NCT04941131

The Role of Chlorhexidine in Minimizing the Viral Load Among COVID-19 Patients

Completed Phase 4 Results posted Last updated 12 June 2025

What this trial tests

Phase 4 trial testing Chlorhexidine digluconate, povidone iodine in COVID-19 in 60 participants. Completed in 20 August 2023.

Timeline

18 May 2023

Primary endpoint
25 July 2023

20 August 2023

Quick facts

Lead sponsor	King Abdulaziz University
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	60
Start date	18 May 2023
Primary completion	25 July 2023
Estimated completion	20 August 2023
Sites	1 location across Saudi Arabia

Drugs / interventions tested

• Chlorhexidine digluconate, povidone iodine — full drug profile →

Conditions studied

• COVID-19 — all drugs for COVID-19 →

Sponsor

King Abdulaziz University

Who can join

Adults 21 to 80, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

E Genes Primary · 6 months

Gene viral load serves as a proxy measure for the presence and quantity of SARS-CoV-2 virus in patient samples. Since the E gene is expressed early and reliably during viral replication, changes in its detected levels reflect the dynamics of viral presence. Quantified using RT-qPCR, with results expressed as cycle threshold (Ct) values-the number of amplification cycles required to detect the gene above background levels. Lower Ct values indicate higher viral loads.

Group	Value	95% CI
Chlorhexidine Digluconate Mouthwash	28.50	± 5.21
Chlorhexidine Digluconate Lozenges	27.33	± 4.9
Povidone Iodine Mouthwash	30.28	± 6.33
Tap Water	27.80	± 4.33

S Genes Secondary · 6 months

Gene viral load serves as a proxy measure for the presence and quantity of SARS-CoV-2 virus in patient samples. Since the S gene is expressed early and reliably during viral replication, changes in its detected levels reflect the dynamics of viral presence. Quantified using RT-qPCR, with results expressed as cycle threshold (Ct) values-the number of amplification cycles required to detect the gene above background levels. Lower Ct values indicate higher viral loads.

Group	Value	95% CI
Chlorhexidine Digluconate Mouthwash	27.86	± 5.89
Chlorhexidine Digluconate Lozenges	26.74	± 5.27
Povidone Iodine Mouthwash	28.09	± 6.37
Tap Water	27.87	± 3.83

Sponsor's own description

Existing evidence confirmed that saliva and oral cavity to be a reservoir for SARS-CoV-2. In dental clinic aerosol-producing-procedures pose a significant risk for transmission of the infection . It is very important to minimize the risk of transmission in dental office reducing the load of SARS-CoV-2 in saliva if possible, in suspect or conformed cases. Preprocedural mouth rises have been used widely to minimize the number of oral microorganisms. Multiple studies confirmed the efficacy of those mouth rinses in reducing the possibility of transmission of SARS-CoV-2 infection .

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The short-term effect of different chlorhexidine forms versus povidone iodine mouth rinse in minimizing the oral SARS-CoV-2 viral load: An open label randomized controlled clinical trial study.
   Natto ZS, Bakhrebah MA, Afeef M, Al-Harbi S, et al · · 2022 · cited 11× · PMID 35905275 · DOI 10.1097/md.0000000000028925