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Efficacy and Safety of Nitazoxanide for Post Exposure Prophylaxis of COVID-19

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: NCT04435314
Recruitment Status : Not yet recruiting
First Posted : June 17, 2020
Last Update Posted : June 17, 2020
Sponsor:
Collaborator:
Farmoquimica S.A.
Information provided by (Responsible Party):
Azidus Brasil

Brief Summary:
The primary objective of this study is to evaluate the efficacy of the drug nitazoxanide 600 mg, administered three times a day, in relation to placebo in preventing the development of COVID-19 in subjects from vulnerable communities that had direct contact with patients diagnosed with the disease.

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

Detailed Description:

The primary objective of this study is to evaluate the efficacy of the drug nitazoxanide 600 mg, administered three times a day, in relation to placebo in preventing the development of COVID-19 in subjects from vulnerable communities that had direct contact with patients diagnosed with the disease.

Subjects that PCR is negative after having direct contact with symptomatic subjects and diagnosed with COVID-19 (PCR positive) will be randomized to receive Nitazoxanide TID or placebo TID for 7 days.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects will be randomized to receive either nitazoxanide (n=100) or placebo (n=100)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prospective, Randomized, Double-blind, Parallel, Placebo Controlled Study to Evaluate the Safety and Efficacy of Nitazoxanide 600 mg Three Times a Day for Post Exposure Prophylaxis of COVID-19 in Subjects From Vulnerable Communities
Estimated Study Start Date : June 2020
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: nitazoxanide
Subjects will receive nitazonanide 600 mg TID.
Drug: Nitazoxanide
Subjects will receive nitazonanide 600 mg TID for 7 days
Other Name: Viranitta

Placebo Comparator: Placebo
Subjects will receive placebo TID.
Drug: Placebo
Subjects will receive placebo TID for 7 days.




Primary Outcome Measures :
  1. The proportion of subjects with laboratory-confirmed COVID-19 identified after start of treatment and before the end of the study [ Time Frame: 28 days ]
    PCR will be done to evaluate infection


Secondary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events [ Time Frame: 28 days ]
    Number of participants with treatment-related adverse events

  2. The proportion of subjects with symptomatic laboratory-confirmed COVID-19 identified after start of treatment and before the end of the study [ Time Frame: 28 days ]
    Symptomatic PCR positive subjects

  3. The proportion of subjects with asymptomatic laboratory-confirmed COVID identified after the start of treatment and before the end of the study [ Time Frame: 28 days ]
    Asymptomatic PCR will be done to evaluate infection

  4. Treatment adherence [ Time Frame: 7 days ]
    Subject adherence to treatment will be assessed through study diary record

  5. Disease complication [ Time Frame: 28 days ]
    Proportion of patients with severe condition

  6. Incidence of subjects that underwent unscheduled visit [ Time Frame: 28 days ]
    Proportion of patient that needed undergo an unscheduled visit



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 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 18 years or over;
  • Subject that lives in a vulnerable community;
  • Subject that were in direct contact with confirmed cases of SARS-CoV-2 infection, as they live or work directly with index patients;
  • Not showing symptoms compatible with COVID-19 and and that do not have a positive RT-PCR test in a nasopharyngeal swab sample before randomization;
  • Participant capable of understanding and fulfilling all activities planned for the study;
  • In use of an acceptable method of contraception throughout the study.

Exclusion Criteria:

  • Participating in another RCT in the past 12 months;
  • Positive PCR result for COVID-19 during screening;
  • History of infection confirmed by SARS-CoV-2;
  • Present symptoms suggestive of SARS-CoV-2 infection;
  • 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 antivirals and / or antiparasitic drugs in the last 30 days;
  • 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.

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): NCT04435314


Contacts
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Contact: Marcelo Fonseca, MD +55 11 984228329 mcmf1964@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: Reginaldo Raimundo Fujita Federal University of São Paulo
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Responsible Party: Azidus Brasil
ClinicalTrials.gov Identifier: NCT04435314    
Other Study ID Numbers: NITFQM0620OR
First Posted: June 17, 2020    Key Record Dates
Last Update Posted: June 17, 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