TO ASSESS THE EFFICACY OF POVIDONE IODINE GARGLES AND INTRANASAL INSTILLATION ON CHECKING THE PROGRESSION OF THE COVID-19 DISEASE AND VIRAL LOAD - A PROSPECTIVE RANDOMISED AND CONTROLLED STUDY

TOPIC**: To assess the efficacy of povidone iodine gargles and intranasal instillation on checking   the progression of the COVID 19 disease and viral load -A Prospective Randomized and Controlled Study.**

The novel Coronavirus disease 2019 (COVID-19) is an illness caused by Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) which spreads between people through direct, indirect, or close contact with infected people via oral and nasal secretions. The nasopharyngeal epithelium serves as route of entry for the virus. Povidone Iodine (PVP I) is a widely used antiseptic agent with proven, broad spectrum antimicrobial properties and established safety profile. In vitro studies have demonstrated that PVP I has virucidal activity against SARS CoV 2. In this study, conducted in the COVID wards and HDU of SGPGI Lucknow, we aim to determine if the use of gargle and intranasal solution of Povidone Iodine 1 % along with standard of care will be effective in reducing viral load in the nasopharynx and improving the clinical outcomes of SARS CoV 2 infection.

Our objectives will be to evaluate efficacy of intranasal povidone iodine 1% solution and gargles in reducing the viral load of SARS CoV2 in nasopharynx of patients with mild COVID 19 disease and to evaluate clinical course in patients with mild COVID 19 illness who were treated with PVP-I gargle and intranasal solution with respect to, progression of disease, radiological features                                               and inflammatory markers. We will also assess tolerability of PVP-I as gargle and intranasal solution in COVID 19 patients along with its influence on the duration of hospital stay.

 Patient admitted in Covid ward/HDU in SGPGIMS Lucknow with a positive RT-PCR test for SARS CoV 2 will be categorized into mild, moderate and severe. Patients meeting inclusion and exclusion criteria will be identified and an informed, written consent will be obtained. The patients will randomly be allocated into 2 groups with the help of a computer-generated table of random numbers:

Group 1: Standard treatment + intranasal Povidone Iodine1% and gargles

Group 2: Standard treatment alone

A total of 200 patients will be recruited with 100 in each group. Baseline characteristics will be recorded using the proforma. Patients in group 2 will be given standard treatment alone. Patients in Group 1 will receive intranasal Povidone Iodine 1% solution  2 drops thrice daily for 6 days along with standard care. The patient’s clinical parameters will be followed up daily. On day 7 following start of treatment, patient will undergo RTPCR testing from nasopharyngeal and oropharyngeal swabs with estimation of viral load as indicated by cycle time. The patient will continue to be followed up until discharge or death. The relevant investigations, clinical course, length of hospital stay,will be recorded on the proforma and will be analysed using SPSS.

Mild nasal irritation can occur on intranasal administration of Povidone Iodine solution. There is no other foreseen significant risk or hazard. If intranasal Povidone Iodine and gargle is found to be useful, this may help us improve the treatment of this illness, which may benefit future patients.