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

NCT04894721 | Completed Phase 2 DMC

• 1 other identifier: 5077/410 CH 2020
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Covid19

Keywords

Ivermectin; Prophylaxis; COVID-19; Epidemiological link

Outcome Measures

Primary Outcomes (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

  At 2 weeks

Secondary Outcomes (2)

• Contagion risk.

  Up to 2 weeks

• Prophylactic effect associated with patient's preexisting comorbidity

  Up to 2 weeks

Study Arms (2)

Experimental Group

EXPERIMENTAL

The EG receives ivermectin 0,6mg/kg of weight orally on days 1 (one) and 7 (seven) plus standard biosecurity care

Drug: Ivermectin

Control Group

PLACEBO COMPARATOR

The CG receives a placebo on days 1 (one) and 7 (seven) plus standard biosecurity care

Other: Placebo

Interventions

Ivermectin DRUG

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

Also known as: Iver

Experimental Group

Placebo OTHER

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

Control Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ministry of Public Health, Argentina: lead

Study Sites (1)

SI.PRO.SA, Ministerio de Salud Pública

San Miguel de Tucumán, 4000, Argentina

Location

Related Publications (5)

• 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.

  PMID: 17687303 BACKGROUND

• 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.

  PMID: 32251768 BACKGROUND

• 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.

  PMID: 33278625 BACKGROUND

• 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]

  BACKGROUND

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

  BACKGROUND

MeSH Terms

Conditions

COVID-19

Interventions

Ivermectin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Rossana Chahla, Ph. D

  Ministry of Public Health, Tucumán, Argentina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double-Blind
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research - Ministry of Health of Tucumán

Model Details: Randomized controlled. Experimental and Control Group in relationship of 2:1

Study Record Dates

• First Submitted: May 6, 2021
• First Posted: May 20, 2021
• Study Start: June 1, 2021
• Primary Completion: September 30, 2021
• Study Completion: October 1, 2021
• Last Updated: December 7, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)