WithdrawnPhase 3

Trial to Evaluate Nitazoxanide for Treatment of Mild or Moderate COVID-19 in Subjects at High Risk of Severe Illness

Stopped: Sponsor decision

0Started 2024-08

Plain-language summary

The purpose of this study is to determine whether nitazoxanide (NTZ) is safe and effective in treating mild or moderate COVID-19 illness in adults and adolescents at highest risk for severe outcomes. Each participant will be followed for approximately 28 days.

Who can participate

Age range12 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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,
✓. Immunosuppressive disease,
✓. Currently receiving immunosuppressive treatment,
✓. 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),

Exclusion criteria

✕. shortness of breath at rest
✕. resting pulse ≥125 beats per minute
✕. resting respiratory rate ≥30 breaths per minute
✕. Oxygen saturation ≤ 93% on room air at sea level

What they're measuring

Proportion of participants progressing to severe COVID-19 or death from any cause

Timeframe: Day 1 through Day 28

Trial details

NCT IDNCT05157243

SponsorRomark Laboratories L.C.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-05

View on ClinicalTrials.gov More COVID-19 trials