Ivermectin in COVID

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