USEFULNESS of Topic Ivermectin and Carrageenan to Prevent Contagion of Covid Among Healthy People and Health Personnel
Conditions: Covid19
Sponsor: Eurnekian Public Hospital

 
 
 
 
STUDY OFFICIAL TITLE (original title is in Spanish. This 
is a translation into English) 
Topical Ivermectin and Iota Carrageenan 
 
REGISTRY NUMBER (CLINICALTRIALS.GOV) 
NCT04425850 
 
DATE: May 29th, 2020 (last update approved by Ethics 
Committee of Eurnekian Hospital) 
 
 

IVERCAR – STUDY PROTOCOL (SUMMARY) 
 
OBJECTIVES 
Evaluate the effect of the use of repeated doses of buccal ivermectin associated with nasal and 
buccal administration of iota-carrageenan as add-on preventive treatment on contagion and 
progression of COVID-19 in a population of healthy individuals exposed to SARS-CoV-2 with 
increased risk of contagion, i.e. health-care personnel working in Eurnekian Public Hospital, 
compared to standard prophylactic measures only. 
 
STUDY HYPOTHESIS 
Healthcare workers have an increased risk to become infected. The beginning of the disease is 
linked to quick viral replication in the oropharynx and nasopharynx. Treatment with ivermectin 
associated with iota-carrageenan applied locally to the nasal and buccal cavity could lower the 
probability of contagion and progression to severe disease and would lower the viral load in the 
upper airways. 
 
STUDY PROTOCOL (SUMMARY) 
 
Study center 
Hospital Interzonal Universitario Dr. Alberto Eurnekian, EZEIZA. (Eurnekian 
Public Hospital, Ezeiza, Province of Buenos Aires, Argentina) 
Study concept 
Efficacy and safety study to evaluate the use of buccal ivermectin and 
associated with buccal and nasal iota carrageenan in the prophylaxis of 
COVID/19 in health-care workers 
Study type 
Prospective, single-center, two-arm parallel, comparative with standard 
prophylactic measures 
Justification 
The emergency of COVID-19 requires the urgent development of strategies 
to avoid the impact of the disease on our population and the saturation of the 
health system and to allow us to carry out adequate treatments to reduce the 
mortality of the disease. 
Upper respiratory tract infection has a major impact on the transmission and 
pathogenesis of SARSCoV2. The role of nasopharynx, saliva and salivary 
glands in the early stage of viral infection is becoming increasingly well 
understood. Any measure located in the nasopharynx and oral cavity to reduce 
viral load, will reduce the level of contagion in the social environment of each 
person. Given that the viral RNA detection diagnostic test is not immediate 
and that contagion control is essential during the first days after infection, this 
treatment, , could contribute to the control of contagion in the first stage of 
infection, even when there are no symptoms of the disease and in suspected 
cases of COVID-19 
We propose the use of buccal Ivermectin associated with nasal and buccal iota 
carrageenan as a topical antiviral treatment. 

Study outcomes 
Primary outcome: infection rate (contagion rate) in each arm 
Secondary outcome: adverse events in each arm (other than those resulting 
from contagion and disease progression) 
Study population 
Healthy healthcare workers at Eurnekian Public Hospital (physicians, nurses, 
patient transporters, administrative staff, cleaning staff, kitchen staff) who 
accepted to take part in this protocol either in the treated or untreated arm of 
the study 
Elegibility criterio 
Inclusion criteria 
1. Not younger than 18 years of either sex 
2. Health personnel from the Dr. Alberto Eurnekian Interzonal University 
Hospital 
3. No COVID-19 related symptoms 
4. Able to understand and give written informed consent 
 
Exclusion criteria 
1. Known hypersensitivity or allergy to any component of the product under 
evaluation 
2. Age under 18 years 
3. Use of immunosuppressants (including systemic corticosteroids) in the past 
30 days. 
4. Pregnant or nursing. 
5. Patients with other acute infectious diseases. 
6. Patients with autoimmune disease and / or decompensated chronic diseases. 
7. Unable to fulfill the administrative tasks proposed by the study. 
8. Infection with SARSCoV-2 confirmed by PCR or rapid test authorized by 
ANMAT. 
 
Discontinuation criteria 
1. All subjects who use any other nasal or oral topical medication during the 
study period (sprays or nebulization with decongestants, corticosteroids, 
antibiotics, etc.) will be discontinued. 
2. Development of any serious or severe adverse drug reaction that, at the 
discretion of the researcher, puts the subject under study at risk 
 
Treatment  
Ivermectin oral drops (6 mg/ml), Certificate No. 58.382, ANMAT 
Iota-carrageenan (0.17 mg / shot) nasal spray, Certificate No.57.232, ANMAT 
 
Each application consists of: 
One shot of iota carrageenan nasal spray in each nostril and 4 shots in the oral 
cavity. 
After five minutes, apply 1 oral drop of ivermectin (200 µg of ivermectin) on 
the tongue. 
Food and drink consumption avoided 1 hour before and after treatment. 
 

Posology 
This application must be repeated 5 times a day, each 4 hours. The last 
application should be just before night rest. In this case, less than 4 hours may 
have passed by from the previous application. 
Study design 
The study consists of 5 visits at Eurnekian Public Hospital and/or daily remote 
monitoring, according to the following schedule: 
• 
Visit 1 (Day 0): informed consent, check of eligibility criteria, 
physical examination, questionnaire of symptoms, explanation 
about remote monitoring, nasopharyngeal swabbing for COVID-19 
detection by rtPCR or quick LAMP-based test, delivery of drugs to 
patients. 
• 
Visit 2 (Day 7): physical examination, record of adverse events, 
questionnaire of symptoms, nasopharyngeal swabbing for COVID-
19 testing. 
• 
Visit 3 (Day 14): physical examinatioin, record of adverse events, 
questionnaire of symptoms, nasopharyngeal swabbing for COVID-
19 testing. 
End of treatment: both groups continue to use standard prophylactic 
measures. 
• 
Visit 4 (Day 21): physical examination, record of adverse events, 
questionnaire of symptoms.  
• 
Visit 5 (Day 28): physical examination, record of adverse events, 
questionnaire of symptoms. End of study 
Statistical analysis 
Chi-squared test for contagion rate in each group.