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Walker et al., medRxiv, doi:10.1101/2021.09.10.21263376 (Preprint) |
An open label, adaptive, phase 1 trial of high-dose oral nitazoxanide in healthy volunteers: an antiviral candidate for SARS-CoV-2 |
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Phase I trial of high dose nitazoxanide, 1500mg twice daily, with 14 participants. Trreatment was safe and well tolerated. PBPK predictions were confirmed on day 1 but with underprediction at day 5. Median Cmin was above the in vitro targ.. |
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| Walker et al., medRxiv, doi:10.1101/2021.09.10.21263376 (Preprint) |
| An open label, adaptive, phase 1 trial of high-dose oral nitazoxanide in healthy volunteers: an antiviral candidate for SARS-CoV-2 |
Phase I trial of high dose nitazoxanide, 1500mg twice daily, with 14 participants. Trreatment was safe and well tolerated. PBPK predictions were confirmed on day 1 but with underprediction at day 5. Median Cmin was above the in vitro target concentration on first dose and maintained throughout. NCT04746183.
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Walker et al., 9/11/2021, preprint, 32 authors.
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News |
Calderón et al., News Report (News) |
news |
Mantiene Hospital Mónica Pretelini bajo índice de muertes Covid de mujeres embarazadas |
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News report on the use of nitazoxanide for pregnant COVID-19 patients in a clinic in Mexico, reporting significant improvements in hospitalization and mortality compared to locations without treatment. |
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News
News
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| Calderón et al., News Report (News) |
| Mantiene Hospital Mónica Pretelini bajo índice de muertes Covid de mujeres embarazadas |
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News report on the use of nitazoxanide for pregnant COVID-19 patients in a clinic in Mexico, reporting significant improvements in hospitalization and mortality compared to locations without treatment.
Calderón et al., 8/10/2021, preprint, 1 author.
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Late |
Enríquez López et al., Cureus, doi:10.7759/cureus.15002 (Peer Reviewed) |
Evolution of COVID-19 Pregnancies Treated With Nitazoxanide in a Third-Level Hospital |
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Case study of 51 COVID-19 positive pregnant women in Mexico treated with nitazoxanide, showing much better survival compared to hospitals not using nitazoxanide. |
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Late treatment study
Late treatment study
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| Enríquez López et al., Cureus, doi:10.7759/cureus.15002 (Peer Reviewed) |
| Evolution of COVID-19 Pregnancies Treated With Nitazoxanide in a Third-Level Hospital |
Case study of 51 COVID-19 positive pregnant women in Mexico treated with nitazoxanide, showing much better survival compared to hospitals not using nitazoxanide.
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Enríquez López et al., 5/13/2021, peer-reviewed, 10 authors.
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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 |
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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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Early treatment study
Early treatment study
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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. NCT04486313.
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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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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 |
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Small RCT with 23 nitazoxanide and 13 control patients showing significantly more patients achieved over 35% reduction in viral load from baseline. NCT04463264. |
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Early treatment study
Early treatment study
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| 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.
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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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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 |
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Non-randomized controlled trial with 62 mild and early moderate patients with home treatment with ivermectin + nitazoxanide + ribavirin + zinc, showing significantly faster viral clearance. |
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Early treatment study
Early treatment study
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| 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, Africa, 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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Late |
Blum et al., EClinicalMedicine, doi:10.1016/j.eclinm.2021.100981 (preprint 1/22) (Peer Reviewed) |
death, ↓66.7%, p=0.25 |
Nitazoxanide superiority to placebo to treat moderate COVID-19 – A Pilot prove of concept randomized double-blind clinical trial |
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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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Late treatment study
Late treatment study
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| Blum et al., EClinicalMedicine, doi:10.1016/j.eclinm.2021.100981 (preprint 1/22) (Peer Reviewed) |
| Nitazoxanide superiority to placebo to treat moderate COVID-19 – A Pilot prove of concept 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.
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risk of death, 66.7% lower, RR 0.33, p = 0.25, treatment 2 of 25 (8.0%), control 6 of 25 (24.0%).
risk of mechanical ventilation, 62.5% lower, RR 0.38, p = 0.17, treatment 3 of 25 (12.0%), control 8 of 25 (32.0%).
relative severity scores, 20.2% lower, RR 0.80, treatment 25, control 25.
hospitalization time, 55.7% lower, relative time 0.44, 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, peer-reviewed, 17 authors.
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Early |
Cadegiani et al., New Microbes and New Infections, doi:10.1016/j.nmni.2021.100915 (preprint 11/4/2020) (Peer Reviewed) |
death, ↓87.8%, p=0.08 |
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 |
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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, ev.. |
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Early treatment study
Early treatment study
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| Cadegiani et al., New Microbes and New Infections, doi:10.1016/j.nmni.2021.100915 (preprint 11/4/2020) (Peer Reviewed) |
| 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 |
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.
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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, peer-reviewed, 4 authors.
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Early |
Rocco et al., European Respiratory Journal, doi:10.1183/13993003.03725-2020 (preprint 10/23/20) (Peer Reviewed) |
ICU, ↑404.1%, p=0.24 |
Early use of nitazoxanide in mild Covid-19 disease: randomized, placebo-controlled trial (preprint 10/23) |
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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.. |
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Early treatment study
Early treatment study
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| Rocco et al., European Respiratory Journal, doi:10.1183/13993003.03725-2020 (preprint 10/23/20) (Peer Reviewed) |
| 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.
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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, peer-reviewed, 29 authors.
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