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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04341688
Recruitment Status : Not yet recruiting
First Posted : April 10, 2020
Last Update Posted : May 7, 2020
Sponsor:
Collaborator:
University of Karachi
Information provided by (Responsible Party):
Farhan Raza Khan, BDS, MS, FCPS, Aga Khan University

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.


Condition or disease Intervention/treatment Phase
Covid-19 Drug: Gargle/Mouthwash Not Applicable

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A quadruple blind randomized controlled trial followed by laboratory based analysis. Six parallel groups of participants using various gargles and nasal lavage.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Identical colored and shaped bottles containing different study drugs. This will be provided by the pharmacy services of the university hospital.
Primary Purpose: Supportive Care
Official Title: A Quadruple Blind, Randomized Controlled Pilot Trial of Gargling Agents in Reducing Intraoral Viral Load Among Laboratory Confirmed COVID-19 Patients: GARGLES STUDY
Estimated Study Start Date : July 1, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : March 31, 2021

Arm Intervention/treatment
Experimental: Povidone-Iodine 0.2% (BETADINE®)
0.2% Povidone-Iodine (BETADINE®) 10 ml gargle and nasal lavage for 20-30 seconds, thrice daily for 6 days.
Drug: Gargle/Mouthwash

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.

Other Names:
  • Gargling agent
  • Mouthrinse

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

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.

Other Names:
  • Gargling agent
  • Mouthrinse

Active Comparator: Neem extract (Azadirachta indicia)
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

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.

Other Names:
  • Gargling agent
  • Mouthrinse

Active Comparator: Hypertonic saline (2%NaCl)
10 ml gargle and nasal lavage using Hypertonic saline for 20-30 seconds, thrice daily for 6 days.
Drug: Gargle/Mouthwash

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.

Other Names:
  • Gargling agent
  • Mouthrinse

Placebo Comparator: Positive controls
10 ml gargle and nasal lavage using distilled water for 20-30 seconds, thrice daily for 6 days.
Drug: Gargle/Mouthwash

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.

Other Names:
  • Gargling agent
  • Mouthrinse




Primary Outcome Measures :
  1. Intraoral viral load [ Time Frame: Five days of using gargles ]
    Intraoral viral load as deciphered by RT-PCR


Secondary Outcome Measures :
  1. Salivary cytokine profile [ Time Frame: Five days of using gargles ]
    Salivary cytokine profiles of IL-2, IL-4, IL-6, IL-10, TNF-α, IFN-γ and IL-17.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The inclusion criteria are laboratory confirmed Covid-19 positive male or female subjects in the age range of 18-65 years, within seven days of the onset of symptoms of viral infection, already admitted in the hospital.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04341688


Contacts
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Contact: Farhan R Khan, MS, FCPS 03052225117 farhan.raza@aku.edu

Sponsors and Collaborators
Aga Khan University
University of Karachi
Investigators
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Principal Investigator: Syed MR Kazmi, FCPS Aga Khan University
Additional Information:
Publications:

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Responsible Party: Farhan Raza Khan, BDS, MS, FCPS, Associate Professor, Aga Khan University
ClinicalTrials.gov Identifier: NCT04341688    
Other Study ID Numbers: 2020-Sur-ERC-20
First Posted: April 10, 2020    Key Record Dates
Last Update Posted: May 7, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Farhan Raza Khan, BDS, MS, FCPS, Aga Khan University:
Covid-19;
coronavirus disease
povidone
hydrogen peroxide
neem extracts
topical therapy
gargle