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

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ClinicalTrials.gov Identifier: NCT04472585
Recruitment Status : Recruiting
First Posted : July 15, 2020
Last Update Posted : February 17, 2021
Sponsor:
Information provided by (Responsible Party):
Sohaib Ashraf, Sheikh Zayed Federal Postgraduate Medical Institute

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..

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized, 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 : November 14, 2020
Estimated Primary Completion Date : August 15, 2021
Estimated Study Completion Date : October 30, 2021


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 Name: 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 Name: 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 Name: 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




Primary Outcome Measures :
  1. qRT-PCR [ Time Frame: 14 days ]
    time needed to turn positive COVID-19 PCR to negative

  2. Time taken for alleviation of symptoms [ Time Frame: upto 14 days ]
    time needed to turn off symptoms

  3. Severity of symptoms [ Time Frame: upto 14 days ]
    time needed of symptom serverity


Secondary Outcome Measures :
  1. Severity of symptoms [ Time Frame: 14 days ]
    time needed to make patients clinically better

  2. Morality [ Time Frame: 30 days ]
    death rate



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04472585


Contacts
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Contact: Sohaib Ashraf, MBBS +923334474523 sohaib-ashraf@outlook.com
Contact: Shoaib Ashraf, PhD +16177949579 sashraf@mgh.harvard.edu

Locations
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Pakistan
Ali Clinic Recruiting
Lahore, MA, Pakistan, 54600
Contact: Ahmad Imran, MBBS    +923334461038    ahmad.imran@skzmdc.edu.pk   
Shaikh Zayed Hospital Recruiting
Lahore, Punjab, Pakistan, 54600
Contact: Sohaib Ashraf, MBBS    +923334474523    sohaib-ashraf@outlook.com   
Contact: Muhammad Ahmad Imran, MBBS    +923338110708    ahmad.ammy93@gmail.com   
Principal Investigator: Muhammad Ahmad Imran, MBBS         
Sponsors and Collaborators
Sohaib Ashraf
Investigators
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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:
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Responsible Party: Sohaib Ashraf, Post-Graduate Resident Cardiology, Sheikh Zayed Federal Postgraduate Medical Institute
ClinicalTrials.gov Identifier: NCT04472585    
Other Study ID Numbers: SZMC/IRB/Internal/215/2020
First Posted: July 15, 2020    Key Record Dates
Last Update Posted: February 17, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Sohaib Ashraf, Sheikh Zayed Federal Postgraduate Medical Institute:
SARS-Cov-2
COVID-19
Coronavirus
Ivermectin
Zinc
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Ivermectin
Antiparasitic Agents
Anti-Infective Agents