Early COVID-19 Therapy with azithromycin plus nitazoxanide, ivermectin or hydroxychloroquine in Outpatient Settings Significantly Improved COVID-19 outcomes compared to Known outcomes in untreated patients
Cadegiani et al.
, Early COVID-19 Therapy with azithromycin plus nitazoxanide, ivermectin or hydroxychloroquine in Outpatient..
, New Microbes and New Infections, doi:10.1016/j.nmni.2021.100915 (date from earlier preprint)
Comparison of HCQ, nitazoxanide, and ivermectin showing similar effectiveness for overall clinical outcomes in COVID-19 when used before seven days of symptoms, and overwhelmingly superior compared to the untreated COVID-19 population, even for those outcomes not influenced by placebo effect, at least when combined with azithromycin, and vitamin C, D and zinc in the majority of the cases. 585 patients with mean treatment delay 2.9 days. There was no hospitalization, mechanical ventilation, or mortality with treatment. Control group 1 was a retrospectively obtained group of untreated patients of the same population.
risk of death, 81.2% lower, RR 0.19, p = 0.21, treatment 0 of 159 (0.0%), control 2 of 137 (1.5%), NNT 68, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm), control group 1.
risk of mechanical ventilation, 95.1% lower, RR 0.05, p < 0.001, treatment 0 of 159 (0.0%), control 9 of 137 (6.6%), NNT 15, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm), control group 1.
risk of hospitalization, 98.3% lower, RR 0.02, p < 0.001, treatment 0 of 159 (0.0%), control 27 of 137 (19.7%), NNT 5.1, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm), control group 1.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Cadegiani et al., 4 Nov 2020, prospective, Brazil, peer-reviewed, 4 authors, average treatment delay 2.9 days, dosage 400mg days 1-5.
Abstract: ORIGINAL ARTICLE
Early COVID-19 therapy with azithromycin plus nitazoxanide, ivermectin
or hydroxychloroquine in outpatient settings signiﬁcantly improved
COVID-19 outcomes compared to known outcomes in untreated patients
F. A. Cadegiani1,2, A. Goren2, C. G. Wambier3 and J. McCoy2
1) Corpometria Institute, Brasília, DF, Brazil, 2) Applied Biology, Inc., Irvine, CA and 3) Department of Dermatology, The Alpert Medical School of Brown University,
In a prospective observational study (pre-AndroCoV Trial), the use of nitazoxanide, ivermectin and hydroxychloroquine demonstrated
unexpected improvements in COVID-19 outcomes when compared to untreated patients. The apparent yet likely positive results raised
ethical concerns on the employment of further full placebo controlled studies in early-stage COVID-19. The present analysis aimed to
elucidate, through a comparative analysis with two control groups, whether full placebo-control randomized clinical trials (RCTs) on
early-stage COVID-19 are still ethically acceptable. The Active group (AG) consisted of patients enrolled in the Pre-AndroCoV-Trial
(n = 585). Control Group 1 (CG1) consisted of a retrospectively obtained group of untreated patients of the same population (n = 137),
and Control Group 2 (CG2) resulted from a precise prediction of clinical outcomes based on a thorough and structured review of
indexed articles and ofﬁcial statements. Patients were matched for sex, age, comorbidities and disease severity at baseline. Compared to
CG1 and CG2, AG showed reduction of 31.5–36.5% in viral shedding (p < 0.0001), 70–85% in disease duration (p < 0.0001), and 100%
in respiratory complications, hospitalization, mechanical ventilation, deaths and post-COVID manifestations (p < 0.0001 for all). For every
1000 conﬁrmed cases for COVID-19, at least 70 hospitalizations, 50 mechanical ventilations and ﬁve deaths were prevented. Beneﬁts
from the combination of early COVID-19 detection and early pharmacological approaches were consistent and overwhelming when
compared to untreated groups, which, together with the well-established safety proﬁle of the drug combinations tested in the PreAndroCoV Trial, precluded our study from continuing employing full placebo in early COVID-19.
© 2021 The Author(s). Published by Elsevier Ltd.
Keywords: Antiandrogen, clinical equipoise, COVID-19, dutasteride, hydroxychloroquine, ivermectin, nitazoxanide, proxalutamide, SARSCoV-2, spironolactone
Article published online: 7 July 2021
Corresponding author: F.A. Cadegiani, Corpometria Institute,
SGAS 915 Sala 260/262/264, Brasilia, DF, 70-390150, Brazil
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Coronavirus Disease 2019 (COVID-19) is a highly heterogeneous and multi-systemic infection caused by the novel Severe
Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV2)  that is particularly harmful to those aged above 60 y/o,
with uncontrolled diabetes, hypertension, obesity, androgenetic
alopecia (AGA), abuse of anabolic steroids in males and
hyperandrogenism in females [2–7].
Effective treatments to improve COVID-19 clinical outcomes, mortality and to prevent post-COVID manifestations
are highly desired, while deﬁnitive solutions such as effective
and safe vaccines are not universally available. Pharmacological
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