Clinical trial NCT04472585: Efficacy of Subcutaneous Ivermectin With or Without Zinc in COVID-19 Patients
Official title: Sub-cutaneous Ivermectin in Combination With and Without Oral Zinc: a Placebo Randomized Control Trial on Mild to Moderate COVID-19 Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Coronavirus Infection
COVID
Sars-CoV2
Keywords: SARS-Cov-2
COVID-19
Coronavirus
Ivermectin
Zinc
Lead sponsor: Sheikh Zayed Federal Postgraduate Medical Institute
Sponsor class: OTHER
First posted: 2020-07-15
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized, controlled, multi-armed, open-label, interventional study
Primary purpose: TREATMENT

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.

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..

Eligibility 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

Primary outcomes:
measure: qRT-PCR
timeFrame: 14 days
measure: Time taken for alleviation of symptoms
timeFrame: upto 14 days
measure: Severity of symptoms
timeFrame: upto 14 days
Secondary outcomes:
measure: Severity of symptoms
timeFrame: 14 days
measure: Morality
timeFrame: 30 days
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Ali Clinic
state: MA
city: Lahore
country: Pakistan
facility: Shaikh Zayed Hospital
state: Punjab
Study officials:
affiliation: University of Veterinary & Animal Sciences, Lahore, Pakistan
name: Muhammad Ashraf, PhD
role: STUDY_CHAIR
affiliation: Harvard University Boston, USA
name: Shoaib Ashraf, PhD
role: STUDY_DIRECTOR
affiliation: Shaikh Zayed Medical Complex, Pakistan
name: Sohaib Ashraf, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Hospital, Pakistan
name: Moneeb Ashraf, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.