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

Covid19 Clinical Trial

— IVERNEX-TUC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04894721
• Other study ID #: 5077/410 CH 2020
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: June 1, 2021
• Est. completion date: October 1, 2021

Study information

• Verified date: December 2021
• Source: Ministry of Public Health, Argentina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 172
• Est. completion date: October 1, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Drug:
• Ivermectin
0,6mg/kg of weight orally on days 1 and 7

Other:
• Placebo
A substance with similar physical characteristics as ivermectin, without the active drug ingredient

Locations

Country	Name	City	State
Argentina	SI.PRO.SA, Ministerio de Salud Pública	Tucumán

Sponsors (1)

Lead Sponsor	Collaborator
Ministry of Public Health, Argentina

Country where clinical trial is conducted

Argentina, 

References & Publications (5)

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]

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. — View Citation

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. — View Citation

Chong CR, Sullivan DJ Jr. New uses for old drugs. Nature. 2007 Aug 9;448(7154):645-6. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	At 2 weeks
Secondary	Contagion risk.	Odd Ratio	Up to 2 weeks
Secondary	Prophylactic effect associated with patient's preexisting comorbidity	Logistic regression test	Up to 2 weeks