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Early |
Medhat et al., Arab Journal of Gastroenterology, doi:10.1016/j.ajg.2022.04.005 |
viral+, ↓55.5%, p=0.02 |
Sofosbuvir/Ledipasvir in Combination or Nitazoxanide Alone are Safe and Efficient Treatments for COVID-19 Infection: A Randomized Controlled Trial for Repurposing antivirals |
Details
RCT with 77 nitazoxanide, 70 sofosbuvir/ledipasvir, and 73 SOC patients in Egypt, showing faster viral clearance with nitazoxanide and with sofosbuvir/ledipasvir. There was no mortality or progression to severe COVID-19 or ICU admission. .. |
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Early treatment study
Early treatment study
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Sofosbuvir/Ledipasvir in Combination or Nitazoxanide Alone are Safe and Efficient Treatments for COVID-19 Infection: A Randomized Controlled Trial for Repurposing antivirals |
Medhat et al., Arab Journal of Gastroenterology, doi:10.1016/j.ajg.2022.04.005 |
RCT with 77 nitazoxanide, 70 sofosbuvir/ledipasvir, and 73 SOC patients in Egypt, showing faster viral clearance with nitazoxanide and with sofosbuvir/ledipasvir. There was no mortality or progression to severe COVID-19 or ICU admission. Nitazoxanide 500mg qid for 14 days. SOC included vitamin C and zinc.
risk of no viral clearance, 55.5% lower, HR 0.44, p = 0.02, treatment 77, control 73, Cox proportional hazards.
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Medhat et al., 5/6/2022, Randomized Controlled Trial, Egypt, Africa, peer-reviewed, 20 authors, study period July 2020 - October 2021, trial NCT04498936.
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Late |
Rocco et al., Frontiers in Medicine, doi:10.3389/fmed.2022.844728 |
death, ↑4.9%, p=0.94 |
Nitazoxanide in Patients Hospitalized With COVID-19 Pneumonia: A Multicentre, Randomized, Double-Blind, Placebo-Controlled Trial |
Details
RCT late stage patients with COVID-19 pneumonia, 202 treated with nitazoxanide and 203 placebo patients, showing improved recovery, but no significant difference in mortality. |
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Late treatment study
Late treatment study
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Nitazoxanide in Patients Hospitalized With COVID-19 Pneumonia: A Multicentre, Randomized, Double-Blind, Placebo-Controlled Trial |
Rocco et al., Frontiers in Medicine, doi:10.3389/fmed.2022.844728 |
RCT late stage patients with COVID-19 pneumonia, 202 treated with nitazoxanide and 203 placebo patients, showing improved recovery, but no significant difference in mortality.
risk of death, 4.9% higher, RR 1.05, p = 0.94, treatment 6 of 202 (3.0%), control 5 of 203 (2.5%), adjusted, OR converted to RR, multivariable, day 14.
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risk of ICU admission, 30.5% lower, RR 0.69, p = 0.18, treatment 20 of 202 (9.9%), control 30 of 203 (14.8%), NNT 21, adjusted, OR converted to RR, multivariable, day 14.
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risk of oxygen therapy, 39.7% lower, RR 0.60, p = 0.06, treatment 22 of 202 (10.9%), control 33 of 203 (16.3%), NNT 19, adjusted, OR converted to RR, multivariable, day 14.
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time to improvement, 63.6% lower, HR 0.36, p < 0.001, treatment 202, control 203, Kaplan–Meier.
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improvement, 34.2% better, OR 0.66, p = 0.14, treatment 202, control 203, adjusted, multivariable, day 14, RR approximated with OR.
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time to discharge, 27.0% lower, HR 0.73, p = 0.004, treatment 202, control 203, Kaplan–Meier.
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discharge, 8.3% lower, OR 0.92, p = 0.82, treatment 202, control 203, adjusted, multivariable, day 14, RR approximated with OR.
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Rocco et al., 4/13/2022, Double Blind Randomized Controlled Trial, placebo-controlled, Brazil, South America, peer-reviewed, median age 56.0, 37 authors, study period 20 April, 2020 - 2 October, 2020, trial NCT04561219.
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Early |
ANTICOV News (News) |
progression, ↑187.7%, p=0.04 |
ANTICOV Trial Finds Nitazoxanide/Ciclesonide Drug Combination Does Not Reduce Hospitalisation Risk in Patients With Mild COVID-19 |
Details
RCT with 462 nitazoxanide/ciclesonide and 443 paracetamol patients, up to 7 days from onset, showing no significant difference in progression. Minimal details, with the primary mortality outcome and treatment delay not being reported. NCT.. |
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Early treatment study
Early treatment study
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ANTICOV Trial Finds Nitazoxanide/Ciclesonide Drug Combination Does Not Reduce Hospitalisation Risk in Patients With Mild COVID-19 |
ANTICOV News (News) |
RCT with 462 nitazoxanide/ciclesonide and 443 paracetamol patients, up to 7 days from onset, showing no significant difference in progression. Minimal details, with the primary mortality outcome and treatment delay not being reported. NCT04920838.
risk of progression, 187.7% higher, RR 2.88, p = 0.04, treatment 15 of 462 (3.2%), control 5 of 443 (1.1%), SpO2 ≤ 93% within 14 days.
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Excluded in after exclusion results of meta analysis:
minimal details provided.
ANTICOV et al., 2/28/2022, Randomized Controlled Trial, multiple countries, multiple regions, preprint, 1 author, this trial compares with another treatment - results may be better when compared to placebo, this trial uses multiple treatments in the treatment arm (combined with ciclesonide) - results of individual treatments may vary, trial NCT04920838.
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Animal |
Miorin et al., bioRxiv, doi:10.1101/2022.02.08.479634 (Preprint) |
animal study |
The oral drug nitazoxanide restricts SARS-CoV-2 infection and attenuates disease pathogenesis in Syrian hamsters |
Details
In Vitro study showing that nitazoxanide inhibits SARS-CoV-2 in H9, iAT2, Vero E6, Vero TMPRSS2, and Ace2-A549 cells. Syrian hamster study showing improvements in SARS-CoV-2 related weight loss, inflammation, viral load, and lung synctia .. |
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Animal study
Animal study
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The oral drug nitazoxanide restricts SARS-CoV-2 infection and attenuates disease pathogenesis in Syrian hamsters |
Miorin et al., bioRxiv, doi:10.1101/2022.02.08.479634 (Preprint) |
In Vitro study showing that nitazoxanide inhibits SARS-CoV-2 in H9, iAT2, Vero E6, Vero TMPRSS2, and Ace2-A549 cells.Syrian hamster study showing improvements in SARS-CoV-2 related weight loss, inflammation, viral load, and lung synctia formation with nitazoxanide.
Miorin et al., 2/9/2022, preprint, 35 authors.
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Submit Corrections or Comments
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Late |
Fowotade et al., medRxiv, doi:10.1101/2022.02.03.22270152 (Preprint) |
no recov., ↑11.4%, p=0.72 |
Efficacy and safety of nitazoxanide combined with ritonavir-boosted atazanavir for the treatment of mild to moderate COVID-19 |
Details
Small RCT in Nigeria with 31 nitazoxanide and atazanavir/ritonavir patients, and 26 control patients, showing no significant differences with treatment. 4 treatment group patients discontinued treatment due to the size of the tablets. Tim.. |
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Late treatment study
Late treatment study
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Efficacy and safety of nitazoxanide combined with ritonavir-boosted atazanavir for the treatment of mild to moderate COVID-19 |
Fowotade et al., medRxiv, doi:10.1101/2022.02.03.22270152 (Preprint) |
Small RCT in Nigeria with 31 nitazoxanide and atazanavir/ritonavir patients, and 26 control patients, showing no significant differences with treatment. 4 treatment group patients discontinued treatment due to the size of the tablets. Time from onset is not provided, only time from diagnosis. NACOVID. 14-day course of nitazoxanide (1000 mg b.i.d.) and atazanavir/ritonavir (300/100 mg od). NCT04459286.
risk of no recovery, 11.4% higher, HR 1.11, p = 0.72, treatment 31, control 26, time to clinical improvement, Cox proportional hazards, primary outcome.
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risk of no recovery, 86.9% higher, HR 1.87, p = 0.10, treatment 31, control 26, time to symptom resolution, Cox proportional hazards.
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viral load, 5.2% lower, relative load 0.95, p = 0.92, treatment 31, control 26, viral load change from days 2 to 28.
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Fowotade et al., 2/4/2022, Randomized Controlled Trial, Nigeria, Africa, preprint, 18 authors, study period 25 November, 2020 - 20 April, 2021, this trial uses multiple treatments in the treatment arm (combined with atazanavir/ritonavir) - results of individual treatments may vary, trial NCT04459286.
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Late |
Calderón et al., PAMJ - Clinical Medicine, doi:10.11604/pamj-cm.2021.7.15.30981 |
death, ↓68.2%, p=0.38 |
Treatment with hydroxychloroquine vs nitazoxanide in patients with COVID-19: brief report |
Details
Planned RCT of HCQ vs. HCQ+nitazoxanide which was aborted due to the retracted Surgisphere paper. Authors retrospectively analyze a small set of HCQ vs. nitazoxanide patients (which were protocol deviations in the planned RCT), showing re.. |
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Late treatment study
Late treatment study
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Treatment with hydroxychloroquine vs nitazoxanide in patients with COVID-19: brief report |
Calderón et al., PAMJ - Clinical Medicine, doi:10.11604/pamj-cm.2021.7.15.30981 |
Planned RCT of HCQ vs. HCQ+nitazoxanide which was aborted due to the retracted Surgisphere paper. Authors retrospectively analyze a small set of HCQ vs. nitazoxanide patients (which were protocol deviations in the planned RCT), showing reduced hospitalization time and ICU admission with nitazoxanide.
risk of death, 68.2% lower, RR 0.32, p = 0.38, treatment 1 of 17 (5.9%), control 5 of 27 (18.5%), NNT 7.9.
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risk of mechanical ventilation, 86.7% lower, RR 0.13, p = 0.15, treatment 0 of 17 (0.0%), control 4 of 27 (14.8%), NNT 6.8, relative risk is not 0 because of continuity correction due to zero events.
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risk of ICU admission, 59.3% lower, RR 0.41, p < 0.001, treatment 0 of 17 (0.0%), control 16 of 27 (59.3%), NNT 1.7, adjusted.
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hospitalization time, 51.8% lower, relative time 0.48, p = 0.006, treatment 17, control 27.
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Calderón et al., 11/23/2021, retrospective, Mexico, North America, peer-reviewed, 7 authors, this trial compares with another treatment - results may be better when compared to placebo.
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N/A |
Walker et al., Clinical Pharmacology & Therapeutics, doi:10.1002/cpt.2463 (preprint 9/11/2021) |
An open label, adaptive, phase 1 trial of high-dose oral nitazoxanide in healthy volunteers: an antiviral candidate for SARS-CoV-2 |
Details
Phase I trial of high dose nitazoxanide, 1500mg twice daily, with 14 participants. Treatment 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 targe.. |
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N/A
N/A
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An open label, adaptive, phase 1 trial of high-dose oral nitazoxanide in healthy volunteers: an antiviral candidate for SARS-CoV-2 |
Walker et al., Clinical Pharmacology & Therapeutics, doi:10.1002/cpt.2463 (preprint 9/11/2021) |
Phase I trial of high dose nitazoxanide, 1500mg twice daily, with 14 participants. Treatment 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 after the first dose and maintained throughout. NCT04746183.
Walker et al., 9/11/2021, peer-reviewed, 33 authors, trial NCT04746183.
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Submit Corrections or Comments
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News |
Calderón et al., News Report (News) |
news |
Mantiene Hospital Mónica Pretelini bajo índice de muertes Covid de mujeres embarazadas |
Details
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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Mantiene Hospital Mónica Pretelini bajo índice de muertes Covid de mujeres embarazadas |
Calderón et al., News Report (News) |
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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Submit Corrections or Comments
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Late |
Enríquez López et al., Cureus, doi:10.7759/cureus.15002 |
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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Evolution of COVID-19 Pregnancies Treated With Nitazoxanide in a Third-Level Hospital |
Enríquez López et al., Cureus, doi:10.7759/cureus.15002 |
Case study of 51 COVID-19 positive pregnant women in Mexico treated with nitazoxanide, showing much better survival compared to hospitals not using nitazoxanide.
Enríquez López et al., 5/13/2021, peer-reviewed, 10 authors.
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Submit Corrections or Comments
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Early |
Rossignol et al., eClinicalMedicine, doi:10.1016/j.eclinm.2022.101310 (preprint 3/31/2021) |
death, ↑206.0%, p=0.49 |
A randomized double-blind placebo-controlled clinical trial of nitazoxanide for treatment of mild or moderate COVID-19 |
Details
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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A randomized double-blind placebo-controlled clinical trial of nitazoxanide for treatment of mild or moderate COVID-19 |
Rossignol et al., eClinicalMedicine, doi:10.1016/j.eclinm.2022.101310 (preprint 3/31/2021) |
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. 600mg twice daily for five days. NCT04486313.
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, COVID-19 deaths.
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risk of hospitalization, 78.8% lower, RR 0.21, p = 0.22, treatment 1 of 184 (0.5%), control 5 of 195 (2.6%), NNT 49.
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risk of severe case, 84.9% lower, RR 0.15, p = 0.07, treatment 1 of 184 (0.5%), control 7 of 195 (3.6%), NNT 33.
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risk of severe case, 83.9% lower, RR 0.16, p = 0.07, treatment 1 of 112 (0.9%), control 7 of 126 (5.6%), NNT 21, high-risk subgroup.
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time to sustained recovery, 7.3% higher, relative time 1.07, p = 0.88, treatment 184, control 195, primary outcome.
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Rossignol et al., 3/31/2021, Double Blind Randomized Controlled Trial, USA, North America, peer-reviewed, 5 authors, study period August 2020 - February 2021, average treatment delay 1.83 days, trial NCT04486313.
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Submit Corrections or Comments
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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 |
Details
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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Efficacy of Nitazoxanide in reducing the viral load in COVID-19 patients. Randomized, placebo-controlled, single-blinded, parallel group, pilot study |
Silva et al., medRxiv, doi:10.1101/2021.03.03.21252509 (Preprint) |
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% better, RR 0.74, p = 0.36, treatment 23, control 13.
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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%), NNT 3.1.
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Silva et al., 3/5/2021, Single Blind Randomized Controlled Trial, Argentina, South America, preprint, 11 authors, trial NCT04463264.
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Submit Corrections or Comments
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Early |
Elalfy et al., J. Med. Virol., doi:10.1002/jmv.26880 |
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 |
Details
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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Effect of a combination of Nitazoxanide, Ribavirin and Ivermectin plus zinc supplement (MANS.NRIZ study) on the clearance of mild COVID-1 |
Elalfy et al., J. Med. Virol., doi:10.1002/jmv.26880 |
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 viral clearance, 86.9% lower, RR 0.13, p < 0.001, treatment 7 of 62 (11.3%), control 44 of 51 (86.3%), NNT 1.3, day 15.
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risk of no viral clearance, 58.1% lower, RR 0.42, p < 0.001, treatment 26 of 62 (41.9%), control 51 of 51 (100.0%), NNT 1.7, day 7.
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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) |
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 |
Details
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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Nitazoxanide superiority to placebo to treat moderate COVID-19 – A Pilot prove of concept randomized double-blind clinical trial |
Blum et al., EClinicalMedicine, doi:10.1016/j.eclinm.2021.100981 (preprint 1/22) |
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%), NNT 6.3.
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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%), NNT 5.0.
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relative severity scores, 20.2% better, RR 0.80, treatment 25, control 25.
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hospitalization time, 55.7% lower, relative time 0.44, p = 0.02, treatment 25, control 25.
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risk of no viral clearance, 89.8% lower, RR 0.10, p = 0.03, treatment 0 of 23 (0.0%), control 4 of 19 (21.1%), NNT 4.8, relative risk is not 0 because of continuity correction due to zero events, day 21.
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Blum et al., 1/22/2021, Double Blind Randomized Controlled Trial, Brazil, South America, peer-reviewed, 17 authors, trial NCT04348409.
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Submit Corrections or Comments
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Early |
Cadegiani et al., New Microbes and New Infections, doi:10.1016/j.nmni.2021.100915 (preprint 11/4/2020) |
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 |
Details
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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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 (preprint 11/4/2020) |
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, 87.8% lower, RR 0.12, p = 0.08, treatment 0 of 357 (0.0%), control 2 of 137 (1.5%), NNT 68, relative risk is not 0 because of continuity correction due to zero events, control group 1.
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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%), NNT 15, relative risk is not 0 because of continuity correction due to zero events, control group 1.
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risk of hospitalization, 99.0% lower, RR 0.01, p < 0.001, treatment 0 of 357 (0.0%), control 27 of 137 (19.7%), NNT 5.1, relative risk is not 0 because of continuity correction due to zero events, control group 1.
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Cadegiani et al., 11/4/2020, prospective, Brazil, South America, peer-reviewed, 4 authors, average treatment delay 2.9 days.
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Submit Corrections or Comments
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Early |
Rocco et al., European Respiratory Journal, doi:10.1183/13993003.03725-2020 (preprint 10/23/20) |
ICU, ↑404.1%, p=0.24 |
Early use of nitazoxanide in mild Covid-19 disease: randomized, placebo-controlled trial (preprint 10/23) |
Details
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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Early use of nitazoxanide in mild Covid-19 disease: randomized, placebo-controlled trial (preprint 10/23) |
Rocco et al., European Respiratory Journal, doi:10.1183/13993003.03725-2020 (preprint 10/23/20) |
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.
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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.
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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.
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relative viral load, 12.1% better, RR 0.88, p = 0.006, treatment 194, control 198, day 5.
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risk of no viral clearance, 14.3% lower, RR 0.86, p = 0.009, treatment 136 of 194 (70.1%), control 162 of 198 (81.8%), NNT 8.5, day 5.
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Rocco et al., 10/23/2020, Randomized Controlled Trial, Brazil, South America, peer-reviewed, 29 authors, average treatment delay 5.0 days.
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Submit Corrections or Comments
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