Nitazoxanide for COVID-19: real-time analysis of all 6 studies

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4/20	Early	Rossignol et al., medRxiv, doi:10.1101/2021.04.19.21255441 (Preprint)	death, ↑206.0%, p=0.49	Early treatment with nitazoxanide prevents worsening of mild and moderate COVID-19 and subsequent hospitalization
	RCT with 184 outpatients treated with an extended release formulation of nitazoxanide, and 195 controls, showing lower hospitalization and progression to severe disease with treatment. There was one COVID-19 related death in the treatment..
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	Rossignol et al., medRxiv, doi:10.1101/2021.04.19.21255441 (Preprint)
	Early treatment with nitazoxanide prevents worsening of mild and moderate COVID-19 and subsequent hospitalization
	RCT with 184 outpatients treated with an extended release formulation of nitazoxanide, and 195 controls, showing lower hospitalization and progression to severe disease with treatment. There was one COVID-19 related death in the treatment arm. risk of death, 206.0% higher, RR 3.06, p = 0.49, treatment 1 of 184 (0.5%), control 0 of 195 (0.0%), continuity correction due to zero event. risk of hospitalization, 78.8% lower, RR 0.21, p = 0.22, treatment 1 of 184 (0.5%), control 5 of 195 (2.6%). risk of COVID-19 severe case, 84.9% lower, RR 0.15, p = 0.07, treatment 1 of 184 (0.5%), control 7 of 195 (3.6%). risk of COVID-19 severe case, 83.9% lower, RR 0.16, p = 0.07, treatment 1 of 112 (0.9%), control 7 of 126 (5.6%), high-risk subgroup. time to sustained response, 7.5% higher, relative time 1.08, treatment 184, control 195. Rossignol et al., 4/20/2021, Double Blind Randomized Controlled Trial, USA, North America, preprint, 8 authors.
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3/5	Early	Silva et al., medRxiv, doi:10.1101/2021.03.03.21252509 (Preprint)	viral+, ↓26.5%, p=0.36	Efficacy of Nitazoxanide in reducing the viral load in COVID-19 patients. Randomized, placebo-controlled, single-blinded, parallel group, pilot study
	Small RCT with 23 nitazoxanide and 13 control patients showing significantly more patients achieved over 35% reduction in viral load from baseline. NCT04463264.
3/5	Details Source PDF Early treatment study Early treatment study
	Silva et al., medRxiv, doi:10.1101/2021.03.03.21252509 (Preprint)
	Efficacy of Nitazoxanide in reducing the viral load in COVID-19 patients. Randomized, placebo-controlled, single-blinded, parallel group, pilot study
	Small RCT with 23 nitazoxanide and 13 control patients showing significantly more patients achieved over 35% reduction in viral load from baseline. NCT04463264. relative mean improvement in Ct, 26.5% lower, RR 0.74, p = 0.36, treatment 23, control 13. risk of viral load reduction < 35% at day 7, 38.3% lower, RR 0.62, p = 0.08, treatment 12 of 23 (52.2%), control 11 of 13 (84.6%). Silva et al., 3/5/2021, Single Blind Randomized Controlled Trial, Argentina, South America, preprint, 11 authors.
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2/16	Early	Elalfy et al., J. Med. Virol., doi:10.1002/jmv.26880 (Peer Reviewed)	viral+, ↓86.9%, p<0.0001	Effect of a combination of Nitazoxanide, Ribavirin and Ivermectin plus zinc supplement (MANS.NRIZ study) on the clearance of mild COVID-1
	Non-randomized controlled trial with 62 mild and early moderate patients with home treatment with ivermectin + nitazoxanide + ribavirin + zinc, showing significantly faster viral clearance.
2/16	Details Source PDF Early treatment study Early treatment study
	Elalfy et al., J. Med. Virol., doi:10.1002/jmv.26880 (Peer Reviewed)
	Effect of a combination of Nitazoxanide, Ribavirin and Ivermectin plus zinc supplement (MANS.NRIZ study) on the clearance of mild COVID-1
	Non-randomized controlled trial with 62 mild and early moderate patients with home treatment with ivermectin + nitazoxanide + ribavirin + zinc, showing significantly faster viral clearance. risk of no virological cure, 86.9% lower, RR 0.13, p < 0.001, treatment 7 of 62 (11.3%), control 44 of 51 (86.3%), day 15. risk of no virological cure, 58.1% lower, RR 0.42, p < 0.001, treatment 26 of 62 (41.9%), control 51 of 51 (100.0%), day 7. Elalfy et al., 2/16/2021, retrospective, Egypt, Middle East, peer-reviewed, 15 authors, this trial uses multiple treatments in the treatment arm (combined with ivermectin, ribavirin, and zinc) - results of individual treatments may vary.
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1/22	Late	Blum et al., SSRN, doi:10.2139/ssrn.3763773 (Preprint)	death, ↓66.7%, p=0.25	Nitazoxanide In Vitro Efficacy Against SARS CoV-2 and In Vivo Superiority to Placebo to Treat Moderate COVID-19 – A Phase 2 Randomized Double-Blind Clinical Trial
	RCT with 25 nitazoxanide patients and 25 control patients, showing improved virological and clinical outcomes with treatment. Authors also perform an in vitro study in Vero E6 cells showing 90% inhibition with 0.5µM, with no cytotoxicity..
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	Blum et al., SSRN, doi:10.2139/ssrn.3763773 (Preprint)
	Nitazoxanide In Vitro Efficacy Against SARS CoV-2 and In Vivo Superiority to Placebo to Treat Moderate COVID-19 – A Phase 2 Randomized Double-Blind Clinical Trial
	RCT with 25 nitazoxanide patients and 25 control patients, showing improved virological and clinical outcomes with treatment. Authors also perform an in vitro study in Vero E6 cells showing 90% inhibition with 0.5µM, with no cytotoxicity. NCT04348409. risk of death, 66.7% lower, RR 0.33, p = 0.25, treatment 2 of 25 (8.0%), control 6 of 25 (24.0%). relative severity scores, 20.2% lower, RR 0.80, treatment 25, control 25. hospitalization time, 32.5% lower, relative time 0.68, p = 0.02, treatment 25, control 25. risk of no virological cure, 89.8% lower, RR 0.10, p = 0.03, treatment 0 of 23 (0.0%), control 4 of 19 (21.1%), continuity correction due to zero event, day 21. Blum et al., 1/22/2021, Double Blind Randomized Controlled Trial, Brazil, South America, preprint, 20 authors.
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11/4	Early	Cadegiani et al., medRxiv, doi:10.1101/2020.10.31.20223883 (Preprint)	death, ↓87.8%, p=0.08	Early COVID-19 Therapy with Azithromycin Plus Nitazoxanide, Ivermectin or Hydroxychloroquine in Outpatient Settings Significantly Reduced Symptoms Compared to Known Outcomes in Untreated Patients
	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, ev..
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	Cadegiani et al., medRxiv, doi:10.1101/2020.10.31.20223883 (Preprint)
	Early COVID-19 Therapy with Azithromycin Plus Nitazoxanide, Ivermectin or Hydroxychloroquine in Outpatient Settings Significantly Reduced Symptoms Compared to Known Outcomes in Untreated Patients
	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. The size of the treatment groups in this trial can be found in [1]. [1] researchsquare.com/article/rs-98106/v1 risk of death, 87.8% lower, RR 0.12, p = 0.08, treatment 0 of 357 (0.0%), control 2 of 137 (1.5%), continuity correction due to zero event, control group 1. risk of mechanical ventilation, 97.0% lower, RR 0.03, p < 0.001, treatment 0 of 357 (0.0%), control 9 of 137 (6.6%), continuity correction due to zero event, control group 1. risk of hospitalization, 99.0% lower, RR 0.01, p < 0.001, treatment 0 of 357 (0.0%), control 27 of 137 (19.7%), continuity correction due to zero event, control group 1. Cadegiani et al., 11/4/2020, prospective, Brazil, South America, preprint, 4 authors.
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10/23	Early	Rocco et al., medRxiv, doi:10.1101/2020.10.21.20217208 (Preprint)	ICU, ↑404.1%, p=0.24	Early use of nitazoxanide in mild Covid-19 disease: randomized, placebo-controlled trial (preprint 10/23)
	RCT 392 patients, median treatment delay 5 days, showing improved viral recovery at 5 days. Symptom recovery was no different at 5 days, and the treatment arm had two ICU admissions compared to zero for control. There were no serious adve..
10/23	Details Source PDF Early treatment study Early treatment study
	Rocco et al., medRxiv, doi:10.1101/2020.10.21.20217208 (Preprint)
	Early use of nitazoxanide in mild Covid-19 disease: randomized, placebo-controlled trial (preprint 10/23)
	RCT 392 patients, median treatment delay 5 days, showing improved viral recovery at 5 days. Symptom recovery was no different at 5 days, and the treatment arm had two ICU admissions compared to zero for control. There were no serious adverse events. risk of ICU admission, 404.1% higher, RR 5.04, p = 0.24, treatment 2 of 194 (1.0%), control 0 of 198 (0.0%), continuity correction due to zero event, table S3. risk of hospitalization, 2.1% higher, RR 1.02, p = 1.00, treatment 5 of 194 (2.6%), control 5 of 198 (2.5%), table S3. risk of no recovery, 15.8% higher, RR 1.16, p = 0.37, treatment 59 of 194 (30.4%), control 52 of 198 (26.3%), day 5. relative viral load, 12.1% lower, RR 0.88, p = 0.006, treatment 194, control 198, day 5. risk of no virological cure, 14.3% lower, RR 0.86, p = 0.009, treatment 136 of 194 (70.1%), control 162 of 198 (81.8%), day 5. Rocco et al., 10/23/2020, Randomized Controlled Trial, Brazil, South America, preprint, 29 authors.
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