Effect of Nasopharyngeal Wash With Normal Saline on SARS-CoV2 Viral Load

NCT05525832 | Completed DMC

• 1 other identifier: 13148
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Although great progress has been made over the past 2 years in the scientific understanding of the biology, epidemiology, and pathogenesis of severe acute respiratory syndrome coronavirus 2 (SARS-CoV2), case morbidity and fatality rates remain a great concern and continue to challenge the healthcare resources worldwide as novel variants emerge. There is therefore an urgent need for affordable and readily available strategies to reduce viral transmission. Previous studies in non coronavirus disease 2019 (COVID-19) patients have demonstrated that administration of low-salt (isotonic but 0.0375% Na) and isotonic saline (0.9% Na) solutions has been associated with an immediate, significant reduction in the microbial antigens and a related decline of microbial burden. The primary aim of the present study is to determine the effect of nasal washes with normal saline 0.9% on nasopharyngeal viral load in hospitalized patients with COVID-19 pneumonia. The secondary aim is to examine if this effect influences escalation to high flow nasal oxygen or non-invasive ventilation and admission to ICU in patients with COVID-19 pneumonia.

Conditions

SARS-CoV2 Infection

Keywords

Nasopharyngeal wash; Normal saline; SARS-CoV2; Viral load

Outcome Measures

Primary Outcomes (1)

• SARS-CoV2 viral load

  SARS-CoV2 viral load in nasopharyngeal swab in hospitalized patients with COVID-19 pneumonia

  24 hours

Secondary Outcomes (1)

• Need for escalation to HFNC / NIV, ICU admission

  From date of randomization until hospital discharge, ICU admission or date of death from any cause, whichever came first assessed up to 3 months

Study Arms (2)

Normal saline group

EXPERIMENTAL

Patients that will receive normal saline 0.9% solution for nasopharyngeal wash

Other: Normal saline

control group

NO INTERVENTION

Patients that will not perform nasopharyngeal washes

Interventions

Normal saline OTHER

Nasopharyngeal washes with NaCl 0.9%

Also known as: NaCl 0.9%

Normal saline group

Eligibility Criteria

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

You may qualify if:

• adult patients hospitalized primarily for COVID-19 pneumonia
• confirmed SARS-CoV2 infection diagnosed through RT-PCR test of nasopharyngeal samples

You may not qualify if:

• patients with confirmed SARS-CoV2 infection who were not primarily admitted for COVID-19 pneumonia
• patients with use of intranasal sprays for at least two weeks prior to study enrollment
• sinonasal surgery within 3 months prior to study enrollment
• patients with sinusitis
• inability to perform nasopharyngeal wash
• participation in other trials

Sponsors & Collaborators

• Larissa University Hospital: lead

Study Sites (1)

University Hospital of Larissa

Larissa, Thessaly, 41110, Greece

Location

Related Publications (7)

• Petersen E, Ntoumi F, Hui DS, Abubakar A, Kramer LD, Obiero C, Tambyah PA, Blumberg L, Yapi R, Al-Abri S, Pinto TCA, Yeboah-Manu D, Haider N, Asogun D, Velavan TP, Kapata N, Bates M, Ansumana R, Montaldo C, Mucheleng'anga L, Tembo J, Mwaba P, Himwaze CM, Hamid MMA, Mfinanga S, Mboera L, Raj T, Aklillu E, Veas F, Edwards S, Kaleebu P, McHugh TD, Chakaya J, Nyirenda T, Bockarie M, Nyasulu PS, Wejse C, Muyembe-Tamfum JJ, Azhar EI, Maeurer M, Nachega JB, Kock R, Ippolito G, Zumla A. Emergence of new SARS-CoV-2 Variant of Concern Omicron (B.1.1.529) - highlights Africa's research capabilities, but exposes major knowledge gaps, inequities of vaccine distribution, inadequacies in global COVID-19 response and control efforts. Int J Infect Dis. 2022 Jan;114:268-272. doi: 10.1016/j.ijid.2021.11.040. Epub 2021 Dec 1. No abstract available.

  PMID: 34863925 BACKGROUND

• Zou L, Ruan F, Huang M, Liang L, Huang H, Hong Z, Yu J, Kang M, Song Y, Xia J, Guo Q, Song T, He J, Yen HL, Peiris M, Wu J. SARS-CoV-2 Viral Load in Upper Respiratory Specimens of Infected Patients. N Engl J Med. 2020 Mar 19;382(12):1177-1179. doi: 10.1056/NEJMc2001737. Epub 2020 Feb 19. No abstract available.

  PMID: 32074444 BACKGROUND

• Jajou R, Mutsaers-van Oudheusden A, Verweij JJ, Rietveld A, Murk JL. SARS-CoV-2 transmitters have more than three times higher viral loads than non-transmitters - Practical use of viral load for disease control. J Clin Virol. 2022 Jun;150-151:105131. doi: 10.1016/j.jcv.2022.105131. Epub 2022 Mar 14.

  PMID: 35395500 BACKGROUND

• Pujadas E, Chaudhry F, McBride R, Richter F, Zhao S, Wajnberg A, Nadkarni G, Glicksberg BS, Houldsworth J, Cordon-Cardo C. SARS-CoV-2 viral load predicts COVID-19 mortality. Lancet Respir Med. 2020 Sep;8(9):e70. doi: 10.1016/S2213-2600(20)30354-4. Epub 2020 Aug 6. No abstract available.

  PMID: 32771081 BACKGROUND

• Rabaan AA, Tirupathi R, Sule AA, Aldali J, Mutair AA, Alhumaid S, Muzaheed, Gupta N, Koritala T, Adhikari R, Bilal M, Dhawan M, Tiwari R, Mitra S, Emran TB, Dhama K. Viral Dynamics and Real-Time RT-PCR Ct Values Correlation with Disease Severity in COVID-19. Diagnostics (Basel). 2021 Jun 15;11(6):1091. doi: 10.3390/diagnostics11061091.

  PMID: 34203738 BACKGROUND

• Tom MR, Mina MJ. To Interpret the SARS-CoV-2 Test, Consider the Cycle Threshold Value. Clin Infect Dis. 2020 Nov 19;71(16):2252-2254. doi: 10.1093/cid/ciaa619. No abstract available.

  PMID: 32435816 BACKGROUND

• Huijghebaert S, Hoste L, Vanham G. Correction to: Essentials in saline pharmacology for nasal or respiratory hygiene in times of COVID-19. Eur J Clin Pharmacol. 2021 Sep;77(9):1295. doi: 10.1007/s00228-021-03141-w. No abstract available.

  PMID: 33893861 BACKGROUND

MeSH Terms

Conditions

COVID-19

Interventions

Saline Solution; Sodium Chloride

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)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Ioannis Pantazopoulos, MD

  University Hospital of Larissa

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Emergency Medicine

Model Details: Randomized Pilot Controlled Trial

Study Record Dates

• First Submitted: August 26, 2022
• First Posted: September 2, 2022
• Study Start: June 1, 2021
• Primary Completion: August 31, 2021
• Study Completion: October 1, 2021
• Last Updated: September 2, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Time Frame: For one year after the end of the study
• Access Criteria: Contact study director by e-mail

Locations

GR (1)