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

Abstract

Juan Manuel Figueroa,1 Mónica Edith Lombardo,2,3 Ariel Dogliotti,4 Luis Pedro Flynn,5 Robert Giugliano,6 Guido Simonelli,7 Ricardo Valentini,2 Agñel Ramos,8 Pablo Romano,9 Marcelo Marcote,10 Alicia Michelini,11 Alejandro Salvado,12 Emilio Sykora,13 Cecilia Kniz,14 Marcelo Kobelinsky,15 David Manuel Salzberg,16 Diana Jerusalinsky,17 Osvaldo Uchitel18 1Sleep and Respiratory Research Center, Instituto de Ciencia y Tecnología Cesar Milstein, Ciudad Autónoma de Buenos Aires, Argentina; 2Clinical Research Unit, Hospital Universitario CEMIC, Ciudad Autónoma de Buenos Aires, Argentina; 3Scientific Direction, Nobeltri S.R.L, Ciudad Autónoma de Buenos Aires, Argentina; 4Department of Cardiology, Instituto Cardiovascular de Rosario, Rosario, Santa Fe, Argentina; 5Department of Infectology, Sanatorio de Niños de Rosario, Rosario, Santa Fe, Argentina; 6Division of Cardiovascular Medicine, Brigham and Women’s Hospital, and Department of Medicine, Harvard Medical School, Boston, MA, USA; 7Département de Médecine, Université de Montréal and Centre d’études avancées en médecine du sommeil, Hôpital du Sacré-Coeur de Montréal, Montréal, Quebec, Canada; 8Intensive Care Department, Sanatorio Parque de Rosario, Rosario, Santa Fe, Argentina; 9Otolaryngology Department, Clínica y Maternidad Santa Isabel, Ciudad Autónoma de Buenos Aires, Argentina; 10Medical Direction Department, Hospital Interzonal de Agudos Pte. Perón, Avellaneda, Buenos Aires, Argentina; 11Pulmonology Department, Hospital Pediátrico Avelino Castelán, Resistencia, Chaco, Argentina; 12Pulmonology Department, Hospital Británico de Buenos Aires, Ciudad Autónoma de Buenos Aires, Argentina; 13Department of Medicine, Clínica Monte Grande, Monte Grande, Buenos Aires, Argentina; 14Pulmonology Department, Hospital 4 de Junio Dr Ramón Carrillo, Chaco, Argentina; 15Medical Direction, Clínica Modelo De Morón, Morón, Provincia de Buenos Aires, Argentina; 16Department of Family Medicine, Hospital Gral. de Agudos Dr. Teodoro Alvarez, Ciudad Autónoma de Buenos Aires, Argentina; 17Cell Biology and Neurosciences Institute (IBCN), Buenos Aires University–CONICET, Ciudad Autónoma de Buenos Aires, Argentina; 18Institute of Physiology, Molecular Biology and Neurosciences, Buenos Aires University-CONICET, Ciudad Autónoma de Buenos Aires, ArgentinaCorrespondence: Juan Manuel FigueroaInstituto de Ciencia y Tecnología Cesar Milstein, Ciudad Autónoma de Buenos Aires, ArgentinaEmail [email protected]: 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, prophylaxis, nasal, spray, hospital workers

Keywords

• covid-19
• prophylaxis
• nasal
• spray
• hospital workers