Ivermectin for Post Exposure Prophylaxis of Covid-19 (I-CPEP)

Clinical Research Centre, Malaysia

Status and phase

Terminated

Phase 3

Conditions

COVID-19

Treatments

Other: Placebo

Drug: Ivermectin

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05231603

NMRR-21-1371-60569

Details and patient eligibility

About

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.

Full description

Primary Objective:

To assess the efficacy of Ivermectin as post exposure prophylaxis in asymptomatic adults (≥18 years of age) who had close-contact exposure to a confirmed case of COVID-19 patient

Secondary Objectives:

To compare the viral load (using CT value reading) among close contacts who become positive COVID-19 during follow up period between the Ivermectin and placebo group
To assess the adverse effects of Ivermectin within 7 days after each dose

Study Population and Sampel Size Asymptomatic adults (≥18 years of age) who had recent history (less than 5 days) of close contact exposure to a confirmed COVID-19 positive patient as per the definition by CDC.

In this study, the study teams decide to recruit 150 subjects per group, a total of 300 subjects; 30 subjects in each site (15 Ivermectins, 15 placebos)

Enrollment

50 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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