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

COVID Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04472585
• Other study ID #: SZMC/IRB/Internal/215/2020
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: November 14, 2020
• Est. completion date: October 30, 2021

Study information

• Verified date: February 2021
• Source: Sheikh Zayed Federal Postgraduate Medical Institute
• Contact: Sohaib Ashraf, MBBS
• Phone: +923334474523
• Email: sohaib-ashraf[@]outlook.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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..

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: October 30, 2021
• Est. primary completion date: August 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus Infection
• Coronavirus Infections
• COVID
• Sars-CoV2
• Severe Acute Respiratory Syndrome

Intervention

Drug:
• Ivermectin Injectable Solution
Subcutaneous Ivermectin 200ug/kg body weight 48 hourly

Other:
• Injectable Placebo
0.9% normal saline

Drug:
• Zinc
Zinc Sulphate 20mg 3 times a day
• Placebo empty capsule
Placebo empty capsule
• Oral Ivermectin
0.2mg/kg/day

Locations

Country	Name	City	State
Pakistan	Ali Clinic	Lahore	MA
Pakistan	Shaikh Zayed Hospital	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Sohaib Ashraf

Country where clinical trial is conducted

Pakistan, 

References & Publications (3)

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. — View Citation

Patrì 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. — View Citation

Simsek Yavuz S, Ünal S. Antiviral treatment of COVID-19. Turk J Med Sci. 2020 Apr 21;50(SI-1):611-619. doi: 10.3906/sag-2004-145. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	qRT-PCR	time needed to turn positive COVID-19 PCR to negative	14 days
Primary	Time taken for alleviation of symptoms	time needed to turn off symptoms	upto 14 days
Primary	Severity of symptoms	time needed of symptom serverity	upto 14 days
Secondary	Severity of symptoms	time needed to make patients clinically better	14 days
Secondary	Morality	death rate	30 days