Trial IRCT20111224008507N3
Publication Shahbaznejad L, Clin Ther, 2021 (published paper)
Dates: 2020-05-23 to 2020-07-31
Funding: No specific funding (Mazandaran University of Medical Sciences)
Conflict of interest: No
| Methods | |
| RCT Blinding: double blinding | |
| Location :
Multicenter / Iran Follow-up duration (days): 7 | |
| Inclusion criteria | Hospitalized patients (age >5 years, weight >15 kg) with any of the following: a positive result of COVID-19 RT-PCR; or clinical complaints of COVID-19 with a history of contact with a COVID-19 patient; or abnormalities in chest computed tomography scan compatible with COVID-19 (ground-glass opacity, halo sign, reversed halo sign, and patchy infiltration). |
| Exclusion criteria | History of chronic liver and/or renal disease; receiving treatment with warfarin, angiotensin-converting enzyme inhibitors, or angiotensin II receptor antagonists; acquired immunodeficiency; pregnant women and lactating mothers. |
| Interventions | |
| Treatment
Ivermectin 0.2 mg/kg orally once-off (weight-based doses, i.e. 15-24 kg: 3 mg; 25-30 kg: 6 mg; 36-50 kg: 9 mg; 51-80 kg: 12 mg; >80 kg: 0.2 mg/kg). |
|
| Control
Standard care ( / ) Definition of Standard care: Supportive medical treatment for COVID-19 according to the national protocols of Iran at the time of this study (hydroxychloroquine and/or lopinavir/ritonavir). All of the participants received appropriate antibiotics and/or supplementary oxygen as indicated. | |
| Participants | |
| Randomized 73 participants (n1=35 / n2= 38) | |
| Characteristics of participants N=73 Mean age : 46.4 36 males Severity : Mild: n=0 / Moderate: n=*/ Severe: n=* Critical: n=3 | |
| Primary outcome | |
| In the register Clinical symptoms including fever, chills, sore throat, cough, shortness of breath, decreased appetite, abdominal pain, dizziness, insomnia, itching, joint pain, joint swelling, headache, nausea, vomiting, diarrhea, malaise, conjunctivitis, tachycardia, wheezing, rhonchus, retraction, hypotension, rash, other symptoms; respiratory rate and O2 saturation-The first, second, third, fourth, fifth, sixth, seventh day. | |
| In the report Clinical improvement after baseline defined as resolving patients’ baseline status on persistent and continuous cough (coughing a lot for more than an hour, or ≥3 coughing episodes in 24 hours that interferes with daily life and ability to work) and tachypnea in addition to increasing oxygen saturation >94%. | |
| 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 |
Some concerns |
| General comment | In addition to the published report (pre-proof), the retrospective registry was used in data extraction and assessment of the risk of bias. The protocol or statistical analysis plan was not available. The study achieved the target sample size specified in the trial registry (n=60). There is no change from the trial registration in the intervention and control treatments. After selecting the samples, none of the participants was aware of randomization and allocation to groups. The evaluator nurse of data recording is from out of the study and questionnaires was provided in the form of coding to him/her. So, the present study is double-blinded (registry). Some outcomes from the report are not mentioned in the registry (e.g. adverse events, mortality). |