Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202108837577420 Date of Approval: 20/08/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of Antimicrobial Mouthwashes on the Detection of SARS-COV-2 in Ghana
Official scientific title Viral shedding dynamics and the effect of antimicrobial mouthwashes on the detection of SARS-COV-2 in Ghana
Brief summary describing the background and objectives of the trial In Ghana, up to 95% of individuals confirmed positive for SARS-CoV-2 by RTPCR are asymptomatic. However, RTPCR testing cannot tell if the individual is shedding viable virus. While some studies have investigated viral shedding dynamics in symptomatic patients, not much have been done for asymptomatic patients, especially in Africa. Furthermore, healthcare personnel (HCP) have been disproportionately affected by COVID-19, and a major factor accounting for HCP infections are asymptomatic clients shedding SARS-CoV-2. The primary goal of this study is to determine the viral shedding dynamics among asymptomatic persons infected with SARS-CoV-2 and find ways to reduce the spread of infections in the outpatient setting. We will do this by looking at the following specific objectives: Objective 1: Quantify the viral load of SARS-CoV-2 in the mouth and nasopharynx of confirmed asymptomatic COVID-19 individuals in Ghana. Objective 2: Determine the ability of four common antimicrobial mouthwashes to reduce the viral load of SARS-CoV-2 in the mouth and nasopharynx of infected asymptomatic individuals.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied COVID-19
Purpose of the trial Prevention
Anticipated trial start date 01/08/2021
Actual trial start date
Anticipated date of last follow up 31/12/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 216
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Chlorhexidine mouth wash 5 mls of 0.2% Chlorhexidine mouthwash (Corsodyl) used as a mouthwash/ gargle once. 2 minutes Baseline NP swabs will be taken by a well-trained health professional in recommended personal protective equipment (PPE). 5 mls of 0.2% Chlorhexidine mouthwash would be poured into paper cups and given to the participant. The participant would be asked to gently gargle the mouthwash for 2 minutes with head tilted backwards, as far back as possible without swallowing. New NP swab sampling will be done at 15, 30 and 60 minutes after the intervention. 54
Experimental Group Wokadine Mouthwash 5 mls Povidone Iodine 2% w/v mouthwash 2 minutes Baseline NP swabs will be taken by a well-trained health professional in recommended personal protective equipment (PPE). 5mls Povidone Iodine 2% w/v mouthwash would be poured into a paper cup and given to the participant. The participant would be asked to gently gargle the mouthwash for 2 minutes with head tilted backwards, as far back as possible without swallowing. New NP swap sampling will be done at 15, 30 and 60 minutes after the intervention. 54
Experimental Group Hydrogen Peroxide Mouthwash 5 ml Hydrogen Peroxide Solution 3% 2 minutes Baseline NP swabs will be taken by a well-trained health professional in recommended personal protective equipment (PPE). 5mls Hydrogen Peroxide Solution 3% mouthwash would be poured into a paper cup and given to the participant. The participant would be asked to gently gargle the mouthwash for 2 minutes with head tilted backwards, as far back as possible without swallowing. New NP swap sampling will be done at 15, 30 and 60 minutes after the intervention. 54
Control Group Warm saline mouth rinse 5 mls Warm (35-38 C) saline mouth rinse to be used once 2 minutes Baseline NP swabs will be taken by a well-trained health professional in recommended personal protective equipment (PPE). 5mls warm (35-38 C) saline mouth rinse would be poured into a paper cup and given to the participant. The participant would be asked to gently gargle the mouthwash for 2 minutes with head tilted backwards, as far back as possible without swallowing. New NP swap sampling will be done at 15, 30 and 60 minutes after the intervention. 54 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Ghanaian adults with confirmed diagnoses of COVID-19 Persons who are willing, and consent to be part of the study Critically ill COVID-19 persons Medical condition, laboratory finding, or physical exam finding that precludes participation Persons who are allergic to any of the antimicrobial agents to be tested Persons with illnesses that prevent them from talking Pregnant and breastfeeding women 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 100 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 01/03/2021 Ghana Health Service Ethical Review Committee
Ethics Committee Address
Street address City Postal code Country
Ghana Health Service Ethical Review Research and Development Division Ghana Health Service Adabraka Polyclinic Opposite Accra Psychiatric Hospital Cathedral Square Castle Road Accra Accra MB190 Ghana
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 14/07/2021 THE NOGUCHI MEMORIAL INSTITUTE FOR MEDICAL RESEARCH INSTITUTIONAL REVIEW BOARD
Ethics Committee Address
Street address City Postal code Country
Kajima Building Noguchi Memorial Institute for Medical Research University of Ghana Legon Accra Accra LG581 Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome A reduction in viral load of SARS-CoV-2 15, 30 and 60 minutes after Intervention
Secondary Outcome The time taken for reduction in viral load to be maintained 15, 30 and 60 minutes after Intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Noguchi Memorial Institute for Medical Research University of Ghana Legon Accra Noguchi Memorial Institute for Medical Research University of Ghana Legon Accra Acca LG 581 Ghana
Ga East Municipal Hospital. Haatso Atomic Road GA-029-4296 Accra GA-029-4 Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
National research foundation Covid19 Africa rapid grant fund Meiring Naude Road Brummeria PO Box 2600 Pretoria, 0001 South Africa Pretoria 2600 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor National Research Foundation South Africa Meiring Naude Road Brummeria PO Box 2600 Pretoria, 0001 South Africa Pretoria South Africa Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Ghana Health Service Dodoo Ln, Accra Accra GA1434609 Ghana
Noguchi Memorial Institute for Medical Research University of Ghana Legon Accra Ghana
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator George Boateng Kyei gkyei@noguchi.ug.edu.gh +233551989937 Noguchi Memorial Institute for Medical Research
City Postal code Country Position/Affiliation
Accra Ghana Senior Research Fellow Noguchi Memorial Institute for Medical Research
Role Name Email Phone Street address
Scientific Enquiries Sandra Hewlett shewlett@ug.edu.gh +233208112262 University of Ghana Dental school
City Postal code Country Position/Affiliation
Accra Ghana Senior Lecturer University of Ghana Dental School
Role Name Email Phone Street address
Public Enquiries Paa Kwesi Blankson pkblankson@yahoo.com +233208887878 Department of Oral and maxillofacial surgery Korle Bu teaching Hospital
City Postal code Country Position/Affiliation
Accra Ghana Dental Surgeon Korle Bu teaching Hospital
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes There is a plan to make IPD and related data dictionaries available and this will include all IPD that underlie results in a publication. Informed Consent Form,Statistical Analysis Plan,Study Protocol Between 6 months and 3 years after the completion of study Access to IPD and any additional supporting information will be shared by requesting directly through mail to the Co-PI at sandrahewlett@yahoo.co.uk, this would be shared with anyone with a sound methodology and for general statistical analyses , mechanism of Information will be via direct email.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information