Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy and Safety of Nitazoxanide 600 mg to Treat Mild Ambulatory COVID-19 Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04441398
Recruitment Status : Not yet recruiting
First Posted : June 22, 2020
Last Update Posted : June 22, 2020
Sponsor:
Collaborator:
Farmoquimica S.A.
Information provided by (Responsible Party):
Azidus Brasil

Tracking Information
First Submitted Date  ICMJE June 18, 2020
First Posted Date  ICMJE June 22, 2020
Last Update Posted Date June 22, 2020
Estimated Study Start Date  ICMJE July 2020
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 19, 2020)
Change in signs and symptoms scale [ Time Frame: 21 days ]
Symptoms will be assessed using a 5 point scale (1- excellent, 2- good, 3- fair, 4 - poor 5 - very poor).
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 19, 2020)
  • Incidence of Treatment-Emergent Adverse Events [ Time Frame: 21 days ]
    Number of participants with treatment-related adverse events
  • The proportion of subjects hospitalized after start of treatment and before the end of the study [ Time Frame: 21 days ]
    Change in clinical condition - WHO Ordinal Scale for Clinical Improvement that measures illness severity over time (0=uninfected; ambulatory, no limitation of activities=1; ambulatory, limitation of activities=2, hospitalized no oxygen therapy=3; hospitalized oxygen by mask or nasal prongs=4; hospitalized non invasive ventilation or high-flow oxygen=5; hospitalized intubation or mechanical ventilation=6; hospitalized ventilation + additional organ support=7; death=8)
  • The proportion of subjects that need mechanical ventilation after start of treatment and before the end of the study [ Time Frame: 21 days ]
    Change in clinical condition - WHO Ordinal Scale for Clinical Improvement that measures illness severity over time (0=uninfected; ambulatory, no limitation of activities=1; ambulatory, limitation of activities=2, hospitalized no oxygen therapy=3; hospitalized oxygen by mask or nasal prongs=4; hospitalized non invasive ventilation or high-flow oxygen=5; hospitalized intubation or mechanical ventilation=6; hospitalized ventilation + additional organ support=7; death=8)
  • Duration of symptoms [ Time Frame: 21 days ]
    Time required (days) to full symptom recovery
  • Rate of mortality within 21-days [ Time Frame: 21 days ]
    Evaluation of change in acute respiratory syndrome
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Nitazoxanide 600 mg to Treat Mild Ambulatory COVID-19 Patients
Official Title  ICMJE Prospective, Randomized, Double-blind, Parallel, Placebo Controlled Study to Evaluate the Safety and Efficacy of Nitazoxanide 600 mg Three Times a Day to Treat Ambulatory Adult Subjects Diagnosed With COVID-19 With Mild Symptoms Assisted in the Public Health System of the City of Mesquita -RJ
Brief Summary The aim is to demonstrate a decrease in complications among ambulatory patients who are diagnosed with mild COVID-19 by treating them with nitazoxanide for 7 to 14 days on top of standard care compared to patients who receive standard care and placebo only.
Detailed Description

The aim is to demonstrate a decrease in complications among ambulatory patients who are diagnosed with mild COVID-19 by treating them with nitazoxanide for 7 to 14 days on top of standard care compared to patients who receive standard care and placebo only.

After 7 days of treatment, the Investigator can extend the treatment duration for another 7 days at his/her discretion.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Subjects will be randomized to receive either nitazoxanide (n=150) or placebo (n=150)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE covid19
Intervention  ICMJE
  • Drug: Nitazoxanide
    Subjects will receive nitazonanide 600 mg TID for 7 days. Treatment can be extended for another 7 days at Investigators discretion.
    Other Name: Viranitta
  • Drug: Placebo
    Subjects will receive placebo TID for 7 days. Treatment can be extended for another 7 days at Investigators discretion.
Study Arms  ICMJE
  • Experimental: nitazoxanide
    Subjects will receive nitazonanide 600 mg TID.
    Intervention: Drug: Nitazoxanide
  • Placebo Comparator: Placebo
    Subjects will receive placebo TID.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 19, 2020)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2020
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Informed consent from patient or legal representative.
  • Subject of both genders (male and female not pregnant and not breastfeeding) aged over 49;
  • Laboratory confirmation of 2019-nCoV infection by reverse-transcription polymerase chain reaction (RT-PCR) from any diagnostic sampling source;
  • Symptomatic subject with symptoms for up to 72 hours who does not require hospitalization, with signs and symptoms of acute respiratory viral infection characterized by a feverish sensation or fever, which may or may not be present at the time of the examination (which may be reported to the health professional), accompanied by cough or sore throat or runny nose or difficulty breathing and:

    i) Oxygen saturation ≥ 90%; ii) Risk classification for COVID-19 between low (A) or medium (B) (scores 1 to 19), according to the Brazilian Ministry of Health.

Exclusion Criteria:

  • Participating in another RCT in the past 12 months;
  • Presence of comorbidities, which have a contraindication to the use of the study product, not being restricted to:

    • HIV or HTLV virus infection;
    • Chronic hepatitis C (HCV) treated with direct antiviral drugs;
    • Liver failure;
    • Severe renal failure, including dialysis;
  • Present hypersensitivity to the study product (nitazoxanide), as well as to related compounds;
  • Concomitant administration of drugs that may interact with the product under study (nitazoxanide);
  • Participants who underwent treatment with other antiviral drugs;
  • Subject in antineoplastic treatment with chemotherapy or radiation therapy;
  • Subject with severe autoimmune diseases in immunosuppression;
  • Transplanted participants;
  • Pregnant or lactating women;
  • Any other clinical condition that is deemed by the Investigator to be an imminent risk to the health and life of the subject.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Thiago Wendel, MD +55 21 99309-9668 thiagowendel83@gmail.com
Contact: Luciana Ferrara +55 19 981428814 luciana.ferrara@azidusbrasil.com.br
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04441398
Other Study ID Numbers  ICMJE NITFQM0720OR
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: It is believed that after the data analysis and presentation to the National Commission on Research Ethics, all data of the study will become public.
Responsible Party Azidus Brasil
Study Sponsor  ICMJE Azidus Brasil
Collaborators  ICMJE Farmoquimica S.A.
Investigators  ICMJE
Principal Investigator: Edimilson Migowski, MD NEPS SEMUS Mesquita
PRS Account Azidus Brasil
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP