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Ivermectin as an adjunct treatment for hospitalized adult COVID-19 patients: A randomized multi-center clinical trial

Niaee et al., Asian Pacific Journal of Tropical Medicine, doi:10.4103/1995-7645.318304 (date from preprint)

Nov 2020

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Ivermectin for COVID-19

4th treatment shown to reduce risk in August 2020

^*, now with p < 0.00000000001 from 105 studies, recognized in 23 countries.

Lower risk for mortality, ventilation, ICU admission, hospitalization, recovery, cases, and viral clearance.

No treatment is 100% effective. Protocols combine treatments. ^* >10% efficacy, ≥3 studies.

4,500+ studies for 81 treatments. c19ivm.org

82% lower mortality with ivermectin. RCT with 180 hospitalized patients showing reduced mortality and hospital stay with ivermectin, with a wide margin of safety. All patients received SOC including low dose HCQ. Analysis suggests randomization failure1. This study was reported as pending retraction, however the journal has indicated that this is incorrect and no retraction is pending.

This study is excluded in the after exclusion results of meta analysis: analysis suggests randomization failure.

Important missing comments or errors? Let us know.

risk of death, 81.8% lower, RR 0.18, p = 0.001, treatment 4 of 120 (3.3%), control 11 of 60 (18.3%), NNT 6.7, All IVM vs. all control, primary outcome.

risk of death, 94.3% lower, RR 0.06, p = 0.01, treatment 0 of 30 (0.0%), control 11 of 60 (18.3%), NNT 5.5, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm), IVM single dose 200mcg/kg vs. all control.

risk of death, 45.5% lower, RR 0.55, p = 0.37, treatment 3 of 30 (10.0%), control 11 of 60 (18.3%), NNT 12, IVM three dose 200mcg/kg vs. all control.

risk of death, 81.8% lower, RR 0.18, p = 0.06, treatment 1 of 30 (3.3%), control 11 of 60 (18.3%), NNT 6.7, IVM three dose 400/200/200mcg/kg vs. all control.

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

1. web.archive.org, web.archive.org/web/*/https://twitter.com/Covid19Crusher/status/1447193460046548992.web.archive.org/web/*/https://twitter.com/Covid19Crusher/status/1447193460046548992.

Niaee et al., 24 Nov 2020, Double Blind Randomized Controlled Trial, Iran, peer-reviewed, mean age 56.0, 14 authors, dosage 400μg/kg single dose, dose varies in different groups.

This Paper Ivermectin All

Ivermectin as an adjunct treatment for hospitalized adult COVID-19 patients: A randomized multi-center clinical trial

Nematollah Gheibi, Morteza Shakhsi Niaee, Peyman Namdar, Abbas Allami, Leila Zolghadr, Amir Javadi, Amin Karampour, Mehran Varnaseri, Behzad Bijani, Fatemeh Cheraghi, Yazdan Naderi, Fatemeh Amini, Masoumeh Karamyan, Mohammadjafar Yadyad, Ramin Jamshidian

Asian Pacific Journal of Tropical Medicine, doi:10.4103/1995-7645.318304

To evaluate different doses of ivermectin in adult patients with mild COVID-19 and to evaluate the effect of ivermectin on mortality and clinical consequences. Methods: A randomized, double-blind, placebo-controlled, multicenter clinical trial was performed at five hospitals. A total of 180 mild hospitalized patients with COVID-19 confirmed by PCR or chest image tests were enrolled and allocated to six arms including hydroxychloroquine 200 mg twice per day, placebo plus hydroxychloroquine 200 mg twice per day, single dose ivermectin (200 µg/kg), three low interval doses of ivermectin (200, 200, 200 µg/kg), single dose ivermectin (400 µg/kg), and three high interval doses of ivermectin (400, 200, 200 µg/kg). The primary endpoint of this trial was all-cause of mortality or clinical recovery. The radiographic findings, hospitalization and low O 2 saturation duration, and hematological variables of blood samples were analyzed. Results: A total of 16.7% (5/30) and 20.0% (6/30) patients died in arms treated with hydroxychloroquine 200 mg twice per day and placebo plus hydroxychloroquine 200 mg twice per day, respectively, and a reduction in mortality rate in patients receiving ivermectin treatment to 0%, 10%, 0% and 3.3% for arms 1-4 were observed. Risk of mortality was also decreased about 15% in the ivermectin treated arms. Conclusions: Ivermectin as an adjunct reduces the rate of mortality, time of low O 2 saturation, and duration of hospitalization in adult COVID-19 patients. The improvement of other clinical parameters shows that ivermectin, with a wide margin of safety, had a high therapeutic effect on COVID-19.

Conflict of interest statement We declare that we have no conflict of interest. Authors' contributions GN, NMS, NP, AA designed the study. BB,VM,YYMJ, KA, FA, KM and JR were responsible for overall data collection and clinical studies. ZL, JA, AA conducted data analysis and interpretation. ZL drafted the first manuscript and has designed Figure1. GN and AA revised the manuscript critically. NY and ZL were in charge of drug formulation. All authors read and approved the final manuscript. NMS,GN,CHF and NP supervised the project.

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The 34th Annual ' 'Meeting the Royal College of Physicians of Thailand ‘Internal Medicine ' 'and One Health’. 26th-28th April 2018, PEACH Royal Cliff Beach Resort, ' 'Pattaya, Chonburi, Thailand.'}, { 'key': 'key-10.4103/1995-7645.318304-39', 'first-page': 'e0242184', 'volume-title': 'Lack of efficacy of standard doses of ivermectin in severe COVID-19 ' 'patients', 'author': 'Camprubí', 'year': '2020', 'journal-title': 'PloS One'}, { 'key': 'key-10.4103/1995-7645.318304-40', 'first-page': '1218', 'volume-title': 'Early outpatient treatment of symptomatic, high-risk covid-19 patients ' 'that should be ramped up immediately as key to the pandemic crisis', 'author': 'Risch', 'year': '2020', 'journal-title': 'Am J Epidemiol'}, { 'key': 'key-10.4103/1995-7645.318304-41', 'first-page': '241', 'volume-title': 'Chloroquine and hydroxychloroquine in the treatment of COVID-19 with or ' 'without diabetes: A systematic search and a narrative review with a ' 'special reference to India and other developing countries', 'author': 'Singh', 'year': '2020', 'journal-title': 'Diabetes Metab Syndr'}, { 'key': 'key-10.4103/1995-7645.318304-42', 'first-page': '85', 'volume-title': 'Use of ivermectin is associated with lower mortality in hospitalized ' 'patients with coronavirus disease 2019: The ivermectin in covid nineteen ' 'study', 'author': 'Rajter', 'year': '2021', 'journal-title': 'Chest'}, { 'key': 'key-10.4103/1995-7645.318304-43', 'first-page': '104874', 'volume-title': 'Nitazoxanide/azithromycin combination for COVID-19: A suggested new ' 'protocol for early management', 'author': 'Kelleni', 'year': '2020', 'journal-title': 'Pharmacol Res'}, { 'key': 'key-10.4103/1995-7645.318304-44', 'first-page': 'ofaa598', 'volume-title': 'Tocilizumab for the treatment of covid-19 among hospitalized patients: A ' 'matched retrospective cohort analysis', 'author': 'Ignatius', 'year': '2021', 'journal-title': 'Open Forum Infect Dis'}, { 'key': 'key-10.4103/1995-7645.318304-45', 'first-page': '24', 'volume-title': 'Mesenchymal stem cells in COVID-19: A journey from bench to bedside', 'author': 'Sahu', 'year': '2021', 'journal-title': 'Lab Med'}, { 'key': 'key-10.4103/1995-7645.318304-46', 'first-page': 'e2020175', 'volume-title': 'Current Perspectives of convalescent plasma therapy in COVID-19', 'author': 'Sahu', 'year': '2020', 'journal-title': 'Acta Biomed'}], 'container-title': 'Asian Pacific Journal of Tropical Medicine', 'original-title': [], 'language': 'en', 'deposited': { 'date-parts': [[2023, 10, 21]], 'date-time': '2023-10-21T11:13:37Z', 'timestamp': 1697886817000}, 'score': 1, 'resource': {'primary': {'URL': 'https://journals.lww.com/10.4103/1995-7645.318304'}}, 'subtitle': [], 'short-title': [], 'issued': {'date-parts': [[2021]]}, 'references-count': 46, 'journal-issue': {'issue': '6', 'published-print': {'date-parts': [[2021]]}}, 'alternative-id': ['318304'], 'URL': 'http://dx.doi.org/10.4103/1995-7645.318304', 'relation': { 'has-preprint': [ { 'id-type': 'doi', 'id': '10.21203/rs.3.rs-109670/v1', 'asserted-by': 'object'}]}, 'ISSN': ['1995-7645'], 'subject': ['General Medicine'], 'container-title-short': 'Asian Pac J Trop Med', 'published': {'date-parts': [[2021]]}}

Late treatment
is less effective

Please send us corrections, updates, or comments. c19early involves the extraction of 100,000+ datapoints from thousands of papers. Community updates help ensure high accuracy. Treatments and other interventions are complementary. All practical, effective, and safe means should be used based on risk/benefit analysis. No treatment or intervention is 100% available and effective for all current and future variants. We do not provide medical advice. Before taking any medication, consult a qualified physician who can provide personalized advice and details of risks and benefits based on your medical history and situation. FLCCC and WCH provide treatment protocols.

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