is funding the study?
Governmental funds are provided by the city of Mamanguape (Paraíba, Brazil) running by the health secretary of the city and the private resources by the Institute of Clinical Research Scinet, Recife, Pernambuco, Brazil.

Who is the main contact?
Prof. Taciana Castro
taciana@scinetinstitute.com

Trial website

Contact information

Type

Scientific

Primary contact

Prof Taciana de Castro

ORCID ID

Contact details

Rua Simão Mendes
200 apartamento 1602
Tamarineira
Recife
52 050 145
Brazil
+55 81 994517225
taciana@scinetinstitute.com

Type

Scientific

Additional contact

Prof Denia Fittipaldi-Duarte

ORCID ID

Contact details

Rua do Futuro
77
501 Graças
Recife
52 050-005
Brazil
+55 81 997305276
dpfittipaldi@gmail.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

IvermecPrev-Brazil ScinetN001.2020

Study information

Scientific title

Investigation of efficacy and safety for Preventing COVID-19 using a single dose of Ivermectin (IvermecPrev-Brazil) in the general asymptomatic susceptible population under SARS-CoV-2 exposition during a pandemic period in Brazil: randomized double-blind placebo-controlled trial

Acronym

IvermecPrev-Brazil

Study hypothesis

A single dose of ivermectin plus usual health prophylaxis recommendations significantly reduces the number of new COVID-19 cases in the community compared to prophylaxis recommendations alone.

Ethics approval

Approved 06/06/2020, National Commission for Research Ethics (CONEP) (Ministério da Saúde - Esplanada dos Ministérios Edifício Anexo Bl. G Ala B Sl. 13-B, 70.058-900, Brasíl; +55 61 3315-295; conep@saude.gov.br), ref: 31523220.0.1001.0008

Study design

Two-armed randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Prevention of COVID-19 (SARS-CoV-2 infection)

Intervention

Study participants eligible for treatment will be randomly assigned to receive single, oral doses of placebo or ivermectin using a computer-generated stratified block randomization code. The random allocation sequence with varying random blocks will be provided by an independent pharmaceutic.

To those allocated in the intervention arm, ivermectin will be used as a single dose of 400 μg/kg and to those allocated in the control arm a dummy drug (placebo ) of identic appearance from a sealed opaque envelope . Participants, researchers and community health workers are all blinded regarding treatment or placebo arm. The treatment will be administered on one day only and follow up will be conducted for all treatment arms 90 days after treatment.

Intervention type

Drug

Phase

Phase III

Drug names

Ivermectin

Primary outcome measure

Covid-19 case diagnosis (conversion from being asymptomatic pre-treatment to symptomatic post-treatment for COVID-19) by using a questionnaire for screening clinical symptoms of COVID-19, at baseline, and during the follow up at 7, 14, 30 and 90 days . All clinically diagnosed COVID-19 cases will be confirmed by serologic IgM and IgG anti-SARS-CoV2 test at 14 days post-initial symptoms.

Secondary outcome measures

1. Clinical status of COVID-19 using the WHO Clinical Progression Scale measured at 14 and 30 days after COVID-19 diagnosis (if applicable)
2. Incidence of severe COVID-19 cases determined by active cases detection and defined by WHO Clinical Progression Scale at days 14 and 30 after treatment
3. Rate of adverse events using active case detection with questionnaire and adverse events grades (mild, moderate and severe) using Common Terminology Criteria for Adverse Events (CTCAE) v5.0 at days 2 and 7 after treatment
4. Hospitalization rate at 7,14, 30 and 90 days measured using patient records
5. Deaths at the follow-up period (90 days) measured using patient records

Overall trial start date

10/04/2020

Overall trial end date

30/06/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Adult participants susceptible to be infected by SARS-CoV-19 (not previous infection) tested negative for IgM and IgG immunological test
2. No symptoms of COVID-19
3. Written informed consent signed by participating for the study

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

The target total recruitment of participants for the trial is 800 adults, 400 in each arm.

Participant exclusion criteria

1. Pregnant or breastfeeding
2. Known allergy to study medications used at intervention
3. Known or reported history of liver disease
4. Use of coumarin (anticoagulant)

Recruitment start date

15/09/2020

Recruitment end date

31/03/2021

Locations

Countries of recruitment

Brazil

Trial participating centre

Centro Odontomédico
Rua Aristides Lobo, S/N - Centro
Mamanguape - Paraíba
58280-000
Brazil

Sponsor information

Organisation

Federal University of Pernambuco

Sponsor details

Laboratório de Imunopatologia Keizo Asami – LIKA; Pernambuco Federal University– UFPE
Av. Prof.Moraes Rego
1235
Recife (Pernambuco)
50 670-901
Brazil
+55 81 2101.2508
joseluiz60@gmail.com

Sponsor type

Research organisation

Website

https://www.ufpe.br/lika/equipe

Organisation

Clinical Research Institute Scinet

Sponsor details

Rua Manoel Caetano
142
Derby
Recife
52 010-220
Brazil
+55 81 994517225
taciana@scinetinstitute.com

Sponsor type

Research organisation

Website

Funders

Funder type

Research organisation

Funder name

Clinical Research Institute Scinet

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Mamanguape’s Health Secretariat

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.


IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.
What data in particular will be shared?
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
What other documents will be available?
Study Protocol
When will data be available (start and end dates)?
Beginning 3 months and ending 36 months following article publication.
With whom?
Researchers who provide a methodologically sound proposal.
For what types of analyses?
To achieve aims in the approved proposal. For individual participant data meta-analysis
By what mechanism will data be made available?
Proposals may be submitted up to 36 months following article publication. After 36
months the data will be available in our University's data warehouse but without investigator support other than deposited metadata. Information regarding submitting proposals and accessing data may be found at (Link to be provided).

Intention to publish date

15/05/2021

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

13/11/2020: Trial’s existence confirmed by the National Commission for Research Ethics (CONEP) of Brazil .