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

Sponsor

Sohaib Ashraf (Other)

Overall Status

Recruiting

CT.gov ID

NCT04472585

Collaborator

(none)

180

Enrollment

Locations

Arms

11.5

Anticipated Duration (Months)

Patients Per Site

7.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronavirus Infection COVID Sars-CoV2	Drug: Ivermectin Injectable Solution Other: Injectable Placebo Drug: Zinc Drug: Placebo empty capsule Drug: Oral Ivermectin	Phase 1/Phase 2

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..

Study Design

Study Type:

Interventional

Anticipated Enrollment :

180 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

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

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 14, 2020

Anticipated Primary Completion Date :

Aug 15, 2021

Anticipated Study Completion Date :

Oct 30, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

Severity of symptoms [14 days]
time needed to make patients clinically better
Morality [30 days]
death rate

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ali Clinic	Lahore	MA	Pakistan	54600
2	Shaikh Zayed Hospital	Lahore	Punjab	Pakistan	54600

Sponsors and Collaborators

Sohaib Ashraf

Investigators

Study Chair: Muhammad Ashraf, PhD, University of Veterinary & Animal Sciences, Lahore, Pakistan
Study Director: Shoaib Ashraf, PhD, Harvard University Boston, USA
Principal Investigator: Sohaib Ashraf, MBBS, Shaikh Zayed Medical Complex, Pakistan
Principal Investigator: Moneeb Ashraf, MBBS, Mayo Hospital, Pakistan