Difference between prophylactic and therapeutic trials

Ravikirti [ 31 ] patients with mild-moderate disease. The mean age of pts. RCT, double blind, placebo-controlled trial Two groups of intervention with ivermectin 12 mg on day 1 and day 2 of admission or placebo, but in both groups, all patients also received hydroxychloroquine, steroids, enoxaparin, remdesivir, antibiotics, convalescent plasma, tocilizumab, and other drugs. Negative PCR test at day 6; symptoms status at day 6; discharge status; admission to ICU; need of mechanical ventilation; mortality.

Similarly, there was no significant difference between the two groups in most of the secondary outcome measures. However, while there was no in-hospital mortality in the intervention arm, there were four deaths in the placebo arm. The non-intervention group received no treatment. Ivermectin was given at day 1 diagnosis day and repeated once more at day 3 total of two doses.

The protection rate for ivermectin was more prominent in contacts aged less than 60 years old. Open in a separate window. Data Collection and Analysis The following data were extracted by two reviewers I. Therefore, we considered the following sub-group analyses: -.

Results The search yielded potentially relevant studies Figure 1 , study flow chart. Figure 1. Allocation We assessed two studies as being with high risk of selection bias due to the randomization by alternation of the two treatments and because the intervention allocations could have been foreseen in advance [ 26 , 30 ]. Blinding Performance bias.

Other Potential Sources of Bias Nine studies were deemed with low risk of other bias, and two studies with unclear risk of other bias. Effects of Interventions A summary of the outcomes reported in the included study is provided in Figure 2 data and analysis. Figure 2. Mortality Data on mortality were reported in all nine studies evaluating ivermectin treatment. The average benefit is higher in the high-risk population. Figure 3.

Figure 4. Figure 5. Adverse Events Few participants were reported undergoing a serious event in either Ivermectin or control groups Figure S3. Acknowledgments We would like to thank Marcus Perryman for revising the manuscript. Click here for additional data file.

Author Contributions M. Funding This research received no external funding. Institutional Review Board Statement Not applicable. Informed Consent Statement Not applicable. Conflicts of Interest The authors declare no conflict of interest. References 1. Keskinidou C. Bartoszko J. Kim M. Comparative efficacy and safety of pharmacological interventions for the treatment of COVID A systematic review and network meta-analysis. PLoS Med. Kaddoura M. Front Pharmacol. Kaur H. Ivermectin as a potential drug for treatment of COVID An in-sync review with clinical and computational attributes.

Pharmacol Rep. Padhy B. Wehbe Z. Front Immunol. Ottesen E. Ivermectin in human medicine. Heidary F. Formiga F. Mastrangelo E. Ivermectin is a potent inhibitor of flavivirus replication specifically targeting NS3 helicase activity: New prospects for an old drug. Yang S. Caly L.

Yan S. Anti-inflammatory effects of ivermectin in mouse model of allergic asthma. Zhang X. DiNicolantonio J. Anti-inflammatory activity of ivermectin in late-stage COVID may reflect activation of systemic glycine receptors. Open Heart. Nardelli P. Crying wolf in time of Corona: The strange case of ivermectin and hydroxychloroquine.

Is the fear of failure withholding potential life-saving treatment from clinical use? Kow C. Garegnani L. BMJ Evid. Based Med. Deeks J. Cochrane Handbook for Systematic Reviews of Interventions. Analysing data and undertaking meta-analyses; pp. Moher D. Ahmed S. Chaccour C. The effect of early treatment with ivermectin on viral load, symptoms and humoral response in patients with non-severe COVID A pilot, double-blind, placebo-controlled, randomized clinical trial.

Chahla R. A Randomized trial-intensive treatment based in ivermectin and iota-carrageenan as preexposure prophylaxis for COVID in healthcare agents. Elgazzar A. Hashim H. Mahmud R. Niaee M. Ivermectin as an adjunct treatment for hospitalized adult COVID patients: A randomized multi-center clinical trial.

Evaluation of the effectiveness and safety of adding ivermectin to treatment in severe COVID patients. BMC Infect. Ravikirti R. Shoumann W. Higgins J. The Cochrane Collaboration: Guyatt G. Statistical heterogeneity in systematic reviews of clinical trials: A critical appraisal of guidelines and practice.

Health Serv. Vallejos J. Garcia P. Hosseini F. The efficacy and safety of Ivermectin in patients with mild and moderate COVID A structured summary of a study protocol for a randomized controlled trial. Gorial F. Elalfy H. Effect of a combination of nitazoxanide, ribavirin, and ivermectin plus zinc supplement MANS. Rajter J. Schmith V. Pharmacol Ther. Samaha A. Navarro M. Safety of high-dose ivermectin: A systematic review and meta-analysis.

Guzzo C. Safety, tolerability, and pharmacokinetics of escalating high doses of ivermectin in healthy adult subjects. Bhimraj A. Lamontagne F. Support Center Support Center. External link. Our study may have been limited by the small sample size and lack of follow-up regarding the long-term adverse outcomes for newborns who received the two phototherapy regimens.

While phototherapy is relatively safe and effective in reducing the bilirubin level, the risks of such treatment could be significant for preterm infants, leading to dehydration, temperature instability, and electrolyte imbalance. According to our study, phototherapy should not be used as a prophylactic therapy for all VLBW infants, but rather it should be individualized to maintain low bilirubin levels.

Further studies to evaluate the effects of prophylactic phototherapy on neurodevelopment and other the long-term outcomes for VLBW infants are warranted. Lazarus C, Avchen RN. Neonatal hyperbilirubinemia management: a model for change. J Perinatol. Nuntnarumit P, Naka C.

Comparison of the effectiveness between the adapted-double phototherapy versus conventional-single phototherapy. J Med Assoc Thai. Bratlid D. Criteria for treatment of neonatal jaundice. Treatment of jaundice in low birthweight infants. Jaundice in low birthweight infants: pathobiology and outcome.

J Pediatr Rio J. A prospective randomized controlled study of phototherapy using blue and blue-green light-emitting devices, and conventional halogen-quartz phototherapy. Effect of position changing on bilirubin levels during phototherapy. Irradiance of phototherapy equipment in maternity wards in Maceio. Rev Lat Am Enfermagem. Jaundice and liver disease. Neonatal - Perinatal Medicine. Diseases of The Fetus and Infant. Fifth ed. United States: Mosby; ; : Association between peak serum bilirubin and neurodevelopmental outcomes in extremely low birth weight infants.

Hansen TW. Mechanisms of bilirubin toxicity: clinical implications. Clin Perinatol. Randomized trial of prophylactic phototherapy in the infant with very low birth weight. J Pediatr. Iran J Pediatr. Aggressive vs. Cancel Print. Email citation. Please enter a valid email address. Cancel Send. Export citation list.

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