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

Juan Manuel Figueroa, Mónica Edith Lombardo, Ariel Dogliotti, Luis Pedro Flynn, Robert Giugliano, Guido Simonelli, Ricardo Valentini, Agñel Ramos, Pablo Romano, Marcelo Marcote, Alicia Michelini, Alejandro Salvado, Emilio Sykora, Cecilia Kniz, Marcelo Kobelinsky, David Manuel Salzberg, Diana Jerusalinsky, Osvaldo Uchitel, Juan Manuel Figueroa, Mónica Edith Lombardo, Ariel Dogliotti, Luis Pedro Flynn, Robert Giugliano, Guido Simonelli, Ricardo Valentini, Agñel Ramos, Pablo Romano, Marcelo Marcote, Alicia Michelini, Alejandro Salvado, Emilio Sykora, Cecilia Kniz, Marcelo Kobelinsky, David Manuel Salzberg, Diana Jerusalinsky, Osvaldo Uchitel

Abstract

Background: Iota-Carrageenan (I-C) is a sulfate polysaccharide synthesized by red algae, with demonstrated antiviral activity and clinical efficacy as nasal spray in the treatment of common cold. In vitro, I-C inhibits SARS-CoV-2 infection in cell culture.

Research question: Can a nasal spray with Iota-Carrageenan be useful in the prophylaxis of COVID-19 in health care workers managing patients with COVID-19 disease?

Study design and methods: This is a pilot pragmatic multicenter, randomized, double-blind, placebo-controlled study assessing the use of a nasal spray containing I-C in the prophylaxis of COVID-19 in hospital personnel dedicated to care of COVID-19 patients. Clinically healthy physicians, nurses, kinesiologists and other health care providers managing patients hospitalized for COVID-19 were assigned in a 1:1 ratio to receive four daily doses of I-C spray or placebo for 21 days. The primary end point was clinical COVID-19, as confirmed by reverse transcriptase polymerase chain reaction testing, over a period of 21 days. The trial is registered at ClinicalTrials.gov (NCT04521322).

Results: A total of 394 individuals were randomly assigned to receive I-C or placebo. Both treatment groups had similar baseline characteristics. The incidence of COVID-19 differs significantly between subjects receiving the nasal spray with I-C (2 of 196 [1.0%]) and those receiving placebo (10 of 198 [5.0%]). Relative risk reduction: 79.8% (95% CI 5.3 to 95.4; p=0.03). Absolute risk reduction: 4% (95% CI 0.6 to 7.4).

Interpretation: In this pilot study a nasal spray with I-C showed significant efficacy in preventing COVID-19 in health care workers managing patients with COVID-19 disease.

Clinical trials registration: NCT04521322.

Keywords: COVID-19; hospital workers; nasal; prophylaxis; spray.

Conflict of interest statement

Dr Juan Manuel Figueroa report grantfrom Programa de articulación y fortalecimiento federal de las capacidades en ciencia y tecnología COVID-19, Proyecto CABA 20. Ministerio de Ciencia, Tecnología e Innovación, Argentina; Freely provided drug and placebo samples from Laboratorio Pablo Cassará, during the conduct of the study; personal fees from Laboratorio Pablo Cassará, outside the submitted work; Dr Mónica Lombardo report personal fees from Laboratorio Pablo Cassará, outside the submitted work, is a Director of Scientific Affairs at Nobeltri S.R.L; Dr Robert Giugliano report personal fees from Astra Zeneca, personal fees from CVS Caremark, personal fees from Pfizer, personal fees from Novartis, outside the submitted work; and Institutional research grant to the TIMI Study Group at Brigham and Women’s Hospital for research he is not directly involved in from Abbott; Aralez; AstraZeneca; Bayer; Eisai; GlaxoSmithKline; Intarcia; Janssen Research and Development; Medicines Company; MedImmune; Novartis; Poxel; Pfizer; Quark Pharmaceuticals; Roche; Takeda; Zora Biosciences. The authors report no other conflicts of interest in this work.

© 2021 Figueroa et al.

Figures

Figure 1
Figure 1
Study flowchart.
Figure 2
Figure 2
Kaplan-Meier survival plot of COVID-19 disease in the trial participants.

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