Xylitol Based Nasal Spray for COVID-19 Treatment

NCT05618483 | Unknown

• 1 other identifier: 2022-XYLNS-01
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

Xlear have developed and patented a xylitol containing nasal spray for the treatment of upper-respiratory tract infections. The nasal spray is comprised of xylitol and GSE (Grapefruit Seed extract) which provides antibacterial properties as well as preventing viral adhesion in the nasal passage. Studies into Xlear's antiviral effects on SARS-CoV-2 are currently ongoing but hypothetically, a Xylitol Based Nasal spray may prove to be a useful and inexpensive treatment for COVID-19 infection.

Conditions

Respiratory Viral Infection

Outcome Measures

Primary Outcomes (1)

• Viral load reduction

  The between-groups difference in log-viral load over the total treatment period

  Day 0 (baseline), Day 2, 4 6 and 8

Secondary Outcomes (5)

• Undetectable viral load

  baseline to Day 2, 4, 6 and 8

• Hospitalization requirement

  Baseline through Day 8

• Reduction of clinical symptoms score

  Baseline through Day 14

• Tolerability of Nasal Spray

  Baseline through Day 14

• Safety of Nasal Spray

  Baseline through Day 14

Study Arms (2)

Interventional

EXPERIMENTAL

The participants will receive Xylitol based nasal spray

Device: Nasal Spray

Control

PLACEBO COMPARATOR

The participants will receive saline based placebo

Device: Nasal Spray

Interventions

Nasal Spray DEVICE

The nasal spray is made of xylitol and grapefruit seed extract. The spray is antiviral, but there is no data of its clinical efficacy against Covid-19.

Also known as: Xlear nasal spray

Control; Interventional

Eligibility Criteria

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

You may qualify if:

• Capable of understanding and providing signed informed consent and ability to adhere to the requirements and restrictions of this protocol;
• Adult aged ≥18 years old with at least two comorbidities: diabetes (type 1 \&2), obesity (BMI \>30), hypertension, chronic heart disease, chronic pulmonary disease, chronic liver disease.
• Internet access and capability and willingness to participate in audio or audio/video engagements with medical professionals, receive texts, emails, and phone calls from study staff and have a device and reasonable cellular data or other internet access to submit daily study required information using a smart phone, tablet, laptop, or desktop computer during the study period;
• COVID-19 infection confirmed with a laboratory SARS-CoV-2 RT-PCR nasal swab;
• Specimen collected within the past 48 hours;
• Mild COVID-19 symptoms which may include fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, lack of taste or smell without shortness of breath

You may not qualify if:

• Not fit to consent and unable to follow the protocol;
• Age \<18 years;
• Current tracheostomy or laryngectomy;
• Hypersensitivity to the active substance or to any of the excipients;
• Concomitant respiratory therapy such as oxygen or ventilator support. Positive airway pressure for obstructive sleep apnea is permitted if treatment was established with good compliance at least 3 months before enrolment;
• Need for hospitalisation for any reason;
• Inability to safely self-administer nasal spray
• Any clinical contraindications, as judged by the Qualified Medical Practitioner;
• Clinical signs indicative of moderate, severe or critical COVID severity symptoms (as defined by FDA COVID-19 Guidance Document)
• Mentally or neurologically disabled patients who are considered not fit to consent to their participation in the study;
• Lactating, pregnant or planning to become pregnant during the study period;
• Diagnosed with prior COVID-19 infection (\>48 hours from the time the test is reported prior to the time of screening).
• No relevant comorbidity or only one comorbidity

Sponsors & Collaborators

• Xlear, Inc: lead
• Metanoic Health Ltd.: collaborator

Related Publications (18)

• Bansal S, Jonsson CB, Taylor SL, Figueroa JM, Dugour AV, Palacios C, Vega JC. Iota-carrageenan and xylitol inhibit SARS-CoV-2 in Vero cell culture. PLoS One. 2021 Nov 19;16(11):e0259943. doi: 10.1371/journal.pone.0259943. eCollection 2021.

  PMID: 34797868 RESULT

• Boopathi S, Poma AB, Kolandaivel P. Novel 2019 coronavirus structure, mechanism of action, antiviral drug promises and rule out against its treatment. J Biomol Struct Dyn. 2021 Jun;39(9):3409-3418. doi: 10.1080/07391102.2020.1758788. Epub 2020 Apr 30.

  PMID: 32306836 RESULT

• Go CC, Pandav K, Sanchez-Gonzalez MA, Ferrer G. Potential Role of Xylitol Plus Grapefruit Seed Extract Nasal Spray Solution in COVID-19: Case Series. Cureus. 2020 Nov 3;12(11):e11315. doi: 10.7759/cureus.11315.

  PMID: 33173650 RESULT

• He X, Lau EHY, Wu P, Deng X, Wang J, Hao X, Lau YC, Wong JY, Guan Y, Tan X, Mo X, Chen Y, Liao B, Chen W, Hu F, Zhang Q, Zhong M, Wu Y, Zhao L, Zhang F, Cowling BJ, Li F, Leung GM. Author Correction: Temporal dynamics in viral shedding and transmissibility of COVID-19. Nat Med. 2020 Sep;26(9):1491-1493. doi: 10.1038/s41591-020-1016-z.

  PMID: 32770170 RESULT

• Janakiram C, Deepan Kumar CV, Joseph J. Xylitol in preventing dental caries: A systematic review and meta-analyses. J Nat Sci Biol Med. 2017 Jan-Jun;8(1):16-21. doi: 10.4103/0976-9668.198344.

  PMID: 28250669 RESULT

• Komura M, Suzuki M, Sangsriratanakul N, Ito M, Takahashi S, Alam MS, Ono M, Daio C, Shoham D, Takehara K. Inhibitory effect of grapefruit seed extract (GSE) on avian pathogens. J Vet Med Sci. 2019 Mar 30;81(3):466-472. doi: 10.1292/jvms.18-0754. Epub 2019 Feb 4.

  PMID: 30713281 RESULT

• Kontiokari T, Uhari M, Koskela M. Effect of xylitol on growth of nasopharyngeal bacteria in vitro. Antimicrob Agents Chemother. 1995 Aug;39(8):1820-3. doi: 10.1128/AAC.39.8.1820.

  PMID: 7486925 RESULT

• Salehi B, Fokou PVT, Sharifi-Rad M, Zucca P, Pezzani R, Martins N, Sharifi-Rad J. The Therapeutic Potential of Naringenin: A Review of Clinical Trials. Pharmaceuticals (Basel). 2019 Jan 10;12(1):11. doi: 10.3390/ph12010011.

  PMID: 30634637 RESULT

• Salli K, Lehtinen MJ, Tiihonen K, Ouwehand AC. Xylitol's Health Benefits beyond Dental Health: A Comprehensive Review. Nutrients. 2019 Aug 6;11(8):1813. doi: 10.3390/nu11081813.

  PMID: 31390800 RESULT

• Schoeman D, Fielding BC. Coronavirus envelope protein: current knowledge. Virol J. 2019 May 27;16(1):69. doi: 10.1186/s12985-019-1182-0.

  PMID: 31133031 RESULT

• 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 RESULT

• Tu YP, O'Leary TJ. Testing for Severe Acute Respiratory Syndrome-Coronavirus 2: Challenges in Getting Good Specimens, Choosing the Right Test, and Interpreting the Results. Crit Care Med. 2020 Nov;48(11):1680-1689. doi: 10.1097/CCM.0000000000004594.

  PMID: 32826428 RESULT

• Xu ML, Wi GR, Kim HJ, Kim HJ. Ameliorating Effect of Dietary Xylitol on Human Respiratory Syncytial Virus (hRSV) Infection. Biol Pharm Bull. 2016;39(4):540-6. doi: 10.1248/bpb.b15-00773.

  PMID: 27040626 RESULT

• Yin SY, Kim HJ, Kim HJ. Protective effect of dietary xylitol on influenza A virus infection. PLoS One. 2014 Jan 2;9(1):e84633. doi: 10.1371/journal.pone.0084633. eCollection 2014.

  PMID: 24392148 RESULT

• Zabner J, Seiler MP, Launspach JL, Karp PH, Kearney WR, Look DC, Smith JJ, Welsh MJ. The osmolyte xylitol reduces the salt concentration of airway surface liquid and may enhance bacterial killing. Proc Natl Acad Sci U S A. 2000 Oct 10;97(21):11614-9. doi: 10.1073/pnas.97.21.11614.

  PMID: 11027360 RESULT

• Zhou P, Yang XL, Wang XG, Hu B, Zhang L, Zhang W, Si HR, Zhu Y, Li B, Huang CL, Chen HD, Chen J, Luo Y, Guo H, Jiang RD, Liu MQ, Chen Y, Shen XR, Wang X, Zheng XS, Zhao K, Chen QJ, Deng F, Liu LL, Yan B, Zhan FX, Wang YY, Xiao GF, Shi ZL. Addendum: A pneumonia outbreak associated with a new coronavirus of probable bat origin. Nature. 2020 Dec;588(7836):E6. doi: 10.1038/s41586-020-2951-z. No abstract available.

  PMID: 33199918 RESULT

• Reagor L, Gusman J, McCoy L, Carino E, Heggers JP. The effectiveness of processed grapefruit-seed extract as an antibacterial agent: I. An in vitro agar assay. J Altern Complement Med. 2002 Jun;8(3):325-32. doi: 10.1089/10755530260128014.

  PMID: 12165190 RESULT

• Sungnak W, Huang N, Becavin C, Berg M, Queen R, Litvinukova M, Talavera-Lopez C, Maatz H, Reichart D, Sampaziotis F, Worlock KB, Yoshida M, Barnes JL; HCA Lung Biological Network. SARS-CoV-2 entry factors are highly expressed in nasal epithelial cells together with innate immune genes. Nat Med. 2020 May;26(5):681-687. doi: 10.1038/s41591-020-0868-6. Epub 2020 Apr 23.

  PMID: 32327758 RESULT

Related Links

• Cannon, M., Westover, J., Bleher, R., Sanchez-Gonzalez, M. and Ferrer, G. In Vitro Analysis of the Anti-viral Potential of nasal spray constituents against SARS-CoV-2. bioRxiv, 2020. doi/10.1101/2020.12.02.408575
• Ferrer, G., Betancourt, A., Go, C., Vazquez, H., Westover, J., Cagno, V., Tapparel, C. and Sanchez-Gonzalez, M. A Nasal Spray Solution of Grapefruit Seed Extract plus Xylitol Displays Virucidal Activity Against SARS-Cov-2 In Vitro. bioRxiv

MeSH Terms

Interventions

Tobacco Use Cessation Devices

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Ahsan W Rathore, MBBS

  University of Health Sciences Lahore

  PRINCIPAL INVESTIGATOR

• Saqib Mahmood, MBBS PhD

  University of Health Sciences Lahore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Isaac John, PhD

CONTACT

+447798566612; Isaac.John@metanoichealth.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Subjects will be randomized 1:1 to receive the Xylitol Based Nasal Spray or a matching saline base placebo. This is a double blinded study. The Nasal Spray Kits will be randomized and allocated to patients in chronological order.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomization to Nasal Spray or Placebo

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: November 16, 2022
• Study Start: November 28, 2022
• Primary Completion: December 31, 2023
• Study Completion: June 30, 2024
• Last Updated: November 23, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share