Virucidal Effect of Povidone Iodine on COVID-19 In-Vivo
Status:
Recruiting
Trial end date:
2020-10-30
Target enrollment:
Participant gender:
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