COVID-19
Conditions
Interventions
The study will be based at several COVID-19 treatment centres namely the National Institute of Infectious Diseases (NIID) commonly known as Infectious Diseases hospital-Angoda,
This is a blinded stu
Sponsors
Dr Ananda Wijewickrama
Eligibility
Inclusion criteria
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 = 20 but 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
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 =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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Reduction of viral burden (by 50%) based on the natural log Cycle threshold (Ct) value of the reverse transcriptase- quantitative PCR test (RT-PCR) for SARS-COV-2. (Specimen will be a nasopharyngeal swab or aspirate. Viral burden will be calculated using the Ct values as done in BLAZE-1 study protocol. [Baseline, day 06 and day 10 from the date of intervention.] 2.Clinical progression of the patient using WHO Clinical Progression Scale [Day 03, 06, 10, 14, 21 and 28 from the date of intervention (remote monitoring if discharged)] 3.Percentage of participants who experience side effects recorded by the patient on data sheet for assessment of symptoms and side effects. [Day of intervention, days 03, 06, 10 and 14] [ ] [] [] [ ] [ ] [ ] [ ] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Improvement of the symptoms by 50% by day 6 and by 100% by day 10 of intervention. Each symptom is scored by the research assistant as absent (score 0), mild (1), moderate (2) or severe (3) as used in the BLAZE-1 study. 50% improvement in treatment arm and 20% in the control arm – difference of 30%: Can detect an effect size (odds ratio) of 4.0. [At baseline, day 03, 06, 10, 14, 21 and 28 from the time of ingestion of the first dose (remote monitoring if discharged)] 3.50% reduction of development of hypoxia (SPO2 <94%) [On day 03, 06, 10 and 14] 4.50% improvement of lymphopaenia by day 6. Lymphopaenia is defined as lymphocyte count <1.0 × 109/L. [On day 6 after admission.] [] [] [ ] [] [] [] [ ] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] | — |
Countries
Sri Lanka
Contacts
Public ContactDr Ananda Wijewickrama
Consultant Physician
Outcome results
None listed