Efficacy of Subcutaneous Ivermectin With or Without Zinc in COVID-19 Patients
- Conditions
- COVIDSars-CoV2Coronavirus Infection
- Interventions
- Other: Injectable PlaceboDrug: Placebo empty capsule
- Registration Number
- NCT04472585
- Lead Sponsor
- Sohaib Ashraf
- 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..
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 180
- Nasopharyngeal RT-PCR positive SARS-CoV-2 patient with mild to moderate disease
- Age 18 and above
- BMI 18-28 kg/m
- Allergy to any drug
- Co-morbidities: any pre-existing cardiac disease, pulmonary disease
- Arrhythmias
- Pregnancy
- RT-PCR performed >3 days prior to enrollment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ivermectin with Zinc Ivermectin Injectable Solution Sub-cutaneous injection ivermectin 200ug/kg body weight once every 48 hourly with 20mg Zinc Sulphate 8 hourly plus standard care Ivermectin alone Placebo empty capsule Sub-cutaneous injection ivermectin 200ug/kg body weight once every 48 hourly plus standard care Ivermectin (oral) alone Oral Ivermectin Oral ivermectin 0.2mg/kg/day Placebo Injectable Placebo Placebo drug plus standard care Ivermectin with Zinc Placebo empty capsule Sub-cutaneous injection ivermectin 200ug/kg body weight once every 48 hourly with 20mg Zinc Sulphate 8 hourly plus standard care Zinc Alone Placebo empty capsule 20mg Zinc Sulphate 8 hourly plus standard care Ivermectin alone Ivermectin Injectable Solution Sub-cutaneous injection ivermectin 200ug/kg body weight once every 48 hourly plus standard care Placebo Placebo empty capsule Placebo drug plus standard care Ivermectin (oral) alone Placebo empty capsule Oral ivermectin 0.2mg/kg/day Ivermectin (oral) with Zinc Placebo empty capsule Oral ivermectin 0.2mg/kg/day with 20mg Zinc Sulphate 8 hourly plus standard care Ivermectin (oral) with Zinc Oral Ivermectin Oral ivermectin 0.2mg/kg/day with 20mg Zinc Sulphate 8 hourly plus standard care Ivermectin with Zinc Zinc Sub-cutaneous injection ivermectin 200ug/kg body weight once every 48 hourly with 20mg Zinc Sulphate 8 hourly plus standard care Ivermectin (oral) with Zinc Zinc Oral ivermectin 0.2mg/kg/day with 20mg Zinc Sulphate 8 hourly plus standard care Zinc Alone Zinc 20mg Zinc Sulphate 8 hourly plus standard care
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Severity of symptoms 14 days time needed to make patients clinically better
Morality 30 days death rate
Trial Locations
- Locations (2)
Ali Clinic
🇵🇰Lahore, MA, Pakistan
Shaikh Zayed Hospital
🇵🇰Lahore, Punjab, Pakistan