INTERVENTION: Intervention1: Ivermectin: 12 mg orally to be administered once daily on days 1 and 2 Control Intervention1: Placebo tablets: A placebo tablet similar to Ivermectin 12 mg (provided by the manufacturer) to be given once daily on days 1 and 2. CONDITION: Health Condition 1: B972‐ Coronavirus as the cause of diseases classified elsewhere PRIMARY OUTCOME: Negative RT‐PCRTimepoint: Day 6 SECONDARY OUTCOME: Discharge by day 10Timepoint: Day 10 ICU AdmissionTimepoint: NA In‐hospital mortalityTimepoint: NA Mechanical VentilationTimepoint: NA INCLUSION CRITERIA: Patients admitted with COVID‐19 with mild to moderate severity
ObjectiveIvermectin has been suggested as a treatment for COVID-19.This randomised control trial was conducted to test the efficacy of Ivermectin in the treatment of mild and moderate COVID-19.
DesignParallel, double blind, randomised, placebo controlled trial Setting: A tertiary care dedicated COVID-19 hospital in Bihar, India
ParticipantsAdult patients (> 18 years) admitted with mild to moderate COVID 19 disease (saturation > 90% on room air, respiratory rate < 30 and no features of shock) with no contraindications to ivermectin and willing to participate in the study
InterventionPatients in the intervention arm were given ivermectin 12 mg on day 1 and day 2 of admission. Patients in the placebo arm were given identical looking placebo tablets. Rest of the treatment was continued as per the existing protocol and the clinical judgment of the treating teams.
Outcome MeasuresThe primary outcome measure was a negative RT-PCR test for SARS-CoV-2 on day 6 of admission. The secondary outcome measures were symptom status on day 6, discharge status on day 10, admission to ICU, need for invasive mechanical ventilation and in-hospital mortality.
ResultsA total of 115 patients were enrolled for the study of which 112 were included in the final analysis. Of them, 55 were randomised to the intervention arm while 57 were randomised to the placebo arm. There was no significant difference in the baseline characteristics of the two arms. There was no significant difference in the primary outcome, i.e. negative RT-PCR status on day 6 between the two groups. Similarly, there was no significant difference between the two groups in most of the secondary outcome measures, viz. symptom status on day 6, discharge status on day 10, admission to ICU, and need for invasive mechanical ventilation. However, while there was no in-hospital mortality in the intervention arm, there were 4 deaths in the placebo arm. As a result, all patients in the intervention arm (n=56) were successfully discharged as compared to 93.1% (n=54/58) in the placebo arm (RR 1.1, 95% CI 1.0 to 1.2, p=0.019).
ConclusionThere was no difference in the primary outcome i.e. negative RT-PCR status on day 6 of admission with the use of ivermectin. However, a significantly higher proportion of patients were discharged alive from the hospital when they received ivermectin.
Strengths and Limitations of the StudyO_LIThis study was randomised and double blind, thereby minimizing the chance of bias.
C_LIO_LIAll outcome measures except symptom status on day 6 were objective and placebo control was used for comparison.
C_LIO_LIOnly single repeat RT-PCR was done. So median time to viral clearance in the two groups could not be calculated.
C_LIO_LISevere cases were not included in the study.
C_LI
Journal»Journal of pharmacy & pharmaceutical sciences : a publication of the Canadian Society for Pharmaceutical Sciences, Societe canadienne des sciences pharmaceutiques
BACKGROUND: There has been a growing interest in ivermectin ever since it was reported to have an in-vitro activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This trial was conducted to test the efficacy of ivermectin in mild and moderate coronavirus disease 19 (COVID-19).
METHODS: A double blind, parallel, randomised, placebo-controlled trial conducted among adult COVID-19 patients with mild to moderate disease severity on admission in a COVID dedicated tertiary healthcare of eastern India. Enrolment was done between 1st August and 31st October 2020. On day 1 and 2 post enrolment, patients in the intervention arm received ivermectin 12 mg while the patients in the non-interventional arm received placebo tablets.
RESULTS: About one-fourth (23.6%) of the patients in the intervention arm and one-third (31.6%) in the placebo arm were tested reverse transcriptase polymerase chain reaction (RTPCR) negative for SARS-CoV-2 on 6th day. Although this difference was found to be statistically insignificant [rate ratio (RR): 0.8; 95% confidence interval (CI): 0.4-1.4; p=0.348]. All patients in the ivermectin group were successfully discharged. In comparison the same for the placebo group was observed to be 93%. This difference was found to be statistically significant (RR: 1.1; 95% CI; 1.0-1.2; p=0.045).
CONCLUSIONS: Inclusion of ivermectin in treatment regimen of mild to moderate COVID-19 patients could not be said with certainty based on our study results as it had shown only marginal benefit in successful discharge from the hospital with no other observed benefits.
Intervention1: Ivermectin: 12 mg orally to be administered once daily on days 1 and 2 Control Intervention1: Placebo tablets: A placebo tablet similar to Ivermectin 12 mg (provided by the manufacturer) to be given once daily on days 1 and 2.
CONDITION:
Health Condition 1: B972‐ Coronavirus as the cause of diseases classified elsewhere
PRIMARY OUTCOME:
Negative RT‐PCRTimepoint: Day 6
SECONDARY OUTCOME:
Discharge by day 10Timepoint: Day 10 ICU AdmissionTimepoint: NA In‐hospital mortalityTimepoint: NA Mechanical VentilationTimepoint:
NA INCLUSION CRITERIA:
Patients admitted with COVID‐19 with mild to moderate severity
