Virucidal Effect of PVP-I on COVID-19 and as Well as Safety of Its Application on Nasopharynx & Oropharynx

PHASE3CompletedINTERVENTIONAL
Enrollment

798

Participants

Timeline

Start Date

April 10, 2021

Primary Completion Date

May 25, 2021

Study Completion Date

May 30, 2021

Conditions
Virus Infection, RNAEffect of DrugEfficacy, Self
Interventions
DRUG

0.6% PVP-I oral and nasal spray to moderately ill COVID-19 positive patient

"Number of participants 768 COVID-19 positive, moderately ill admitted patient who will receive intervention~Step 1: Enrollment of the study populations by applying inclusion and exclusion criteria Step 2: Randomization to allocate experimental and controlled group by using table of random number Step 3: Application of 0.6% PVP-I spray to experimental group and distilled water to control group Step 4: Follow up (waiting for 2-5 minutes) Step 5: Collection of nasopharyngeal and oropharyngealsawab for RT-PCR test for both group Step 6: Observation of the patients for 30 minutes for possible early adverse effects (if any) and subsequent management (if needed).~Step 7: Analysis data collection, data processing and analysis by using SPSS software."

DRUG

0.6% PVP-I Oral and nasal spray to asymptomatic to mild COVID-19 patient having multiple comorbidity

"Number of participants 20 asymptomatic to mild COVID -19 patients having multiple comorbidity who will receive intervention~Step 1: Selection of 20 patients randomly with no or mild symptoms and obtain their consent for the further tests.~Step 2: Collection of 2nd, 3rd and 4th sample from nasopharynx and oropharynx hourly Step 3: Data collection, data processing and analysis by using SPSS software"

DRUG

0.6% PVP-I Oral and nasal spray to healthy volunteer

"Number of participants 10 healthy individual who accept intervention 0.6% PVP-I oronasal spray~Step 1: Selection of 10 healthy volunteers randomly who will be selected for using 0.6% PVP-I Oro-Nasal spray 2 puff inside both nostrils and mouth 3 to 4 times a day for one month.~Step 2: Collection of blood \& urine of participants on day 0, 10, 20, 30 for determination of any change in biochemical marker (thyroid, kidney and liver functions will be done) Step 3: Data collection, data processing and analysis by using SPSS software"

OTHER

Oral and nasal spray by distilled water to control group

Placebo comparator: Distilled Water Oral and Nasal spray will be provided by Distilled water to control group

Trial Locations (4)

1000

Dhaka Medical College Hospital, Dhaka

1205

Bangladesh Reference Institute for Chemical Measurements, Dhaka

1206

Kurmitola General Hospital, Dhaka

1230

Kuwait-Moitree Hospital, Dhaka

All Listed Sponsors
collaborator

Bangladesh Reference Institute of Chemical Measurements (BRICM)

OTHER_GOV

lead

DR. MALA KHAN

OTHER_GOV