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

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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
covid19 Drug: Nitazoxanide Drug: Placebo Phase 2 Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
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
Official Title: 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
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: nitazoxanide
Subjects will receive nitazonanide 600 mg TID.
 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
Placebo Comparator: Placebo
Subjects will receive placebo TID.
 Drug: Placebo
Subjects will receive placebo TID for 7 days. Treatment can be extended for another 7 days at Investigators discretion.


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events [ Time Frame: 21 days ]
    Number of participants with treatment-related adverse events

  2. 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)

  3. 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)

  4. Duration of symptoms [ Time Frame: 21 days ]
    Time required (days) to full symptom recovery

  5. Rate of mortality within 21-days [ Time Frame: 21 days ]
    Evaluation of change in acute respiratory syndrome


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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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): NCT04441398


Contacts
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Contact: Thiago Wendel, MD +55 21 99309-9668 thiagowendel83@gmail.com
Contact: Luciana Ferrara +55 19 981428814 luciana.ferrara@azidusbrasil.com.br

Sponsors and Collaborators
Azidus Brasil
Farmoquimica S.A.
Investigators
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Principal Investigator: Edimilson Migowski, MD NEPS SEMUS Mesquita
More Information
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Responsible Party: Azidus Brasil
ClinicalTrials.gov Identifier: NCT04441398    
Other Study ID Numbers: NITFQM0720OR
First Posted: June 22, 2020    Key Record Dates
Last Update Posted: June 22, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Nitazoxanide
Antiparasitic Agents
Anti-Infective Agents