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Efficacy of a nasal spray containing Iota-Carrageenan in the prophylaxis of COVID-19 in hospital personnel dedicated to patients care with COVID-19 disease A pragmatic multicenter, randomized, double-blind, placebo-controlled trial (CARR-COV-02)

Figueroa et al., International Journal of General Medicine, doi:10.2147/IJGM.S328486 (date from preprint), CARR-COV-02, NCT04521322
Apr 2021  
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Symp. case 80% Improvement Relative Risk Iota-carrageenan  CARR-COV-02  Prophylaxis  DB RCT Is prophylaxis with iota-carrageenan beneficial for COVID-19? Double-blind RCT 394 patients in Argentina (July - December 2020) Fewer symptomatic cases with iota-carrageenan (p=0.03) Figueroa et al., Int. J. General Medic.., Apr 2021 Favorscarrageenan Favorscontrol 0 0.5 1 1.5 2+
Prophylaxis RCT with 394 healthcare workers, 196 treated with iota-carrageenan, showing significantly lower symptomatic cases with treatment. There were no deaths or hospitalizations. There was a significant number of PCR- symptomatic cases (7.6% treatment and 8.6% control). The two treatment cases occurred shortly after randomization - infection may have occurred before the start of treatment.
Targeted administration to the respiratory tract provides treatment directly to the typical source of initial SARS-CoV-2 infection and replication, and allows for rapid onset of action, higher local drug concentration, and reduced systemic side effects.
risk of symptomatic case, 80.2% lower, RR 0.20, p = 0.03, treatment 2 of 196 (1.0%), control 10 of 198 (5.1%), NNT 25, odds ratio converted to relative risk.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Figueroa et al., 15 Apr 2021, Double Blind Randomized Controlled Trial, Argentina, peer-reviewed, 18 authors, study period 24 July, 2020 - 20 December, 2020, trial NCT04521322 (history) (CARR-COV-02).
This PaperIota-carragee..All
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
International Journal of General Medicine, doi:10.2147/ijgm.s328486
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, doubleblind, 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 (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.
Funding The study did not receive any support for hospitals, staff or patients involved. Publication and administrative costs were supported by: Programa de articulación y fortalecimiento federal de las capacidades en ciencia y tecnología COVID- International Journal of General Medicine Dovepress
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