Clinical trial NCT05157269: 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
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: COVID-19
Keywords: SARS-CoV-2
Lead sponsor: Romark Laboratories L.C.
Sponsor class: INDUSTRY
First posted: 2021-12-14
Enrollment: 0
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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):

  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 AND
  2. 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:

  1. shortness of breath at rest,
  2. resting pulse ≥90 beats per minute,
  3. resting respiratory rate ≥20 breaths per minute, or
  4. 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:

  1. Age ≥ 55 years (with or without comorbidities),
  2. 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,
  3. Chronic kidney disease,
  4. Diabetes,
  5. Cardiovascular disease (including congenital heart disease) or hypertension,
  6. Chronic lung disease (e.g., chronic obstructive pulmonary disease, moderate-to-severe asthma, interstitial lung disease, cystic fibrosis, pulmonary hypertension),
  7. Sickle cell disease,
  8. 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.

Primary outcomes:
measure: Time to sustained COVID-19 Recovery
timeFrame: Day 1 through Day 21
Secondary outcomes:
Other outcomes:
measure: Time to return to usual health
timeFrame: Day 1 through Day 21
measure: Proportion of participants progressing to severe COVID-19 illness or death by any cause
timeFrame: Day 1 through Day 28
measure: Change in cytokine levels
timeFrame: Day 1 through Day 4
Locations:
Study officials:
References: