Efficacy of Subcutaneous Ivermectin With or Without Zinc in COVID-19 Patients
NCT ID: NCT04472585
Last Updated: 2021-02-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
180 participants
INTERVENTIONAL
2020-11-14
2021-10-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Ivermectin alone
Sub-cutaneous injection ivermectin 200ug/kg body weight once every 48 hourly plus standard care
Ivermectin Injectable Solution
Subcutaneous Ivermectin 200ug/kg body weight 48 hourly
Placebo empty capsule
Placebo empty capsule
Ivermectin with Zinc
Sub-cutaneous injection ivermectin 200ug/kg body weight once every 48 hourly with 20mg Zinc Sulphate 8 hourly plus standard care
Ivermectin Injectable Solution
Subcutaneous Ivermectin 200ug/kg body weight 48 hourly
Zinc
Zinc Sulphate 20mg 3 times a day
Placebo empty capsule
Placebo empty capsule
Placebo
Placebo drug plus standard care
Injectable Placebo
0.9% normal saline
Placebo empty capsule
Placebo empty capsule
Ivermectin (oral) alone
Oral ivermectin 0.2mg/kg/day
Placebo empty capsule
Placebo empty capsule
Oral Ivermectin
0.2mg/kg/day
Ivermectin (oral) with Zinc
Oral ivermectin 0.2mg/kg/day with 20mg Zinc Sulphate 8 hourly plus standard care
Zinc
Zinc Sulphate 20mg 3 times a day
Placebo empty capsule
Placebo empty capsule
Oral Ivermectin
0.2mg/kg/day
Zinc Alone
20mg Zinc Sulphate 8 hourly plus standard care
Zinc
Zinc Sulphate 20mg 3 times a day
Placebo empty capsule
Placebo empty capsule
Interventions
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Ivermectin Injectable Solution
Subcutaneous Ivermectin 200ug/kg body weight 48 hourly
Injectable Placebo
0.9% normal saline
Zinc
Zinc Sulphate 20mg 3 times a day
Placebo empty capsule
Placebo empty capsule
Oral Ivermectin
0.2mg/kg/day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 18 and above
* BMI 18-28 kg/m
Exclusion Criteria
* Co-morbidities: any pre-existing cardiac disease, pulmonary disease
* Arrhythmias
* Pregnancy
* RT-PCR performed \>3 days prior to enrollment
18 Years
60 Years
ALL
No
Sponsors
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Sohaib Ashraf
OTHER
Responsible Party
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Sohaib Ashraf
Post-Graduate Resident Cardiology
Principal Investigators
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Muhammad Ashraf, PhD
Role: STUDY_CHAIR
University of Veterinary & Animal Sciences, Lahore, Pakistan
Shoaib Ashraf, PhD
Role: STUDY_DIRECTOR
Harvard University Boston, USA
Sohaib Ashraf, MBBS
Role: PRINCIPAL_INVESTIGATOR
Shaikh Zayed Medical Complex, Pakistan
Moneeb Ashraf, MBBS
Role: PRINCIPAL_INVESTIGATOR
Mayo Hospital, Pakistan
Locations
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Ali Clinic
Lahore, MA, Pakistan
Shaikh Zayed Hospital
Lahore, Punjab Province, Pakistan
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
Other Identifiers
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SZMC/IRB/Internal/215/2020
Identifier Type: -
Identifier Source: org_study_id
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