Trial IRCT20200408046987N1
Publication Niaee MS, Asian Pac J Trop Med, 2021 (published paper)

Funding: Mixed (Qazvin University of Medical Sciences and Science (pre-print); Chistasazan Notash Fartak Company Limited (registry))
Conflict of interest: *

Methods
RCT
Blinding: double blinding
Location : Multicenter / Iran
Follow-up duration (days): *
Inclusion criteriaAge >18 years;
Signed the informed consent;
Clinical symptoms of suggestive of COVID-19 pneumonia: cough (with or without sputum), fever, pleuritic chest pain or dyspnea;
Mild to severe COVID-19 disease confirmed by chest computed tomography (CT) scan findings compatible with COVID-19 or positive real-time reverse transcription polymerase chain reaction (RT-PCR).
Exclusion criteriaPresence of severe immunosuppression (e.g., use of immune-suppressants and HIV positive);
Pregnant women; Chronic kidney disease;
Malignancy;
Indications that the patients were unable and/or unlikely to comprehend and/or follow the protocol.
Interventions
Treatment 1
Ivermectin Once-off (200 mcg/kg)
Co-Intervention: Standard care
Duration : 1 day
Control
Standard care
Control
Placebo
Treatment 4
Ivermectin 3-day LD (200 mcg/kg)
Co-Intervention: Standard care
Duration : 5 days
Treatment 5
Ivermectin 1-day BDS (200 mcg/kg)
Co-Intervention: Standard care
Duration : 1 day
Treatment 6
Ivermectin 3-day HD (200 mcg/kg)
Co-Intervention: Standard care
Duration : 5 days
Participants
Randomized
180 participants n1=30/ n2=30/ n3=30/ n4=30/ n5=30/ n6=30/
Characteristics of participants
N=180
Mean age : NR
90 males
Severity : Mild: n=* / Moderate: n=*/ Severe: n=* Critical: n=*
Primary outcome
In the register
Chest image (CT scan) at hospital clearance;
Hospitalization time;
CBC and CRP
In the report
The primary endpoint of this trial was all-cause of mortalityor clinical recovery. Clinical recovery was defined as normaltemperature, respiratory rate, and oxygen saturation (>94%)without oxygen therapy sustained for 24 h.
Documents
available

Protocol

NR

Statistical plan

NR

Data-sharing stated

Unclear
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 and pre-print articles, the trial registry was used in data extraction and assessment of risk of bias. Neither study protocol nor statistical analysis plan was available. There were some differences between the registry and the pre-print article in terms of inclusion criteria, number of treatment arms, and outcomes (registry: chest CT scan, length of hospitalization, complete blood count, C-reactive protein; article: clinical recovery defined as normal fever, respiratory rate, and oxygen saturation >94% without oxygen therapy sustained for 24h). Mortality was not listed as an outcome in the registry. The study achieved its pre-stated sample size. The overall follow-up of the study is unclear.