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Trial to Evaluate Efficacy and Safety of Nitazoxanide in the Treatment of Mild or Moderate 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: NCT04486313
Recruitment Status : Recruiting
First Posted : July 24, 2020
Last Update Posted : September 29, 2020
Sponsor:
Information provided by (Responsible Party):
Romark Laboratories L.C.

Brief Summary:
Trial to Evaluate Efficacy and Safety of Nitazoxanide in the Treatment of Mild or Moderate COVID-19

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Nitazoxanide Drug: Placebo Dietary Supplement: Vitamin Super B-Complex Phase 3

Detailed Description:
Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate Efficacy and Safety of Nitazoxanide in the Treatment of Mild or Moderate COVID-19

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Phase 3, Randomized, Double-Blind, Placebo-Controlled, Trial to Evaluate Efficacy and Safety of Nitazoxanide in the Treatment of Mild or Moderate COVID-19
Actual Study Start Date : August 13, 2020
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Nitazoxanide
Two nitazoxanide 300 mg tablets orally twice daily for 5 days
Drug: Nitazoxanide
Two nitazoxanide 300 mg tablets administered orally twice daily with food for 5 days
Other Names:
  • NTZ (nitazoxanide)
  • NT-300

Dietary Supplement: Vitamin Super B-Complex
Vitamin Super B-Complex administered orally twice daily to maintain the blind

Placebo Comparator: Placebo
Two placebo tablets orally twice daily for 5 days
Drug: Placebo
Two placebo tablets administered orally twice daily with food for 5 days

Dietary Supplement: Vitamin Super B-Complex
Vitamin Super B-Complex administered orally twice daily to maintain the blind




Primary Outcome Measures :
  1. Reducing the Time to Sustained Response [ Time Frame: Up to 21 days ]
    To evaluate the effect of nitazoxanide in reducing the time to sustained response compared to placebo in subjects with mild or moderate COVID-19


Secondary Outcome Measures :
  1. Reducing the Rate of Progression [ Time Frame: Up to 21 days ]
    To evaluate the effect of nitazoxanide in reducing the rate of progression to severe COVID-19 illness compared to placebo



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:   12 Years to 120 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female outpatients at least 12 years of age
  • Presence of clinical signs and/or symptoms consistent with worsening or stable mild or moderate COVID-19 (one of the following is required):

    1. Presence of at least two respiratory symptom domains (head, throat, nose, chest, cough) with a score of ≥2 as determined by Screening FLU-PRO OR
    2. Presence of at least one respiratory symptom domain (head, throat, nose, chest, cough) with a score of ≥2 as determined by Screening FLU-PRO with pulse rate ≥90 OR
    3. Presence of at least one respiratory symptom domain (head, throat, nose, chest, cough) with a score of ≥2 as determined by Screening FLU-PRO with respiratory rate ≥16

AND patient reported assessment that symptoms are present, the symptoms are not consistent with the subject's usual health, the symptoms interfere with daily activities, and the symptoms have worsened or remained the same relative to the previous day, as confirmed by responses to questions in the Screening FLU-PRO.

  • Onset of symptoms no more than 72 hours before enrollment in the trial. Onset of symptoms is defined as the earlier of the first time at which the subject experienced subjective fever or any respiratory symptom (head, throat, nose, chest, or cough symptoms).
  • Willing and able to provide written informed consent (including assent by legal guardian if under 18 years of age) and comply with the requirements of the protocol, including completion of the subject diary and all protocol procedures.

Exclusion Criteria:

  • Persons with any clinical sign or symptoms suggestive of severe systemic illness with COVID-19, including the following:

    1. shortness of breath at rest,
    2. resting pulse ≥125 beats per minute,
    3. resting respiratory rate ≥30 breaths per minute, or
    4. SpO2 ≤ 93% on room air at sea level.
  • Subjects who experienced a previous episode of acute upper respiratory tract infection, otitis, bronchitis or sinusitis or received antibiotics for these conditions within two weeks prior to and including study day 1.
  • Severely immunodeficient persons including:

    1. Subjects with immunologic disorders or receiving immunosuppressive therapy (e.g., for organ or bone marrow transplants, immunomodulatory therapies for certain autoimmune diseases)
    2. Subjects with untreated human immunodeficiency virus (HIV) infection or treated human immunodeficiency virus (HIV) infection with a CD4 count below 350 cells/mm3 in the last six months
    3. Subjects actively undergoing systemic chemotherapy or radiotherapy treatment for malignancy
    4. Subjects using steroids as maintenance therapy for chronic conditions
  • Subjects with active respiratory allergies or subjects expected to require anti- allergy medications during the study period for respiratory allergies.
  • Females of childbearing potential who are either pregnant or sexually active without the use of birth control. Female subjects of child-bearing potential that are sexually active must have a negative baseline pregnancy test and must agree to continue an acceptable method of birth control for the duration of the study and for 1 month post-treatment. A double barrier method, oral birth control pills administered for at least 2 monthly cycles prior to study drug administration, an intrauterine device (IUD), or medroxyprogesterone acetate administered intramuscularly for a minimum of one month prior to study drug administration are acceptable methods of birth control for inclusion into the study. Female subjects are considered of childbearing potential unless they are postmenopausal (absence of menstrual bleeding for 1 year - or 6 months if laboratory confirmation of hormonal status), or have had a hysterectomy, bilateral tubular ligation or bilateral oophorectomy.
  • Subjects with a history of COVID-19 or known to have developed anti-SARS- CoV-2 antibodies.
  • Subjects residing in the same household with another subject participating in the study.
  • Treatment with any investigational drug or vaccine therapy within 30 days prior to screening and willing to avoid them during the course of the study.
  • Receipt of any dose of nitazoxanide within seven days prior to screening.
  • Known sensitivity to nitazoxanide or any of the excipients comprising the study medication.
  • Subjects unable to swallow oral tablets or capsules.
  • Subjects with known severe heart, lung, neurological or other systemic disease that the Investigator believes could preclude safe participation.
  • Subjects likely or expected to require hospitalization unrelated to COVID-19 during the study period.
  • Subjects taking medications considered to be major CYP2C8 substrates.
  • Subjects who, in the judgment of the Investigator, will be unlikely to comply with the requirements of this protocol including completion of the subject diary.

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): NCT04486313


Contacts
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Contact: Stefan Comhaire 813-282-8544 stefan.comhaire@celerion.com

Locations
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United States, Florida
Invesclinic US LLC Recruiting
Fort Lauderdale, Florida, United States, 33308
Contact: Romark    877-925-4642      
United States, New York
RH Medical Urgent Care Recruiting
Bronx, New York, United States, 10456
Contact: Romark    877-925-4642      
Sponsors and Collaborators
Romark Laboratories L.C.
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Responsible Party: Romark Laboratories L.C.
ClinicalTrials.gov Identifier: NCT04486313    
Other Study ID Numbers: RM08-3008
First Posted: July 24, 2020    Key Record Dates
Last Update Posted: September 29, 2020
Last Verified: September 2020

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