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An Open Label Randomized Controlled Trial of Ivermectin Plus Favipiravir-Based Standard of Care versus Favipiravir-Based Standard of Care for Treatment of Moderate COVID-19 in Thailand

Sarojvisut et al., Infection & Chemotherapy, doi:10.3947/ic.2022.0127, TCTR20220427005

Dec 2022

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Ivermectin for COVID-19

4th treatment shown to reduce risk in August 2020

^*, now known with p < 0.00000000001 from 102 studies, recognized in 22 countries.

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

No treatment is 100% effective. Protocols combine complementary and synergistic treatments. ^* >10% efficacy in meta analysis with ≥3 clinical studies.

4,100+ studies for 60+ treatments. c19ivm.org

RCT low risk hospitalized patients in Thailand showing no significant difference with the addition of ivermectin to favipiravir based SOC. Only the abstract is currently available. The trial was registered retrospectively thaiclinicaltrials.org. The primary outcome was WHO-category ordinal scale improvement of 2 points at days 3, 7, 14, 21, for which only a single unspecified time point (when almost all patients have recovered) is provided in the abstract (details may be in the full paper). The registration indicates that the intervention was only provided "after laboratory result", without explanation.

This is the 45th of 49 COVID-19 RCTs for ivermectin, which collectively show efficacy with p=0.00000038.

This is the 95th of 102 COVID-19 controlled studies for ivermectin, which collectively show efficacy with p<0.0000000001 (1 in 560 quintillion).

1. thaiclinicaltrials.org, www.thaiclinicaltrials.org/show/TCTR20220427005.www.thaiclinicaltrials.org/show/TCTR20220427005.

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risk of ICU admission, 103.8% higher, RR 2.04, p = 0.62, treatment 2 of 157 (1.3%), control 1 of 160 (0.6%).

risk of no improvement, 103.8% higher, RR 2.04, p = 0.62, treatment 2 of 157 (1.3%), control 1 of 160 (0.6%).

recovery time, 3.8% lower, relative time 0.96, p = 0.63, treatment 157, control 160.

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

Sarojvisut et al., 12 Dec 2022, Randomized Controlled Trial, Thailand, peer-reviewed, 8 authors, study period 1 October, 2021 - 31 May, 2022, dosage 400μg/kg days 1-5, trial TCTR20220427005.

This Paper Ivermectin All

An Open Label Randomized Controlled Trial of Ivermectin Plus Favipiravir-Based Standard of Care versus Favipiravir-Based Standard of Care for Treatment of Moderate COVID-19 in Thailand

Phahol Sarojvisut, MD Anucha Apisarnthanarak, Kittiya Jantarathaneewat, Ornnicha Sathitakorn, Thanus Pienthong, Chatchai Mingmalairak, David K Warren, David J Weber

Infection & Chemotherapy, doi:10.3947/ic.2022.0127

Background: The role of ivermectin in the treatment of moderate coronavirus disease 2019 (COVID-19) is controversial. We performed an open label randomized controlled trial to evaluate the role of ivermectin plus favipiravir-based standard of care versus favipiravir-based standard of care for the treatment of moderate COVID-19 infection. Materials and Methods: An open-label randomized control trial was performed at Thammasat Field Hospital and Thammasat University Hospital from October 1st, 2021 to May 31st, 2022. Patients with moderate COVID-19 infections were randomized to the intervention (ivermectin plus favipiravir-based standard of care) or control group (favipiravirbased standard of care alone). Patients were followed up to 21 days. The primary outcome was the improvement in World Health Organization (WHO) category ordinal scale by 2 points. Secondary outcomes included duration of illness, development of severe COVID-19, and adverse reactions. Results: There were 157 patients in the intervention and 160 patients in the control group. Characteristics, underlying diseases, and risk factors for severe COVID-19 were comparable in both groups. Improvement in the WHO-category ordinal scale by 2 points was achieved in 98.7% of the intervention group and in 99.4% of the control group (relative risk [RR]: 0.487; 95% confidence interval [CI]: 0.044-5.430). The median illness duration was 5.0 days (range, 3 -28 days) in intervention group versus 5.2 days (range, 3 -28 days) in control group (P = 0.630). Severe COVID-19 that required intensive care occurred in 2 patients (1.3%) in the intervention group and 1 patient (0.6%) in the control group (RR: 2.052; 95% CI: 0.184 -22.857). No significant difference in serious drug adverse events was seen.

SUPPLEMENTARY MATERIAL Supplementary

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Late treatment
is less effective

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