NCT04521322: CARR-COV-02

Efficacy of a Nasal Spray Containing Iota-Carrageenan in the Prophylaxis of COVID-19 Disease in Health Personnel Dedicated to Patients Care With COVID-19 Disease

Status unknown Phase 4 Last updated 21 August 2020

What this trial tests

Phase 4 trial testing Iota-Carrageenan in Covid19 in 400 participants. Status unknown.

Timeline

24 July 2020

Primary endpoint
30 October 2020

30 November 2020

Quick facts

Lead sponsor	Ariel Dogliotti
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	400
Start date	24 July 2020
Primary completion	30 October 2020
Estimated completion	30 November 2020
Sites	1 location across Argentina

Drugs / interventions tested

• Iota-Carrageenan — full drug profile →

Conditions studied

• Covid19 — all drugs for Covid19 →

Sponsor

Ariel Dogliotti

Who can join

18 and older, any sex, with Covid19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Coronaviruses are enveloped viruses with an RNA genome. Carrageenans are sulfate polysaccharides synthesized by red algae. Studies conducted in adults and children with the common cold showed the effectiveness of the use of Carrageenan in nasal spray.

For decades, the antiviral action of Carrageenans has been described in numerous studies with different viruses that infect humans: herpes viruses types 1 and 2, human immunodeficiency virus, human papillomavirus, H1N1 influenza virus, dengue virus, rhinovirus, hepatitis A virus, and enteroviruses. Studies on the dynamics of COVID-19 disease show an intense and rapid pharyngeal multiplication in the first 3-5 days of the onset of symptoms, prior to the onset of pulmonary disease.

Finally, this molecule has shown a viricidal effect against SARS-Cov2 in vitro. All this underscores the potential value of a therapy that inhibits the virus in the rhinopharynx.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Traditional Herbal Medicines, Bioactive Metabolites, and Plant Products Against COVID-19: Update on Clinical Trials and Mechanism of Actions.
   Alam S, Sarker MMR, Afrin S, Richi FT, et al · · 2021 · cited 61× · PMID 34122096 · DOI 10.3389/fphar.2021.671498
2. Efficacy of a Nasal Spray Containing Iota-Carrageenan in the Postexposure Prophylaxis of COVID-19 in Hospital Personnel Dedicated to Patients Care with COVID-19 Disease.
   Figueroa JM, Lombardo ME, Dogliotti A, Flynn LP, et al · · 2021 · cited 55× · PMID 34629893 · DOI 10.2147/ijgm.s328486
3. Therapeutics for COVID-19 and post COVID-19 complications: An update.
   Basu D, Chavda VP, Mehta AA. · · 2022 · cited 44× · PMID 35136858 · DOI 10.1016/j.crphar.2022.100086
4. Iota-carrageenan and xylitol inhibit SARS-CoV-2 in Vero cell culture.
   Bansal S, Jonsson CB, Taylor SL, Figueroa JM, et al · · 2021 · cited 39× · PMID 34797868 · DOI 10.1371/journal.pone.0259943
5. Antiviral Strategies Using Natural Source-Derived Sulfated Polysaccharides in the Light of the COVID-19 Pandemic and Major Human Pathogenic Viruses.
   Ray B, Ali I, Jana S, Mukherjee S, et al · · 2021 · cited 38× · PMID 35062238 · DOI 10.3390/v14010035
6. Probiotics and prebiotics: potential prevention and therapeutic target for nutritional management of COVID-19?
   Batista KS, de Albuquerque JG, Vasconcelos MHA, Bezerra MLR, et al · · 2023 · cited 33× · PMID 34668465 · DOI 10.1017/s0954422421000317
7. 2-Deoxy-D-Glucose and its Derivatives for the COVID-19 Treatment: An Update.
   Huang Z, Chavda VP, Vora LK, Gajjar N, et al · · 2022 · cited 29× · PMID 35496298 · DOI 10.3389/fphar.2022.899633
8. Review of the use of nasal and oral antiseptics during a global pandemic.
   Stathis C, Victoria N, Loomis K, Nguyen SA, et al · · 2021 · cited 21× · PMID 33464122 · DOI 10.2217/fmb-2020-0286