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

Primary Purpose

Coronavirus Infection, COVID, Sars-CoV2

Status
Unknown status
Phase
Phase 1
Locations
Pakistan
Study Type
Interventional
Intervention
Ivermectin Injectable Solution
Injectable Placebo
Zinc
Placebo empty capsule
Oral Ivermectin
Sponsored by
Sohaib Ashraf
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronavirus Infection focused on measuring SARS-Cov-2, COVID-19, Coronavirus, Ivermectin, Zinc

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Ali ClinicRecruiting
  • Shaikh Zayed HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Ivermectin alone

Ivermectin with Zinc

Placebo

Ivermectin (oral) alone

Ivermectin (oral) with Zinc

Zinc Alone

Arm Description

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

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

Placebo drug plus standard care

Oral ivermectin 0.2mg/kg/day

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

20mg Zinc Sulphate 8 hourly plus standard care

Outcomes

Primary Outcome Measures

qRT-PCR
time needed to turn positive COVID-19 PCR to negative
Time taken for alleviation of symptoms
time needed to turn off symptoms
Severity of symptoms
time needed of symptom serverity

Secondary Outcome Measures

Severity of symptoms
time needed to make patients clinically better
Morality
death rate

Full Information

First Posted
July 14, 2020
Last Updated
February 13, 2021
Sponsor
Sohaib Ashraf
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1. Study Identification

Unique Protocol Identification Number
NCT04472585
Brief Title
Efficacy of Subcutaneous Ivermectin With or Without Zinc in COVID-19 Patients
Acronym
SIZI-COVID-PK
Official Title
Sub-cutaneous Ivermectin in Combination With and Without Oral Zinc: a Placebo Randomized Control Trial on Mild to Moderate COVID-19 Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 14, 2020 (Actual)
Primary Completion Date
August 15, 2021 (Anticipated)
Study Completion Date
October 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sohaib Ashraf

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.
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..

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronavirus Infection, COVID, Sars-CoV2
Keywords
SARS-Cov-2, COVID-19, Coronavirus, Ivermectin, Zinc

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
randomized, controlled, multi-armed, open-label, interventional study
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Empty capsule will sub-cutaneous injection of ivermectin will be used
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ivermectin alone
Arm Type
Active Comparator
Arm Description
Sub-cutaneous injection ivermectin 200ug/kg body weight once every 48 hourly plus standard care
Arm Title
Ivermectin with Zinc
Arm Type
Active Comparator
Arm Description
Sub-cutaneous injection ivermectin 200ug/kg body weight once every 48 hourly with 20mg Zinc Sulphate 8 hourly plus standard care
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo drug plus standard care
Arm Title
Ivermectin (oral) alone
Arm Type
Active Comparator
Arm Description
Oral ivermectin 0.2mg/kg/day
Arm Title
Ivermectin (oral) with Zinc
Arm Type
Active Comparator
Arm Description
Oral ivermectin 0.2mg/kg/day with 20mg Zinc Sulphate 8 hourly plus standard care
Arm Title
Zinc Alone
Arm Type
Active Comparator
Arm Description
20mg Zinc Sulphate 8 hourly plus standard care
Intervention Type
Drug
Intervention Name(s)
Ivermectin Injectable Solution
Other Intervention Name(s)
Montpellier
Intervention Description
Subcutaneous Ivermectin 200ug/kg body weight 48 hourly
Intervention Type
Other
Intervention Name(s)
Injectable Placebo
Other Intervention Name(s)
0.9% normal saline
Intervention Description
0.9% normal saline
Intervention Type
Drug
Intervention Name(s)
Zinc
Intervention Description
Zinc Sulphate 20mg 3 times a day
Intervention Type
Drug
Intervention Name(s)
Placebo empty capsule
Intervention Description
Placebo empty capsule
Intervention Type
Drug
Intervention Name(s)
Oral Ivermectin
Intervention Description
0.2mg/kg/day
Primary Outcome Measure Information:
Title
qRT-PCR
Description
time needed to turn positive COVID-19 PCR to negative
Time Frame
14 days
Title
Time taken for alleviation of symptoms
Description
time needed to turn off symptoms
Time Frame
upto 14 days
Title
Severity of symptoms
Description
time needed of symptom serverity
Time Frame
upto 14 days
Secondary Outcome Measure Information:
Title
Severity of symptoms
Description
time needed to make patients clinically better
Time Frame
14 days
Title
Morality
Description
death rate
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sohaib Ashraf, MBBS
Phone
+923334474523
Email
sohaib-ashraf@outlook.com
First Name & Middle Initial & Last Name or Official Title & Degree
Shoaib Ashraf, PhD
Phone
+16177949579
Email
sashraf@mgh.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammad Ashraf, PhD
Organizational Affiliation
University of Veterinary & Animal Sciences, Lahore, Pakistan
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Shoaib Ashraf, PhD
Organizational Affiliation
Harvard University Boston, USA
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sohaib Ashraf, MBBS
Organizational Affiliation
Shaikh Zayed Medical Complex, Pakistan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Moneeb Ashraf, MBBS
Organizational Affiliation
Mayo Hospital, Pakistan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ali Clinic
City
Lahore
State/Province
MA
ZIP/Postal Code
54600
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmad Imran, MBBS
Phone
+923334461038
Email
ahmad.imran@skzmdc.edu.pk
Facility Name
Shaikh Zayed Hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54600
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sohaib Ashraf, MBBS
Phone
+923334474523
Email
sohaib-ashraf@outlook.com
First Name & Middle Initial & Last Name & Degree
Muhammad Ahmad Imran, MBBS
Phone
+923338110708
Email
ahmad.ammy93@gmail.com
First Name & Middle Initial & Last Name & Degree
Muhammad Ahmad Imran, MBBS

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32293834
Citation
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.
Results Reference
background
PubMed Identifier
32283237
Citation
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.
Results Reference
background
PubMed Identifier
32251768
Citation
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.
Results Reference
background
PubMed Identifier
34488858
Citation
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.
Results Reference
derived

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

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