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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
Sponsor:
Information provided by (Responsible Party):
Laboratorios Roemmers S.A.I.C.F.

Brief Summary:
Evaluation of the efficacy and safety of NTX in adult patients (≥18 years and <60 years), with SARS-CoV-2 infection with mild symptoms of COVID-19, compared to a placebo control arm. 135 patients will be randomized to either Nitazoxanide (n=90) or placebo (n=45) (2:1). Simple blind design. Primary endpoint: eradication of virus from patients' respiratory tract secretions by the 7th day of treatment.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Nitazoxanide Drug: Placebo Phase 2 Phase 3

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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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: NTX active treatment
Intervention: NTX (500 mg every 6 hours for 14 days) orally with food (P.O.).
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.).
Drug: Placebo
Placebo (1 tablet every 6 hours for 14 days) orally with food (P.O.).




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.

  2. 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)

  3. Pneumonia patients meeting severity criteria. [ Time Frame: 1 - 35 days ]
    Percentage of pneumonia patients meeting severity criteria.

  4. Number of days with fever [ Time Frame: 1 - 35 days ]
    Number of days with fever (axillary temperature higher than 37.5°C).


Other Outcome Measures:
  1. Patients requiring mechanical ventilation [ Time Frame: 1 - 35 days ]
    Percentage of patients requiring mechanical ventilation through orotracheal intubation (OT) and/or ICU hospitalization.

  2. Mortality rate. [ Time Frame: 1- 35 days ]
    Mortality rate.

  3. Lymphocyte recovery [ Time Frame: 7 day ]
    Lymphocyte recovery (absolute lymphocyte count > 1000 / mm3).

  4. ICU hospitalization. [ Time Frame: 1 - 35 days ]
    Days of ICU hospitalization.

  5. Oxygen saturation [ Time Frame: 1 - 35 days ]
    Oxygen saturation (SpO2) > 92% (at ambient FiO2).

  6. Days of hospitalization [ Time Frame: 1 - 35 days ]
    Days of hospitalization

  7. 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
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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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

Locations
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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   
Sponsors and Collaborators
Laboratorios Roemmers S.A.I.C.F.
Investigators
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Principal Investigator: Marcelo Silva, MD Austral University, Argentina
Publications:

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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Laboratorios Roemmers S.A.I.C.F.:
Nitazoxanide
Coronavirus Infections
RNA Virus Infections
Respiratory Tract Infections
Virus Diseases
Respiratory Tract Diseases
Antiparasitic Agents
Additional relevant MeSH terms:
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Infection
Virus Diseases
Nitazoxanide
Antiparasitic Agents
Anti-Infective Agents