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Clinical, Biochemical and Molecular Evaluations of Ivermectin Mucoadhesive Nanosuspension Nasal Spray in Reducing Upper Respiratory Symptoms of Mild COVID-19

Aref et al., International Journal of Nanomedicine, doi:10.2147/IJN.S313093 , NCT04716569

Jun 2021

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Ivermectin for COVID-19

4th treatment shown to reduce risk in August 2020

^*, now known with p < 0.00000000001 from 102 studies, recognized in 22 countries.

Lower risk for mortality, ventilation, ICU admission, hospitalization, recovery, cases, and viral clearance.

No treatment is 100% effective. Protocols combine complementary and synergistic treatments. ^* >10% efficacy in meta analysis with ≥3 clinical studies.

4,000+ studies for 60+ treatments. c19ivm.org

RCT 114 patients in Egypt, 57 treated with ivermectin mucoadhesive nanosuspension intranasal spray, showing faster recovery and viral clearance with treatment. NCT04716569 (history).

5 studies use direct respiratory tract administration Aref, Aref (B), Carvallo, Carvallo (B), Chahla

Targeted administration to the respiratory tract provides treatment directly to the typical source of initial SARS-CoV-2 infection and replication, and allows for rapid onset of action, higher local drug concentration, and reduced systemic side effects.

This is the 26th of 49 COVID-19 RCTs for ivermectin, which collectively show efficacy with p=0.00000038.

This is the 56th of 102 COVID-19 controlled studies for ivermectin, which collectively show efficacy with p<0.0000000001 (1 in 560 quintillion).

Important missing comments or errors? Let us know.

relative duration of fever, 63.2% lower, relative time 0.37, p < 0.001, treatment 57, control 57, primary outcome.

relative duration of dyspnea, 56.4% lower, relative time 0.44, p < 0.001, treatment 57, control 57.

relative duration of anosmia, 68.8% lower, relative time 0.31, p < 0.001, treatment 57, control 57.

relative duration of cough, 64.3% lower, relative time 0.36, p < 0.001, treatment 57, control 57.

risk of no viral clearance, 78.6% lower, RR 0.21, p = 0.004, treatment 3 of 57 (5.3%), control 14 of 57 (24.6%), NNT 5.2.

time to viral-, 35.7% lower, relative time 0.64, p < 0.001, treatment 57, control 57.

Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates

1. Aref et al., Possible Role of Ivermectin Mucoadhesive Nanosuspension Nasal Spray in Recovery of Post-COVID-19 Anosmia, Infection and Drug Resistance, doi:10.2147/IDR.S381715.dovepress.com, doi.org.

2. Aref (B) et al., Clinical, Biochemical and Molecular Evaluations of Ivermectin Mucoadhesive Nanosuspension Nasal Spray in Reducing Upper Respiratory Symptoms of Mild COVID-19, International Journal of Nanomedicine, doi:10.2147/IJN.S313093.dovepress.com, doi.org.

3. Carvallo et al., Study of the Efficacy and Safety of Topical Ivermectin + Iota-Carrageenan in the Prophylaxis against COVID-19 in Health Personnel, Journal of Biomedical Research and Clinical Investigation, doi:10.31546/2633-8653.1007.medicalpressopenaccess.com, doi.org.

4. Carvallo (B) et al., Usefulness of Topic Ivermectin and Carrageenan to Prevent Contagion of Covid 19 (IVERCAR), NCT04425850, clinicaltrials.gov/ct2/show/results/NCT04425850.clinicaltrials.gov.

5. Chahla et al., Intensive Treatment With Ivermectin and Iota-Carrageenan as Pre-exposure Prophylaxis for COVID-19 in Health Care Workers From Tucuman, Argentina, American Journal of Therapeutics, doi:10.1097/MJT.0000000000001433.lww.com, doi.org.

Aref et al., 15 Jun 2021, Randomized Controlled Trial, Egypt, peer-reviewed, 7 authors, study period February 2021 - March 2021, dosage not specified, trial NCT04716569 (history).

This Paper Ivermectin All

Clinical, Biochemical and Molecular Evaluations of Ivermectin Mucoadhesive Nanosuspension Nasal Spray in Reducing Upper Respiratory Symptoms of Mild COVID-19

Zaki F Aref, Shamardan Ezz Eldin S Bazeed, Mohammed H Hassan, Abeer S Hassan, Alaa Rashad, Rehab G Hassan, Aida A Abdelmaksoud

International Journal of Nanomedicine, doi:10.2147/ijn.s313093

Background: Ivermectin is an FDA-approved broad-spectrum anti-parasitic agent that has been shown to inhibit SARS-CoV-2 replication in vitro. Objective: We aimed to assess the therapeutic efficacy of ivermectin mucoadhesive nanosuspension intranasal spray in treatment of patients with mild COVID-19. Methods: This clinical trial included 114 patients diagnosed as mild COVID-19. Patients were divided randomly into two age and sex-matched groups; group A comprising 57 patients received ivermectin nanosuspension nasal spray twice daily plus the Egyptian protocol of treatment for mild COVID-19 and group B comprising 57 patients received the Egyptian protocol for mild COVID-19 only. Evaluation of the patients was performed depending on improvement of presenting manifestations, negativity of two consecutive pharyngeal swabs for the COVID-19 nucleic acid via rRT-PCR and assessments of hematological and biochemical parameters in the form of complete blood counts, C-reactive protein, serum ferritin and d-dimer which were performed at presentation and 7 days later. Results: Of the included patients confirmed with mild COVID-19, 82 were males (71.9%) and 32 females (28.1%) with mean age 45.1 ± 18.9. In group A, 54 patients (94.7%) achieved 2 consecutive negative PCR nasopharyngeal swabs in comparison to 43 patients (75.4%) in group B with P = 0.004. The durations of fever, cough, dyspnea and anosmia were significantly shorter in group A than group B, without significant difference regarding the duration of gastrointestinal symptoms. Duration taken for nasopharyngeal swab to be negative was significantly shorter in group A than in group B (8.3± 2.8 days versus 12.9 ± 4.3 days; P = 0.0001). Conclusion: Local use of ivermectin mucoadhesive nanosuspension nasal spray is safe and effective in treatment of patients with mild COVID-19 with rapid viral clearance and shortening the anosmia duration. Clinicaltrials.gov Identifier: NCT04716569; https://clinicaltrials.gov/ct2/show/ NCT04716569.

Disclosure No potential conflicts of interest between authors to be declare. Dovepress

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