Effectiveness and Safety of Niclosamaide as Add-on Therapy to the Standard of Care Measures in COVID-19 Management: Randomized controlled clinical trial

Abdulamir, Ahmed Sahib; Gorial, Faiq I.; Saaedi, Sattar J; Maulood, Mohammed Fauzi; Hashim, Hashim Ali; abdulrrazaq, Manal K.

doi:10.1101/2021.06.10.21258709

Cited by 4 publications

(5 citation statements)

References 20 publications

(19 reference statements)

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“…However, other studies did not report statistically significant differences in mortality ( Ravikirti and Pattadar, 2021 ), length of hospitalization ( Abdulamir et al, 2021a ) and clinical endpoints, disease progression, recovery, the occurrence of symptoms ( Okumuş et al, 2021 ). The study authors did not recommend the routine use of ivermectin in COVID-19 patients, limiting its use to a clinical trial.…”

Section: Other Agents Tested For Potential Efficacy In Treating Covid-19 Infectionmentioning

confidence: 95%

“… Drug No. patients Dose Outcome Effect Ivermectin ( AFMZ et al, 2021 ) 1,788 140 - 400 µg/kg Mortality reduction RR = 0.39 (95% CI: 0.20 - 0.74); p = 0.004 Colchicine ( Golpour et al, 2021 ) 5,901 NA Mortality reduction RR = 0.644 (95% CI: 0.555 – 0.748) Niclosamide ( Abdulamir et al, 2021a ) 150 3 g per day Reduced recovery time p ≤ 0.05 Tofacitinib ( Gunay et al, 2021 ) 289 10 mg twice a day Mortality reduction HR = 0.49 (95% CI: 0.15 to 1.63) Bamlanivimab - Etesevimab ( Dougan et al, 2021 ) 1,035 2.8 g + 2.8 g Hospitalizations or death absolute risk difference = −4.8%; (95% CI − 7.4 - −2.3); RR = 0.3; p < 0.001 Bamlanivimab - Etesevimab ( Gottlieb et al, 2021 ) 577 2.8 g + 2.8 g Viral load Viral load change = - 0.57 (95% CI: −1.00 to −0.14); p = 0.01 Anticoagulants ( Parisi et al, 2021 ) 25,719 therapeutic and prophylactic dose Mortality reduction RR = 0.50 (95% CI: 0.40 - 0.62) ASA ( RECOVERY Collaborative Group, 2021 ) 14,892 150 mg Mortality reduction RR = 0.96 (95% CI 0.89 – 1.04); p = 0.35 …”

Section: Other Agents Tested For Potential Efficacy In Treating Covid-19 Infectionmentioning

confidence: 99%

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An update on drugs with therapeutic potential for SARS-CoV-2 (COVID-19) treatment

Drożdżal

Rosik

Lechowicz

et al. 2021

Drug Resistance Updates

211

157

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The COVID-19 pandemic is one of the greatest threats to human health in the 21 st century with more than 257 million cases and over 5.17 million deaths reported worldwide (as of November 23, 2021. Various agents were initially proclaimed to be effective against SARS-CoV-2, the etiological agent of COVID-19. Hydroxychloroquine, lopinavir/ritonavir, and ribavirin are all examples of therapeutic agents, whose efficacy against COVID-19 was later disproved. Meanwhile, concentrated efforts of researchers and clinicians worldwide have led to the identification of novel therapeutic options to control the disease including PAXLOVID™ (PF-07321332). Although COVID-19 cases are currently treated using a comprehensive approach of anticoagulants, oxygen, and antibiotics, the novel Pfizer agent PAXLOVID™ (PF-07321332), an investigational COVID-19 oral antiviral candidate, significantly reduced hospitalization time and death rates, based on an interim analysis of the phase 2/3 EPIC-HR (Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients) randomized, double-blind study of non-hospitalized adult patients with COVID-19, who are at high risk of progressing to severe illness. The scheduled interim analysis demonstrated an 89% reduction in risk of COVID-19-related hospitalization or death from any cause compared to placebo in patients treated within three days of symptom onset (primary endpoint). However, there still exists a great need for the development of additional treatments, as the recommended therapeutic options are insufficient in many cases. Thus far, mRNA and vector vaccines appear to be the most effective modalities to control the pandemic. In the current review, we provide an update on the progress that has been made since April 2020 in clinical trials concerning the effectiveness of therapies available to combat COVID-19. We focus on currently recommended therapeutic agents, including steroids, various monoclonal antibodies, remdesivir, baricitinib, anticoagulants and PAXLOVID™ summarizing the latest original studies and meta-analyses. Moreover, we aim to discuss other currently and previously studied agents targeting COVID-19 that either show no or only limited therapeutic activity. The results of recent studies report that hydroxychloroquine and convalescent plasma demonstrate no efficacy against SARS-CoV-2 infection. Lastly, we summarize the studies on various drugs with incoherent or insufficient data concerning their effectiveness, such as amantadine, ivermectin, or niclosamide.

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Section: Other Agents Tested For Potential Efficacy In Treating Covid-19 Infectionmentioning

confidence: 95%

Section: Other Agents Tested For Potential Efficacy In Treating Covid-19 Infectionmentioning

confidence: 99%

An update on drugs with therapeutic potential for SARS-CoV-2 (COVID-19) treatment

Drożdżal

Rosik

Lechowicz

et al. 2021

Drug Resistance Updates

211

157

View full text Add to dashboard Cite

show abstract

“…The results of this study showed that the UNI91104 is a promising and safe anti-COVID-19 drug candidate following intranasal administration [168]. (b) Another study comprised 75 COVID-19 patients who received SOC plus niclosamide in the experimental group and 75 COVID-19 patients who received only SOC therapy as a control group [169]. Within 30 days of follow-up, there was no significant difference in the incidence of death versus recovery between the two research groups.…”

Section: Niclosamidementioning

confidence: 81%

“…The niclosamide supplement group's median survival time to cure was considerably shorter than the control group. After adjusting for comorbidity count, niclosamide add-on treatment increased the chance of cure by 60% each day compared to the control group [169].…”

Section: Niclosamidementioning

confidence: 89%

Coronavirus Disease (COVID-19) Control between Drug Repurposing and Vaccination: A Comprehensive Overview

et al. 2021

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Respiratory viruses represent a major public health concern, as they are highly mutated, resulting in new strains emerging with high pathogenicity. Currently, the world is suffering from the newly evolving severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This virus is the cause of coronavirus disease 2019 (COVID-19), a mild-to-severe respiratory tract infection with frequent ability to give rise to fatal pneumonia in humans. The overwhelming outbreak of SARS-CoV-2 continues to unfold all over the world, urging scientists to put an end to this global pandemic through biological and pharmaceutical interventions. Currently, there is no specific treatment option that is capable of COVID-19 pandemic eradication, so several repurposed drugs and newly conditionally approved vaccines are in use and heavily applied to control the COVID-19 pandemic. The emergence of new variants of the virus that partially or totally escape from the immune response elicited by the approved vaccines requires continuous monitoring of the emerging variants to update the content of the developed vaccines or modify them totally to match the new variants. Herein, we discuss the potential therapeutic and prophylactic interventions including repurposed drugs and the newly developed/approved vaccines, highlighting the impact of virus evolution on the immune evasion of the virus from currently licensed vaccines for COVID-19.

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“…After abstract screening and full-text reading, 152 RCTs were included in the analysis. All 152 RCTs were posted on the medRxiv server …”

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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Effectiveness and Safety of Niclosamaide as Add-on Therapy to the Standard of Care Measures in COVID-19 Management: Randomized controlled clinical trial

Cited by 4 publications

References 20 publications

An update on drugs with therapeutic potential for SARS-CoV-2 (COVID-19) treatment

An update on drugs with therapeutic potential for SARS-CoV-2 (COVID-19) treatment

Coronavirus Disease (COVID-19) Control between Drug Repurposing and Vaccination: A Comprehensive Overview

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

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