Trial to Evaluate Nitazoxanide for Treatment of Mild COVID-19 in Subjects Not at High Risk of Severe Illness
Primary Purpose
COVID-19
Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Nitazoxanide
Placebo
Vitamin Super-B Complex
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring SARS-CoV-2
Eligibility Criteria
Inclusion Criteria:
- Male or female at least 12 years of age
- Positive test for SARS-CoV-2 by RT-PCR or validated rapid antigen test within 72 hours prior to enrollment in the trial (positive sample must be collected within 72 hours prior to enrollment).
Presence of clinical signs and/or symptoms consistent with worsening or stable mild COVID-19 (one of the following is required):
- Presence of at least two respiratory symptom domains (head, throat, nose, chest, cough) with a score of ≥2 as determined by Screening FLU-PRO 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 (headache/head congestion, throat symptoms, nasal symptoms, chest symptoms, cough).
- 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 moderate or severe systemic illness with COVID-19, including the following:
- shortness of breath at rest,
- resting pulse ≥90 beats per minute,
- resting respiratory rate ≥20 breaths per minute, or
- oxygen saturation ≤ 93% on room air at sea level.
Persons who have not been fully vaccinated against SARS-CoV-2 and are at high risk of progressing to severe COVID-19 illness due to having one of the following underlying conditions and/or sociodemographic risk factors:
- Age ≥ 55 years (with or without comorbidities),
- Body mass index (BMI) ≥30 kg/m² if ≥ 18 years of age or BMI ≥85th percentile for age and gender based on CDC growth charts,
- Chronic kidney disease,
- Diabetes,
- Cardiovascular disease (including congenital heart disease) or hypertension,
- Chronic lung disease (e.g., chronic obstructive pulmonary disease, moderate-to-severe asthma, interstitial lung disease, cystic fibrosis, pulmonary hypertension),
- Sickle cell disease,
- Neurodevelopmental disorders or other conditions that confer medical complexity.
- Subjects with immunosuppressive disease or receiving immunosuppressive treatment regardless of SARS-CoV-2 vaccination status.
- 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.
- 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.
- Subjects who have received within the past 90 days or are expected to receive during the study period monoclonal antibody treatment or convalescent COVID-19 plasma for COVID-19.
- Receipt of any dose of NTZ within seven days prior to screening.
- Known sensitivity to NTZ 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Nitazoxanide
Placebo
Arm Description
Nitazoxanide 300 mg extended release tablets
Placebo tablets
Outcomes
Primary Outcome Measures
Time to sustained COVID-19 Recovery
Secondary Outcome Measures
Full Information
NCT ID
NCT05157269
First Posted
December 10, 2021
Last Updated
September 28, 2023
Sponsor
Romark Laboratories L.C.
1. Study Identification
Unique Protocol Identification Number
NCT05157269
Brief Title
Trial to Evaluate Nitazoxanide for Treatment of Mild COVID-19 in Subjects Not at High Risk of Severe Illness
Official Title
Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate Efficacy and Safety of Nitazoxanide in the Treatment of Mild COVID-19 in Subjects Not at High Risk of Severe Illness
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 2024 (Anticipated)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
March 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Romark Laboratories L.C.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The purpose of this study is to determine whether nitazoxanide (NTZ) is safe and effective for treatment of mild COVID-19 illness. Adults and adolescent participants will be followed for approximately 28 days.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
SARS-CoV-2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Nitazoxanide
Arm Type
Active Comparator
Arm Description
Nitazoxanide 300 mg extended release tablets
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tablets
Intervention Type
Drug
Intervention Name(s)
Nitazoxanide
Other Intervention Name(s)
NTZ, NT-300
Intervention Description
Two NTZ 300 mg extended release tablets administered orally with food twice daily for 5 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Two matching placebo tablets administered orally twice daily for 5 days
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin Super-B Complex
Intervention Description
Vitamin Super-B Complex administered orally with food twice daily for 5 days to maintain the blind
Primary Outcome Measure Information:
Title
Time to sustained COVID-19 Recovery
Time Frame
Day 1 through Day 21
Other Pre-specified Outcome Measures:
Title
Time to return to usual health
Time Frame
Day 1 through Day 21
Title
Proportion of participants progressing to severe COVID-19 illness or death by any cause
Time Frame
Day 1 through Day 28
Title
Change in cytokine levels
Time Frame
Day 1 through Day 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female at least 12 years of age
Positive test for SARS-CoV-2 by RT-PCR or validated rapid antigen test within 72 hours prior to enrollment in the trial (positive sample must be collected within 72 hours prior to enrollment).
Presence of clinical signs and/or symptoms consistent with worsening or stable mild COVID-19 (one of the following is required):
Presence of at least two respiratory symptom domains (head, throat, nose, chest, cough) with a score of ≥2 as determined by Screening FLU-PRO 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 (headache/head congestion, throat symptoms, nasal symptoms, chest symptoms, cough).
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 moderate or severe systemic illness with COVID-19, including the following:
shortness of breath at rest,
resting pulse ≥90 beats per minute,
resting respiratory rate ≥20 breaths per minute, or
oxygen saturation ≤ 93% on room air at sea level.
Persons who have not been fully vaccinated against SARS-CoV-2 and are at high risk of progressing to severe COVID-19 illness due to having one of the following underlying conditions and/or sociodemographic risk factors:
Age ≥ 55 years (with or without comorbidities),
Body mass index (BMI) ≥30 kg/m² if ≥ 18 years of age or BMI ≥85th percentile for age and gender based on CDC growth charts,
Chronic kidney disease,
Diabetes,
Cardiovascular disease (including congenital heart disease) or hypertension,
Chronic lung disease (e.g., chronic obstructive pulmonary disease, moderate-to-severe asthma, interstitial lung disease, cystic fibrosis, pulmonary hypertension),
Sickle cell disease,
Neurodevelopmental disorders or other conditions that confer medical complexity.
Subjects with immunosuppressive disease or receiving immunosuppressive treatment regardless of SARS-CoV-2 vaccination status.
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.
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.
Subjects who have received within the past 90 days or are expected to receive during the study period monoclonal antibody treatment or convalescent COVID-19 plasma for COVID-19.
Receipt of any dose of NTZ within seven days prior to screening.
Known sensitivity to NTZ 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.
12. IPD Sharing Statement
Learn more about this trial
Trial to Evaluate Nitazoxanide for Treatment of Mild COVID-19 in Subjects Not at High Risk of Severe Illness
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