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0 0.5 1 1.5 2+ Mortality 81% Improvement Relative Risk Ventilation 95% Hospitalization 98% HCQ for COVID-19  Cadegiani et al.  EARLY TREATMENT Is early treatment with HCQ beneficial for COVID-19? Prospective study of 296 patients in Brazil Lower ventilation (p=0.00084) and hospitalization (p<0.0001) c19hcq.org Cadegiani et al., New Microbes and New.., Nov 2020 Favors HCQ Favors control

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., New Microbes and New Infections, doi:10.1016/j.nmni.2021.100915 (date from preprint)
Nov 2020  
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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.
This study includes nitazoxanide, ivermectin, and HCQ.
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.
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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 Cadegiani, A Goren, C G Wambier, J Mccoy
New Microbes and New Infections, doi:10.1016/j.nmni.2021.100915
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 Pre-AndroCoV Trial, precluded our study from continuing employing full placebo in early COVID-19.
Transparency declaration The authors declare no conflict of interest with any of the pharmacological interventions proposed by the present study. Authorship statement Dr. Cadegiani was the principal investigator and contributed to the study conception and design, compiled and analyzed the data, and helped write the manuscript. Dr Goren contributed with the study design, analysis of the data, and review of the manuscript. Dr. Wambier performed the statistical analysis, analyzed the data, and helped write the manuscript. Dr. McCoy helped with the study design, helped to analyze the data, and reviewed the last version of the manuscript.
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