The effect of ivermectin on the viral load and culture viability in early treatment of nonhospitalized patients with mild COVID-19 – a double-blind, randomized placebo-controlled trial

Biber, Asaf; Harmelin, Geva; Lev, Dana; Ram, Li; Shaham, Amit; Nemet, Ital; Kliker, Limor; Erster, Oran; Mandelboim, Michal; Schwartz, Eli

doi:10.1016/j.ijid.2022.07.003

Cited by 16 publications

(13 citation statements)

References 35 publications

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“…As of October 1, 2022, 119 preprints (78.3%) had been published in a scientific, peer-reviewed journal (Figure 2 and eTable 3 in Supplement 1). Two preprints were published in a single journal publication . The median time to publication was 186 days (range, 17-407 days).…”

Section: Resultsmentioning

confidence: 99%

Comparison of Preprint Postings of Randomized Clinical Trials on COVID-19 and Corresponding Published Journal Articles

et al. 2023

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ImportanceRandomized clinical trials (RCTs) on COVID-19 are increasingly being posted as preprints before publication in a scientific, peer-reviewed journal.ObjectiveTo assess time to journal publication for COVID-19 RCT preprints and to compare differences between pairs of preprints and corresponding journal articles.Evidence ReviewThis systematic review used a meta-epidemiologic approach to conduct a literature search using the World Health Organization COVID-19 database and Embase to identify preprints published between January 1 and December 31, 2021. This review included RCTs with human participants and research questions regarding the treatment or prevention of COVID-19. For each preprint, a literature search was done to locate the corresponding journal article. Two independent reviewers read the full text, extracted data, and assessed risk of bias using the Cochrane Risk of Bias 2 tool. Time to publication was analyzed using a Cox proportional hazards regression model. Differences between preprint and journal article pairs in terms of outcomes, analyses, results, or conclusions were described. Statistical analysis was performed on October 17, 2022.FindingsThis study included 152 preprints. As of October 1, 2022, 119 of 152 preprints (78.3%) had been published in journals. The median time to publication was 186 days (range, 17-407 days). In a multivariable model, larger sample size and low risk of bias were associated with journal publication. With a sample size of less than 200 as the reference, sample sizes of 201 to 1000 and greater than 1000 had hazard ratios (HRs) of 1.23 (95% CI, 0.80-1.91) and 2.19 (95% CI, 1.36-3.53) for publication, respectively. With high risk of bias as the reference, medium-risk articles with some concerns for bias had an HR of 1.77 (95% CI, 1.02-3.09); those with a low risk of bias had an HR of 3.01 (95% CI, 1.71-5.30). Of the 119 published preprints, there were differences in terms of outcomes, analyses, results, or conclusions in 65 studies (54.6%). The main conclusion in the preprint contradicted the conclusion in the journal article for 2 studies (1.7%).Conclusions and RelevanceThese findings suggest that there is a substantial time lag from preprint posting to journal publication. Preprints with smaller sample sizes and high risk of bias were less likely to be published. Finally, although differences in terms of outcomes, analyses, results, or conclusions were observed for preprint and journal article pairs in most studies, the main conclusion remained consistent for the majority of studies.

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Section: Resultsmentioning

confidence: 99%

Comparison of Preprint Postings of Randomized Clinical Trials on COVID-19 and Corresponding Published Journal Articles

et al. 2023

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“…Only prospective randomized double-blinded studies were selected. Source Publication time Comparator Dose, mg/day Number of treatment days Patient status Effect on Primary Endpoints Conflict of interest reported Abd-Elsalam et al [ 36 ] 31 May, 2021 Standard protocol of treatment 12 3 Mild, moderate No significant effect No Lopez-Medina et al [ 37 ] 4 March, 2021 Placebo 24 5 Mild No significant effect Yes Vallejos et al [ 38 ] 02 July, 2021 Placebo 24 2 Mild, moderate No significant effect No Mohan et al [ 39 ] 25 August, 2021 Placebo 12 and 24 1 Mild, moderate No significant effect No Samaha et al [ 40 ] 26 May, 2021 Supplements 9 to 16 1 Asymptomatic, prophylaxis Significant No Beltran Gonzalez et al [ 41 ] 3 March, 2022 Hydroxychloroquine and placebo 12 or 18 4 Severe No significant effect No Krolewiecki et al [ 42 ] 18 June, 2021 “No treatment” 30 or 48 5 Mild-to moderate, not in intensive care Dose-dependent significance Yes Biber et al [ 43 ] 2 July, 2022 Placebo 12 and 15 3 Mild Significant No ...…”

Section: Discussionmentioning

confidence: 99%

Results of a systematic review and meta-analysis of early studies on ivermectin in SARS-CoV-2 infection

et al. 2023

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Ivermectin, an antiparasitic drug, has been repurposed for COVID-19 treatment during the SARS-CoV-2 pandemic. Although its antiviral efficacy was confirmed early in vitro and in preclinical studies, its clinical efficacy remained ambiguous. Our purpose was to assess the efficacy of ivermectin in terms of time to viral clearance based on the meta-analysis of available clinical trials at the closing date of the data search period, one year after the start of the pandemic. This meta-analysis was reported by following the PRISMA guidelines and by using the PICO format for formulating the question. The study protocol was registered on PROSPERO. Embase, MEDLINE (via PubMed), Cochrane Central Register of Controlled Trials (CENTRAL), bioRvix, and medRvix were searched for human studies of patients receiving ivermectin therapy with control groups. No language or publication status restrictions were applied. The search ended on 1/31/2021 exactly one year after WHO declared the public health emergency on novel coronavirus. The meta-analysis of three trials involving 382 patients revealed that the mean time to viral clearance was 5.74 days shorter in case of ivermectin treatment compared to the control groups [WMD = −5.74, 95% CI (−11.1, −0.39), p = 0.036]. Ivermectin has significantly reduced the time to viral clearance in mild to moderate COVID-19 diseases compared to control groups. However, more eligible studies are needed for analysis to increase the quality of evidence of ivermectin use in COVID-19.

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“…Antiretrovirals such as remdesivir have emergency use authorization (EUA) for infants > 28 days and > 3.5 kg [ 20 ], while Paxlovid and monoclonal antibodies have EUA for children 12 years and older [ 21 ]. A double-blind study comparing ivermectin vs. placebo showed decreased viral load in COVID-19 adult patients, but the use of the same has not been evaluated adequately with the associated side effects [ 22 - 23 ]. The Centers for Disease Control and Prevention (CDC) has declared vaccination for COVID-19 safe for pregnant women, and it is prudent to vaccinate expecting mothers in the last trimester so the fetus can have the passive transfer of protective antibodies, given the information that vaccine-based immune response is maximum for three months duration [ 24 ].…”

Section: Discussionmentioning

confidence: 99%

Possible COVID-19 Maternal-to-Neonate Vertical Transmission in a Case of Early Neonatal Infection

Pandit¹,

Pandit²,

Bhattar³

2022

Cureus

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Coronavirus disease 2019 (COVID-19) is a disease caused by a novel strain of coronavirus and has resulted in a global pandemic. Information regarding the COVID-19 pathophysiology and its long-term impacts on humans is yet to be found. The knowledge about the COVID -19 infection's effects on the fetus is limited. The maternal to fetal transmission during various trimesters is not adequately studied. We present a case concerning maternal-to-fetal vertical transmission focusing on congenital infection.

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The effect of ivermectin on the viral load and culture viability in early treatment of nonhospitalized patients with mild COVID-19 – a double-blind, randomized placebo-controlled trial

Cited by 16 publications

References 35 publications

Comparison of Preprint Postings of Randomized Clinical Trials on COVID-19 and Corresponding Published Journal Articles

Comparison of Preprint Postings of Randomized Clinical Trials on COVID-19 and Corresponding Published Journal Articles

Results of a systematic review and meta-analysis of early studies on ivermectin in SARS-CoV-2 infection

Possible COVID-19 Maternal-to-Neonate Vertical Transmission in a Case of Early Neonatal Infection

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