Clinical, Biochemical and Molecular Evaluations of Ivermectin Mucoadhesive Nanosuspension Nasal Spray in Reducing Upper Respiratory Symptoms of Mild COVID-19
Aref et al.,
Clinical, Biochemical and Molecular Evaluations of Ivermectin Mucoadhesive Nanosuspension Nasal Spray in..,
International Journal of Nanomedicine, doi:10.2147/IJN.S313093 , NCT04716569
RCT 114 patients in Egypt, 57 treated with ivermectin mucoadhesive nanosuspension intranasal spray, showing faster recovery and viral clearance with treatment.
NCT04716569 (history).
relative duration of fever, 63.2% lower, relative time 0.37, p < 0.001, treatment 57, control 57, primary outcome.
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relative duration of dyspnea, 56.4% lower, relative time 0.44, p < 0.001, treatment 57, control 57.
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relative duration of anosmia, 68.8% lower, relative time 0.31, p < 0.001, treatment 57, control 57.
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relative duration of cough, 64.3% lower, relative time 0.36, p < 0.001, treatment 57, control 57.
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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.
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time to viral-, 35.7% lower, relative time 0.64, p < 0.001, treatment 57, control 57.
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Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
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Aref et al., 15 Jun 2021, Randomized Controlled Trial, Egypt, peer-reviewed, 7 authors, dosage not specified, trial
NCT04716569 (history).
Abstract: International Journal of Nanomedicine
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ORIGINAL RESEARCH
Clinical, Biochemical and Molecular Evaluations of
Ivermectin Mucoadhesive Nanosuspension Nasal
Spray in Reducing Upper Respiratory Symptoms
of Mild COVID-19
Zaki F Aref 1
Shamardan Ezz Eldin S Bazeed
Mohammed H Hassan 3
Abeer S Hassan 4
Alaa Rashad5
Rehab G Hassan6
Aida A Abdelmaksoud1
2
1
ENT Department, Faculty of Medicine,
South Valley University, Qena, Egypt;
2
Tropical Medicine and Gastroenterology
Department, Faculty of Medicine, South
Valley University, Qena, Egypt;
3
Department of Medical Biochemistry,
Faculty of Medicine, South Valley
University, Qena, Egypt; 4Department of
Pharmaceutics, Faculty of Pharmacy,
South Valley University, Qena, Egypt;
5
Department of Chest Diseases and
Tuberculosis, Faculty of Medicine, South
Vally University, Qena, Egypt;
6
Department of Public Health and
Community Medicine, Faculty of
Medicine, South Valley University, Qena,
Egypt
Correspondence: Mohammed H Hassan
Department of Medical Biochemistry,
Faculty of Medicine, South Valley
University, Qena, 83523, Egypt
Tel +201098473605
Email mohammedhosnyhassaan@med.
svu.edu.eg
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 nano
suspension 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 hemato
logical 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 short
ening the anosmia duration.
Clinicaltrials.gov Identifier: NCT04716569; https://clinicaltrials.gov/ct2/show/
NCT04716569.
Keywords: ivermectin nanosuspension, nasal spray, COVID-19, biochemical and molecular
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