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

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. This quadruple-blinded, placebo-controlled randomized c...

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Published in:	Current controlled trials in cardiovascular medicine Vol. 22; no. 1; p. 591
Main Authors:	Ashraf, Shoaib, Ashraf, Sohaib, Farooq, Iqra, Ashraf, Sidra, Ashraf, Moneeb, Imran, Muhammad Ahmad, Kalsoom, Larab, Akmal, Rutaba, Ghufran, Muhammad, Rafique, Sundas, Akram, Muhammad Kiwan, Habib, Zaigham, Siddiqui, Uzma Nasim, Ahmad, Ammara, Arshad, Shahroze, Virk, Muhammad Abdul Rehman, Gul, Mehak, Awais, Abeer Bin, Hassan, Muhammad, Sherazi, Syed Sami Hussain, Safdar, Zartasha, Munir, Isra, Khalid, Hamna, Munir, Khalid, Majeed, Nighat, Alahmadi, Yaser Masuod, Humayun, Ayesha, Saboor, Qazi Abdul, Ahmad, Ali, Ashraf, Muhammad, Izhar, Mateen
Format:	Journal Article
Language:	English
Published:	England BioMed Central Ltd 06-09-2021 BioMed Central BMC
Subjects:	Clinical trials Coronaviruses COVID-19 Dosage and administration Female Hospitalization Humans Ivermectin Ivermectin - adverse effects Letter Multicenter Studies as Topic Pakistan Pregnancy Randomised controlled trial Randomized Controlled Trials as Topic SARS-CoV-2 Severe acute respiratory syndrome coronavirus 2 Subcutaneous Ivermectin Testing Treatment Outcome Ventilation Zinc Zinc - adverse effects Zinc in the body Pakistan Lahore Pakistan COVID-19 Subcutaneous Ivermectin protocol Pakistan Randomised controlled trial Zinc Ivermectin
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Summary:	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. This quadruple-blinded, placebo-controlled randomized clinical trial will be a multiarmed multi-centered study with superiority framework. 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). 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). 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). A simple lottery method will be used to randomly allocate scrutinized patients in 1:1:1:1:1:1 ratio in 6 groups. Patients, primary care physicians, outcome assessors and the data collection team will be blinded. 180 participants will be randomized into six arms with five investigational and one placebo group. 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. Clinical Trial has been retrospectively registered on www.clinicaltrials.gov with registration ID NCT04472585 dated July 16, 2020. 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.
Bibliography:	SourceType-Other Sources-1 content type line 63 ObjectType-Correspondence-1 ObjectType-Undefined-2
ISSN:	1745-6215 1745-6215
DOI:	10.1186/s13063-021-05487-z