Summary of COVID-19 nitazoxanide studies

50 patient nitazoxanide late treatment RCT: 67% lower mortality (p=0.25), 62% lower ventilation (p=0.17), 20% lower severe cases, and 56% shorter hospitalization (p=0.02).
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.
Jan 2021, eClinicalMedicine, https://www.thelancet.com/journals/eclinm/article/PIIS2589-5370(21)00261-3/fulltext, https://c19p.org/blum

2. Romark et al., Trial to Evaluate the Efficacy and Safety of Nitazoxanide (NTZ) for Pre- and Post Exposure Prophylaxis of COVID-19 and Other Viral Respiratory Illnesses (VRI) in Healthcare Workers and Others at Increased Risk of SARS-CoV-2 Infection

1,407 patient nitazoxanide prophylaxis RCT: 43% lower progression (p=0.02), 50% faster recovery (p=0.1), and 3% fewer cases (p=1).
RCT 1,407 healthcare workers and others at high risk of SARS-CoV-2 exposure, showing no difference in COVID-19 cases (13 in each group). There was lower symptom severity for nitazoxanide and a trend towards shorter illness duration. There is no publication, results are only available on clinicaltrials.gov, posted 3 years after completion (FDA pre-notice of noncompliance [fda.gov]).
Jun 2024, Romark, NCT04359680, https://clinicaltrials.gov/study/NCT04359680?term=NCT04359680&rank=1&tab=results, https://c19p.org/romark

3. Sokhela et al., Randomized clinical trial of nitazoxanide or sofosbuvir/daclatasvir for the prevention of SARS-CoV-2 infection

505 patient nitazoxanide prophylaxis RCT: 66% lower mortality (p=1), 79% lower hospitalization (p=0.5), 17% fewer symptomatic cases (p=0.49), and 21% more cases (p=0.67).
Prophylaxis RCT 828 high-risk participants in South Africa, showing no significant difference with nitazoxanide and sofosbuvir/daclatasvir treatment. FLU-PRO results were available for 74% of the nitazoxanide arm compared to 54% of the control arm.
Aug 2022, J. Antimicrobial Chemotherapy, https://academic.oup.com/jac/advance-article/doi/10.1093/jac/dkac266/6661458, https://c19p.org/sokhela

4. Rocco et al., Nitazoxanide in Patients Hospitalized With COVID-19 Pneumonia: A Multicentre, Randomized, Double-Blind, Placebo-Controlled Trial

405 patient nitazoxanide late treatment RCT: 5% higher mortality (p=0.95), 31% lower ICU admission (p=0.18), 40% lower need for oxygen therapy (p=0.06), and 64% faster improvement (p<0.0001).
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.
Apr 2022, Frontiers in Medicine, https://www.frontiersin.org/articles/10.3389/fmed.2022.844728/full, https://c19p.org/rocco2

5. Medhat et al., Sofosbuvir/Ledipasvir in Combination or Nitazoxanide Alone are Safe and Efficient Treatments for COVID-19 Infection: A Randomized Controlled Trial for Repurposing antivirals

150 patient nitazoxanide early treatment RCT: 56% improved viral clearance (p=0.02).
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.
May 2022, Arab J. Gastroenterology, https://www.sciencedirect.com/science/article/pii/S1687197922000326, https://c19p.org/medhat

6. Cadegiani et al., 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

494 patient nitazoxanide early treatment study: 88% lower mortality (p=0.08), 97% lower ventilation (p<0.0001), and 99% lower hospitalization (p<0.0001).
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.
Nov 2020, New Microbes and New Infections, https://www.sciencedirect.com/science/article/pii/S2052297521000792, https://c19p.org/cadegianin

7. Silva et al., Efficacy of Nitazoxanide in reducing the viral load in COVID-19 patients. Randomized, placebo-controlled, single-blinded, parallel group, pilot study

36 patient nitazoxanide early treatment RCT: 26% improved viral clearance (p=0.36).
Small RCT with 23 nitazoxanide and 13 control patients showing significantly more patients achieved over 35% reduction in viral load from baseline. NCT04463264.
Mar 2021, Medical Research Archives, https://esmed.org/MRA/mra/article/view/3364, https://c19p.org/silva

8. Calderón et al., Treatment with hydroxychloroquine vs nitazoxanide in patients with COVID-19: brief report

44 patient nitazoxanide late treatment study: 68% lower mortality (p=0.38), 87% lower ventilation (p=0.15), 59% lower ICU admission (p<0.0001), and 52% shorter hospitalization (p=0.007).
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.
Nov 2021, PAMJ - Clinical Medicine, https://www.clinical-medicine.panafrican-med-journal.com/content/article/7/15/full/, https://c19p.org/calderon2

9. Elalfy et al., Effect of a combination of Nitazoxanide, Ribavirin and Ivermectin plus zinc supplement (MANS.NRIZ study) on the clearance of mild COVID-1

113 patient nitazoxanide early treatment study: 87% improved viral clearance (p<0.0001).
Non-randomized controlled trial with 62 mild and early moderate patients with home treatment with ivermectin + nitazoxanide + ribavirin + zinc, showing significantly faster viral clearance.
Feb 2021, J. Med. Virol., https://onlinelibrary.wiley.com/doi/10.1002/jmv.26880, https://c19p.org/elalfyn

10. Fowotade et al., Efficacy and safety of nitazoxanide combined with ritonavir-boosted atazanavir for the treatment of mild to moderate COVID-19

57 patient nitazoxanide late treatment RCT: 11% worse recovery (p=0.73) and 5% improved viral clearance (p=0.92).
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.
Feb 2022, medRxiv, https://www.medrxiv.org/content/10.1101/2022.02.03.22270152, https://c19p.org/fowotade

11. ANTICOV et al., ANTICOV Trial Finds Nitazoxanide/Ciclesonide Drug Combination Does Not Reduce Hospitalisation Risk in Patients With Mild COVID-19

905 patient nitazoxanide early treatment RCT: 188% higher progression (p=0.04).
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.
Feb 2022, ANTICOV, News, https://www.isglobal.org/en/new/-/asset_publisher/JZ9fGljXnWpI/content/ensayo-anticov-halla-combinacion-nitazoxanida-ciclesonida-no-reduce-riesgo-hospitalizacion-pacientes-covid-19-leve, https://c19p.org/anticovn

12. Rossignol et al., A randomized double-blind placebo-controlled clinical trial of nitazoxanide for treatment of mild or moderate COVID-19

379 patient nitazoxanide early treatment RCT: 79% lower hospitalization (p=0.22), 85% lower severe cases (p=0.07), and 7% slower recovery (p=0.88).
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.
Mar 2022, eClinicalMedicine, https://www.thelancet.com/journals/eclinm/article/PIIS2589-5370(22)00040-2/fulltext, https://c19p.org/rossignol

13. Chandiwana et al., Safety and efficacy of four drug regimens versus standard-of-care for the treatment of symptomatic outpatients with COVID-19: A randomised, open-label, multi-arm, phase 2 clinical trial

76 patient nitazoxanide early treatment RCT: 13% higher progression (p=0.89), 23% slower recovery (p=0.42), and 67% worse viral clearance (p=0.13).
Very high COI low-risk patient RCT in South Africa, showing no significant differences with favipiravir plus nitazoxanide. There were no deaths and no COVID-19 hospitalizations for favipiravir plus nitazoxanide. More patients were seropositive at baseline in the treatment arm (28% vs 22%). Favipiravir 1600mg 12-hourly for 1 day, then 600mg 12-hourly for 6 days. Nitazoxanide 1000mg 12-hourly for 7 days.
Oct 2022, eBioMedicine, https://www.sciencedirect.com/science/article/pii/S2352396422005047, https://c19p.org/chandiwanan

14. Rocco et al., Early use of nitazoxanide in mild Covid-19 disease: randomized, placebo-controlled trial (preprint 10/23)

392 patient nitazoxanide early treatment RCT: 404% higher ICU admission (p=0.24), 2% higher hospitalization (p=1), 16% worse recovery (p=0.37), and 12% improved viral clearance (p=0.006).
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.
Oct 2020, European Respiratory J., https://erj.ersjournals.com/content/early/2020/12/17/13993003.03725-2020, https://c19p.org/rocco

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