A Clinical Trial of Gargling Agents in Reducing Intraoral Viral Load Among COVID-19 Patients

NCT04341688 | Unknown DMC

• 1 other identifier: 2020-Sur-ERC-4926
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

Pakistan is a resource restraint country, it's not possible to carry out coronavirus testing at mass scale. Simple cost effective intervention against the present pandemic is highly desirable. For patients: Identifying an antiviral gargle that could substantially reduce the colonies of COVID-19 residing in mouth and oro-naso-pharynx is likely to reduce the viral load. Such reduction in the viral load through surface debridement could aid the effective immune response in improving the overall symptoms of the patients. For dentists: This study is important because the nature of the dental profession involves aerosol production, carrying out dental work on asymptomatic patients carrying coronavirus puts the entire dental team at a great risk of not only acquiring the infection but also transmitting it to the others. Antiviral gargles could be used by dentist and their auxiliaries as prophylaxis. For physicians and nurses: The risk of morbidity and mortality is high among physicians and nurses involved in the screening and management of Covid-19 patients. Globally, over 215 physicians and surgeons have died while taking care of Covid-19 patients. The cause of death is attributed to high exposure of viral load. The antiviral gargles and nasal lavage can decrease the fatalities among doctors and nurses. Thus, patients, physicians, nurses and dentists, all could be benefited with this findings of this study.

Conditions

Covid-19

Keywords

Covid-19;; coronavirus disease; povidone; hydrogen peroxide; neem extracts; topical therapy; gargle

Outcome Measures

Primary Outcomes (1)

• Intraoral viral load

  Intraoral viral load as deciphered by RT-PCR

  Five days of using gargles

Secondary Outcomes (1)

• Salivary cytokine profile

  Five days of using gargles

Study Arms (5)

Povidone-Iodine 0.2% (BETADINE®)

EXPERIMENTAL

0.2% Povidone-Iodine (BETADINE®) 10 ml gargle and nasal lavage for 20-30 seconds, thrice daily for 6 days.

Drug: Gargle/Mouthwash

Hydrogen peroxide 1% (ActiveOxy)

EXPERIMENTAL

ActiveOxy (1% Hydrogen peroxide) 10 ml gargle and nasal lavage for 20-30 seconds, thrice daily for 6 days.

Drug: Gargle/Mouthwash

Neem extract (Azadirachta indicia)

ACTIVE COMPARATOR

Neem extract (Azadirachta indicia) gargle will be prepared by chemistry laboratory. patients will do 10ml gargle and nasal lavage for 20-30 seconds, thrice daily for 6 days.

Drug: Gargle/Mouthwash

Hypertonic saline (2%NaCl)

ACTIVE COMPARATOR

10 ml gargle and nasal lavage using Hypertonic saline for 20-30 seconds, thrice daily for 6 days.

Drug: Gargle/Mouthwash

Positive controls

PLACEBO COMPARATOR

10 ml gargle and nasal lavage using distilled water for 20-30 seconds, thrice daily for 6 days.

Drug: Gargle/Mouthwash

Interventions

Gargle/Mouthwash DRUG

There will be 50 patients in six study groups. Group A (n=10) patients on 10 ml gargle and nasal lavage using 0.2% Povidone-Iodine (Betadiene®) for 20-30 seconds, thrice daily for 6 days. Group B (n=10) patients will be subjected to 10 ml gargle and nasal lavage using 1% Hydrogen peroxide (ActiveOxy®) for 20-30 seconds, thrice daily for 6 days. Group C will comprised of (n=10) subjects on 10ml gargle and nasal lavage using Neem extract solution (Azardirachta indica) formulated locally) for 20-30 seconds, thrice daily for 6 days. Group D (n=10) patients will use 2% hypertonic saline (Plabottle®) gargle and nasal lavage for a similar time period. Group E (n=10) will serve as positive controls. These will be given simple distilled water gargles and nasal lavage for 20-30 seconds, thrice daily for six days Whereas Group F (n=5) will comprise of negative controls, who will not use any gargles or nasal lavage during study period.

Also known as: Gargling agent, Mouthrinse

Hydrogen peroxide 1% (ActiveOxy); Hypertonic saline (2%NaCl); Neem extract (Azadirachta indicia); Positive controls; Povidone-Iodine 0.2% (BETADINE®)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Edentulous patients, patients with low Glasgow coma score, intubated, immune-compromised, history of radiotherapy or chemotherapy will be excluded. Patients with known pre-existing chronic mucosal lesions such as lichen planus will also be excluded.

Sponsors & Collaborators

• Aga Khan University: lead
• University of Karachi: collaborator

Related Publications (21)

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  PMID: 32936948 DERIVED

• Khan FR, Kazmi SMR, Iqbal NT, Iqbal J, Ali ST, Abbas SA. A quadruple blind, randomised controlled trial of gargling agents in reducing intraoral viral load among hospitalised COVID-19 patients: A structured summary of a study protocol for a randomised controlled trial. Trials. 2020 Sep 14;21(1):785. doi: 10.1186/s13063-020-04634-2.

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Related Links

• Burden of disease in COVID-19 pandemic
• Recommendation on elective and cosmetic dental procedures by ADA
• Report on mortality of doctors and nurses combating corona virus pandemic

MeSH Terms

Conditions

COVID-19

Interventions

Mouthwashes

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Biomedical and Dental Materials; Specialty Uses of Chemicals; Chemical Actions and Uses; Cosmetics; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Syed MR Kazmi, FCPS

  Aga Khan University

  STUDY DIRECTOR

Central Study Contacts

Farhan R Khan, MS, FCPS

CONTACT

03052225117; farhan.raza@aku.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Identical colored and shaped bottles containing different study drugs. This will be provided by the pharmacy services of the university hospital.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: A quadruple blind randomized controlled trial followed by laboratory based analysis. Six parallel groups of participants using various gargles and nasal lavage.

Study Record Dates

• First Submitted: April 6, 2020
• First Posted: April 10, 2020
• Study Start: December 1, 2021
• Primary Completion: June 30, 2022
• Study Completion: July 31, 2022
• Last Updated: July 20, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share