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
et al., Infection & Chemotherapy, doi:10.3947/ic.2022.0127, TCTR20220427005
, An Open Label Randomized Controlled Trial of Ivermectin Plus Favipiravir-Based Standard of Care versus.., Infection & Chemotherapy, doi:10.3947/ic.2022.0127, TCTR20220427005
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 44th of 46 COVID-19 RCTs for ivermectin, which collectively show efficacy with p=0.00000014.This is the 94th of 97 COVID-19 controlled studies for ivermectin, which collectively show efficacy with p<0.0000000001 (1 in 2 sextillion).
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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%).
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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%).
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recovery time, 3.8% lower, relative time 0.96, p = 0.63, treatment 157, control 160.
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| 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.
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
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
References
Ahmed, Karim, Ross, Hossain, Clemens et al., A five-day course of ivermectin for the treatment of COVID-19 may reduce the duration of illness, Int J Infect Dis, doi:10.1016/j.ijid.2020.11.191
Bhimraj, Morgan, Shumaker, Baden, Cheng et al., Infectious Diseases Society of America guidelines on the treatment and management of patients with COVID-19, Infectious Diseases Society of America
Bramante, Huling, Tignanelli, Buse, Liebovitz et al., Randomized trial of metformin, ivermectin, and fluvoxamine for Covid-19, N Engl J Med, doi:10.1056/NEJMoa2201662
Caly, Druce, Catton, Jans, Wagstaff, The FDA-approved drug ivermectin inhibits the replication of SARS-CoV-2 in vitro, Antiviral Res, doi:10.1016/j.antiviral.2020.104787
Cevik, Kuppalli, Kindrachuk, Peiris, Virology, transmission, and pathogenesis of SARS-CoV-2, BMJ, doi:10.1136/bmj.m3862
Chaccour, Casellas, Blanco-Di Matteo, Pineda, Fernandez-Montero et al., None
Chen, Feng, Xu, Huang, Sun et al., Patterns of deterioration in moderate patients with COVID-19 from Jan 2020 to Mar 2020: a multi-center, retrospective cohort study in China, Front Med, doi:10.3389/fmed.2020.567296
Chowdhury, Shahbaz, Karim, Islam, Dan et al., A comparative study on ivermectindoxycycline and hydroxychloroquine-azithromycin therapy on COVID-19 patients, EJMO, doi:10.14744/ejmo.2021.16263
Karatas, Aksoy, Ozaslan, Association of early favipiravir use with reduced COVID-19 fatality among hospitalized patients, Infect Chemother, doi:10.3947/ic.2020.0149
Kim, Ryoo, Huh, Joo, Kim et al., Revised Korean Society of Infectious Diseases/national evidence-based healthcarea collaborating agency guidelines on the treatment of patients with COVID-19, Infect Chemother, doi:10.3947/ic.2021.0303
Lifschitz, Virkel, Sallovitz, Sutra, Galtier et al., Comparative distribution of ivermectin and doramectin to parasite location tissues in cattle, Vet Parasitol, doi:10.1016/S0304-4017(99)00175-2
Lim, Hor, Tay, Jelani, Tan et al., Efficacy of ivermectin treatment on disease progression among adults with mild to moderate COVID-19 and comorbidities: The I-TECH randomized clinical trial, JAMA Intern Med, doi:10.1001/jamainternmed.2022.0189
López-Medina, López, Hurtado, Dávalos, Ramirez et al., Effect of ivermectin on time to resolution of symptoms among adults with mild COVID-19: a randomized clinical trial, JAMA, doi:10.1001/jama.2021.3071
Marcolino, Meira, Guimarães, Motta, Chagas et al., Systematic review and meta-analysis of ivermectin for treatment of COVID-19: evidence beyond the hype, BMC Infect Dis, doi:10.1186/s12879-022-07589-8
Rattanaumpawan, Jirajariyavej, Lerdlamyong, Palavutitotai, Saiyarin, Real-world effectiveness and optimal dosage of favipiravir for treatment of COVID-19: results from a multicenter observational study in Thailand, Antibiotics, doi:10.3390/antibiotics11060805
Reina, Sadaba, Fernández-Alonso, The effect of early treatment with ivermectin on viral load, symptoms and humoral response in patients with non-severe COVID-19: A pilot, double-blind, placebocontrolled, randomized clinical trial, EClinicalMedicine, doi:10.1016/j.eclinm.2020.100720
Reis, Silva, Silva, Thabane, Milagres et al., Effect of early treatment with ivermectin among patients with Covid-19, N Engl J Med, doi:10.1056/NEJMoa2115869
Schmith, Zhou, Lohmer, The approved dose of ivermectin alone is not the ideal dose for the treatment of COVID-19, Clin Pharmacol Ther, doi:10.1002/cpt.1889
Sirijatuphat, Suputtamongkol, Angkasekwinai, Horthongkham, Chayakulkeeree et al., Epidemiology, clinical characteristics, and treatment outcomes of patients with COVID-19 at Thailand's university-based referral hospital, BMC Infect Dis, doi:10.1186/s12879-021-06081-z
Wagstaff, Sivakumaran, Heaton, Harrich, Jans, Ivermectin is a specific inhibitor of importin α/β-mediated nuclear import able to inhibit replication of HIV-1 and dengue virus, Biochem J, doi:10.1042/BJ20120150
Working, Group on the Clinical Characterisation and Management of COVID-19 infection. A minimal common outcome measure set for COVID-19 clinical research, Lancet Infect Dis, doi:10.1016/S1473-3099(20)30483-7
Özlüşen, Kozan, Akcan, Kalender, Yaprak et al., Effectiveness of favipiravir in COVID-19: a live systematic review, Eur J Clin Microbiol Infect Dis, doi:10.1007/s10096-021-04307-1
Late treatment
is less effective
is less effective
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