Trial CTRI/2020/08/027225
Publication Ravikirti R, J Pharm Pharm Sci, 2021 (published paper)
Dates: 2020-08-28 to 2020-10-31
Funding: Mixed (All India Institute of Medical Sciences; Sun Pharma Pvt. Ltd. (placebo provision); learning resource allowance of the principal investigator (ivermectin procurement))
Conflict of interest: No
| Methods | |
| RCT Blinding: double blinding | |
| Location :
Single center / India Follow-up duration (days): * | |
| Inclusion criteria | All patients above the age of 18 admitted with a diagnosis of COVID-19 (on the basis of a positive RT-PCR or Rapid Antigen Test report) at AIIMS, Patna, India with mild or moderate disease as defined by the ministry of health and family welfare guidelines and not meeting any of the exclusion criteria were considered eligible for the study
Definitions of Mild, moderate and severe COVID-19 - Mild: No evidence of breathlessness or Hypoxia (normal saturation) - Moderate: Breathlessness and/or hypoxia (saturation 90-94% on room air), respiratory rate of 24 or more and no features of severe disease - Severe: Any of the following – Severe respiratory distress, oxygen saturation < 90% on room air, respiratory rate > 30, shock or evidence of a life threatening organ dysfunction |
| Exclusion criteria | - Known allergy to or adverse drug reaction with Ivermectin
- Unwillingness or inability to provide consent to participate in the study - Prior use of ivermectin during the course of this illness - Pregnancy and lactation |
| Interventions | |
| Treatment
Ivermectin 12 mg enterally once daily on days 1 and 2 |
|
| Control
Placebo Duration : 2 days | |
| Participants | |
| Randomized 115 participants (n1=57 / n2= 58) | |
| Characteristics of participants N=115 Mean age : 52.5 81 males Severity : Mild: n=* / Moderate: n=*/ Severe: n=* Critical: n=0 | |
| Primary outcome | |
| In the register Negative RT-PCR [Day 6] | |
| In the report Negative RT-PCR report on day 6 | |
| 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 |
High |
| General comment | In addition to the published/pre-print article, the trial registry was used in data extraction and assessment of risk of bias. Neither the protocol nor statistical analysis plan were available. There were no substantive differences between the article and the trial registry in population, procedures, or interventions. The study achieved its pre-stated sample size. Although negative conversion by RT-PCR was reported as an outcome, it is unclear what proportion of patients was positive by the same measure at baseline: inclusion criteria included diagnosis confirmed by RT-PCR or Rapid Antigen Test. Some outcomes were reported with no details of duration of follow-up (admission to ICU, invasive ventilation, in-hospital mortality). Two secondary outcomes reported (symptom free on day 6 and later discharge) and drug-related adverse events were not included in the registry |