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Positive impact of oral hydroxychloroquine and povidone-iodine throat spray for COVID-19 prophylaxis: an open-label randomized trial

Seet et al., International Journal of Infectious Diseases, doi:10.1016/j.ijid.2021.04.035, NCT04446104
Apr 2021  
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Symp. case 50% Improvement Relative Risk Case 6% primary Ivermectin  Seet et al.  Prophylaxis  RCT Is prophylaxis with ivermectin beneficial for COVID-19? RCT 1,236 patients in Singapore (May - August 2020) Trial compares with vitamin C, results vs. placebo may differ Fewer symptomatic cases with ivermectin (p=0.0009) c19ivm.org Seet et al., Int. J. Infectious Diseases, Apr 2021 Favorsivermectin Favorsvitamin C 0 0.5 1 1.5 2+
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.
No treatment is 100% effective. Protocols combine treatments.
5,000+ studies for 104 treatments. c19ivm.org
Prophylaxis RCT in Singapore with 3,037 low risk patients, showing lower serious cases, lower symptomatic cases, and lower confirmed cases of COVID-19 with all treatments (ivermectin, HCQ, PVP-I, and Zinc + vitamin C) compared to vitamin C.
The ivermectin dosage was low for 42 days prophylaxis - only a single dose of 200µg/kg, with a maximum of 12mg.
Meta-analysis of vitamin C in 6 previous trials shows a benefit of 16%, so the actual benefit of ivermectin, HCQ, and PVP-I may be higher. Cluster RCT with 40 clusters.
There were no hospitalizations and no deaths.
This is the 23rd of 52 COVID-19 RCTs for ivermectin, which collectively show efficacy with p=0.00000021.
This is the 48th of 105 COVID-19 controlled studies for ivermectin, which collectively show efficacy with p<0.0000000001 (1 in 774 quintillion).
Study covers ivermectin, zinc, povidone-iodine, and HCQ.
risk of symptomatic case, 49.8% lower, RR 0.50, p < 0.001, treatment 32 of 617 (5.2%), control 64 of 619 (10.3%), NNT 19.
risk of case, 5.8% lower, RR 0.94, p = 0.61, treatment 398 of 617 (64.5%), control 433 of 619 (70.0%), NNT 18, adjusted per study, odds ratio converted to relative risk, model 6, primary outcome.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Seet et al., 14 Apr 2021, Cluster Randomized Controlled Trial, Singapore, peer-reviewed, 15 authors, study period 13 May, 2020 - 31 August, 2020, dosage 12mg single dose, 200µg/kg, maximum 12mg, this trial compares with another treatment - results may be better when compared to placebo, trial NCT04446104 (history).
This PaperIvermectinAll
COVID-19 chemoprevention
Cintia Cruz, Nicholas J White
International Journal of Infectious Diseases, doi:10.1016/j.ijid.2021.04.045
Background: We examined whether existing licensed pharmacotherapies could reduce the spread of coronavirus disease 2019 . Methods: An open-label parallel randomized controlled trial was performed among healthy migrant workers quarantined in a large multi-storey dormitory in Singapore. Forty clusters (each defined as individual floors of the dormitory) were randomly assigned to receive a 42-day prophylaxis regimen of either oral hydroxychloroquine (400 mg once, followed by 200 mg/day), oral ivermectin (12 mg once), povidone-iodine throat spray (3 times/day, 270 mg/day), oral zinc (80 mg/day)/vitamin C (500 mg/day) combination, or oral vitamin C, 500 mg/day. The primary outcome was laboratory evidence of SARS-CoV-2 infection as shown by either: (1) a positive serologic test for SARS-CoV-2 antibody on day 42, or (2) a positive PCR test for SARS-CoV-2 at any time between baseline and day 42. Results: A total of 3037 asymptomatic participants (mean age, 33.0 years; all men) who were seronegative to SARS-CoV-2 at baseline were included in the primary analysis. Follow-up was nearly complete (99.6%). Compared with vitamin C, significant absolute risk reductions (%, 98.75% confidence interval) were observed for oral hydroxychloroquine (21%, 2-42%) and povidone-iodine throat spray (24%, 7-39%). No statistically significant differences were observed with oral zinc/vitamin C combination (23%, -5 to +41%) and ivermectin (5%, -10 to +22%). Interruptions due to side effects were highest among participants who received zinc/vitamin C combination (6.9%), followed by vitamin C (4.7%), povidone-iodine (2.0%), and hydroxychloroquine (0.7%). Conclusions: Chemoprophylaxis with either oral hydroxychloroquine or povidone-iodine throat spray was superior to oral vitamin C in reducing SARS-CoV-2 infection in young and healthy men.
Authors contributions All authors have made substantial contributions to the publication. RSCS, QMLA, PAT, and MH contributed to the conception and design of the study and acquisition of data, drafted the article, revised it critically for important intellectual content, and approved the final version for submission. DSQO, SS, SRL, CYK, JBYS, BCG, KSL, DF, and HLT have contributed to the conception and design of the study and acquisition of data, revised it critically for important intellectual content, and approved the final version for submission. JS and ARC have contributed to statistical analysis, revised the manuscript for important intellectual content, and approved the final version for submission. Conflicts of interest Dr. Seet reported receiving grants from the National Medical Research Council and Temasek Foundation, Singapore. Dr. Tambyah reported receiving grants from Johnson and Johnson, GlaxoSmithKline, and Roche. Data availability statement The data underlying this article will be shared on reasonable request to the corresponding author. Data suppression rules apply to ensure the anonymity of the study participants. ClinicalTrials.gov number NCT04446104 Appendix A. Supplementary data Supplementary material related to this article can be found, in the online version, at doi:https://doi.org/10.1016/j.ijid.2021.04.035.
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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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