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

NCT04872686 | Completed Phase 3 DMC

• 1 other identifier: BRiCM LABS BANGASAFE SPRAY
• Study Type: interventional
• Target: 798
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Virus Infection, RNA; Effect of Drug; Efficacy, Self

Keywords

Viral load; PVP-I; SARS-CoV-2; Shelf-life; Stability

Outcome Measures

Primary Outcomes (2)

• Viral concentration assessment in Naso-Oropharynx by applying 0.6% PVP-I on COVID-19 positive, moderately ill admitted patient

  Application of 0.6% PVP-I spray once (2 puff 0.6% PVP-I in each nostril and 2 puff inside mouth) to experimental group and distilled water to control group. Then follow up (waiting for 2-5 minutes) and collection of nasopharyngeal and oropharyngeal sawab for RT-PCR test for both group to assess viral concentration. Observation of the patients for 30 minutes for possible early adverse effects (if any) and subsequent management (if needed).

  24 hours

• Effectiveness of 0.6% PVP-I assessment through viral concentration measurement

  Selection of 20 patients randomly with no or mild symptoms and obtain their consent for the further tests. Then application of 0.6% PVP-I spray 4 times (2 puff 0.6% PVP-I containing oronasal spray to each nostril and 2 puff inside mouth). Then collection of 2nd, 3rd and 4th sample from nasopharynx and oropharynx hourly for RT-PCR test to assess the viral concentration.

  24 hours

Secondary Outcomes (2)

• TSH, FT3, FT4 and Unirine iodine concentration determination for assessing side effect on thyroid function after using 0.6% PVP-I oronasal spray on healthy volunteer

  10 Days

• Serum creatinine concentration determination for assessing side effect on kidney function after using 0.6% PVP-I oronasal spray on healthy volunteer

  10 Days

Study Arms (4)

Oral and nasal spray to moderately ill COVID-19 positive patient

EXPERIMENTAL

Drug Name: Povidone-Iodine Dosage form: 0.6% Povidone-Iodine Dosage: 2 puff 0.6% PVP-I in each nostril and 2 puff inside mouth Frequency and duration: Single

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

Oral and nasal spray to asymptomatic to mild COVID-19 patient having multiple comorbidity

EXPERIMENTAL

Drug Name: Povidone-Iodine Dosage form: 0.6% Povidone-Iodine Dosage: 2 puff 0.6% PVP-I in each nostril and 2 puff inside mouth Frequency and duration: hourly for 4 hours in a single day

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

Oral and nasal spray to healthy volunteer

EXPERIMENTAL

Drug Name: Povidone-Iodine Dosage form: 0.6% Povidone-Iodine Dosage: 2 puff 0.6% PVP-I in each nostril and 2 puff inside mouth Frequency and duration: 3-4 times interval but not more than 4 times a day for 30 days

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

Oral and nasal spray by distilled water to control group

PLACEBO COMPARATOR

Placebo comparator: Distilled water Dosage form: Oral and Nasal spray will be provided by Distilled water

Other: Oral and nasal spray by distilled water to control group

Interventions

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

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.

Also known as: Group A

Oral and nasal spray to moderately ill COVID-19 positive patient

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

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

Also known as: Group B

Oral and nasal spray to asymptomatic to mild COVID-19 patient having multiple comorbidity

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

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

Also known as: Group C

Oral and nasal spray to healthy volunteer

Oral and nasal spray by distilled water to control group OTHER

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

Also known as: Control Group

Oral and nasal spray by distilled water to control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hospital admitted patients tested positive COVID-19 within 24 hours in the laboratory by RT-PCR.
• Patients with asymptomatic, mild to moderate illness of COVID-19.
• Age group 18 year and above.
• Consent of the patients, wish to be included in the study willingly.

You may not qualify if:

• Patients with critical COVID-19 and moderate COVID-19 with other complication.
• Patients having thyroid dysfunction, pregnant or lactating mother.
• It should not be used prior to or after radioiodine scintigraphy or radioiodine treatment of thyroid carcinoma.
• Patients allergic to iodine should be avoided
• Have participated in other clinical study
• 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
• Healthy individual (non COVID-19)
• Age -18 years and above (as below18 years lesser concentration of drug may be required).
• Consent of the participants who wish to participate.
• Participants who has any major comorbidity.
• Participants having thyroid dysfunction, pregnant or lactating mother.
• It should not be used prior to or after radioiodine scintigraphy or radioiodine treatment of thyroid carcinoma.
• Participants allergic to iodine should be avoided
• Have participated in other clinical study

Sponsors & Collaborators

• DR. MALA KHAN: lead
• Bangladesh Reference Institute of Chemical Measurements (BRICM): collaborator

Study Sites (4)

Bangladesh Reference Institute for Chemical Measurements

Dhaka, Dhanmondi, 1205, Bangladesh

Location

Dhaka Medical College Hospital

Dhaka, 1000, Bangladesh

Location

Kurmitola General Hospital

Dhaka, 1206, Bangladesh

Location

Kuwait-Moitree Hospital

Dhaka, 1230, Bangladesh

Location

MeSH Terms

Conditions

RNA Virus Infections

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Mostafa Kamal Arefin, Dr.

  Indoor Medical Officer, Department of ENT & Head-Neck Surgery, Dhaka Medical College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director General and Chief ScientificOfficer

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: May 4, 2021
• Study Start: April 10, 2021
• Primary Completion: May 25, 2021
• Study Completion: May 30, 2021
• Last Updated: January 20, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF, CSR
• Time Frame: 3 months
• Access Criteria: Available on public domain like figure share, research gate, Linkdin and others

Locations

BA (4)