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Virucidal Effect of Povidone Iodine on SARS-CoV-2 in Nasopharynx: An Open-label Randomized Clinical Trial.
Kamal Arefin, Mostafa; Banu, Sultana Sahana; Nasir Uddin, A K M; Nurul Fattah Rumi, S K; Khan, Mala; Kaiser, Ahsanul; Arafat, Muhammad Shaharior; Chowdhury, Joybaer Anam; Khan, Md Abdullah Saeed; Hasan, Mohammad Jahid.
  • Kamal Arefin M; Department of ENT and Head Neck Surgery, Dhaka Medical College Hospital, Dhaka, Bangladesh.
  • Banu SS; Dept. of Virology, Dhaka Medical College, Dhaka, Bangladesh.
  • Nasir Uddin AKM; DNCC Dedicated COVID-19 Hospital, Dhaka, Bangladesh.
  • Nurul Fattah Rumi SK; Department of ENT and Head Neck Surgery, Dhaka Medical College Hospital, Dhaka, Bangladesh.
  • Khan M; Bangladesh Reference Institute of Chemical Measurements (BRICM), Dhaka, Bangladesh.
  • Kaiser A; Nanotechnology and Theranostic, Bangladesh Council of Scientific and Industrial Research (BCSIR), Dhaka, Bangladesh.
  • Arafat MS; Department of ENT and Head Neck Surgery, Dhaka Medical College Hospital, Dhaka, Bangladesh.
  • Chowdhury JA; National Institute of Cardiovascular Diseases (NICVD), Dhaka, Bangladesh.
  • Khan MAS; Pi Research Consultancy Center, Dhaka, Bangladesh.
  • Hasan MJ; Pi Research Consultancy Center, Dhaka, Bangladesh.
Indian J Otolaryngol Head Neck Surg ; 74(Suppl 2): 3283-3292, 2022 Oct.
Article in English | MEDLINE | ID: covidwho-2317419
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.
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Full text: Available Collection: International databases Database: MEDLINE Type of study: Experimental Studies / Observational study / Prognostic study / Qualitative research / Randomized controlled trials Language: English Journal: Indian J Otolaryngol Head Neck Surg Year: 2022 Document Type: Article Affiliation country: S12070-022-03106-0

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Full text: Available Collection: International databases Database: MEDLINE Type of study: Experimental Studies / Observational study / Prognostic study / Qualitative research / Randomized controlled trials Language: English Journal: Indian J Otolaryngol Head Neck Surg Year: 2022 Document Type: Article Affiliation country: S12070-022-03106-0