Efficacy of Subcutaneous Ivermectin With or Without Zinc in COVID-19 Patients

Sub-cutaneous Ivermectin in Combination With and Without Oral Zinc: a Placebo Randomized Control Trial on Mild to Moderate COVID-19 Patients

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04472585

Acronym

SIZI-COVID-PK

Enrollment

180

Registered

2020-07-15

Start date

2020-11-14

Completion date

2021-10-30

Last updated

2021-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronavirus Infection, COVID, Sars-CoV2

Keywords

SARS-Cov-2, COVID-19, Coronavirus, Ivermectin, Zinc

Brief summary

To measure the effect of Ivermectin (sub-cutaneous) with or without zinc in treating the COVID-19 patients to clear viral load of SARS-CoV-2 along with reduction in severity of symptoms and length of hospitalization of patients with COVID-19.

Detailed description

This is a parallel assigned, randomized, controlled, multi-armed, investigator Initiated interventional study is designed to demonstrate efficacy to lower the viral load of COVID-19 and to demonstrate the antiviral effects of subcutaneous Ivermectin with or without zinc in mild to moderate symptomatic patients who consent to randomization following a new diagnosis in Pakistan with COVID-19 (PCR positive). Investigators will follow up with participants daily and PCR will be done on alternate days in BSL-3 lab. Dose will only be repeated if test remained positive..

Interventions

DRUGIvermectin Injectable Solution

Subcutaneous Ivermectin 200ug/kg body weight 48 hourly

OTHERInjectable Placebo

0.9% normal saline

DRUGZinc

Zinc Sulphate 20mg 3 times a day

DRUGPlacebo empty capsule

Placebo empty capsule

DRUGOral Ivermectin

0.2mg/kg/day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Empty capsule will sub-cutaneous injection of ivermectin will be used

Intervention model description

randomized, controlled, multi-armed, open-label, interventional study

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

* Nasopharyngeal RT-PCR positive SARS-CoV-2 patient with mild to moderate disease * Age 18 and above * BMI 18-28 kg/m

Exclusion criteria

* Allergy to any drug * Co-morbidities: any pre-existing cardiac disease, pulmonary disease * Arrhythmias * Pregnancy * RT-PCR performed \>3 days prior to enrollment

Design outcomes

Primary

Measure	Time frame	Description
qRT-PCR	14 days	time needed to turn positive COVID-19 PCR to negative
Time taken for alleviation of symptoms	upto 14 days	time needed to turn off symptoms
Severity of symptoms	upto 14 days	time needed of symptom serverity

Secondary

Measure	Time frame	Description
Severity of symptoms	14 days	time needed to make patients clinically better
Morality	30 days	death rate

Countries

Pakistan

Contacts

Primary ContactSohaib Ashraf, MBBS

sohaib-ashraf@outlook.com+923334474523

Backup ContactShoaib Ashraf, PhD

sashraf@mgh.harvard.edu+16177949579

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026