Efficacy of Subcutaneous Ivermectin With or Without Zinc in COVID-19 Patients (SIZI-COVID-PK)

Sohaib Ashraf

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Sars-CoV2; COVID; Coronavirus Infection

Treatments: Drug: Placebo empty capsule; Drug: Oral Ivermectin; Other: Injectable Placebo; Drug: Zinc; Drug: Ivermectin Injectable Solution

Study type: Interventional

Funder types: Other

Identifiers

NCT04472585

SZMC/IRB/Internal/215/2020

Details and patient eligibility

About

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.

Full 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..

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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180 participants in 6 patient groups, including a placebo group

Ivermectin alone

Active Comparator group

Description:

Sub-cutaneous injection ivermectin 200ug/kg body weight once every 48 hourly plus standard care

Treatment:

Drug: Placebo empty capsule

Drug: Ivermectin Injectable Solution

Ivermectin with Zinc

Active Comparator group

Description:

Sub-cutaneous injection ivermectin 200ug/kg body weight once every 48 hourly with 20mg Zinc Sulphate 8 hourly plus standard care

Treatment:

Drug: Placebo empty capsule

Drug: Ivermectin Injectable Solution

Drug: Zinc

Placebo

Placebo Comparator group

Description:

Placebo drug plus standard care

Treatment:

Drug: Placebo empty capsule

Other: Injectable Placebo

Ivermectin (oral) alone

Active Comparator group

Description:

Oral ivermectin 0.2mg/kg/day

Treatment:

Drug: Placebo empty capsule

Drug: Oral Ivermectin

Ivermectin (oral) with Zinc

Active Comparator group

Description:

Oral ivermectin 0.2mg/kg/day with 20mg Zinc Sulphate 8 hourly plus standard care

Treatment:

Drug: Placebo empty capsule

Drug: Zinc

Drug: Oral Ivermectin

Zinc Alone

Active Comparator group

Description:

20mg Zinc Sulphate 8 hourly plus standard care

Treatment:

Drug: Placebo empty capsule

Drug: Zinc