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

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

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.

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..

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Contacts

Contact: Sohaib Ashraf, MBBS; +923334474523; sohaib-ashraf@outlook.com

Contact: Shoaib Ashraf, PhD; +16177949579; sashraf@mgh.harvard.edu

Locations

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

• 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

More Information

Publications:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• 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
• Last Update Posted: February 17, 2021
• Last Verified: February 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

COVID-19; Coronavirus Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Ivermectin; Antiparasitic Agents; Anti-Infective Agents