INTERVENTION: Intervention1: Intervention Arm 1: 12 mg (200 microgram/kg) Formulation: elixir Route of administration: oral Frequency: Only single dose Intervention2: Intervention Arm 2: 24 mg (400 microgram/kg) Formulation: elixir Route of administration: oral Frequency: Only single dose Intervention3: Intervention Arm 3: 48 mg (800 microgram/kg) Formulation: elixir Route of administration: oral Frequency: Only single dose Intervention4: Intervention Arm 4 : 96 mg (1600 microgram/kg) Formulation: elixir Route of administration: oral Frequency: Only single dose Intervention5: Intervention Arm 5 : 120 mg (2000 microgram/kg) Formulation: elixir Route of administration: oral Frequency: Only single dose Control Intervention1: Standard of care: Standard medical care as per treating physician and institution CONDITION: Health Condition 1: B972‐ Coronavirus as the cause of diseases classified elsewhere PRIMARY OUTCOME: To evaluate the efficacy of different doses of single dose ivermectin in reducing viral load as estimated by cycle threshold of nasopharyngeal/oropharyngeal RTPCR at Day 4 in patients with COVID19Timepoint: Day 4 after drug administration SECONDARY OUTCOME: Clinical status of subject at week 2 (on a 7‐point ordinal scale) as follows: Not hospitalized, no limitations on activities; Not hospitalized, limitation on activities; Hospitalized, not requiring supplemental oxygen; Hospitalized, requiring supplemental oxygen; Hospitalized, on non‐invasive ventilation or high flow oxygen devices; Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); Death.Timepoint: Week 2 Frequency of clinical worsening in study group as compared to standard careTimepoint: till discharge or death Qualitative and quantitative PCR for SARS‐CoV‐2 in pharyngeal swab on days 0, 4, 8, 11, and 15 (while hospitalized) in both armsTimepoint: days 0, 4, 8, 11, and 15 (while hospitalized) Time to clinical resolution in study group as compared to standard careTimepoint: till discharge or death INCLUSION CRITERIA: diagnosed COVID19 patients admitted to AIIMS COVID facility Age > 18 years Informed consent Non‐severe disease: SpO2 >94% on room air; no evidence of sepsis/septic shock, no requirement of oxygen/assisted ventilation, or intensive care requirement
INTRODUCTION: Till date, no drug has shown definite benefit in non-severe COVID-19. Ivermectin is an antiparasitic drug which has in-vitro efficacy in reducing coronavirus-2 (SARS-CoV-2) load in severe disease. OBJECTIVES: To determine if a single oral administration of Ivermectin to patients with mild and moderate COVID-19 is effective in converting SARS-CoV-2 RT-PCR to negative result and in reducing viral load. METHODS: In this double-blind trial, patients were randomized to elixir formulation of Ivermectin in 24 mg, 12 mg or placebo in 1:1:1 ratio. The co-primary outcomes were conversion of RT-PCR to negative result and the decline of viral load at day 5 of enrolment and were assessed in patients with positive RT-PCR at enrolment (modified intention-to-treat population). Safety outcomes included total and serious adverse events and were assessed in all patients who received the trial drug (intention-to-treat population). RESULTS: Among 157 patients randomized, 125 patients were included in mITT analysis. Forty patients each were assigned to Ivermectin 24 mg and 12 mg, and 45 patients to placebo. The RT-PCR negativity at day 5 was higher in the two Ivermectin arms but failed to attain statistical significance (Ivermectin 24 mg, 47.5%; 12 mg, 35.0%; and placebo, 31.1%; p= 0.30). The decline of viral load at day 5 was similar in the three arms. No serious adverse events were encountered. CONCLUSION: In patients with mild and moderate COVID-19, a single administration of Ivermectin elixir (either 24 mg or 12 mg) demonstrated a trend towards higher proportion of RT-PCR negativity at day 5 of enrolment. The protocol was registered in the Clinical Trial Registry – India (CTRI) vide ref No CTRI/2020/06/026001.
Unpublished»Information reported in a systematic review
Year»2021
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This reference is based on information provided by a systematic review (Andrew Hill and International Ivermectin Project Team. 2021).
The review reports unpublished data provided by one of the authors of the trial which is also part of the International Ivermectin Project Team and an author of the review.
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INTRODUCTION: Ivermectin is an antiparasitic drug which has in-vitro efficacy in reducing severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) viral load. Hence, Ivermectin is under investigation as a repurposed agent for treating COVID-19.
METHODS: In this pilot, double blind, randomized controlled trial, hospitalized patients with mild-to-moderate COVID-19 were assigned to a single oral administration of an elixir formulation of Ivermectin at either 24 mg or 12 mg dose, or placebo in a 1:1:1 ratio. The co-primary outcomes were conversion of RT-PCR to negative result and the decline of viral load at day 5 of enrolment. Safety outcomes included total and serious adverse events. The primary outcomes were assessed in patients who had positive RT-PCR at enrolment (modified intention-to-treat population). Safety outcomes were assessed in all patients who received the intervention (intention-to-treat population).
RESULTS: Among the 157 patients randomized, 125 were included in modified intention-to-treat analysis. 40 patients each were assigned to Ivermectin 24 mg and 12 mg, and 45 patients to placebo. The RT-PCR negativity at day 5 was higher in the two Ivermectin arms but failed to attain statistical significance (Ivermectin 24 mg, 47.5%; 12 mg arm, 35.0%; and placebo arm, 31.1%; p-value = 0.30). The decline of viral load at day 5 was similar in each arm. No serious adverse events occurred.
CONCLUSIONS: In patients with mild and moderate COVID-19, a single oral administration of Ivermectin did not significantly increase either the negativity of RT-PCR or decline in viral load at day 5 of enrolment compared with placebo.
Intervention1: Intervention Arm 1: 12 mg (200 microgram/kg) Formulation: elixir Route of administration: oral Frequency: Only single dose Intervention2: Intervention Arm 2: 24 mg (400 microgram/kg) Formulation: elixir Route of administration: oral Frequency: Only single dose Intervention3: Intervention Arm 3: 48 mg (800 microgram/kg) Formulation: elixir Route of administration: oral Frequency: Only single dose Intervention4: Intervention Arm 4 : 96 mg (1600 microgram/kg) Formulation: elixir Route of administration: oral Frequency: Only single dose Intervention5: Intervention Arm 5 : 120 mg (2000 microgram/kg) Formulation: elixir Route of administration: oral Frequency: Only single dose Control Intervention1: Standard of care: Standard medical care as per treating physician and institution
CONDITION:
Health Condition 1: B972‐ Coronavirus as the cause of diseases classified elsewhere
PRIMARY OUTCOME:
To evaluate the efficacy of different doses of single dose ivermectin in reducing viral load as estimated by cycle threshold of nasopharyngeal/oropharyngeal RTPCR at Day 4 in patients with COVID19Timepoint: Day 4 after drug administration
SECONDARY OUTCOME:
Clinical status of subject at week 2 (on a 7‐point ordinal scale) as follows: Not hospitalized, no limitations on activities; Not hospitalized, limitation on activities; Hospitalized, not requiring supplemental oxygen; Hospitalized, requiring supplemental oxygen; Hospitalized, on non‐invasive ventilation or high flow oxygen devices; Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); Death.Timepoint: Week 2 Frequency of clinical worsening in study group as compared to standard careTimepoint: till discharge or death Qualitative and quantitative PCR for SARS‐CoV‐2 in pharyngeal swab on days 0, 4, 8, 11, and 15 (while hospitalized) in both armsTimepoint: days 0, 4, 8, 11, and 15 (while hospitalized) Time to clinical resolution in study group as compared to standard careTimepoint: till discharge or death
INCLUSION CRITERIA:
diagnosed COVID19 patients admitted to AIIMS COVID facility Age > 18 years Informed consent Non‐severe disease: SpO2 >94% on room air; no evidence of sepsis/septic shock, no requirement of oxygen/assisted ventilation, or intensive care requirement
