Gaertner Protocol
Gaertner Protocol
Gaertner Protocol
Double-blind, placebo-controlled, randomly assigned The following criteria, if any or all are met, will classify a
clinical trial. patient as at high risk of progression to severe illness.[50][51]
1 .
Adam Gaertner et al. Ivermectin and L-Ascorbic Acid for COVID-19 (ILAC)
1. ORAL L-ASCORBIC ACID: 55 milligrams per The following mild adverse events are expected to occur
kilogram of body weight, reduced by 1mg per for a subset of patients.[7][54][55]
kilogram per 5 kilograms above 110 kilograms,
per 3 hours, maintained until 24 hours after last Diarrhea (esp. patients above 110kg and upon bolus
dose of ivermectin. Presentation: 80+ mesh administration)
powder measured into dissolving capsules.
• Nausea
A 115 kilogram patient will receive (55-1) x
115 = 6210 milligrams. • Stomach irritation
A 155 kilogram patient will receive (55-9) x • Bowel irritation
155 = 7130 milligrams. • Hypocoagulability
An 85 kilogram patient will receive 55 x 85
= 4675 milligrams.
The following severe adverse event, while not expected to
2. ORAL L-ASCORBIC ACID: Bolus, 110 occur in a statistically significant subset of patients, may
milligrams per kilogram of body weight, reduced occur.
by 3mg per 5 kilograms above 110 kilograms.
Presentation: 80+ mesh powder measured into • Black or bloody stool
dissolving capsules.
A 115 kilogram patient will receive (110-3)
x 115 = 12305 milligrams.
ADVERSE EVENTS
A 155 kilogram patient will receive (110-
27) x 155 = 12865 milligrams. IVERMECTIN
An 85 kilogram patient will receive 110 x
85 = 9350 milligrams. The following mild adverse events are expected to occur
for a subset of patients. [48]
3. ORAL IVERMECTIN: 150 micrograms per
kilogram of body weight, per 24 hours, rounded • Dizziness
up to the nearest increment of 3mg, and limited • Diarrhea
to a maximum of 24mg. Group A and B will • Stomach irritation
receive two doses, 24 hours apart; Group C will • Loss of appetite
receive four doses, 24 hours apart. Presentation: • Nausea
3mg pills or equivalent other preparation as • Lethargy
available. • Itchiness
A 115 kilogram patient will receive 18
• Dyspnea
milligrams.
A 155 kilogram patient will receive 24
milligrams.
A 65 kilogram patient will receive 12 The following severe adverse events may occur with
milligrams. comorbid parasitic infection. If suspected, the patient
should be directed to take only a single dose, followed by
three days of observation before proceeding with further
doses.[52]
ADVERSE EVENTS
Some minor and major adverse events concerning each • Neck and back pain
interventional drug have been reported in literature. • Red eyes
Patients should be advised and enroll with informed • Loss of vision
consent as per ethical guidelines. • Incontinence
• Confusion
• Skin disorders
COMBINATION THERAPY
The following severe adverse events have been reported in
No adverse events deriving from interactions between media as having potential to occur, presumably based on
interventional drugs are reported in literature. interpretation of drug pharmacokinetics, but without
correlation or citation. No report or observation of any of
these events has been made across a multitude of well-
2 .
Adam Gaertner et al. Ivermectin and L-Ascorbic Acid for COVID-19 (ILAC)
Upon reporting of an unexpected adverse event, A/B ASCORBIC ACID 80+ MESH 110mg/kg* ONCE
POWDER
continuation of treatment shall be decided by the treating ASCORBIC ACID 80+ MESH 55mg/kg** PER 3
medical professional based on severity, resolution, POWDER HOURS
IVERMECTIN 6MG TABLETS 150mcg/kg† PER 24
likelihood of recurrence and patient wishes, in accordance HOURS
with ethical guidelines, and blood sample shall be analyzed REPEAT 1x
at the earliest opportunity to rule out undetected C ASCORBIC ACID 80+ MESH 110mg/kg* ONCE
disqualifying factors. Adverse events shall be recorded on POWDER
ASCORBIC ACID 80+ MESH 55mg/kg** PER 3
numerically indexed ENROLMENT RECORD. POWDER HOURS
IVERMECTIN 6MG TABLETS 150mcg/kg† PER 24
Upon reporting of an expected mild adverse event, the HOURS
REPEAT 3x
treating physician’s good judgment is engaged as to *Reduce by 3mg per 5kg above 110kg. Until 24h after last dose of of ivermectin.
necessary/necessity of treatment, and continuation of **Reduce by 1mg per 5kg above 110kg. Until 24h after last dose of of ivermectin.
†If comorbid parasitic infection is suspected, observe for 3 days between 1st and further doses.
treatment is recommended. Ensure patient remains well hydrated in order to minimize likelihood of adverse events with
ascorbic acid & ensure optimal kidney function.
Upon reporting of an expected severe adverse event,
continuation of treatment shall be decided by the treating
physician based on resolution, likelihood of recurrence and
patient wishes, in accordance with ethical guidelines.
COMPLIANCE
6. Nurse shall calculate required intervention doses • Symptomatic recovery has been observed.
and record on ENROLMENT RECORD. OR
• Trial has terminated.
7. Nurse shall affix numerical index to PRE-
SCREENING and ENROLMENT RECORD Discharged patients are to be followed up by phone-call
paperwork, and index number shall be provided and asked to self-report their condition, no later than 5 days
to the patient. after discharge. The treating physician’s good judgement is
engaged as to whether a patient who otherwise meets
8. Nurse shall evaluate patient, take SpO2 criteria shall be discharged.
measurement with pulse oximeter, collect blood
sample, record on ENROLMENT RECORD,
and send patient for CXR imaging, to be stored
with ENROLMENT RECORD. ETHICS BRIEFING
PREPARATION OF INTERVENTION & CONTROL have been consistently overstated due to various
confounding factors[38], and thorough review of
To maintain blinding, appearance of intervention and literature[39][40][41][42] provides no apparent justification for
control must be identical. Presentation of L-ascorbic acid presently understood contra-indications in pregnancy,
as 80+ mesh powder is mandatory; therefore, before nursing, infants or young children. It has also been proven
commencement, Pharmacist or assistant shall prepare an safe at doses far higher than necessary therapeutic dose.
appropriate quantity of oral dissolving capsules containing Adverse events have been reported, however with very
L-ascorbic acid for intervention. Alternatively, powder may weak evidentiary linkage to ivermectin[48]. While the
be mixed with a small cup of cold water. Taste will be very absence of evidence is not evidence in itself, previously
distinctive; however as patients will not be provided both conducted studies have concluded that pregnant women
intervention and control, a strong taste is not expected to and young children at risk of disease should not be excluded
breach blinding. Such preparation measures will be from treatment.[43] In summary, this is an exceptionally safe
recorded, reported and analyzed. drug with overwhelmingly positive reports of efficacy.
5 .
Adam Gaertner et al. Ivermectin and L-Ascorbic Acid for COVID-19 (ILAC)
The first study published of the usage of ivermectin in Patients exhibiting mild-moderate symptoms were enrolled
patients with COVID-19, entitled “Usefulness of randomly to trial either ivermectin with doxycycline, or
Ivermectin in COVID-19 Illness”[44], was available online hydroxychloroquine with azithromycin. Count of patients
since April 19th, 2020. The study was based on potentially is not disclosed. In the ivermectin arm, patients were
falsified data from Surgisphere and later retracted; due to provided a single 200mcg/kg dose of ivermectin. All
this retraction, interest in ivermectin waned in Western reached symptomatic recovery at mean 5.93 days, with first
countries. However, its publication spurred the initiation of PCR negative test at mean 8.93 days. The trial demonstrated
multiple studies across various countries, which have all strong efficacy of both drug combinations, with statistically
since reported much stronger results than originally insignificant difference in time to symptom-free and PCR-
asserted by interpretation of the unreliable Surgisphere negative results.
data.
55 articles were chosen from PubMed, Google Scholar, IVERMECTIN APPROVED FOR 204 MILLION
Scopus, PubMed Central and Medline for scoping review RESIDENTS OF UTTER PRADESH, INDIA[19]
of ivermectin, examining in vitro and in vivo results in
antiviral application and pharmacokinetic mechanisms. The Indian media report the approval of ivermectin as
review concludes ivermectin demonstrates inhibitory replacement for hydroxychloroquine in Uttar Pradesh,
effects in vivo against both RNA and DNA viruses at India’s most populous state, with approximately 204 million
approved doses. Notably, the review also highlights the residents. Indian state government has noted ongoing
absence of evolved disease resistance to ivermectin. excellent results with a perfect safety record, and issued a
mandate that all persons diagnosed with, or suspected to
have COVID-19 must be provided with ivermectin.
TREATMENT OF LONG-TERM COVID-19
PATIENTS WITH PERSISTENT SYMPTOMS[21]
‘EXTRAORDINARY RESULTS’ REPORTED FOR 622
Gustavo Chang and Eduardo Saavedra enrolled 33 patients IN DOMINICAN REPUBLIC[22]
demonstrating chronic infection and symptoms of
COVID-19. Treatment with two standard doses of Dr. José Natalio Redondo reports recovery occurring as
ivermectin resulted in complete recovery for 87.9%, with quickly as 48-72 hours after administration. 783 patients
some improvement in 94%. Further daily repeats of were received in an emergency room, of which 622 received
ivermectin brought complete recovery to 94% of enrollees. ivermectin; all made a quick recovery.
The study concludes treatment with ivermectin resulted in
clinical improvement in a very high percentage of cases.
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Adam Gaertner et al. Ivermectin and L-Ascorbic Acid for COVID-19 (ILAC)
MAYOR OF ITAJAI, BRAZIL, PROVIDES nausea and stomach pain amongst the more common, and
PROPHYLAXIS TO 200,000+ RESIDENTS[26] one patient presented urticaria.
Dr. Volnei Morastoni, the mayor of Itajai, having reviewed As of April 28th, 2020, 247 patients have been treated with
a multitude of promising reports across the Brazil Ivermectin, all of them having favorable results. From the
concerning the use of ivermectin, made available 247 cases, more than 100 were only given ivermectin,
prophylactic ivermectin to all residents who wished to opposed to the other remaining cases which were initially
receive it. No negative events were reported and no further treated with hydroxychloroquine, but was discontinued
information is available at this time. after a shortage in the city; this was one of the reasons why
ivermectin started to be used. Currently, data is being
gathered for a retrospective study. Follow-up of treated
OFFICIAL APPROVALS cases shows that none of them have had any complications
and that they are apparently healthy.
On 8 May 2020, the government of Peru approved
ivermectin for COVID-19 treatment[24]. Peru has since
experienced supply shortages and logistical challenges that ANTIVIRAL ACTIVITY OF ASCORBIC ACID
have yet to be overcome, however the impact of pandemic
has significantly eased. On 12 May 2020, the government Ascorbic acid has long been targeted by misleading science
of Bolivia approved the use of ivermectin for COVID-19 and media, and commercially available formulations
treatment under informed consent structures[25]. On Aug 8 including sugar products that significantly reduce
2020, Uttar Pradesh, India’s most populous state, efficacy[14]. Primary utility of ascorbic acid against COVID-
consisting of over 200 million residents, replaced 19 is engorgement of human neutrophil immune cells[3][2],
hydroxychloroquine with ivermectin in standard greatly increasing efficacy of virion phagocytosis to reduce
protocol[19]. viral load[61]. Secondary utility is found in modulation of
immune cytokine profile to downregulate production of
inflammatory cytokines[49][57]. Tertiary beneficial effects are
WORLDWIDE ANECDOTAL EXPERIENCE many and varied[58], and outside the scope of this document.
Reports are considered of its use in both intravenous and
Results from multiple independent physicians are collated. oral form. Correct dosing schedule is referenced from
Due to lack of established guidance, protocols differ confidential documents which are presently unavailable.
slightly; risk groups are unaccounted for. In Colombia, Dr. Similar, but less precise and lower dosing schedules are
Andres Velasco reports 64 patients; 22 PCR positive, 40 reported in various literature as demonstrating good, but
presumed symptomatic, with 2 in critical care. All treated limited effect.
with ivermectin and doxycycline, and all have made full
recovery. In Brazil, Dr. Raphael Furtado reports 45
symptomatic cases, without testing data. All treated with THE EFFECTIVENESS OF VITAMIN C IN
ivermectin and ancillary drugs per needed, and all have PREVENTING AND RELIEVING THE SYMPTOMS
made full recovery. In India, Dr. Dharmendra Singh, OF VIRUS-INDUCED RESPIRATORY
cardiology specialist at Metro Hospital & Heart Institute, INFECTIONS[6]
reports significant official resistance to the use of
ivermectin, necessitating secretive training of other doctors Participants were administered 1000mg oral ascorbic acid
who have subsequently successfully treated “thousands” of per hour for 6 hours at commencement of the trial, and
patients. three times daily subsequently. Intervention group reported
85% rate of reduction of symptoms as compared to control.
This study considered cold and flu viruses.
REPORT OF 247 OUTPATIENT CASES OF COVID-
19 TREATED WITH IVERMECTIN[16]
RELATIONSHIP BETWEEN VITAMIN C AND
Dr. Tavarez notes that ivermectin administered within the PHAGOCYTIC ACTIVITY[2]
illness’ first stages is very effective and demonstrates
positive results, with most cases becoming asymptomatic
within 24 hours. In addition, he remarks that even cases
with over 50% pulmonary involvement responded Uptake of Vitamin C is greatly enhanced in neutrophils
positively. None of the treated patients has had when faced with infection. This enables enhanced
complications. No fatalities have been reported, presenting functionality in viral phagocytosis.
a mortality rate of 0%. Side effects have been minimal;
7 .