Abstract
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.
Clinicaltrialsgov identifier: NCT04716569 ; https://clinicaltrials.gov/ct2/show/NCT04716569.
Keywords: COVID-19; biochemical and molecular; ivermectin nanosuspension; nasal spray.
【저자키워드】 COVID-19, biochemical and molecular, ivermectin nanosuspension, nasal spray., 【초록키워드】 Ivermectin, Treatment, clinical trial, protocol, C-reactive protein, D-dimer, nasal, in vitro, cough, viral clearance, Anosmia, Nasal spray, Replication, Nasopharyngeal swab, nucleic acid, rRT-PCR, Duration, nasopharyngeal swabs, Fever, Dyspnea, male, female, Patient, Mild, Manifestations, age, assessment, SARS-CoV-2 replication, intranasal, Blood, gastrointestinal symptoms, Safe, Pharyngeal swab, Biochemical parameters, Serum ferritin, significant difference, biochemical, assessments, therapeutic efficacy, dimer, Negative PCR, hematological, negativity, Complete, effective, complete blood counts, Randomly, shown, performed, the patient, diagnosed, was performed, presenting, anti-parasitic, biochemical parameter, inhibit SARS-CoV-2, significantly shorter, 【제목키워드】 clinical, respiratory, spray, upper,