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1.
Indian J Otolaryngol Head Neck Surg ; 74(Suppl 2): 2963-2967, 2022 Oct.
Article in English | MEDLINE | ID: mdl-34026595

ABSTRACT

Povidone-iodine (PVP-I) is a time-tested antiseptic agent with excellent virucidal (99.99%) properties. Repurposing it against coronavirus disease-19 (COVID-19) is a relatively newer concept and has been sparsely tested in vivo. The most common route of entry of severe acute respiratory syndrome coronavirus 2 (SARS CoV-2) is the nasopharynx. Averting colonization of the virus could be one of the best options to reduce the incidence of infection. PVP-I gargle and mouthwash were found to be effective in vitro rapid inactivation against SARS-CoV-2 on a smaller scale (Hassandarvish et al. in BDJ 1-4, 2020, Pelletier et al. in ENTJ 1-5, 2020). However, efficacy in humans is lacking. To assess the virucidal effect of PVP-I against SARS-CoV-2 located in the nasopharynx was the objective of this parallel armed randomized clinical trial. We screened all RT-PCR-confirmed COVID-19 cases aged 18 years and above with symptoms. Written informed consent was obtained before randomization. Nasopharyngeal clearance of SARS-CoV-2 was tested after single time application of PVP-I nasal irrigation (NI) at diluted concentrations of .4%, .5% and .6% and PVP-I nasal spray (NS) at diluted concentrations of .5% and .6%. All groups were compared to the corresponding controls (distilled water). The primary outcome was viral clearance in a repeat RT-PCR (qualitative), and the secondary outcome was the number of adverse events. Final data analysis was performed using the statistical software SPSS (Version 20). A total of 189 confirmed COVID-19 cases were randomized into seven groups: 27 patients in each group. Of all, 159 (84.1%) were male, and 30 (15.9%) were female. We observed a statistically significant proportion of nasopharyngeal clearance with all strengths of PVP-I NI and PVP-I NS compared to the corresponding controls. Additionally, 0.5% NI was significantly better than 0.5% NS for viral clearance (p = 0.018) and had the highest nasopharyngeal clearance among all strengths (n = 25, 92.6%). 0.6% NS is better than CNS and 0.5%NS in viral clearance. The only adverse event was nasal irritation recorded in two patients each in the 0.4% and 0.6% PVP-I NI groups (Tables 1 and 2). PVP-I NI and NS are proved as effective virucidal agent against SARS-CoV-2 in human body. Our recommendation is to use PVP-I in naopharynx (as well as oropharynx) to prevent COVID-19.

2.
Indian J Otolaryngol Head Neck Surg ; 74(Suppl 2): 2906-2911, 2022 Oct.
Article in English | MEDLINE | ID: mdl-33846691

ABSTRACT

SARS- CoV-2 or novel coronavirus enters in human body through nose and mouth, stays there for a while. Then binds with ACE2 receptor, enters inside cell, multiply there and manifests. Again, Polyvinyl Pyrrolidone or Povidone Iodine (PVP-I) is a strong microbicidal agent having 99.99% virucidal efficacy in its only 0.23% concentration, irrespective of all known viruses, even in SARS- CoV-2 (in vitro). An oro-nasal spray is designed to apply the PVP-I in nose and oral cavity to gain a protective layer or coating over nasal and oral mucosa, so that SARS-CoV-2 can't bind with the ACE-2 receptor and prevent their entry inside. So, it will be effective for prevention of COVID-19. Moreover, as PVP-I has the ability for destruction of SARS-CoV-2, transmission of SARS- CoV-2 from patient will be reduced also. Thus PVP-I oro-nasal spray can act as an effective shield for COVID-19 protection for healthcare workers, for all.

3.
Trials ; 22(1): 2, 2021 Jan 04.
Article in English | MEDLINE | ID: mdl-33397432

ABSTRACT

OBJECTIVE: General: To assess the virucidal efficacy of povidone iodine (PVP-I) on COVID-19 virus located in the nasopharynx Specific: i. To evaluate the efficacy of povidone iodine (PVP-I) to removeCOVID-19 virus located in the nasopharynx ii. To assess the adverse events of PVP-I TRIAL DESIGN: This is a single-center, open-label randomized clinical trial with a 7-arm parallel-group design. PARTICIPANTS: The study will be conducted at Dhaka Medical College Hospital, Dhaka, Bangladesh. INCLUSION CRITERIA: All RT-PCR-confirmed COVID-19 cases aged between 15-90 years with symptoms for the past 4 days will be screened. Those who give informed consent, are willing to participate, and accept being randomized to any assigned group will also be considered for final inclusion. EXCLUSION CRITERIA: Patients with known sensitivity to PVP-I aqueous antiseptic solution or any of its listed excipients or previously diagnosed thyroid disease or who had a history of chronic renal failure: stage ≥3 by estimated glomerular filtration rate (eGFR) Modification of Diet in Renal Disease (MDRD) or had acute renal failure (KDIGO ≥stage 2: creatinine ≥2 times from the baseline) or patients who required invasive or noninvasive ventilation or planned within the next 6 hours were considered for exclusion. Moreover, lactating or pregnant women will also be restricted to include here. INTERVENTION AND COMPARATOR: This RCT consist of seven arms: Arm-1 (intervention group): will receive povidone iodine (PVP-I) nasal irrigation (NI) at a concentration of 0.4% Arm-2 (intervention group): will receive PVP-I nasal irrigation at a concentration of 0.5% Arm-3 (intervention group): will receive PVP-I nasal irrigation at a concentration of 0.6%. Arm-4 (intervention group): will receive PVP-I nasal spray (NS) at a concentration of 0.5%. Arm-5 (intervention group): will receive PVP-I nasal spray at a concentration of 0.6%. Arm-6 (placebo comparator group): will receive distilled water through NI Arm-7 (Placebo comparator group): will receive distilled water through NS The intervention arms will be compared to the placebo comparator arms. Other supportive and routine care will be the same in both groups. MAIN OUTCOMES: The primary outcome is the proportion of cases that remain COVID-19 positive following the intervention. It will be assessed from 1 minutes to 15 minutes after the intervention. Any occurrence of adverse effects following the intervention will be documented as a secondary outcome. RANDOMIZATION: The assignment to the study (intervention) or control (comparator) group will be allocated in equal numbers through randomization using random number generation in Microsoft Excel by a statistician who is not involved in the trial. The allocation scheme will be made by an independent statistician using a sealed envelope. The participants will be allocated immediately after the eligibility assessment and consenting procedures. BLINDING (MASKING): This is an open-label clinical trial, and no blinding or masking will be performed. NUMBERS TO BE RANDOMIZED (SAMPLE SIZE): A total of 189 confirmed cases of COVID-19 will be randomized into seven groups. In each arm, a total of 27 participants will be recruited. TRIAL STATUS: The current trial protocol is Version 1.5 from September 10, 2020. Recruitment began September 30, 2020 and is anticipated to be completed, including data analysis by February 28, 2021. TRIAL REGISTRATION: The trial protocol has been registered in the ClinicalTrials.gov on September 16, 2020. NCT Identifier number: NCT04549376 . FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting the dissemination of this material, the familiar formatting has been eliminated; this letter serves as a summary of the key elements of the full protocol.


Subject(s)
Anti-Infective Agents, Local/administration & dosage , COVID-19 Drug Treatment , Nasopharynx/virology , Povidone-Iodine/administration & dosage , SARS-CoV-2/drug effects , Administration, Intranasal , Adolescent , Adult , Aged , Aged, 80 and over , Bangladesh , COVID-19/diagnosis , COVID-19/virology , Clinical Trials, Phase II as Topic , Dose-Response Relationship, Drug , Female , Humans , Male , Middle Aged , Nasal Lavage , Nasal Sprays , Nasopharynx/drug effects , Placebos/administration & dosage , Placebos/adverse effects , Povidone-Iodine/adverse effects , Randomized Controlled Trials as Topic , SARS-CoV-2/isolation & purification , Treatment Outcome , Young Adult
4.
Indian J Otolaryngol Head Neck Surg ; 73(1): 111-115, 2021 Mar.
Article in English | MEDLINE | ID: mdl-33102188

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.

5.
SN Compr Clin Med ; 2(10): 1733-1739, 2020.
Article in English | MEDLINE | ID: mdl-32904377

ABSTRACT

This study aims to determine the role of personal protective measures in the prevention of COVID-19 spread among the physicians working at different health facilities in Bangladesh. This hospital-based cross-sectional comparative study was conducted from May to June 2020. A total of 98 COVID-19 positive physicians and 92 COVID-19 negative physicians (physicians with no symptoms of COVID-19 or who tested negative) were enrolled. The questionnaire was adapted from a tool developed by the World Health Organization (WHO) for risk assessment and management of exposure of healthcare workers in the context of COVID-19. Data were collected from the respondents online using Google forms. There was no significant difference in baseline information between COVID-19 positive and COVID-19 negative physicians. The physicians, who were unaware of direct participation in COVID-19 patient care, had higher odds of being COVID-19 positive (OR = 4.018; CI: 1.532-10.535). Additionally, the physicians, who were unaware of the COVID-19 status while performing the aerosol-generated procedure (AGP), had a higher chance of being COVID-19 positive (OR = 2.522; CI: 1.020-6.233). Using face shields/goggles (OR = 0.437; CI:0.228-0.837) and regular decontamination of the patient's surroundings (OR = 0.392; CI:0.176-0.873) while usual take care of patients and use of N95 masks while performing AGP (OR = 0.372; CI:0.159-0.873) had protective roles against COVID-19 among the physicians. The physicians who had reused the medical gown had two times more chances of being tested positive for COVID-19 than those who had not reused it (OR = 2.3; CI:1.251-4.259). The use of face shields/goggles and N95 masks and decontamination of the patient's surroundings may give protection against COVID-19. Additionally, reusing medical gowns should be avoided as much as possible.

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