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
1 other identifier
interventional
180
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Nov 2020
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 14, 2020
CompletedFirst Posted
Study publicly available on registry
July 15, 2020
CompletedStudy Start
First participant enrolled
November 14, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2021
CompletedFebruary 17, 2021
February 1, 2021
9 months
July 14, 2020
February 13, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (2)
Severity of symptoms
14 days
Morality
30 days
Study Arms (6)
Ivermectin alone
ACTIVE COMPARATORSub-cutaneous injection ivermectin 200ug/kg body weight once every 48 hourly plus standard care
Ivermectin with Zinc
ACTIVE COMPARATORSub-cutaneous injection ivermectin 200ug/kg body weight once every 48 hourly with 20mg Zinc Sulphate 8 hourly plus standard care
Placebo
PLACEBO COMPARATORPlacebo drug plus standard care
Ivermectin (oral) alone
ACTIVE COMPARATOROral ivermectin 0.2mg/kg/day
Ivermectin (oral) with Zinc
ACTIVE COMPARATOROral ivermectin 0.2mg/kg/day with 20mg Zinc Sulphate 8 hourly plus standard care
Zinc Alone
ACTIVE COMPARATOR20mg Zinc Sulphate 8 hourly plus standard care
Interventions
Subcutaneous Ivermectin 200ug/kg body weight 48 hourly
Placebo empty capsule
Eligibility Criteria
You may qualify if:
- Nasopharyngeal RT-PCR positive SARS-CoV-2 patient with mild to moderate disease
- Age 18 and above
- BMI 18-28 kg/m
You may not qualify if:
- Allergy to any drug
- Co-morbidities: any pre-existing cardiac disease, pulmonary disease
- Arrhythmias
- Pregnancy
- RT-PCR performed \>3 days prior to enrollment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sohaib Ashraflead
Study Sites (2)
Ali Clinic
Lahore, MA, 54600, Pakistan
Shaikh Zayed Hospital
Lahore, Punjab Province, 54600, Pakistan
Related Publications (4)
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.
PMID: 32293834BACKGROUNDPatri 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.
PMID: 32283237BACKGROUNDCaly 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.
PMID: 32251768BACKGROUNDAshraf 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.
PMID: 34488858DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Empty capsule will sub-cutaneous injection of ivermectin will be used
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Post-Graduate Resident Cardiology
Study Record Dates
First Submitted
July 14, 2020
First Posted
July 15, 2020
Study Start
November 14, 2020
Primary Completion
August 15, 2021
Study Completion
October 30, 2021
Last Updated
February 17, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share