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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Coronavirus Infection; COVID; Sars-CoV2
• Intervention / Treatment: Drug: Ivermectin Injectable Solution; Drug: Placebo empty capsule; Drug: Zinc; Other: Injectable Placebo; Drug: Oral Ivermectin

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 Type: Interventional
• Enrollment (Anticipated): 180
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Sohaib Ashraf, MBBS; Phone Number: +923334474523; Email: sohaib-ashraf@outlook.com
• Study Contact Backup: Name: Shoaib Ashraf, PhD; Phone Number: +16177949579; Email: sashraf@mgh.harvard.edu

Study Locations

• Pakistan
  • MA
    • Lahore, MA, Pakistan, 54600
      • Recruiting
      • Ali Clinic
      • Contact: Ahmad Imran, MBBS; Phone Number: +923334461038; Email: ahmad.imran@skzmdc.edu.pk
  • Punjab
    • Lahore, Punjab, Pakistan, 54600
      • Recruiting
      • Shaikh Zayed Hospital
      • Contact: Sohaib Ashraf, MBBS; Phone Number: +923334474523; Email: sohaib-ashraf@outlook.com
      • Contact: Muhammad Ahmad Imran, MBBS; Phone Number: +923338110708; Email: ahmad.ammy93@gmail.com
      • Principal Investigator: Muhammad Ahmad Imran, MBBS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / 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: Placebo empty capsule; Placebo empty capsule; Drug: Zinc; Zinc Sulphate 20mg 3 times a day
Placebo Comparator: Placebo; Placebo drug plus standard care	Drug: Placebo empty capsule; Placebo empty capsule; Other: Injectable Placebo; 0.9% normal saline; Other Names: 0.9% normal saline
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: Placebo empty capsule; Placebo empty capsule; Drug: Zinc; Zinc Sulphate 20mg 3 times a day; Drug: Oral Ivermectin; 0.2mg/kg/day
Active Comparator: Zinc Alone; 20mg Zinc Sulphate 8 hourly plus standard care	Drug: Placebo empty capsule; Placebo empty capsule; Drug: Zinc; Zinc Sulphate 20mg 3 times a day

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

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• Caly L, Druce JD, Catton MG, Jans DA, Wagstaff KM. The FDA-approved drug ivermectin inhibits the replication of SARS-CoV-2 in vitro. Antiviral Res. 2020 Jun;178:104787. doi: 10.1016/j.antiviral.2020.104787. Epub 2020 Apr 3.
• Patri A, Fabbrocini G. Hydroxychloroquine and ivermectin: A synergistic combination for COVID-19 chemoprophylaxis and treatment? J Am Acad Dermatol. 2020 Jun;82(6):e221. doi: 10.1016/j.jaad.2020.04.017. Epub 2020 Apr 10. No abstract available.
• Simsek Yavuz S, Unal S. Antiviral treatment of COVID-19. Turk J Med Sci. 2020 Apr 21;50(SI-1):611-619. doi: 10.3906/sag-2004-145.
• Ashraf S, Ashraf S, Farooq I, Ashraf S, Ashraf M, Imran MA, Kalsoom L, Akmal R, Ghufran M, Rafique S, Akram MK, Habib Z, Siddiqui UN, Ahmad A, Arshad S, Virk MAR, Gul M, Awais AB, Hassan M, Sherazi SSH, Safdar Z, Munir I, Khalid H, Munir K, Majeed N, Alahmadi YM, Humayun A, Saboor QA, Ahmad A, Ashraf M, Izhar M; DOCTORS LOUNGE Consortium. Anti-COVID property of subcutaneous ivermectin in synergy with zinc among midlife moderately symptomatic patients: a structured summary of a study protocol for a randomised controlled trial. Trials. 2021 Sep 6;22(1):591. doi: 10.1186/s13063-021-05487-z.

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2020
• Primary Completion (Anticipated): August 15, 2021
• Study Completion (Anticipated): October 30, 2021

Study Registration Dates

• First Submitted: July 14, 2020
• First Submitted That Met QC Criteria: July 14, 2020
• First Posted (Actual): July 15, 2020

Study Record Updates

• Last Update Posted (Actual): February 17, 2021
• Last Update Submitted That Met QC Criteria: February 13, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Coronavirus; COVID-19; Zinc; SARS-Cov-2; Ivermectin
• Additional Relevant MeSH Terms: Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Coronavirus Infections; Anti-Infective Agents; Antiparasitic Agents; Ivermectin
• Other Study ID Numbers: SZMC/IRB/Internal/215/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No