COVID-19 trials registries data warehouse

https://slctr.lk/trials/slctr-2021-020

Dr Ananda Wijewickrama

anandawijewickrama012@gmail.com

2021-07-19

Recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

• 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

• 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

2

Dr Ananda Wijewickrama

18

100

Sri Lanka

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

236118

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] [ ] [] [] [ ] [ ] [ ] [ ] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] []

Phase 2

[{"arm_notes": "", "treatment_id": 693, "treatment_name": "Ivermectin", "treatment_type": "Antiparasitics", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]