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

Trial to Evaluate the Efficacy and Safety of Nitazoxanide (NTZ) for Post Exposure Prophylaxis of COVID-19 and Other Viral Respiratory Illnesses (VRI) in Healthcare Workers

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: NCT04359680
Recruitment Status : Recruiting
First Posted : April 24, 2020
Last Update Posted : May 29, 2020
Sponsor:
Information provided by (Responsible Party):
Romark Laboratories L.C.

Brief Summary:
Trial to Evaluate the Efficacy and Safety of Nitazoxanide (NTZ) for Post Exposure Prophylaxis of COVID-19 and Other Viral Respiratory Illnesses (VRI) in Healthcare Workers

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

Detailed Description:
Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Nitazoxanide (NTZ) for Post Exposure Prophylaxis of COVID-19 and Other Viral Respiratory Illnesses (VRI) in Healthcare Workers

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: A Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Nitazoxanide (NTZ) for Post Exposure Prophylaxis of COVID-19 and Other Viral Respiratory Illnesses (VRI) in Healthcare Workers
Actual Study Start Date : May 13, 2020
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Nitazoxanide
Two NTZ 300 mg tablets orally twice daily for 6 weeks.
Drug: Nitazoxanide
Nitazoxanide 600 mg administered orally twice daily for six weeks
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 6 weeks.
Drug: Placebo
Placebo administered orally twice daily for six weeks

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




Primary Outcome Measures :
  1. The proportion of subjects with symptomatic laboratory-confirmed COVID-19 identified after start of treatment and before the end of the 6-week treatment period. [ Time Frame: Up to 6 weeks ]
  2. The proportion of subjects with symptomatic laboratory-confirmed VRI identified after the start of treatment and before the end of the 6-week treatment period. [ Time Frame: Up to 6 weeks ]


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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females at least 18 years of age.
  • Healthcare workers at increased risk for direct occupational exposure to COVID-19. (Subject meets the definition of "healthcare worker": provides healthcare to patients and/or typically positions themselves within 6 feet of patients ("close contact") and is a full-time employee (average of ≥ 24 hours/week) in a high contact area (Emergency Department, Intensive Care Unit, COVID-specific Care Unit, Walk-in Clinic, Paramedic/First Responder).
  • Must have a smartphone, tablet, computer, or other qualifying internet- enabled device and daily internet access.
  • Occupational exposure to a person infected with SAR-CoV-2 within 7 days prior to enrollment.
  • Willing and able to provide written informed consent and comply with the requirements of the protocol, including completion of the subject diary.

Exclusion Criteria:

  • Subjects with indirect occupational exposure or not meeting the study definition of "healthcare worker".
  • Subjects with known severe heart, lung, neurological or other systemic disease that the Investigator believes could preclude safe participation.
  • Subjects with a history of COVID-19 or known to have developed anti- SARS-CoV-2 antibodies.
  • Subjects who experienced a previous episode of acute upper respiratory tract infection, otitis, bronchitis or sinusitis or received antibiotics for these conditions or antiviral therapy for influenza within two weeks prior to and including study day 1.
  • Subjects residing in the same household with another a subject participating in the study.
  • Receipt of any dose of NTZ within 7 days prior to screening.
  • 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.
  • Known sensitivity to NTZ or any of the excipients comprising the study medication.
  • Subjects unable to swallow oral tablets or capsules.
  • 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.
  • Females who are breastfeeding.
  • Subjects with active respiratory allergies or subjects expected to require anti- allergy medications during the study period for respiratory allergies.
  • 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): NCT04359680


Contacts
Layout table for location contacts
Contact: Matthew Bardin, PharmD, BCPS 813-282-8544 matthew.bardin@romark.com

Locations
Layout table for location information
United States, Florida
Clinical Trial Site Recruiting
Orlando, Florida, United States, 32801
Contact: Romark    877-925-4642      
United States, New York
Clinical Trial Site Recruiting
Brooklyn, New York, United States, 11229
Contact: Romark    877-925-4642      
United States, Texas
Clinical Trial Site Recruiting
Houston, Texas, United States, 77058
Contact: Romark    877-925-4642      
Sponsors and Collaborators
Romark Laboratories L.C.
Layout table for additonal information
Responsible Party: Romark Laboratories L.C.
ClinicalTrials.gov Identifier: NCT04359680    
Other Study ID Numbers: RM08-3007
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: May 29, 2020
Last Verified: May 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Romark Laboratories L.C.:
COVID-19
Viral Respiratory Illnesses
Additional relevant MeSH terms:
Layout table for MeSH terms
Nitazoxanide
Antiparasitic Agents
Anti-Infective Agents