Trial NCT04486313
Publication Rossignol JF, EClinicalMedicine, 2022 (published paper)
Dates: 2020-08-18 to 2021-01-08
Funding: Private (Romark Institute of Medical Research)
Conflict of interest: Yes
Methods | |
RCT Blinding: double blinding | |
Location :
Multicenter / Puerto Rico, USA Follow-up duration (days): 28 | |
Inclusion criteria | At least 12 years of age presenting within 72 hours of onset of symptoms of mild or moderate COVID-19; Minimum symptom requirements were: At least two respiratory symptom domains (head, throat, nose, chest, cough) with a score of ≥2 as determined by scoring the InFLUenza Patient-Reported Outcomes (FLU-PRO©) questionnaire administered at screening (only one domain score required to be ≥2 if pulse rate ≥90 beats per minute or respiratory rate ≥16 breaths per minute) ; no improvement in overall symptom severity from the prior day. |
Exclusion criteria | Signs or symptoms suggestive of severe COVID-19 including shortness of breath at rest, resting pulse rate ≥125 beats per minute, resting respiratory rate ≥30 breaths per minute, or SpO2 ≤ 93% on room air at sea level ; previous COVID-19 infection or any symptom suggestive of COVID-19 ; recent episodes (two weeks) of acute upper respiratory tract infection, otitis, bronchitis or sinusitis; immunodeficiency, such as in subjects undergoing chemotherapy, transplant recipients receiving immunosuppressive therapy, and HIV patients with a CD4 count below 350 cells/mm3 in the last six months ; females of childbearing potential who were either pregnant or sexually active and not using birth control. |
Interventions | |
Treatment
Nitazoxanide 600 mg orally twice a day for 5 days |
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Control
Placebo | |
Participants | |
Randomized * participants (n1=* / n2= *) | |
Characteristics of participants N=* Mean age : NR 165 males Severity : Mild: n=0 / Moderate: n=0/ Severe: n=0 Critical: n=0 | |
Primary outcome | |
In the register Reducing the Time to Sustained Response [ Time Frame: Up to 21 days ] | |
In the report Time from the first dose to sustained response (TSR), a measure of meaningful within-subject change in symptoms | |
Documents available |
Protocol NR Statistical plan NR Data-sharing stated
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Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review |
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General comment |