Ivermectin for Post Exposure Prophylaxis of Covid-19

NCT05231603 | Terminated Phase 3 DMC

• 1 other identifier: NMRR-21-1371-60569
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 10

Brief Summary

Post exposure prophylaxis of healthy contacts is among the measures used for outbreak control of several infectious diseases (e.g., pandemic influenza). No agent is known to be effective in preventing COVID-19, but Ivermectin is one of the drugs that have shown antiviral activity against SARS-CoV-2 in the laboratory. This study aims to evaluate the effect of post exposure prophylaxis with Ivermectin after exposure to COVID-19 among the asymptomatic close contacts.

Conditions

COVID-19

Keywords

Ivermectin; Post exposure; Prophylaxis

Outcome Measures

Primary Outcomes (1)

• Number of Covid-19 cases

  Comparison of the number of confirmed COVID-19 cases among the close contacts after exposure to a confirmed case of COVID-19 patient in Ivermectin and placebo group

  8 weeks

Secondary Outcomes (1)

• CT value in Covid-19

  14 days

Other Outcomes (1)

• Adverse effects of Ivermectin

  14 days

Study Arms (2)

Treatment group:

ACTIVE COMPARATOR

Ivermectin 0.4 mg/kg/day (maximum 24 mg)

Drug: Ivermectin

Control group

PLACEBO COMPARATOR

Placebo-inactive substance

Other: Placebo

Interventions

Ivermectin DRUG

0.4 mg/kg/day-maximum dose is 24 mg.

Treatment group:

Placebo OTHER

Similar to drug in term of tablets

Control group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Male and Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Asymptomatic individuals exposed to a confirmed positive COVID-19 case within 5 days from the study recruitment day (include household, workplace and social close contact)
• Aged ≥18 years; male or female
• No fever with temperature less than 37.5ºC
• RTK Ag for COVID-19 is negative on the recruitment day.
• For subject who had received COVID-19 vaccination:
• Any primary series vaccine (eg: Pfizer, Sinovac, AstraZeneca etc) : past 90 days after the second dose
• Any booster vaccine: past 90 days after the booster dose
• In women of childbearing potential (18-55 years old), negative pregnancy test and agree to use any contraceptive method up to 7 days after the second dose of IP administration
• Have access to video and phone call
• Willing to take 2 doses of study medication (2 days apart between Dose 1 and Dose 2)
• Willing to comply with all study procedures
• Able to provide written informed consent

You may not qualify if:

• Unable to take drugs by mouth
• History of positive confirmed COVID-19 infection within past 3 months
• Involved in any COVID-19 vaccine clinical trial
• Patients with suspected concomitant bacterial, fungal infections, concurrent congestive heart failure prior to initiation of study drug
• Known case of liver disease (any severity)
• Alcohol intake more than recommended (2 drinks or more in a day for men and 1 drink or more in a day for women)
• Mal-absorption syndrome or other clinically significant gastrointestinal disease that may affect absorption of the study drug (non-correctable vomiting, diarrhea, ulcerative colitis, and others).
• Pregnant or nursing/breastfeeding women or women planning for pregnancy.
• Female patients who cannot consent to contraceptive use (any method) from the start of IP administration to 7 days after the second dose of IP administration
• Male patients whose partner cannot agree to use the contraception method as in 9)
• Patients with a history of gout or on treatment for gout or hyperuricemia
• Patients receiving immunosuppressant
• Patients who have previously received Ivermectin.
• Patients who are not able to provide written consent.
• Other patients judged ineligible by the principal investigator or sub-investigator

Sponsors & Collaborators

• Clinical Research Centre, Malaysia: lead
• Hovid Berhad: collaborator

Study Sites (10)

KK Bandar Sg Petani

Sungai Petani, Kedah, 08000, Malaysia

Location

KK Bagan Serai

Bagan Serai, Perak, 34300, Malaysia

Location

KK Greentown

Ipoh, Perak, 30450, Malaysia

Location

KK Karai

Kuala Kangsar, Perak, 31050, Malaysia

Location

KK Ayer Tawar

Sitiawan, Perak, 32400, Malaysia

Location

KK Tanjung Malim

Slim River, Perak, 35900, Malaysia

Location

KK Simpang

Taiping, Perak, 34000, Malaysia

Location

KK Tapah

Tapah, Perak, 35000, Malaysia

Location

KK Kangar

Kangar, Perlis, 01000, Malaysia

Location

KK Seberang Jaya

Butterworth, Pulau Pinang, 13700, Malaysia

Location

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 Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This is a randomized, double blind, placebo controlled clinical trial evaluating the effect of Ivermectin for post exposure prophylaxis among close contacts of COVID-19 positive case patient as an index case.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, double blind, placebo controlled clinical trial

Study Record Dates

• First Submitted: January 27, 2022
• First Posted: February 9, 2022
• Study Start: February 16, 2022
• Primary Completion: May 31, 2022
• Study Completion: October 11, 2022
• Last Updated: October 18, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

MY (10)