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)
Bibliographic record
Abstract
Summary 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. Methods This is a pragmatic multicenter, randomized, double-blind, placebo-controlled trial 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 others medical providers 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 ). Findings A total of 394 individuals were randomly assigned to receive I-C or placebo. Both treatment groups had similar baseline characteristics. The incidence of COVID19 was significantly lower in the I-C group compared to placebo (1·0% vs 5·0%) (Odds Ratio 0·19 (95% confidence interval 0·05 to 0·77; p= 0·03). Workday loss in placebo group compared to I-Cc were 1.6% days / person (95% ci, 1.0 to 2.2); p <0.0001 There were no differences in the incidence of adverse events across the two groups (17·3% in the I-C group and 15·2% in the placebo group, p= 0·5). Interpretation I-C showed significant efficacy in preventing SARS-Cov-2 infection in hospital personnel dedicated to care patients with COVID-19 disease. Research in context Evidence before this study We searched PubMed for research articles published up to February 14, 2021, with no language restrictions, using the terms “SARS-CoV-2” or “COVID-19”, “prevention”, “clinical trial”, and “prophylaxis”. Except for studies on vaccines we only found three peer-reviewed publications available on the efficacy of Hydroxycholoquine to prevent COVID-19 disease in individuals at risk of exposure. Hydroxychloroquine did not prevent COVID-19 used as pre or postexposure prophylaxis. We also did not find results from clinical trials on the efficacy of carrageenan in the prevention or treatment of cOVID-19. Added value of this study We report the clinical efficacy of a nasal spray with Iota-Carrageenan for the prevention of COVID-19 disease in a randomised, double-blind, placebo-controlled, multicentre study in República Argentina, including 394 participants. Implications of all the available evidence A simple intervention such as the administration of a nasal spray with Iota-Carrageenan, in addition to hand hygiene, use of personal protective equipment and social distancing, could provide additional protection until vaccines can be administered to the majority of the population.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.003 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.002 | 0.001 |
| Insufficient payload (model declined to judge) | 0.004 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".