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

BACKGROUNDIota-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 QUESTIONCan a nasal spray with Iota-C...

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Veröffentlicht in:International journal of general medicine 2021, Vol.14, p.6277-6286
Hauptverfasser: Figueroa, Juan Manuel, Lombardo, Mónica Edith, Dogliotti, Ariel, Flynn, Luis Pedro, Giugliano, Robert, Simonelli, Guido, Valentini, Ricardo, Ramos, Agñel, Romano, Pablo, Marcote, Marcelo, Michelini, Alicia, Salvado, Alejandro, Sykora, Emilio, Kniz, Cecilia, Kobelinsky, Marcelo, Salzberg, David Manuel, Jerusalinsky, Diana, Uchitel, Osvaldo
Format: Report
Sprache:eng
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Zusammenfassung:BACKGROUNDIota-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 QUESTIONCan 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 METHODSThis 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).RESULTSA 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).INTERPRETATIONIn 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 REGISTRATIONNCT04521322.
ISSN:1178-7074
1178-7074
DOI:10.2147/IJGM.S328486