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

Study Overview
=================
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..

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

Conditions
-----------------
Coronavirus Infection, COVID, Sars-CoV2

Intervention / Treatment
-----------------
* Drug: Ivermectin Injectable Solution
* Other: Injectable Placebo
* Drug: Zinc
* Drug: Placebo empty capsule
* Drug: Oral Ivermectin


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized, controlled, multi-armed, open-label, interventional study
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ivermectin alone<br>Sub-cutaneous injection ivermectin 200ug/kg body weight once every 48 hourly plus standard care | Drug: Ivermectin Injectable Solution<br>* Subcutaneous Ivermectin 200ug/kg body weight 48 hourly<br>* Other names: Montpellier;Drug: Placebo empty capsule<br>* Placebo empty capsule<br>|
| Active Comparator: Ivermectin with Zinc<br>Sub-cutaneous injection ivermectin 200ug/kg body weight once every 48 hourly with 20mg Zinc Sulphate 8 hourly plus standard care | Drug: Ivermectin Injectable Solution<br>* Subcutaneous Ivermectin 200ug/kg body weight 48 hourly<br>* Other names: Montpellier;Drug: Zinc<br>* Zinc Sulphate 20mg 3 times a day<br>Drug: Placebo empty capsule<br>* Placebo empty capsule<br>|
| Placebo Comparator: Placebo<br>Placebo drug plus standard care | Other: Injectable Placebo<br>* 0.9% normal saline<br>* Other names: 0.9% normal saline;Drug: Placebo empty capsule<br>* Placebo empty capsule<br>|
| Active Comparator: Ivermectin (oral) alone<br>Oral ivermectin 0.2mg/kg/day | Drug: Placebo empty capsule<br>* Placebo empty capsule<br>Drug: Oral Ivermectin<br>* 0.2mg/kg/day<br>|
| Active Comparator: Ivermectin (oral) with Zinc<br>Oral ivermectin 0.2mg/kg/day with 20mg Zinc Sulphate 8 hourly plus standard care | Drug: Zinc<br>* Zinc Sulphate 20mg 3 times a day<br>Drug: Placebo empty capsule<br>* Placebo empty capsule<br>Drug: Oral Ivermectin<br>* 0.2mg/kg/day<br>|
| Active Comparator: Zinc Alone<br>20mg Zinc Sulphate 8 hourly plus standard care | Drug: Zinc<br>* Zinc Sulphate 20mg 3 times a day<br>Drug: Placebo empty capsule<br>* Placebo empty capsule<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of symptoms | time needed to make patients clinically better | 14 days | 
| Morality | death rate | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SARS-Cov-2, COVID-19, Coronavirus, Ivermectin, Zinc