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.
| Title: | 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. |
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| Authors: | Ashraf S; Wellman Center for Photomedicine, Massachusetts General Hospital, Harvard Medical School, Boston, USA. shoaib.ashraf@mail.mcgill.ca.; Department of Pathobiology, Riphah International, Lahore, Pakistan. shoaib.ashraf@mail.mcgill.ca.; Ashraf S; Wellman Center for Photomedicine, Massachusetts General Hospital, Harvard Medical School, Boston, USA. sohaib-ashraf@outlook.com.; Department of Cardiology, Shaikh Zayed Post-Graduate Medical Institute, Lahore, Pakistan. sohaib-ashraf@outlook.com.; Farooq I; Department of Paediatric Surgery, Children Hospital, Lahore, Pakistan. iqrafarooq93@gmail.com.; Ashraf S; Institute of Biochemistry and Biotechnology, University of Veterinary and Animal Sciences, Lahore, Pakistan. sidra.ashraf@uvas.edu.pk.; Ashraf M; Department of Pharmacology, Mayo Hospital, Kingedward Medical University, Lahore, Pakistan. moneeb-ashraf@hotmail.com.; Imran MA; Department of Microbiology, Shaikh Zayed Post-Graduate Medical Institute, Lahore, Pakistan.; Kalsoom L; Department of Medicine, Services Institute of Medical Sciences, Lahore, Pakistan.; Akmal R; Department of Medicine, Sahara Medical College, Narowal, Pakistan.; Ghufran M; Department of Medicine, Sahara Medical College, Narowal, Pakistan.; Rafique S; Department of West Medicine, Mayo Hospital, King Edward Medical University, Lahore, Pakistan.; Akram MK; Department of animal nutrition, University of veterinary and animal sciences, Lahore, Pakistan.; Habib Z; Department of Orthopedics, Shaikh Zayed Post-Graduate Medical Institute, Lahore, Pakistan.; Siddiqui UN; Department of Medicine, Shaikh Zayed Post-Graduate Medical Institute, Lahore, Pakistan.; Ahmad A; Department of Radiology, Shaikh Zayed Post-Graduate Medical Institute, Lahore, Pakistan.; Arshad S; Department of Microbiology, Shaikh Zayed Post-Graduate Medical Institute, Lahore, Pakistan.; Virk MAR; Department of Medicine, Shaikh Zayed Post-Graduate Medical Institute, Lahore, Pakistan.; Gul M; Department of Medicine, Shaikh Zayed Post-Graduate Medical Institute, Lahore, Pakistan.; Awais AB; Department of Medicine, Shaikh Zayed Post-Graduate Medical Institute, Lahore, Pakistan.; Hassan M; Department of Medicine, Shaikh Zayed Post-Graduate Medical Institute, Lahore, Pakistan.; Sherazi SSH; Department of Pharmacology and Toxicology, University of veterinary and animal sciences, Lahore, Pakistan.; Safdar Z; Department of Pharmacology and Toxicology, University of veterinary and animal sciences, Lahore, Pakistan.; Munir I; Department of Restorative & Preventative Sciences University of Pennsylvania School of Dental Medicine University of Pennsylvania, Philadelphia, PA, USA.; Khalid H; Specialized Sciences Post-Baccalaureate Program, College of Liberal Arts & Sciences, University of Pennsylvania, Philadelphia, PA, USA.; Munir K; Department of Pathobiology, Riphah International, Lahore, Pakistan.; Majeed N; Department of Internal Medicine, Services Institute of Medical Sciences, Lahore, Pakistan.; Alahmadi YM; Clinical and Hospital Pharmacy Department, College of Pharmacy, Taibah University Madinah, Medina, Kingdom of Saudi Arabia.; Humayun A; Department of Community Medicine and Public Health, Shaikh Zayed Post-Graduate Medical Complex, Lahore, Pakistan.; Saboor QA; Department of Cardiology, Shaikh Zayed Post-Graduate Medical Institute, Lahore, Pakistan. drsaboor04@gmail.com.; Ahmad A; Department of Microbiology, Infectiology and Immunology, Centre Hospitalier Universitaire (CHU) Sainte Justin/University of Montreal, Montreal, Canada. ali.ahmad@recherche-ste-justine.qc.ca.; Ashraf M; Department of Pharmacology and Toxicology, University of veterinary and animal sciences, Lahore, Pakistan. drashraf2001@uvas.edu.pk.; Izhar M; Department of Microbiology, Shaikh Zayed Post-Graduate Medical Institute, Lahore, Pakistan. mateen@cantab.net. |
| Corporate Authors: | DOCTORS LOUNGE Consortium |
| Source: | Trials [Trials] 2021 Sep 06; Vol. 22 (1), pp. 591. Date of Electronic Publication: 2021 Sep 06. |
| Publication Type: | Clinical Trial Protocol; Letter |
| Language: | English |
| Journal Info: | Publisher: BioMed Central Country of Publication: England NLM ID: 101263253 Publication Model: Electronic Cited Medium: Internet ISSN: 1745-6215 (Electronic) Linking ISSN: 17456215 NLM ISO Abbreviation: Trials Subsets: MEDLINE |
| Imprint Name(s): | Original Publication: [London] : BioMed Central, 2006- |
| MeSH Terms: | Ivermectin*/adverse effects ; COVID-19*; Zinc/adverse effects ; Female ; Humans ; Multicenter Studies as Topic ; Randomized Controlled Trials as Topic ; SARS-CoV-2 ; Treatment Outcome ; Equivalence Trials as Topic |
| Abstract: | Objectives: The study objective is to quantify the effectiveness of ivermectin (subcutaneous/oral IVM) in the presence or absence of zinc (Zn) for clinical and radiological improvement in coronavirus disease 2019 (COVID-19) patients with moderate severity.; Trial Design: This quadruple-blinded, placebo-controlled randomized clinical trial will be a multiarmed multi-centered study with superiority framework.; Participants: Quinquagenarian and sexagenarian patients with moderate COVID-19 symptoms and positive severe respiratory syndrome coronavirus -2 (SARS-CoV-2) PCR will be included. Participants with co-morbidities and pregnant women will be excluded. Patient recruitment will be done in Shaikh Zayed Medical Complex, Doctors Lounge and Ali Clinic in Lahore (Pakistan).; Intervention and Comparator: The registered patients will be allocated in 6 groups (30 participants each). Patients will be taking subcutaneous IVM at 200 μg/kg/48 h (Arm A) or subcutaneous IVM at 200 μg/kg/48 h and oral Zn 20mg/8 h (Arm B) or oral IVM at 0.2 mg/kg/day (Arm C) or oral IVM at 0.2 mg/kg/day and oral Zn 20mg/8 h (Arm D) or alone oral Zn 20mg/8 h (Arm E) or placebo alone (Arm X). Patients in all arms will receive standard care and respective placebo (empty capsule 8 hourly and/or subcutaneous normal saline 2ml/48 h).; Main Outcomes: Primary endpoints will be duration of symptomatic phase and SARS-CoV-2 clearance along with high resolution CT (HRCT) chest score and clinical grade scale (CGS) on day 6. 30-day mortality will be documented as a secondary endpoint. SARS-CoV-2 clearance will be calculated by second PCR on day 7. HRCT chest score will be measured by the percentage and lung lobes involvement on day 6 with a maximum score of 25. CGS will be recorded on a seven-point scale; grade 1 (not hospitalized, no evidence of infection and resumption of normal activities), grade 2 (not hospitalized, but unable to resume normal activities), grade 3 (hospitalized, not requiring supplemental oxygen), grade 4 (hospitalized, requiring supplemental oxygen), grade 5 (hospitalized, requiring nasal high-flow oxygen therapy and/or noninvasive mechanical ventilation), grade 6 (hospitalized, requiring ECMO and/or invasive mechanical ventilation) and grade 7 (death).; Randomisation: A simple lottery method will be used to randomly allocate scrutinized patients in 1:1:1:1:1:1 ratio in 6 groups.; Blinding (masking): Patients, primary care physicians, outcome assessors and the data collection team will be blinded.; Numbers to Be Randomised (sample Size): 180 participants will be randomized into six arms with five investigational and one placebo group.; Trial Status: Institutional Review Board Shaikh Zayed Post-Graduate Medical Complex, Lahore, Pakistan has approved the protocol (version 2.3) with ID SZMC/IRB/Internal0056/2020. The trial was approved on July 14, 2020, and enrolment started on July 30, 2020. The estimated completion date is October 30, 2021.; Trial Registration: Clinical Trial has been retrospectively registered on www.clinicaltrials.gov with registration ID NCT04472585 dated July 16, 2020.; Full Protocol: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). With the intention of expediting dissemination of this trial, the conventional formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines.; (© 2021. The Author(s).) |
| Contributed Indexing: | Investigator: A Hilal; A Muhammad; Z Shaukat; S Ahmad; K Hayat; G Amjad; M Kousar; HT Hafsa; ZA Choudhary; U Hafeez; T Mughal; N Khalid; QU Iqbal; R Umer; T Muzafar; S Zulfiqar; SS Alam; S Sarfraz; MI Anwar; A Malik; T Mahmud; A Akmal; MF Nadeem; N Matti; M Azam; N Majeed; A Arshad; K Nawaz; MIK Yousaf; AMAA Baig; M Bilal; MN Zahid; Keywords: COVID-19; Ivermectin; Pakistan; Randomised controlled trial; Subcutaneous Ivermectin; Zinc; protocol |
| Molecular Sequence: | ClinicalTrials.gov NCT04472585 |
| Substance Nomenclature: | 70288-86-7 (Ivermectin); J41CSQ7QDS (Zinc) |
| Entry Date(s): | Date Created: 20210907 Date Completed: 20210908 Latest Revision: 20260109 |
| Update Code: | 20260130 |
| PubMed Central ID: | PMC8419386 |
| DOI: | 10.1186/s13063-021-05487-z |
| PMID: | 34488858 |
| Database: | MEDLINE |
Clinical Trial Protocol; Letter