A randomized control trial to assess the efficacy and safety of ivermectin in the treatment of mild to moderate COVID 19 patients

Phase 2

Recruiting

Conditions: COVID-19

Registration Number: SLCTR/2021/020

Lead Sponsor: Dr Ananda Wijewickrama

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: Not specified

Inclusion Criteria

•Patients who are over 18 years of age
•Both male and female
•Any patient positive for SARS 2-Corona Virus by RT-PCR tests or antigen testing using nasopharyngeal swab/aspirate within 48 hours prior to randomization and is admitted for treatment to NIID.
•Cycle threshold (Ct) value <38 at the time of recruitment
•Mild to moderate COVID-19 infection
Mild disease: Symptoms such as fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, anosmia.
Moderate disease: Symptoms of mild disease and Signs such as shortness of breath with exertion, respiratory rate >= 20 but <30/min, saturation of oxygen >93% of room air , heart rate >= 90/min but <125/min
•Negative antibody test
•Within 4 days of onset of symptoms and RT-PCR positivity within 48 hours in a symptomatic patient

Exclusion Criteria

•Pregnancy (confirmed or suspected with a history of a missing menstrual period for more than a week)
•Breast-feeding mothers
•Adolescents below 18 years
•HIV co-infection
•Patients who are known to have allergy to ivermectin or anthelminths
•Patients with severe disease as indicated by SpO2 <=93% on room air at sea level or PaO2/FiO2 < 300, respiratory rate >=30 per minute, heart rate >=125 per minute
•Patients with critical disease ie. those who require mechanical ventilation or anticipated impending need for mechanical ventilation
•Those who have received the vaccine
*. A patient recruited in any other trials simultaneously