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Covid19Phase 2/3IVERNEX-TUCNCT04894721

Prophylaxis for COVID-19: Ivermectin in Close Contacts of COVID-19 Cases (IVERNEX-TUC)

A Phase 2/3 study testing Ivermectin in people with Covid19, run by Ministry of Public Health, Argentina at 1 site in Argentina.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Randomized controlled clinical trial on using oral ivermectin in COVID-19 prophylaxis supplying the drug to close contacts of confirmed cases. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Covid19
What is being tested?
Ivermectin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
172 participants
Where
1 siteArgentina
Study dates
1 Jun 2021to 1 Oct 2021
Phase
Phase 2/3
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 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Over 18 years either sex
  • Women of childbearing age with a negative pregnancy test
  • In close contact group or epidemiological nexus of a positive COVID-19 case
  • Able to understand and grant informed consent
  • Real-time - polymerase chain reaction test with a negative result

Who cannot join

  • Known hypersensitivity or allergy to any component of the drug under evaluation
  • Age under 18 years
  • Use of immunosuppressants (including systemic corticosteroids) in the last 30 days
  • Pregnant or lactating
  • Patients with other acute infectious diseases
  • Patients with autoimmune disease and/or chronic decompensated diseases
  • Who have received a vaccine for COVID-19 (1/2 dose) or that have taken ivermectin (prior to 30 days of the study) or who are participating in another COVID-19 prophylaxis study

Trial locations and contacts

1 site in 1 country.

Argentina1 site

  • SI.PRO.SA, Ministerio de Salud Pública

    San Miguel de Tucumán, 4000

Other trials in Argentina

About this study

Official title: Study of Efficacy and Safety of Ivermectin for COVID-19 Prophylaxis in Post-exposure Contact or Epidemiological Link

Randomized controlled clinical trial on using oral ivermectin in COVID-19 prophylaxis supplying the drug to close contacts of confirmed cases.

Read the detailed description

This is a randomized, double-blind, and controlled clinical trial that aims to evaluate the use of oral ivermectin in COVID-19 prophylaxis. The study has two arms in a relationship of 2:1: Experimental Group (EG n=500) and Placebo Group (CG n=250).

The sample size was calculated by applying a two-proportion comparison test. Type of two-sided test, 95% confidence or safety level (1-α), 95% statistical power, 75% P1 (proportion in the placebo group), 65% P2 (proportion in the new treatment or intervention group), size sample without adjustment (n = 543), 25% expected proportion of losses, n= 724 sample adjusted for losses.

The hypothesis of the study is that treatment with ivermectin may decrease the chance of occurrence/progress of clinical manifestations and onset of severe disease. Whereas control of the contagion on the first days of development of the disease, this treatment with ivermectin in suspected cases of COVID-19 (by epidemiological nexus) would contribute to the control of contagion at the first part of the infection, even in the absence of symptoms.

Categorical variables will be represented with frequencies and proportions, while continuous quantitative variables will be expressed as mean ± standard deviation (SD) or as median and interquartile range (IQR). The proportions will be compared using Pearson's Chi-square test or Fisher's exact test as appropriate, and continuous quantitative variables with Student's t test. The estimation of the efficacy of intensive treatment with Ivermectin will be calculated using Kaplan-Meier curves and the differences will be analyzed by means of the log-rank test. The risk will be calculated as a ratio of advantages for Intensive treatment with Ivermectin (Odds Ratio, OR) with its 95% confidence intervals (95% CI). A value of p <0.05 will be considered significant. Analyzes will be performed using Stata 11.2 software.

Conditions
Covid19
Being tested
Ivermectin, Placebo
Keywords
Ivermectin, Prophylaxis, COVID-19, Epidemiological link
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IvermectinDrug

    Also called Iver

    0,6mg/kg of weight orally on days 1 and 7

  • PlaceboOther

    A substance with similar physical characteristics as ivermectin, without the active drug ingredient

Study groups in NCT04894721
Study groupRoleWhat they receive
Experimental GroupExperimentalThe EG receives ivermectin 0,6mg/kg of weight orally on days 1 (one) and 7 (seven) plus standard biosecurity care
Receives: Drug: Ivermectin
Control GroupPlacebo comparatorThe CG receives a placebo on days 1 (one) and 7 (seven) plus standard biosecurity care
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of subjects who were diagnosed with COVID-19 in EG and CG (Negative polymerase chain reaction - real-time).

    Pearson's Chi-square and proportion test

    Measured: At 2 weeks

Secondary outcomes (2)

  1. Contagion risk.

    Odd Ratio

    Measured: Up to 2 weeks

  2. Prophylactic effect associated with patient's preexisting comorbidity

    Logistic regression test

    Measured: Up to 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2021
  2. Study start1 Jun 2021
  3. Primary completion30 Sep 2021
  4. Study completion1 Oct 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized controlled. Experimental and Control Group in relationship of 2:1
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
172 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04894721
Sponsor's protocol ID
5077/410 CH 2020
Acronym
IVERNEX-TUC
Status last verified
Dec 2021
First submitted
6 May 2021
Last updated
7 Dec 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chong CR, Sullivan DJ Jr. New uses for old drugs. Nature. 2007 Aug 9;448(7154):645-6. doi: 10.1038/448645a. No abstract available.

    PubMed 17687303

  • Caly L, Druce JD, Catton MG, Jans DA, Wagstaff KM. The FDA-approved drug ivermectin inhibits the replication of SARS-CoV-2 in vitro. Antiviral Res. 2020 Jun;178:104787. doi: 10.1016/j.antiviral.2020.104787. Epub 2020 Apr 3.

    PubMed 32251768

  • Ahmed S, Karim MM, Ross AG, Hossain MS, Clemens JD, Sumiya MK, Phru CS, Rahman M, Zaman K, Somani J, Yasmin R, Hasnat MA, Kabir A, Aziz AB, Khan WA. A five-day course of ivermectin for the treatment of COVID-19 may reduce the duration of illness. Int J Infect Dis. 2021 Feb;103:214-216. doi: 10.1016/j.ijid.2020.11.191. Epub 2020 Dec 2.

    PubMed 33278625

  • Ahmed Elgazzar, Basma Hany, Shaimaa Abo Youssef et al. Efficacy and Safety of Ivermectin for Treatment and prophylaxis of COVID-19 Pandemic, 13 November 2020, PREPRINT (Version 1) available at Research Square [https://doi.org/10.21203/rs.3.rs-100956/v1]

  • Hirsch RR, Carvallo, Héctor E. Ivermectin as Prophylaxis Against COVID-19 Retrospective Cases Evaluation. Microbiol Infect Dis. 2020; 4(4): 1-8.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Ivermectin in people with Covid19, run by Ministry of Public Health, Argentina at 1 site in Argentina.

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 5 inclusion and 7 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 7 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Argentina. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 subjects who were diagnosed with COVID-19 in EG and CG (Negative polymerase chain reaction - real-time). (time frame: At 2 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04894721, which also lists 5 linked publications.

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 7 Dec 2021.

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