Ashraf: Honey and Nigella sativa against COVID-19 in Pakistan (HNS-COVID-PK): A multi-center placebo-controlled randomized clinical trial

Honey and Nigella sativa against COVID-19 in Pakistan (HNS-COVID-PK): A multi-center placebo-controlled randomized clinical trial

Ashraf et al., Phytotherapy Research, doi:10.1002/ptr.7640 (date from earlier preprint), HNS-COVID-PK, NCT04347382 (history)

Ashraf et al., Honey and Nigella sativa against COVID-19 in Pakistan (HNS-COVID-PK): A multi-center placebo-controlled.., Phytotherapy Research, doi:10.1002/ptr.7640 (date from earlier preprint), HNS-COVID-PK, NCT04347382

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RCT with 157 patients treated with honey and nigella sativa, and 156 control patients, showing significantly faster recovery and viral clearance.

Honey (1gm/kg/day) plus encapsulated nigella sativa seeds (80mg/kg/day) orally in 2-3 divided doses daily for up to 13 days.

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risk of death, 81.9% lower, RR 0.18, p = 0.01, treatment 2 of 157 (1.3%), control 11 of 156 (7.1%), NNT 17, all cases.

risk of death, 67.1% lower, RR 0.33, p = 0.49, treatment 0 of 107 (0.0%), control 1 of 103 (1.0%), NNT 103, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm), moderate cases.

risk of death, 78.8% lower, RR 0.21, p = 0.03, treatment 2 of 50 (4.0%), control 10 of 53 (18.9%), NNT 6.7, severe cases.

risk of no recovery, 83.6% lower, HR 0.16, p < 0.001, treatment 107, control 103, inverted to make HR<1 favor treatment, moderate cases.

risk of no recovery, 75.2% lower, HR 0.25, p < 0.001, treatment 50, control 53, inverted to make HR<1 favor treatment, severe cases.

risk of no viral clearance, 81.9% lower, HR 0.18, p < 0.001, treatment 107, control 103, inverted to make HR<1 favor treatment, moderate cases.

risk of no viral clearance, 76.9% lower, HR 0.23, p < 0.001, treatment 50, control 53, inverted to make HR<1 favor treatment, severe cases.

Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates

Ashraf et al., 3 Nov 2020, Randomized Controlled Trial, placebo-controlled, Pakistan, peer-reviewed, 29 authors, study period 30 April, 2020 - 29 July, 2020, this trial uses multiple treatments in the treatment arm (combined with honey) - results of individual treatments may vary, trial NCT04347382 (history) (HNS-COVID-PK).

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Abstract: medRxiv preprint doi: https://doi.org/10.1101/2020.10.30.20217364; this version posted November 30, 2020. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY 4.0 International license . Honey and Nigella sativa against COVID-19 in Pakistan (HNS-COVID-PK): A multi-center placebo-controlled randomized clinical trial Sohaib Ashraf1,2, Shoaib Ashraf 2, Moneeb Ashraf3, Muhammad Ahmad Imran3, Larab Kalsoom3, Uzma Nasim Siddiqui3, Iqra Farooq3, Zaighum Habib, Sidra Ashraf, Muhammad Ghufran, Muhammad Kiwan Akram, Nighat Majeed, Zain-ul-Abdin, Rutaba Akmal, Sundas Rafique, Khawar Nawaz, Muhammad Ismail K Yousaf, Sohail Ahmad, Muhammad Sarmad Shahab, Muhammad Faisal Nadeem, Muhammad Azam, Hui Zheng, Amber Malik, Mahmood Ayyaz, Talha Mahmud, Qazi Abdul Saboor, Ali Ahmad, Muhammad Ashraf, Mateen Izhar for the COALITION COVID-19 Shaikh Zayed Ω 1 Correspondence to: Dr Sohaib Ashraf: Department of Cardiology, Shaikh Zayed Post-Graduate Medical Complex, Lahore, 54600, Pakistan. sohaib-ashraf@outlook.com 2 Joint 3 First Author Joint Second Author NOTE: This preprint reports new research that has not been certified by peer review and should not be used to guide clinical practice. medRxiv preprint doi: https://doi.org/10.1101/2020.10.30.20217364; this version posted November 30, 2020. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY 4.0 International license . Ω COALITION COVID-19 Shaikh Zayed: Abubakar Hilal, Arz Muhammad, Zeeshan Shaukat, Ayesha Khaqan, Kanwal Hayat, Shahroze Arshad, Muhammad Hassan, Abeer-bin-Awais, Ammara Ahmad, Tayyab Mughal, Abdur Rehman Virk, Muhammad Umer, Muhammad Suhail, Sibgha Zulfiqar, Saulat Sarfraz, Muhammad Imran Anwar, Ayesha Humayun Affiliations: 1. Department of Cardiology, Shaikh Zayed Post-Graduate Medical Complex, Lahore, Pakistan. i. S Ashraf, MBBS ii. Z U Abdin, MBBS iii. A Hilal, MBBS iv. A Muhammad, MBBS v. Z Shaukat, MBBS vi. A Khaqan, MBBS vii. K Hayat, M.Phil viii. Prof. Q A Saboor 2. Department of Pathobiology, Riphah University, Lahore, Pakistan i. Sh Ashraf, PhD 3. Department of Pharmacology, Kingedward Medical University, Mayo Hospital, Lahore, Pakistan. i. M Ashraf, MBBS 4. Department of Microbiology, Shaikh Zayed Post-Graduate Medical Institute, Lahore, Pakistan. i. M A Imran, MBBS medRxiv preprint doi: https://doi.org/10.1101/2020.10.30.20217364; this version posted November 30, 2020. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY 4.0 International license . ii. Prof. M Izhar, PhD 5. Division of Telemedicine, Doctor’s Lounge, Lahore, Pakistan. i. M A Imran, MBBS ii. M S Shahab, MBBS iii. I Farooq, MBBS iv. S Rafique, MBBS 6. Department of Internal Medicine, Services Institute of Medical Sciences, Lahore, Pakistan. i. L Kalsoom, MBBS ii. N Majeed, MBBS 7. Department of Medicine, Port Macquarie Base Hospital, New South Wales, Australia. i. U N Siddique, MBBS 8. Department of Internal Medicine, Shaikh Zayed Post-Graduate Medical Institute, Lahore, Pakistan. i. S Arshad, MBBS ii. M Hassan, MBBS iii. U N Siddique, MBBS 9...

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