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Ivermectin for the treatment of COVID-19: A systematic review and meta-analysis of randomized controlled trials

Roman et al., Clinical Infectious Diseases, doi:10.1093/cid/ciab591 (date from preprint)
Jun 2021  
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Ivermectin for COVID-19
4th treatment shown to reduce risk in August 2020
 
*, now with p < 0.00000000001 from 104 studies, recognized in 23 countries.
No treatment is 100% effective. Protocols combine treatments. * >10% efficacy, ≥3 studies.
4,400+ studies for 79 treatments. c19ivm.org
This is a severely flawed meta analysis. An open letter signed by 40 physicians detailing errors and flaws, and requesting retraction, can be found at1. See also2.
Authors cherry-pick to include only 4 studies reporting non-zero mortality and they initially claimed a mortality RR of 1.11 [0.16-7.65]. However, they reported incorrect values for Niaee et al., claiming an RR of 6.51 [2.18-19.45], when the correct RR for Niaee et al. is 0.18 [0.06-0.55]. After correction, their cherry-picked studies show >60% mortality reduction, however authors did not correct the conclusion.
Similarly, for viral clearance and NCT04392713 (history), they report 20/41 treatment, 18/45 control, whereas the correct day 7 clearance numbers are 37/41 and 20/45 (sum of clearance @72hrs and @7 days), or 17/41 and 2/45 @72 hrs.
The duration of hospital stay for Niaee et al. is also incorrectly reported, showing a lower duration for the control group.
All of the errors are in one direction - incorrectly reporting lower than actual efficacy for ivermectin. Authors claim to include all RCTs excluding prophylaxis, however they only include 10 of the 24 non-prophylaxis RCTs (28 including prophylaxis at the time of publication). Authors actually reference meta analyses that do include the missing RCTs, so they should be aware of the missing RCTs.
The PubMed search strategy provided is syntactically incorrect. For additional errors, see3. Also see4.
The authors state that they have no conflicts of interest on medRxiv, however Dr. Pasupuleti’s affiliation is Cello Health, whose website5 notes that they provide services such as “brand and portfolio commercial strategy for biotech and pharma”, and that their clients are "24 of the top 25 pharmaceutical companies”.
Only one of these errors has been partially fixed as of 5/29 - the Niaee RR was corrected, but the associated conclusion was not. Other errors have not been corrected. Comments on this article appear to be censored, with zero comments posted as of July 5.
7 meta analyses show significant improvements with ivermectin for mortality6-11, hospitalization12, recovery8, and cases8.
Currently there are 104 ivermectin for COVID-19 studies, showing 48% lower mortality [35‑59%], 35% lower ventilation [17‑50%], 40% lower ICU admission [12‑58%], 34% lower hospitalization [21‑44%], and 81% fewer cases [71‑87%].
Roman et al., 28 Jun 2021, peer-reviewed, 6 authors.
This PaperIvermectinAll
Ivermectin for the Treatment of Coronavirus Disease 2019: A Systematic Review and Meta-analysis of Randomized Controlled Trials
Yuani M Roman, Paula Alejandra Burela, Vinay Pasupuleti, Alejandro Piscoya, Jose E Vidal, Adrian V Hernandez
Clinical Infectious Diseases, doi:10.1093/cid/ciab591
Background. We systematically assessed benefits and harms of the use of ivermectin (IVM) in patients with coronavirus disease 2019 . Methods. Published and preprint randomized controlled trials (RCTs) assessing the effects of IVM on adult patients with COVID-19 were searched until 22 March 2021 in 5 engines. Primary outcomes were all-cause mortality rate, length of hospital stay (LOS), and adverse events (AEs). Secondary outcomes included viral clearance and severe AEs (SAEs). The risk of bias (RoB) was evaluated using the Cochrane Risk of Bias 2.0 tool. Inverse variance random effect meta-analyses were performed, with quality of evidence (QoE) evaluated using GRADE methods. Results. Ten RCTs (n = 1173) were included. The controls were the standard of care in 5 RCTs and placebo in 5. COVID-19 disease severity was mild in 8 RCTs, moderate in 1, and mild and moderate in 1. IVM did not reduce all-cause mortality rates compared with controls (relative risk [RR], 0.37 [95% confidence interval, .12-1.13]; very low QoE) or LOS compared with controls (mean difference, 0.72 days [95% confidence interval, −.86 to 2.29 days]; very low QoE). AEs, SAEs, and viral clearance were similar between IVM and control groups (low QoE for all outcomes). Subgroups by severity of COVID-19 or RoB were mostly consistent with main analyses; all-cause mortality rates in 3 RCTs at high RoB were reduced with IVM. Conclusions. Compared with the standard of care or placebo, IVM did not reduce all-cause mortality, LOS, or viral clearance in RCTs in patients with mostly mild COVID-19. IVM did not have an effect on AEs or SAEs and is not a viable option to treat patients with COVID-19.
Supplementary Data Supplementary materials are available at Clinical Infectious Diseases online. Consisting of data provided by the authors to benefit the reader, the posted materials are not copyedited and are the sole responsibility of the authors, so questions or comments should be addressed to the corresponding author. Note Potential conflicts of interest. All authors: No reported conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed.
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'https://academic.oup.com/cid/article/74/6/1022/6310839'}}, 'subtitle': [], 'short-title': [], 'issued': {'date-parts': [[2021, 6, 28]]}, 'references-count': 46, 'journal-issue': { 'issue': '6', 'published-online': {'date-parts': [[2021, 6, 28]]}, 'published-print': {'date-parts': [[2022, 3, 23]]}}, 'URL': 'http://dx.doi.org/10.1093/cid/ciab591', 'relation': { 'has-preprint': [ { 'id-type': 'doi', 'id': '10.1101/2021.05.21.21257595', 'asserted-by': 'object'}]}, 'ISSN': ['1058-4838', '1537-6591'], 'subject': [], 'published-other': {'date-parts': [[2022, 3, 15]]}, 'published': {'date-parts': [[2021, 6, 28]]}}
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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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