Ivermectina

IVERMECTINA
Solución oral - Gotas
Experiencia Argentina
medRxiv preprint doi: https://doi.org/10.1101/2020.09.10.20191619.this version posted September 15, 2020. The copyright holder for this
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SAFETY AND EFFICACY OF THE COMBINED USE OF IVERMECTIN,

DEXAMETHASONE, ENOXAPARIN AND ASPIRIN AGAINST COVID 19
Authors
Carvallo Héctor1, Hirsch Roberto2, Farinella María Eugenia3
1
Professor of Internal Medicine, Universidad Abierta Interamericana, Argentina; Academic
Coordinator at Eurnekian Public Hospital, Argentina
2
Director of Postgraduate degree program in Infectious Diseases, Universidad de Buenos Aires,
Argentina; Head of Department of Infectious Diseases at Hospital of Infectious Diseases
Francisco Javier Muñiz, Buenos Aires, Argentina
3
Head of Service of Clinical Medicine at Eurnekian Public Hospital, Argentina
NOTE: This Protocol and its trial were duly submitted to: ClinicalTrials.gov Identifier:
NCT04425863 Eurnekian Public Hospital Protocol Record IDEA, Ivermectin, Dexametasone,
Enoxaparin and Aspirin as treatment for Covid 19.
Abstract
From the first outbreak in Wuhan (China) in December 2019, until today the number of deaths
worldwide due to the coronavirus pandemic exceeds eight hundred thousand people and the
number of infected people arises to more than 25 million.
No treatment tested worldwide has shown unquestionable efficacy in the fight against COVID
19, according to NICE reports.
We have designed an experimental treatment called IDEA based on four affordable drugs already
available on the market in Argentina, based on the following rationale:
- Ivermectin solution at a relatively high dose to lower the viral load in all stages of COVID
19
- Dexamethasone 4-mg injection, as anti-inflammatory drug to treat hyperinflammatory
reaction to COVID-infection
- Enoxaparin injection as anticoagulant to treat hypercoagulation in severe cases.
- Aspirin 250-mg tablets to prevent hypercoagulation in mild and moderate cases
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perpetuity.
Except for Ivermection oral solution, which was used in a higher dose than approved for
parasitosis, all other drugs were used in the already approved dose and indication. Regarding
Ivermectin safety, several oral studies have shown it to be safe even when used at daily doses
much higher than those approved already.
A clinical study has been conducted on COVID-19 patients at Eurnekian Hospital in the Province
of Buenos Aires, Argentina. The study protocol and its final outcomes are described in this article.
Results were compared with published data and data from patients admitted to the hospital
receiving other treatments.
None of the patient presenting mild symptoms needed to be hospitalized. Only one patient died
(0.59 % of all included patients vs. 2.1 % overall mortality for the disease in Argentina today; 3.1
% of hospitalized patients vs. 26.8 % mortality in published data). IDEA protocol appears to be a
useful alternative to prevent disease progression of COVID-19 when applied to mild cases and to
decrease mortality in patients at all stages of the disease with a favorable risk-benefit ratio.
Introduction
In late December 2019, the incidence of atypical pneumonia cases of unknown cause was reported
in the Chinese city of Wuhan. PCR (Polymerase Chain Reaction) studies found a new
coronavirus, named SARS-CoV-2. The disease caused by the virus has been named COVID-19.
To design a treatment protocol using affordable, already marketed drugs, we have considered the
information already available about SARS-CoV-2 and COVID-19.
SARS-CoV 2 proved to be remarkably similar to SARS-CoV, the only significant different bein
a furin-binding domain in the SARS-CoV-2 protein S, which may expand tropism or increase
virus transmission (1). Studies on several RNA viruses
(2). Moreover, entry of SARS-CoV-2 into cells is facilitated by its optimized
binding to ACE2 (angiotensin conversion enzyme 2) (3). This enzyme acts a receptor for SARS-
CoV-2 and is found in multiple tissues (4, 5, 6), including alveolar epithelium of the lung, arterial
and venous endothelium, smooth muscle, renal tubular epithelium, oropharyngeal mucosa and
epithelium of the small intestine, largely explaining the clinical presentation of patients with
COVID-19. Ivermectin, an antiparasitic drug, already known to inhibit RNA viruses by
(2 7prima) has been shown to inhibit SARS-CoV-2 in vitro (8).
Ivermectin is already available as oral tablets and drops on the market in several countries and
may be useful to treat COVID-19. Therefore, we have included Ivermectin oral solution as an
antiviral drug in our treatment protocol. We selected an oral dose much higher than that being
used for parasitosis but within safety margins according to previous clinical trials published in the
literature (9, 10). Guzzo et al. (9) administered up to three doses of 60 mg to adults and Levy
reports doses higher than 500 400
with good safety profile. IDEA protocol includes doses of 24, 36 and 48 mg on days 0 and 7 of
treatment equivalent to doses of ca. 300, 450 and 600
of 80-kg adults, which are lower than the maximum doses already tested in adult humans. The
reason of this decision is that,in spite of pharmacokinetic data available show that the maximum
plasma concentration are far below the concentration needed to achieve inhibition of SARS-CoV-
2 in-vitro (11), we consider ivermectin to be potentially effective to fight COVID-19 because it
tends to be distributed in different organs due to its lipophilicity and could reach higher levels in
2
perpetuity.
high ACE2 expressing organs than in bloodstream (12) . Posology consisted of two doses of
Ivermectin on day 0 (start of treatment) and 7. This time interval avoids accumulation of drug
according to plasma half life reported in literature (9, 10). Ivermectin oral solution was used
because previous studies allowed the hypothesis of a better bioavailability (higher plasma
concentrations) (13).
A significant percentage of patients, ca. 30 – 50 % of total, suffering from COVID-19 may not
present any symptoms (14). Most patients develop mild symptoms. However, a substantial
percentage of patients develop moderate to severe forms of the disease, needing hospital care and
even ICU treatment. Mortality rate is approximately 26.8 % in these patients (15).
The most frequent symptoms of COVID-19 are fever, cough, dyspnea, myalgias or fatigue. Other
reported symptoms are bilateral conjunctival injection without associated secretions, hypogeusia,
skin rash and hyposmia (16). A group of patients with severe forms of COVID-19 develop a
cytokine storm syndrome (16). Several authors link this cytokine storm syndrome to secondary
hemophagocytic lymphohistiocytosis (abridged sHLH), a poorly recognized hyperinflammatory
syndrome leading to multiple organ failure and death, triggered by viral infections (17, 18). The
main features of sHLH include unremitting fever, cytopenias, and hyperferritinaemia. Pulmonary
involvement is present in approximately 50% of patients. A cytokine profile that resembles sHLH
is associated with the severity of COVID-19 disease (19). Mortality predictors from a recent
multicenter retrospective study of 150 confirmed cases of COVID-19 in Wuhan, China included
elevated ferritin (mean -
<0.001) and IL-6 (p <0.0001), suggesting that mortality could be due to viral hyperinflammation
(19). Therefore, we have included Dexamethasone injection in our treatment protocol for
moderate and severe cases to treat hyperinflammation (20).
Even though COVID-19 is primarily a respiratory disease, accumulating data suggests it to be
profoundly prothrombotic (21, 22, 23, 24, 25, 26, 27, 28). In fact, microthrombosis in different
locations has been repeatedly reported in patients with COVID 19. This symptom is due to a
hypercoagulable state (21, 22, 24) caused by this disease. Therefore, we have included aspirin
tablets as antithrombotic agent for mild and moderate cases (29) and enoxaparin injection as
anticoagulant for severe cases in IDEA treatment protocol (30, 31, 32).
Thus, this four-drug treatment protocol may allow to control viral load, as well as the most serious
symptoms leading patients to ICU treatment and death. In moderate to severe cases we added
ventilation and standard supportive care. We present in this article the final outcomes of a clinical
trial on COVID-19 patients treated with this protocol.
Materials and Methods

Materials
Ivermectin , Dexamethasone 4-mg injection, Enoxaparin injection and Aspirin

250-mg tablets purchased from the Argentinean market were used.
3
perpetuity.
Study design
The study was a single-center, prospective clinical trial run at Eurnekian Hospital in the Province
of Buenos Aires, Argentina from May 2020 to July 2020. For ethical reasons, all patients received
treatment and supportive care.
Patients
Patients included in this study protocol were male and female persons not less than 5 years old,
with a positive rt-PCR diagnosis of COVID-19 performed on nasal swab specimens, able to
provide informed consent and not participating in any other clinical study. polymerase chain
reaction (PCR), no participation in other clinical trials during the study period, and able to provide
informed consent. Pregnant women and persons with previous reports of allergy to any of the
drugs included in the treatment were excluded.
Treatment
Symptoms were classified as mild and severe according to the following table:
MILD SYMPTOMS SEVERE SYMPTOMS

Fever not above 38.5 °C Fever above 38.5 °C
Isolated diarrheal episodes Diarrhea (more than 3 daily depositions)
Hyposmia or Hypogeusia Flictenular conjunctivitis
Mild desaturation (93 – 96 %) Strong desaturation (92% or less)
Dyspnea without matter
Polymyoarthralgias, Persistent headache,
Abdominal pain
Disease stages were classified according to the following table:
Mild stage Moderate stage Severe stage

Only mild symptoms and no 3 severe symptoms or 2 4 severe symptoms or 3 severe
clinical sign of viral severe and 2 mild symptoms. symptoms and not less than 2
pneumonia Clinical signs of viral mild symptoms. Clinical signs
pneumonia of bilateral viral pneumonia
The following treatmen protocol was used on each case according to the following table:
4
perpetuity.
IVERMECTIN
DISEASE ANTITHROMBOTIC
ORAL DEXAMETHASONE VENTILATION
SEVERITY /ANTICOAGULANT
SOLUTION
Aspirin 250-mg tablet
24 mg on days 0
Mild stage None once daily for at least No
and 7
30 days
Low Flow
Aspirin 250-mg tablet
Moderate 36 mg on days 0 Dexamethasone 4- mg Washed Oxygen
once daily for at least
stage and 7 injection daily or Oxygen
30 days
Concentrator
48 mg via
Severe Dexamethasone 4- mg Enoxaparin Mechanical
gastric cannulae
stage injection on day daily. (ca. daily Ventilation
on days 0 and 7
Patients at mild stage of COVID-19 were treated as outpatients. They came to the hospital to
receive drugs and remote follow-up via mobile phone was implemented. Patients at moderate
stage of disease were immediately admitted to ward care. Patients at severe stage of COVID-19
were immediately admitted to ICU.
The day on which each patient starts treatment is numbered as “day 0”. All other days are
numbered in relation to this one.
Inpatients were discharged from ICU to hospital ward care when their symptoms were compatible
with moderate stage disease.
Inpatients were discharged home from hospital when they tested negative for COVID-19 as
determined by rt-PCR on specimens obtained from nasal swabbing or when their symptoms were
compatible with mild stage of disease.
Outpatients were considered cured after one negative COVID-19 determination by rt-PCR on
specimens or 10 days without any symptoms.
Ethics Committee aproval

The study was approved both by the ethics committee of the hospital and the County Ethics
Committee, in accordance with the Declaration of Helsinski and its ammendments. All included
patients signed an informed consent before inclusion. This study was registered in
ClinicalTrials.gov website under the identifier number: NCT04425863.
Outcomes
The primary outcomes were:
Percentage of patients progressing from mild to moderate or severe stages of disease
Mortality rate by day 30
The secondary outcomes were safety outcomes related to treatment adverse events and dose
adjustments for any of the drugs used.
5
perpetuity.
Statistical analysis
Data were collected and recorded in MS-Excel spreadsheets and processed. Demographic data,
prevalence of different comorbidities and outcomes were calculated. The outcomes of the study
were compared with data from the literature and, in the case of moderate to severe cases, with a
group of patients admitted to the hospital in the same period of time who did not join the study
protocol and received other treatments.
Results
Population characteristics
A total of 167 patients were included. All of them had confirmed COVID19 infection by the
rtPCR method. Average age was 55.7 years, 48.5 % were female and 51.5 % were male. The
stages of disease of all included patients when they join the study were:
Disease stage at Patients Average age Sex

inclusion (n) (years) (female/male %)
Mild 135 55.7
Moderate to 32 59.7
severe
Total 167 56.5
From the moderate to severe cases included, 23 (71.9 %) presented at list one risk factor.
Disease progression and mortality
All the135 patients who joined the study at a mild stage of COVID-19 did not worsen illness and
had no need of hospitalization of any kind.
Regarding the remaining 32 patients, only one of them died. This patient had been included
already at a severe stage of disease. The remaining 31 patients did not worsen during treatment.
Comparison with other treatments

Overall mortality rate of patients treated according to IDEA protocol was 0.59 % (1 death in 167
treated cases). As a comparison, estimated overall mortality rate in Argentina is approximately
2.1 % (official data by September 2nd, 2020).
Regarding moderate to severe cases, i.e. patients needing hospitalization, only 1 patient out of 32
receiving IDEA treatment died (3.1 %), whereas mortality rate published in articles from Spain,
Italy and Spain is ca. 25 %. Moreover, a group of 12 patients were hospitalized in Eurnekian
hospital in the same period but did not receive IDEA treatment. Three of them died, thus
presenting a mortality rate of 25 %, i.e. significantly higher than that of those receiving IDEA
treatment.
6
perpetuity.
Adverse events
Only one patient suffered from a serious adverse event. It was a patient who had previous history
of gastric ulcer and contracted one during treatment, probably caused by Dexamethasone
injection. The problem was immediately solved with iced water through oropharyngeal cannulae
and omeprazole, without discontinuation of treatment or dose adjustment.
Dose adjustments
No dose adjustment was necessary.
Discussion
IDEA treatment has proved to be efficacious in preventing worsening of the symptoms of
COVID-19 in practically all treated patients.
Overall mortality rate in patients treated according to IDEA protocol is significantly lower (0.59
%) than that of the infected population in Argentina (2.1 % by September 2nd, 2020) and other
countries, like Brazil (3.1 % by September 2nd, 2020) today. Quite strikingly, only 1 out of 32
hospitalized patients died of COVID-19 when treated according to the IDEA protocol, whereas
the published data show a 26.8 % mortality for inpatients (15), i.e. 8 deaths instead of 1. A similar
mortality rate of 25 % (3 deaths) was observed in a group of 12 patients admitted to Eurnekian
hospital in the same period, who received other treatments.
Regarding disease progression, no patient with mild COVID-19 progressed to moderate or severe
disease after treatment according to IDEA protocol. Moreover, even though we did not have a
quantitative follow-up of time to absence of symptoms, we have observed it to be less than 3 days
in many mild cases.
We consider that our data, even though not being placebo-controlled due to ethical reasons, allow
us to conclude that IDEA protocol may be of use to help stop COVID-19 progression and reduce
hospitalization and mortality.
Based on the outcomes of this study, a possible preventive strategy for COVID-19 in communities
of high viral circulation might consist of an oral dose of ivermectin lower than 24 mg (proposed
12 mg) regularly administered once a week (approximately one incubation period) to low-risk
people for a limited period of time, while high risk population remains isolated. This dose might
be enough to reduce viral load at a low level to keep COVID-19 at a mild stage, without
eliminating SARS-CoV-2 completely, so that immunity against SARS-CoV-2 is developed
individually to finally reach herd immunity (“immunizing effect”). This hypothesis is worth
further exploration for the prevention of transmission in healthcare workers and close contacts,
and, if successful, may be further applied for prevention in the community. In the present situation
in some American countries like Brazil and Argentina, this could help reduce overall mortality in
the absence of a vaccine.
Conclusions
Given the rapid advance of COVID-19 pandemic in Argentina and several other countries and the
lack of evidence of efficacy of any other treatments, we consider IDEA protocol to be a
scientifically based, low-cost treatment and sustainable healthcare strategy with a favorable
7
perpetuity.
benefit-risk ratio, based on the results reported in this article: reduction in overall mortality to one
fourth, reduction in mortality of hospitalized patients to one eighth and no progression of mild
cases to moderate or severe cases. It should be emphasized that the earlier the treatment starts, the
better. Mild cases early treated according to our protocol did not progress to more severe stages.
Furthermore, even though not exactly quantitated, we noticed the best results in the treatment of
mild cases, most of them recovering in less than 3 days. The application of early treatment is
consistent with the principles of medicine: even the most efficient therapeutic measures will lose
efficacy if they are applied too late. In conclusion, IDEA seems to be an adequate treatment
strategy for pandemic COVID-19 disease at all stages of disease, but specially so, if applied at
the earliest possible stage thereof.
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IVERMECTINA

Solución oral - Gotas

SAFETY AND EFFICACY OF THE COMBINED USE OF IVERMECTIN,

Carvallo Héctor1, Hirsch Roberto2, Farinella María Eugenia3

Coordinator at Eurnekian Public Hospital, Argentina

Argentina; Head of Department of Infectious Diseases at Hospital of Infectious Diseases

Francisco Javier Muñiz, Buenos Aires, Argentina

Materials and Methods

Ivermectin , Dexamethasone 4-mg injection, Enoxaparin injection and Aspirin

MILD SYMPTOMS SEVERE SYMPTOMS

Disease stages were classified according to the following table:

Mild stage Moderate stage Severe stage

Ethics Committee aproval

Disease stage at Patients Average age Sex

Disease progression and mortality

Comparison with other treatments

15) Bertsimas D, Lukin G, Mingardi L, Nohadani O, Orfanoudaki A, Stellato B et al. (2020),

22) Connors JM, Levy JH (2020), Thromboinflammation and the Hypercoagulability of

Antithrombotic Therapy, and Follow-Up: JACC State-of-the-Art Review. J Am Coll

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