Ivermectin in COVID

Phase 2

Completed

Conditions: Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

Recruitment & Eligibility

Inclusion Criteria

diagnosed COVID19 patients admitted to AIIMS COVID facility

Age > 18 years

Informed consent

Non-severe disease: Non-severe disease (Asymptomatic/ Mild

disease OR moderate): SpO2>=90% on room

air with presence of clinical features of

dyspnea and/or hypoxia, fever, cough and/or

Respiratory Rate more or equal to 24 per

minute

Exclusion Criteria

Not giving written informed consent

ALT/AST >5 times the upper limit of normal.

Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR <30).

Pregnant or breast feeding.

Allergy to any study medication.

Severe co-morbidity as per investigatorâ??s assessment

Comorbid condition like myocardial infarction or heart failure within 90 days of recruitment.

Prolonged QT interval ( >450 ms)

Any other concomitant therapeutic trial

Weight <15 kg

Primary Outcome Measures

Name	Time	Method
Two co-primary outcomes <br/ ><br>1. Frequency of RTPCR negativity at day 5 after drug administration <br/ ><br>2. Change in viral load (as determined by RTPCR cycle threshold) at day 5 as compared to baselineTimepoint: Day 5 after drug administration

Secondary Outcome Measures

Name	Time	Method
Frequency of clinical worsening in study group as compared to standard careTimepoint: till discharge or death;Frequency of serious adverse events in study <br/ ><br>group as compared to standard careTimepoint: till death or discharge;Qualitative and quantitative PCR for SARS CoV-2 in pharyngeal swab on days 0, 3, 5, <br/ ><br>and 7 (while hospitalized) in both armsTimepoint: days 0, 3, 5, and 7 (while hospitalized) <br/ ><br>;Time to clinical resolution in study group as compared to standard careTimepoint: till discharge or death;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