Retrospective 600 PCR+ outpatients in Australia treated with ivermectin, zinc, and doxycycline, showing significantly lower mortality and hospitalization with treatment. This trial uses a synthetic control group, and the preliminary report provides minimal details.
For discussion of the use of a synthetic control group, see1. Notably, advantages include less-biased recruitment (patients do not opt-out if they feel they need treatment and don't want to risk placebo), trials are cheaper, there is less delay in treatment, and trials can be run where it is not ethical to give patients placebo.
This study is excluded in the after exclusion results of meta
analysis:
combined treatments may contribute more to the effect seen.
risk of death, 92.3% lower, RR 0.08, p = 0.03, treatment 0 of 600 (0.0%), control 6 of 600 (1.0%), NNT 100, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm).
risk of hospitalization, 92.9% lower, RR 0.07, p < 0.001, treatment 5 of 600 (0.8%), control 70 of 600 (11.7%), NNT 9.2, primary outcome.
Borody et al., 19 Oct 2021, retrospective, Australia, preprint, 2 authors, study period 1 June, 2021 - 30 September, 2021, this trial uses multiple treatments in the treatment arm (combined with ivermectin and doxycycline) - results of individual treatments may vary.
Abstract: COMBINATION THERAPY FOR COVID-19 BASED ON IVERMECTIN
IN AN AUSTRALIAN POPULATION
Authors:
Thomas J. Borody1 MBBS, BSc(Med), MD, PhD, DSc, FRACP,FACP,FACG, AGAF
Robert L. Clancy2 AM, MB BS PhD DSc FRACP FRCP(A)
Affiliations:
1
Centre for Digestive Diseases, Five Dock, NSW, Australia, 2046
2
Faculty of Health and Medicine, University of Newcastle, NSW, Australia
BACKGROUND
The immediacy of “real-world” data in the pre-hospital treatment of Covid-19 using repurposed drugs has been the keystone to the development of effective therapy in a
pandemic situation. The sense of a “common-message database” for the therapeutic use of
ivermectin (IVM) collated by clinicians over a time frame of little more than 12 months,
involving patients and research workers across geographic and social lines, is extraordinary.
From over 20 countries there are 63 controlled studies accepted for meta-analysis, that
have included 47,500 subjects with 625 authors.
While this compelling database on the effectiveness of IVM would not be possible without
“real-life” studies, at an individual level, these trials give additional value such as
information on dosage and combination therapies. They also give confidence to local
doctors and regulators as they seek optimal management strategies.
Here, we report successful pre-hospital treatment of Covid-19 patients in Sydney and
Melbourne, Australia, using an ivermectin-doxycycline-zinc combination with an important
set of observations on symptom resolution and oximetry.
THE STUDY
Six hundred Australian residents with positive PCR symptomatic Covid-19 were treated with
a combination of ivermectin (24 mg per day), doxycycline (100 mg bd), and zinc (50mg per
day), for 10 days within 48 hrs of obtaining a positive PCR test for Covid-19. The treatment
period was from June to September 2021. Seven percent (7%) were given additional
vitamins and nutritional supplements. Only 7% identified adverse events from the therapy,
mainly minor gut symptoms of nausea, diarrhoea and heartburn. No patient stopped
therapy due to adverse drug events.
A subgroup in hotel and home quarantine was available for a more detailed assessment of
symptoms and oxygenation status. This cohort of 126 was assessed for 10 symptoms
according to a visual analogue scale (ranging from “0” for no symptoms, to “10” for most
severe symptoms). Descriptive statistics are summarised in Table 1. P-Values were
calculated using Wilcoxon matched-pairs signed-rank t-tests. Chi Squared analysis was used
to analyse rates of hospitalisation in the 600-patient cohort.
THE OUTCOME
A total of 600 patients with positive PCR tests were treated with the ten-day course of
“Ivermectin Triple Therapy” (ITT), which was fully completed in over 90% of those treated.
None discontinued therapy as a result of drug side effects. Two visited the hospital for less
than 24 hours following a transient arrhythmia and then went home, while five were
admitted to hospital (0.83%). There were no deaths. In an equivalent control group of 600,
not treated with triple therapy, 70 were admitted to hospital (11.5%), with 6 deaths (1%).
Chi-squared analysis of hospitalisation rate shows a significant decrease (P<0.001) in the
presence of ivermectin triple therapy intervention. The control data was from contemporary
infected subjects in Australia obtained from published Covid Tracking Data.
The subgroup of 126 in quarantine had more detailed documentation. They had an average
age of 42 (range: 17-94). The..
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