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

• Status: Recruiting
• Trial end date: 2021-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The COVID-19 pandemic is the defining global health crisis of our time and the greatest challenge we have faced since World War-II.Corona virus is transmitted via respiratory droplets or aerosol, produced from sneezing or coughing of infected persons to healthy individual through mouth, nose and eye. PVP-I gargle/spray used in throat and nose are shown to have broad spectrum antimicrobial activity and may have preventive effect on SARS-CoV-2.

0.6% PVP-I oro-nasal spray phase 3 clinical trial will be conducted in three dedicated Covid-19 hospitals namely Dhaka Medical College Hospital, Kurmitola General Hospital, Kuwait-Moitree Hospital. Chemical compound of the oro-nasal spray which was developed and tested at Bangladesh Reference Institute for Chemical Measurements, for its quality control/ quality assurance, shelf life and related stability following GLP guideline.

This study aims to evaluate virucidal efficacy of 0.6% PVP-I against SARS-CoV-2 along with its safe uses in oronasal mucosa of healthy and SARS-CoV-2 exposed persons.

The participant will be divided into three groups: Group A 768 COVID-19 positive, moderately ill admitted patient who will receive intervention once. Group B 20 asymptomatic to mild COVID-19 patients having multiple comorbidity will receive intervention 4 times hourly and Group C 10 healthy individual who accept intervention 0.6% PVP-I oronasal spray 3-4 times interval in a day for 30 days. Placebo will be used among control group for better comparison.

The chemical which will be used in this study is available inside the country and also registered to open use in Bangladesh. BRiCM ensures raw material & impurities characterization as per BP 2019, AOAC and AWWA and determination of shelf life by performing the stability studies will be conducted according to Stability Zone Iva and ICH guidelines.

A written consent will be taken by concern participant and a short interview will be taken on the spot prior to intervention. Participant's medical documents will be used and swab from nasopharynx & oropharynx will be taken for performing necessary test (RT-PCR) to confirm viral presence.

There is no potential risk for application of this oro-nasal spray. Even though if any adverse reaction occur while using the oro-nasal spray, necessary medical management will be carried out in the respected hospital.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: DR. MALA KHAN
• Collaborator: Bangladesh Reference Institute of Chemical Measurements (BRICM)
• Treatments: Povidone-Iodine

Criteria

A. Moderately ill COVID-19 patient and asymptomatic to mild COVID-19 patent having multiple comorbidity

Inclusion Criteria

1. Hospital admitted patients tested positive COVID-19 within 24 hours in the laboratory by RT-PCR.

2. Patients with asymptomatic, mild to moderate illness of COVID-19.

3. Age group 18 year and above.

4. Consent of the patients, wish to be included in the study willingly.

Exclusion Criteria:

1. Patients with critical COVID-19 and moderate COVID-19 with other complication.

2. Patients having thyroid dysfunction, pregnant or lactating mother.

3. It should not be used prior to or after radioiodine scintigraphy or radioiodine treatment of thyroid carcinoma.

4. Patients allergic to iodine should be avoided

5. Have participated in other clinical study

6. Subjects with other severe acute or chronic conditions that may increase the risk of participation in the study and study treatment, or may interfere with interpretation of study results, and judged by the investigator as not suitable for participation in this clinical trial.

B. Healthy Individual

Inclusion Criteria:

1. Healthy individual (non COVID-19)

2. Age -18 years and above (as below18 years lesser concentration of drug may be required).

3. Consent of the participants who wish to participate.

Exclusion criteria:

1. Participants who has any major comorbidity.

2. Participants having thyroid dysfunction, pregnant or lactating mother.

3. It should not be used prior to or after radioiodine scintigraphy or radioiodine treatment of thyroid carcinoma.

4. Participants allergic to iodine should be avoided

5. Have participated in other clinical study

6. Subjects with other severe acute or chronic conditions that may increase the risk of participation in the study and study treatment, or may interfere with interpretation of study results, and judged by the investigator as not suitable for participation in this clinical trial.