NCT04472585

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
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Sohaib Ashraf · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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..

Conditions

• Coronavirus Infection
• COVID
• Sars-CoV2

Interventions

Type	Name	Description
DRUG	Ivermectin Injectable Solution	Subcutaneous Ivermectin 200ug/kg body weight 48 hourly
OTHER	Injectable Placebo	0.9% normal saline
DRUG	Zinc	Zinc Sulphate 20mg 3 times a day
DRUG	Placebo empty capsule	Placebo empty capsule
DRUG	Oral Ivermectin	0.2mg/kg/day

Timeline

• Start date: 2020-11-14
• Primary completion: 2021-08-15
• Completion: 2021-10-30
• First posted: 2020-07-15
• Last updated: 2021-02-17

Locations

2 sites across 1 country: Pakistan