ABSTRACT
To assess the virucidal effect of povidone iodine (PVP-I) on severe acute respiratory syndrome coronavirus 2 (SARS CoV-2) located in the nasopharynx and suitable dose-formulation for nasal application were the purpose of this clinical trial. This single-center, open-label randomized clinical trial with a 7-arm parallel-group design was conducted in Dhaka Medical College (DMC) Hospital. A total of 189 reverse transcription-polymerase chain reaction (RT-PCR)-confirmed SARS CoV-2 positive cases aged 12-90 years with symptoms was sequentially enrolled following randomization. Nasopharyngeal clearance of SARS-CoV-2 was tested against PVP-I nasal irrigation (NI) at diluted concentrations of 0.4%, 0.5% and 0.6%, and PVP-I nasal spray (NS) at diluted concentrations of 0.5% and 0.6%. All groups were compared to the corresponding controls (distilled water). Written informed consent was ensured before participation. All procedures were conducted in after ethical clearance from the Ethical Review Board and in accordance with the Declaration of Helsinki. Viral clearance in a repeat RT-PCR (qualitative) was the primary outcome, and occurrence of any adverse event following administration of testing drug was considered as the secondary outcome. Analysis was performed using SPSS (Version 26). All cases were randomized into seven groups and each group consists of 27-patient. Mean age of the cases 43.98 ± 12.67 years (SD). All strength of NI were effective in nasopharyngeal clearance compared to the control (0.4%, p = 0.006; 0.5%, p < 0.001; and 0.6%, p = 0.018). Similarly, all strength of the NS is also effective than control (0.5%, p = < 0.001; and 0.6%, p ≤ 0.001). Highest nasopharyngeal clearance was observed in patients using 0.5% NI (n = 25, 92.6%, p = 0.018). Nasal irritation was the single most adverse event recorded in this trial and found in two patients using 0.4%, and 0.6% PVP-I NI, respectively. Both PVP-I NS and NI are effective for nasopharyngeal clearance in-vivo. However, further community trials are needed to repurpose these solutions as preventive agents against SARS-CoV2. Ethical clearance memo no ERC-DMC/ECC/2020/93. Trial registration NCT Identifier number NCT04549376. Supplementary Information: The online version contains supplementary material available at 10.1007/s12070-022-03106-0.
ABSTRACT
Health care providers (HCP) of ENT and Skull base surgery are highly vulnerable and mostly infected by novel coronavirus as they have to examine and perform procedures directly in oral cavity, oropharynx, nose, nasopharynx, where coronavirus remains in plenty. ENT & Skull base surgeons need to do several aerosol generating procedures (AGP). Most of the endoscopic and microscopic ENT & skull base surgery are AGP; like-mastoid surgery, sinus surgery, surgery of pituitary, tympanomastoid paraganglioma, temporal bone malignancy, tracheostomy etc. All of we know, COVID negative by RT-PCR test is not always COVID negative. In COVID-19 pandemic-routine, even cancer surgeries are avoided or postponed for the sake of safety of HCPs. Moreover, in case of surgical emergency there's no way to refuse a patient for not having a report of COVID test. We thought about neutralizing or destroying the novel coronavirus from it's route of entry zone, as well as preventing aerosol to be transmitted in the air of OT. We designed a novel approach, i.e. 'POLIDON' (POLIDON = Polythene + Povidone Iodine), which can be the solution for these patients as well as surgeons or HCPs of above mentioned specialties. Use of Povidone Iodine as mouthwash and nasal spray or irrigation for both patient and HCPs prior to surgery is proposed. Then, use of simple polythene as barrier drape of patient or operative area for prevention of spread of aerosol in OT during surgery is the other component. With the POLIDON' approach-all these ENT & skull base surgeries can be done with more safety and confidence.