TerminatedPhase 3

Trial to Evaluate Efficacy and Safety of Nitazoxanide in the Treatment of Colds Due to Enterovirus/Rhinovirus Infection

Stopped: Sponsor decision

United States214 participantsStarted 2020-08-19

Plain-language summary

Trial to evaluate the efficacy and safety of nitazoxanide in the treatment of colds due to enterovirus/rhinovirus infection

Age range12 Years – 120 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.

✓. 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
✓. 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
✓. 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

✕. Subjects with immunologic disorders or receiving immunosuppressive therapy (e.g., for organ or bone marrow transplants, immunomodulatory therapies for certain autoimmune diseases).
✕. Subjects with untreated human immunodeficiency viruses (HIV) infection or treated human immunodeficiency viruses (HIV) infection with a CD4 count below 350 cells/mm3 in the last six months.
✕. Subjects actively undergoing systemic chemotherapy or radiotherapy treatment for malignancy.
✕. Subjects using steroids as maintenance therapy for a chronic condition.
✕. shortness of breath at rest,
✕. resting pulse ≥125 beats per minute,
✕. resting respiratory rate ≥ breaths per minute, or
✕. SpO2 ≤ 93% on room air at sea level.

Time From First Dose to Sustained Response

Timeframe: 21 days

NCT IDNCT04489381

SponsorRomark Laboratories L.C.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-01-28

Results submitted2024-09-20

Who can participate

Age range12 Years – 120 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.

✓. 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
✓. 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
✓. 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

✕. Subjects with immunologic disorders or receiving immunosuppressive therapy (e.g., for organ or bone marrow transplants, immunomodulatory therapies for certain autoimmune diseases).
✕. Subjects with untreated human immunodeficiency viruses (HIV) infection or treated human immunodeficiency viruses (HIV) infection with a CD4 count below 350 cells/mm3 in the last six months.
✕. Subjects actively undergoing systemic chemotherapy or radiotherapy treatment for malignancy.
✕. Subjects using steroids as maintenance therapy for a chronic condition.
✕. shortness of breath at rest,
✕. resting pulse ≥125 beats per minute,
✕. resting respiratory rate ≥ breaths per minute, or
✕. SpO2 ≤ 93% on room air at sea level.