Trial NCT04431466
Publication Pott-Junior H, 2021 (published paper)
Funding: No specific funding (non-commercial phase 2a clinical trial )
Conflict of interest: No
Methods | |
RCT Blinding: Unblinded | |
Location :
Single center / Brazil Follow-up duration (days): 28 | |
Inclusion criteria | â¥18 years of age; an Eastern Cooperative Oncology Group (ECOG) score of 0â1; a National Early Warning Score (NEWS) of 0â4; and had SARS-CoV-2 infection confirmed by real-time reverse transcription polymerase chain reaction (RT-PCR) testing performed on nasopharyngeal swab specimens. |
Exclusion criteria | Not able to ingest / absorb the drug orally through spontaneous ingestion or by gastro / enteral tubes; any clinical observation (clinical / physical evaluation) or laboratory findings which, in the investigatorâs opinion, would have put the patient at risk to participate in the study; any abnormal ECG findings that require additional evaluation; known hypersensitivity to the drug components used during the study; pregnancy or breastfeeding; body weight less than 15 kg; an estimated glomerular filtration rate (CKD-Epidemiology Collaboration, CKD-EPI) below 30 mL/min; and values of aspartate aminotransaminase (AST) or alanine aminotransaminase (ALT) 5-fold above the upper limit of normality. |
Interventions | |
Treatment 1 Ivermectin 100 mcg/kg | |
Control Standard care | |
Control Ivermectin 200 mcg/kg | |
Control Ivermectin 400 mcg/kg | |
Participants | |
Randomized 32 participants n1=7/ n2=4/ n3=14/ n4=7/ | |
Characteristics of participants N=32 Mean age : 49.2 14 males Severity : Mild: n=32 / Moderate: n=0/ Severe: n=0 Critical: n=0 | |
Primary outcome | |
In the register Time to undetectable SARS-CoV-2 viral load in the nasopharyngeal swab. [ Time Frame: 7 days following intervention ] | |
In the report Proportion of patients who achieved undetectable viral load during 7 days of follow-up | |
Documents available |
Protocol NR Statistical plan NR Data-sharing stated Yes |
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 |
Some concerns |
General comment | In addition to the published article, the trial registry was used in data extraction and assessment of risk of bias. The registry describes one standard care arm and four treatment arms: 100mcg / kg single dose; 100mcg / kg on the first day, followed by 100mcg / kg after 72h; 200mcg / kg single dose; and 200mcg / kg on the first day, followed by 200mcg / kg after). The article reports three treatment arms: an âaccumulated doseâ of 100 mcg/kg; 200 mcg/kg and 400 mcg/kg. Extraction has assumed the 200 mcg/kg arm includes both the 200 mcg/kg single dose and the 100 mcg/kg two-dose arms. Several outcome measures in the original registration were removed or altered after study commencement. The primary outcome in the report (the proportion of patients who achieved undetectable viral load during 7 days of follow-up) was a secondary outcome in the registry, where the primary outcome was time to undetectable viral load. The trial was originally registered as triple-blinded, and this was changed to open-label after study commencement. The trial did not achieve its pre-stated target sample size. |