Virucidal Effect of Povidone Iodine on COVID-19 In-Vivo

• Status: Recruiting
• Trial end date: 2020-10-30
• Target enrollment: 0
• Participant gender: All

Summary

It is an established fact that, corona virus spread through the respiratory droplets. Colonization of the virus in oropharynx and/or nasopharynx is considered to be major factor for transmissibility of the virus through respiratory secretions. Preventing colonization of the virus by administrating povidone iodine in the nasal passage therefore, a rational thought which is supported by recent evidence of in-vitro virucidal action of povidone iodine in Severe Acute Respiratory Syndrome-Coronavirus 2 (SARS CoV-2). Therefore, the study is designed to assess the virucidal effect of povidone iodine on COVID-19 virus in-vivo.This open label randomized clinical trial will be conducted at Department of Otorhinolaryngology and Head Neck Surgery, in collaboration with Department of Virology and Department of Medicine in Dhaka Medical College (DMC) Hospital. The study will be conducted from September 2020 to October 2020. Total 175 confirmed cases of COVID-19 disease, proven by Reverse transcription polymerase chain reaction (RT-PCR) testing will be enrolled in this study. Written informed consent will be ensured before participation. In case of no literacy, finger print will be considered for written permission.Consent will be sought from the legal guardian in case of minor or underaged.Formal ethical clearance will be taken from Ethical Review Committee (ERC) of Dhaka Medical College. All of the Participants will be divided into seven groups: Group A will receive Povidone iodine (PVP-I) nasal irrigation at concentration of 0.4%, Group B and Group C will received 0.5% and 0.6%; Group D will receive PVP-I nasal spray at concentration of 0.5% and Group E will received at 0.6% concentration. Group F (Placebo comparator group) will receive nasal irrigation by distilled water (DW) and Group G (Placebo comparator group) will received nasal spray by distilled water. The contact time will be minimum 30 seconds. After the individual application of PVP-I and distilled water in respective participant, they will be tested again for RT-PCR for COVID-19 from nasopharyngeal and oropharyngeal sample. All patients will be subjected to detail history, physical examination and adverse events. Block Randomization will be followed for randomization. Data will be recorded in a semi-structured questionnaire and will be analyzed by 'R-4.0.2' data analysis software

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pi Research Consultancy Center, Bangladesh
• Collaborator: Dhaka Medical College
• Treatments: Cadexomer iodine; Iodine; Povidone; Povidone-Iodine

Criteria

Inclusion Criteria:

• Age: 15-90 years

• Either gender

• Patients diagnosed with COVID-19 disease by RT-PCR

• Have confirmed COVID-19 symptoms and symptom onset within the past 10 days

• Capable of using a nasal spray device and perform nasal irrigation required by the study

• Willing to participate

Exclusion Criteria:

• Patient with known sensitivity to PVP-I aqueous antiseptic solution or any of its listed excipients

• Previously diagnosed thyroid disease

• Patients with chronic renal failure (stage ≥3 by estimated Glomerular Filtration rate (eGFR) Modification of Diet in Renal Disease( MDRD)

• Patients with acute renal failure (KDIGO ≥stage 2: creatinine ≥2 X baseline)

• Pregnant and lactating mother

• Current requirement for invasive or non-invasive ventilation or planned within next 6 hours.