RETRACTED: Samaha et al. Effects of a Single Dose of Ivermectin on Viral and Clinical Outcomes in Asymptomatic SARS-CoV-2 Infected Subjects: A Pilot Clinical Trial in Lebanon. Viruses 2021, 13, 989

Samaha, Ali; Mouawia, Hussein; Fawaz, Mirna; Hassan, Hamad; Salami, Ali; Bazzal, Ali Al; Saab, Hamid Bou; Al-Wakeel, Mohamed; Alsaabi, Ahmad; Chouman, Mohamad; Moussawi, Mahmoud Al; Ayoub, Hassan; Raad, Ali; Hajjeh, Ola; Eid, Ali H.; Raad, Houssam

doi:10.3390/v13112154

Cited by 18 publications

(8 citation statements)

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“…Two trials reported on (hydroxy)chloroquine (34, 35)(36, 37), two on favipiravir (36, 37)(38, 39), and two on ivermectin (34, 35)(40, 41). One of the four trials was single-centre (40, 41) and the remainder were multi-centre trials. One of the trials was retracted when the authors noticed an error in their analysis (40, 41) and the remainder were retracted due to concerns about data fabrication or falsification (e.g., inconsistencies between the eligibility criteria and patients included in the trial, discrepancies between when the trial was reported to have been conducted and when patients were recruited, inconsistencies between the dataset and the results reported in the preprint, inconsistencies between the distribution of baseline variables and the described randomization procedure).…”

Section: Resultsmentioning

confidence: 99%

“…We identified four retracted trials (34)(35)(36)(37)(38)(39)(40)(41). Two trials reported on (hydroxy)chloroquine (34,35) (36,37), two on favipiravir (36, 37) (38,39), and two on ivermectin (34,35) (40,41).…”

Section: Retractionsmentioning

confidence: 99%

Section: Retractionsmentioning

confidence: 99%

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The trustworthiness and impact of trial preprints for COVID-19 decision-making: A methodological study

Zeraatkar

Pitre

Leung

et al. 2022

Preprint

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Purpose: To assess the trustworthiness and impact of preprint trial reports during the COVID-19 pandemic. Data sources: WHO COVID-19 database and the L-OVE COVID-19 platform by the Epistemonikos Foundation (up to August 3rd, 2021) Design: We compare the characteristics of COVID-19 trials with and without preprints, estimate time to publication of COVID-19 preprint reports, describe discrepancies in key methods and results between preprint and published trial reports, report the number of retracted preprints and publications, and assess whether including versus excluding preprint reports affects meta-analytic estimates and the certainty of evidence. For the effects of eight therapies on mortality and mechanical ventilation, we performed meta-analyses including preprints and excluding preprints at 1 month, 3 months, and 6 months after the first trial addressing the therapy became available either as a preprint or publication (120 meta-analyses in total). Results: We included 356 trials, 101 of which are only available as preprints, 181 as journal publications, and 74 as preprints first and subsequently published in journals. Half of all preprints remain unpublished at six months and a third at one year. There were few important differences in key methods and results between trial preprints and their subsequent published reports. We identified four retracted trials, three of which were published in peer-reviewed journals. With two exceptions (2/60; 3.3%), point estimates were consistent between meta-analyses including versus excluding preprints as to whether they indicated benefit, no appreciable effect, or harm. There were nine comparisons (9/60; 15%) for which the rating of the certainty of evidence differed when preprints were included versus excluded, for four of these comparisons the certainty of evidence including preprints was higher and for five of these comparisons the certainty of evidence including preprints was lower. Limitations: The generalizability of our results is limited to COVID-19. Preprints that are subsequently published in journals may be the most rigorous and may not represent all trial preprints. Conclusion: We found no compelling evidence that preprints provide less trustworthy results than published papers. We show that preprints remain the only source of findings of many trials for several months, for a length of time that is unacceptable in a health emergency. We show that including preprints may affect the results of meta-analyses and the certainty of evidence. We encourage evidence users to consider data from preprints in contexts in which decisions are being made rapidly and evidence is being produced faster than can be peer-reviewed.

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Section: Resultsmentioning

confidence: 99%

Section: Retractionsmentioning

confidence: 99%

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The trustworthiness and impact of trial preprints for COVID-19 decision-making: A methodological study

Zeraatkar

Pitre

Leung

et al. 2022

Preprint

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“…prophylaxis; [41,42] two for retraction [21,23], one was excluded due to the study design (not RCT) [43] and one for a too short follow-up, having not assessed patients until recovery or death [44] (Figure 1). One study was found through hand searching reference lists.…”

Section: Search Resultsmentioning

confidence: 99%

“…Multiple clinical trials were carried out to assess clinical outcomes [16,17,18,19], with con icting evidence, and some of these studies were withdrawn given concerns about serious data inconsistencies and research fraud [20,21,22,23] Yet, the drug has been widely used, and has even been called a "COVID-19 miracle drug", supported by vaccine opponents, or even by health authorities in some countries [24]. However, there have been reports from different countries of people being hospitalized after self-medicating and developing serious adverse effects due to ivermectin [25].…”

Section: Introductionmentioning

confidence: 99%

Systematic Review and Meta-Analysis of Ivermectin for Treatment of COVID-19: Evidence Beyond the Hype

et al. 2022

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Ivermectin for preventing and treating COVID-19

Popp

Reis

Schießer

et al. 2022

Cochrane Database of Systematic Reviews

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Background Ivermectin, an antiparasitic agent, inhibits the replication of viruses in vitro. The molecular hypothesis of ivermectin's antiviral mode of action suggests an inhibitory effect on severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) replication in early stages of infection. Currently, evidence on ivermectin for prevention of SARS‐CoV‐2 infection and COVID‐19 treatment is conflicting. Objectives To assess the efficacy and safety of ivermectin plus standard of care compared to standard of care plus/minus placebo, or any other proven intervention for people with COVID‐19 receiving treatment as inpatients or outpatients, and for prevention of an infection with SARS‐CoV‐2 (postexposure prophylaxis). Search methods We searched the Cochrane COVID‐19 Study Register, Web of Science (Emerging Citation Index and Science Citation Index), WHO COVID‐19 Global literature on coronavirus disease, and HTA database weekly to identify completed and ongoing trials without language restrictions to 16 December 2021. Additionally, we included trials with > 1000 participants up to April 2022. Selection criteria We included randomized controlled trials (RCTs) comparing ivermectin to standard of care, placebo, or another proven intervention for treatment of people with confirmed COVID‐19 diagnosis, irrespective of disease severity or treatment setting, and for prevention of SARS‐CoV‐2 infection. Co‐interventions had to be the same in both study arms. For this review update, we reappraised eligible trials for research integrity: only RCTs prospectively registered in a trial registry according to WHO guidelines for clinical trial registration were eligible for inclusion. Data collection and analysis We assessed RCTs for bias, using the Cochrane RoB 2 tool. We used GRADE to rate the certainty of evidence for outcomes in the following settings and populations: 1) to treat inpatients with moderate‐to‐severe COVID‐19, 2) to treat outpatients with mild COVID‐19 (outcomes: mortality, clinical worsening or improvement, (serious) adverse events, quality of life, and viral clearance), and 3) to prevent SARS‐CoV‐2 infection (outcomes: SARS‐CoV‐2 infection, development of COVID‐19 symptoms, admission to hospital, mortality, adverse events and quality of life). Main results We excluded seven of the 14 trials included in the previous review version; six were not prospectively registered and one was non‐randomized. This updated review includes 11 trials with 3409 participants investigating ivermectin plus standard of care compared to standard of care plus/minus placebo. No trial investigated ivermectin for prevention of infection or compared ivermectin to an intervention with proven efficacy. Five trials treated participants with moderate COVID‐19 (inpatient settings); six treated mild COVID‐19 (outpatient settings). Eight trials were double‐bli...

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RETRACTED: Samaha et al. Effects of a Single Dose of Ivermectin on Viral and Clinical Outcomes in Asymptomatic SARS-CoV-2 Infected Subjects: A Pilot Clinical Trial in Lebanon. Viruses 2021, 13, 989

Abstract: The journal retracts the article, Effects of a Single Dose of Ivermectin on Viral and Clinical Outcomes in Asymptomatic SARS-CoV-2 Infected Subjects: A Pilot Clinical Trial in Lebanon [...]

Cited by 18 publications

References 1 publication

The trustworthiness and impact of trial preprints for COVID-19 decision-making: A methodological study

The trustworthiness and impact of trial preprints for COVID-19 decision-making: A methodological study

Systematic Review and Meta-Analysis of Ivermectin for Treatment of COVID-19: Evidence Beyond the Hype

Ivermectin for preventing and treating COVID-19

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