Efficacy and Safety Study of Nitazoxanide (NTX) in the Treatment of Patients With SARS-CoV-2 Virus Infection (COVID-19)
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ClinicalTrials.gov Identifier: NCT04463264 |
Recruitment Status :
Recruiting
First Posted : July 9, 2020
Last Update Posted : October 8, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
COVID-19 | Drug: Nitazoxanide Drug: Placebo | Phase 2 Phase 3 |

Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 135 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Randomized. Nitazoxanide : Placebo (2:1), parallel-group study |
Masking: | Single (Participant) |
Masking Description: | Simple blind design |
Primary Purpose: | Treatment |
Official Title: | Efficacy and Safety Study of Nitazoxanide (NTX) in the Treatment of Patients With SARS-CoC-2 Virus Infection (COVID-19). A Pilot, Randomized, Simple Blind, Placebo-controlled, Parallel-group Study |
Actual Study Start Date : | June 26, 2020 |
Estimated Primary Completion Date : | November 15, 2020 |
Estimated Study Completion Date : | December 26, 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: NTX active treatment
Intervention: NTX (500 mg every 6 hours for 14 days) orally with food (P.O.).
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Drug: Nitazoxanide
NTX (500 mg every 6 hours for 14 days) orally with food (P.O.). |
Placebo Comparator: Intervention: placebo
Placebo (1 tablet every 6 hours for 14 days) orally with food (P.O.).
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Drug: Placebo
Placebo (1 tablet every 6 hours for 14 days) orally with food (P.O.). |
- Eradication of SARS COV-2 from patients' respiratory tract secretions by treatment day 7th. [ Time Frame: 7 day ]
Erradication will be considered a reduction of the viral load on day 7 greater than 35% with respect to placebo. Extraction of genomic material will be performed using a QIAgen mini kit (QIAmp viral RNA) validated by the CDC (United States Center for Disease Control and Prevention (https://www.fda.gov/media/134922/download) (CDC-006-00019) Viral load will be quantified with the following detection kits: Commercial Kit: PCR-EUA-CDC-nCoV-IFU. Commercial KIT SENTINEL - STAT-NAT Covid 19B (Berlín).
Rational: In mild cases of COVID-19, 50% of the patients eradicated the virus within a period of 3 weeks, 25% eradicated the virus before the 13th day, 75% during the first month and the rest were " late eradicators." This latter subgroup of patients has been associated with severe cases of COVID-19 disease.
- Comparative decrease of the viral load [ Time Frame: 3 - 35 days ]Consequently, in mild cases, viral eradication will likely occur more frequently during the first to second week of COVID-19 disease; less than 15% could eradicate the virus during the first week of symptom onset. From an epidemiological point of view, increasing the viral eradication rate from less than 15% to more than 35% during the first two weeks of treatment would be clinically relevant.(seven), 14 (fourteen) and 35 (thirty-five) after starting treatment compared to the baseline measurement.
- Clinical improvement [ Time Frame: 1 - 35 days ]Clinical improvement according to the WHO COVID-19 ordinal scale. Minimun 0 (zero), (best), maximum 8 (eight) (worst)
- Pneumonia patients meeting severity criteria. [ Time Frame: 1 - 35 days ]Percentage of pneumonia patients meeting severity criteria.
- Number of days with fever [ Time Frame: 1 - 35 days ]Number of days with fever (axillary temperature higher than 37.5°C).
- Patients requiring mechanical ventilation [ Time Frame: 1 - 35 days ]Percentage of patients requiring mechanical ventilation through orotracheal intubation (OT) and/or ICU hospitalization.
- Mortality rate. [ Time Frame: 1- 35 days ]Mortality rate.
- Lymphocyte recovery [ Time Frame: 7 day ]Lymphocyte recovery (absolute lymphocyte count > 1000 / mm3).
- ICU hospitalization. [ Time Frame: 1 - 35 days ]Days of ICU hospitalization.
- Oxygen saturation [ Time Frame: 1 - 35 days ]Oxygen saturation (SpO2) > 92% (at ambient FiO2).
- Days of hospitalization [ Time Frame: 1 - 35 days ]Days of hospitalization
- Respiratory rate [ Time Frame: 1 - 35 days ]Respiratory rate per minute (in afebrile state conditions).

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Ages Eligible for Study: | 18 Years to 59 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adult male and female patients (≥ 18 years and <60 years).
- Signature of informed consent.
- Patients with a positive test for SARS-CoV-2 and mild symptoms of COVID-19 (without severity criteria as detailed by the Ministry of Health of Argentina - MSN)
Exclusion Criteria:
- Patients under 18 years of age and over 60 years of age.
- Breastfeeding or pregnant women (with positive pregnancy blood test in women of childbearing age).
- Patients with mild pneumonia in the presence of risk factors or moderate or severe pneumonia (based on the severity criteria set by the Ministry of Health of Argentina), or patients who require mechanical ventilation at screening.
- Patients in whom NTX and/or lactose is contraindicated.
- Any other contraindication based on the judgment of the treating physician.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04463264
Contact: Marcelo Silva, MD | (+54 11) 6418-1701 | MSILVA@cas.austral.edu.ar | |
Contact: Diego Enriquez, MD | (+54 11) 6432-3240 | denriquez@roemmers.com.ar |
Argentina | |
Hospital Universitario Austral | Recruiting |
Presidente Derqui, Buenos Aires, Argentina, Argentina, 1629 | |
Contact: Marcelo Silva, MD (+54 11) 6418-1701 MSILVA@cas.austral.edu.ar | |
Contact: Diego Enriquez, MD (+54 11) 6432-3240 denriquez@roemmers.com.ar |
Principal Investigator: | Marcelo Silva, MD | Austral University, Argentina |
Responsible Party: | Laboratorios Roemmers S.A.I.C.F. |
ClinicalTrials.gov Identifier: | NCT04463264 |
Other Study ID Numbers: |
NTZ-COVID ARG1 |
First Posted: | July 9, 2020 Key Record Dates |
Last Update Posted: | October 8, 2020 |
Last Verified: | June 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Nitazoxanide Coronavirus Infections RNA Virus Infections Respiratory Tract Infections |
Virus Diseases Respiratory Tract Diseases Antiparasitic Agents |
Infection Virus Diseases Nitazoxanide Antiparasitic Agents Anti-Infective Agents |