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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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Duration of fever 63% primary Improvement Relative Risk Duration of dyspnea 56% Duration of anosmia 69% Duration of cough 64% Viral clearance 79% Time to viral- 36% Ivermectin  Aref et al.  EARLY TREATMENT  RCT Is early treatment with ivermectin beneficial for COVID-19? RCT 114 patients in Egypt (February - March 2021) Improved recovery (p=0.0001) and viral clearance (p=0.004) Aref et al., Int. J. Nanomedicine, Jun 2021 Favorsivermectin Favorscontrol 0 0.5 1 1.5 2+
Ivermectin for COVID-19
4th treatment shown to reduce risk in August 2020
*, now with p < 0.00000000001 from 104 studies, recognized in 23 countries.
No treatment is 100% effective. Protocols combine treatments. * >10% efficacy, ≥3 studies.
4,400+ studies for 79 treatments.
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 administration1-5
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 51 COVID-19 RCTs for ivermectin, which collectively show efficacy with p=0.00000015.
This is the 56th of 104 COVID-19 controlled studies for ivermectin, which collectively show efficacy with p<0.0000000001 (1 in 1 sextillion).
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
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 PaperIvermectinAll
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. Identifier: NCT04716569; NCT04716569.
Disclosure No potential conflicts of interest between authors to be declare. Dovepress
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