The Effect of Novel D3 Use as a Mouthwash in COVID-19 Patients

King Faisal Specialist Hospital & Research Center

Status and phase: Completed; Phase 1

Conditions: Corona Virus Disease 19 (COVID-19)

Treatments: Drug: Cholecalciferol (vitaminD3)

Study type: Interventional

Funder types: Other

Identifiers

NCT07068282

2022-32

Details and patient eligibility

About

The PI's goal of this [interventional/clinical trial] is to [explore the antiviral properties of vitamin D3 on saliva samples collected before and after the use of a vitamin D3 mouthwash] in [ adult participants, both genders, with COVID-19 who tested positive on a swab test]. The main question[s] aims to answer [is]:

[Assess the antiviral potential of a novel vitamin D-based mouthwash in COVID-19-positive participants].

PI will compare both [Control group: saliva only- before use of mouthwash], and the [study group: after use of the mouthwash in saliva] to see if there is [any veridical effect present in saliva after running lab tests].

Participants will [self-collect saliva in a given tube (color coded orange), then 10-15 minutes later or more, participants will swish with D3 mouthwash, and will give another sample [saliva + mouthwash] in another (green labeled tube). For each participant, each of the following will be given:

• 2 collecting tubes: orange labeled tube (for saliva collection only) and green labeled tube (for saliva collection after mouthwash use).
• The vial containing vitamin D3 mouthwash.

Full description

Twenty-five adult participants confirmed COVID-19-positive, via rapid antigen testing (RAT) thru nasal swabs (NS), followed by saliva samples collected before and after using a vitamin D3 mouthwash. Samples were analyzed using RAT and rapid polymerase chain reaction (R-PCR) to measure viral load.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult participants confirmed positive for COVID-19 by RAT.
• Participants at the King Faisal Specialist Hospital & Research Center in Jeddah (KFSHRC, J) outpatient departments (OPD) and/or department of emergency medicine (DEM).

Exclusion criteria

• Immunocompromised and/or pregnant participants.
• Pediatric participants and patients aged <18 years.
• Participants on a high-dose vitamin D prescription (i.e., 10, 000 IU or more).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

D3 mouthwash in COVID-19 saliva

Experimental group

Treatment:

Drug: Cholecalciferol (vitaminD3)