Table 1.
Clinical studies registered on Nitazoxanide/Nitazoxanide combinations against COVID-19 (Updated August 28, 2020).
| Sr. no. | Trial Number | Study Proposed | Drug Used & Dose | No of patients, Status & Date of Posting |
|---|---|---|---|---|
| A | Nitazoxanidealone | |||
| 1 | NCT04486313 | Efficacy and safety in mild to moderate patients | Two nitazoxanide 300 mg tablets administered orally twice daily with food for 5 days with vitamin B complex versus Placebo and vitamin B complex | 800 Recruiting July 24, 2020 |
| Romark Laboratories L.C. USA | ||||
| Phase III | ||||
| 2 | NCT04463264 | Efficacy and safety in mild patients | Nitazoxanide orally 500 mg every 6 h for 14 days) orally with food versus Placebo |
135 Recruiting July 9, 2020 |
| Austral University, Argentina | ||||
| Phase II/III | ||||
| 3 | NCT04441398 | Efficacy and safety to treat mild ambulatory patients | Nitazoxanide 600 mg three times a day (total dose 1800 mg/day) for 7 days versus Placebo | 300 Not yet recruiting June 22, 2020 |
| Azidus Brazil | ||||
| Phase II/III | ||||
| 4 | NCT04435314 | Efficacy and safety of post exposure prophylaxis | Nitazoxanide 600 mg three times a day (total dose 1800 mg/day) for 7 days versus Placebo | 200 Not yet recruiting June 17, 2020 |
| Azidus Brazil | ||||
| Phase II | ||||
| 5 | NCT04423861 | Efficacy in non-critical patients | Nitazoxanide 600 mg three times a day (total dose 1800 mg/day) for 7 days | 50 Not yet recruiting June 9, 2020 |
| Hospital Casa de Saúde - Vera Cruz - Campinas - SP – Brazil | ||||
| Phase II | ||||
| 6 | NCT04406246 | Prophylactic treatment | Nitazoxanide 500 mg every 6 h for two days and then every 12 h for four days. | 150 Recruiting May 28, 2020 |
|
Materno-Perinatal Hospital of the State of Mexico, Mexico | ||||
| Phase IV | ||||
| 7 | NCT04359680 | Efficacy and safety | Nitazoxanide 600 mg orally twice daily for six weeks versus Placebo | 800 Recruiting April 24, 2020 |
| Romark Laboratories L.C. USA | ||||
| Phase III | ||||
| 8 | NCT04348409 | Safety and efficacy in moderate condition | Nitazoxanide 600 mg twice daily for 6 weeks versus Placebo | 50 Recruiting April 16, 2020 |
| Hospital Vera Cruz Campinas, São Paulo, Brazil | ||||
| Proof of Concept | ||||
| 9 | NCT04343248 | Efficacy and safety | Nitazoxanide 600 mg twice daily for 6 weeks | 300 Recruiting April 13, 2020 |
| Romark Laboratories L. C. USA | ||||
| Phase III | ||||
| 10 | NCT04343248 | Efficacy and safety | Nitazoxanide 600 mg orally twice daily for 6 weeks versus Placebo | 600 Not yet recruiting April 13, 2020 |
| Romark Laboratories L.C. USA | ||||
| Phase III | ||||
| B | Nitazoxanide combination | |||
| 11 | NCT04498936 | Efficacy and safety | Nitazoxanide (500 mg, orally) four times per day for 14 days, plus the standard care treatment versus regimen combination of Sofosbuvir/Ledipasvir (400 mg and 90 mg, orally) once daily for 14 days, plus the standard care treatment | 240 Recruiting August 5, 2020 |
| Assiut University Hospital, Assiut, Egypt | ||||
| Phase IV | ||||
| 12 | NCT04459286 | Efficacy and safety | Nitazoxanide 1000 mg tablets twice daily and 300/100 mg atazanavir/ritonavir tablets once daily with meal for 28 days versus Standard of care treatment | 98 Not yet recruiting July 7, 2020 |
| Infectious Disease Hospital, Olodo | ||||
| Ibadan, Oyo State, Nigeria | ||||
| Phase II | ||||
| 13 | NCT04392427 | Combination efficacy | Nitazoxanide, ivermectin and ribavirin 200 mg or 400 mg for 7 days + zinc supplement versus Placebo | 100 Not yet recruiting May 18, 2020 |
| Mansoura University, Mansoura, Egypt | ||||
| Phase III | ||||
| 14 | NCT04382846 | Efficacy novel regimens |
Nitazoxanide, Ivermectin, Chloroquine, Azithromycin dose not mentioned |
80 Not yet recruiting May 11, 2020 |
| Tanta University, Tanta, Egypt | ||||
| Phase III | ||||
| 15 | NCT04360356 | Combination therapy | Ivermectin 200 mcg/kg once orally on empty stomach plus Nitazoxanide 500 mg twice daily orally with meal for 6 days versus standard care oxygen via ventilators |
100 Not yet recruiting April 24, 2020 |
| Tanta University, Tanta, Egypt | ||||
| Phase II/III | ||||
| 16 | NCT04361318 | Combination therapy | 200 mg of Hydroxychloroquine orally three times daily for 10 days plus 500 mg of Nitazoxanide orally twice daily for 6 days versus Standard care |
100 Not yet recruiting April 24, 2020 |
| Tanta University, Tanta, Egypt | ||||
| Phase II/III | ||||
| 17 | NCT04351347 | Efficacy | Drug: Chloroquine Drug: Nitazoxanide + Chloroquine Drug: Ivermectin + Chloroquine |
60 Recruiting April 17, 2020 |
| Tanta University, Tanta, Egypt | ||||
| Phase II/III | ||||
| 18 | NCT04345419 | Efficacy and safety | Chloroquine versus Favipiravir versus Nitazoxanide versus Ivermectin versus Niclosamide dose not mentioned |
100 Not yet recruiting April 14, 2020 |
| Tanta university hospital | ||||
| Tanta, Egypt | ||||
| Phase II/III | ||||
| 19 | NCT04341493 | Safety and efficacy | Hydroxychloroquine 200 mg twice daily for 10 days versus Nitazoxanide 500 mg twice daily + Hydroxychloroquine 200 mg twice daily for 10 days |
86 Recruiting April 10, 2020 |
| Materno-Perinatal Hospital of the State of Mexico, Mexico | ||||
| Phase IV | ||||
Trials accessed from https://clinicaltrials.gov/.