NCT04425850: IVERCAR

USEFULNESS of Topic Ivermectin and Carrageenan to Prevent Contagion of Covid 19

Completed Results posted Last updated 19 October 2020

What this trial tests

trial testing Iota carrageenan nasal spray and Ivermectin oral drops (used as buccal drops) in Covid19 in 229 participants. Completed in 10 August 2020.

Timeline

1 June 2020

Primary endpoint
10 August 2020

10 August 2020

Quick facts

Lead sponsor	Eurnekian Public Hospital
Status	Completed
Study type	OBSERVATIONAL
Enrollment	229
Start date	1 June 2020
Primary completion	10 August 2020
Estimated completion	10 August 2020
Sites	1 location across Argentina

Drugs / interventions tested

• Iota carrageenan nasal spray and Ivermectin oral drops (used as buccal drops)

Conditions studied

• Covid19 — all drugs for Covid19 →

Sponsor

Eurnekian Public Hospital

Who can join

18 and older, any sex, with Covid19. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Infected Subjects Primary · 28 days

Number of participants testing positive for COVID-19 after inclusion in each arm

Group	Value	95% CI
IVER+	0
IVER-	11

Adverse Events Other Than Those Resulting From Contagion or Disease Progression Secondary · 28 days

Adverse events reported by subjects of each arm are recorded other than those resulting from contagion or disease progression

Group	Value	95% CI
IVER+	0
IVER-	0

Adverse events — posted to ClinicalTrials.gov

Time frame: 30 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

IVER+

Serious: 0/131 (0%)

Deaths: 0/131

IVER-

Serious: 0/98 (0%)

Deaths: 0/98

Other adverse events (1 terms — click to expand)

Reaction	System	IVER+	IVER-
Contagion	Infections and infestations	—	—

Data from ClinicalTrials.gov NCT04425850 adverse events section.

Sponsor's own description

Estimation of the prevalence and contagiousness of undocumented novel coronavirus infections is critical for understanding the overall prevalence and pandemic potential of this disease.

It is estimated that 86% of all infections were undocumented \[95% credible interval (CI): 82-90%\] before the 23 January 2020 travel restrictions. The transmission rate of undocumented infections per person was 55% the transmission rate of documented infections (95% CI: 46-62%), yet, because of their greater numbers, undocumented infections were the source of 79% of the documented cases.

Ivermectin + Carrageenan, taking advantage of their virucidal effects, are aimed at reducing the contagion.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Ivermectin as a potential drug for treatment of COVID-19: an in-sync review with clinical and computational attributes.
   Kaur H, Shekhar N, Sharma S, Sarma P, et al · · 2021 · cited 52× · PMID 33389725 · DOI 10.1007/s43440-020-00195-y
2. Ivermectin as a Broad-Spectrum Host-Directed Antiviral: The Real Deal?
   Jans DA, Wagstaff KM. · · 2020 · cited 52× · PMID 32942671 · DOI 10.3390/cells9092100
3. Antiviral Strategies Using Natural Source-Derived Sulfated Polysaccharides in the Light of the COVID-19 Pandemic and Major Human Pathogenic Viruses.
   Ray B, Ali I, Jana S, Mukherjee S, et al · · 2021 · cited 38× · PMID 35062238 · DOI 10.3390/v14010035
4. The antiviral activity of iota-, kappa-, and lambda-carrageenan against COVID-19: A critical review.
   Frediansyah A. · · 2021 · cited 29× · PMID 34222718 · DOI 10.1016/j.cegh.2021.100826
5. The broad spectrum host-directed agent ivermectin as an antiviral for SARS-CoV-2 ?
   Jans DA, Wagstaff KM. · · 2021 · cited 26× · PMID 33341233 · DOI 10.1016/j.bbrc.2020.10.042
6. COVID-19 associated complications and potential therapeutic targets.
   Monpara JD, Sodha SJ, Gupta PK. · · 2020 · cited 21× · PMID 32926918 · DOI 10.1016/j.ejphar.2020.173548
7. The Potential of Dietary Bioactive Compounds against SARS-CoV-2 and COVID-19-Induced Endothelial Dysfunction.
   Losso JN. · · 2022 · cited 9× · PMID 35268723 · DOI 10.3390/molecules27051623
8. Potential Prophylactic Treatments for COVID-19.
   Ben-Zuk N, Dechtman ID, Henn I, Weiss L, et al · · 2021 · cited 9× · PMID 34372498 · DOI 10.3390/v13071292