CTRI/2020/05/025068.

Study name	A phase IIB open label randomized controlled trial to evaluate the efficacy and safety of Ivermectin in reducing viral loads in patients with hematological disorders who are admitted with COVID 19 infection
Methods	Trial design: open‐label RCT with 2 parallel arms Type of record: trial register entry Sample size: 50 Setting: inpatient Country: India Language: English Number of centres: NR Study purpose (treatment, prevention): treatment Trial registration number: CTRI/2020/05/025068 Date of registration: 7 May 2020
Participants	Inclusion criteria Age 1–65 years Male or female RT‐PCR‐confirmed COVID‐19 diagnosis Exclusion criteria People with other viral infections
Interventions	Details of intervention Type and dose: ivermectin 0.2 mg/kg, single dose Route of administration: oral Treatment details of control group No treatment except standard of care Concomitant therapy: standard of care defined as standard protocol for management of COVID‐19 infection administered in both study arms
Outcomes	Primary study outcome Viral load reduction in participants with haematological illnesses admitted with COVID‐19 infection at 7 days Relevant review outcomes planned Viral load reduction in participants with haematological illnesses admitted with COVID‐19 infection at 7 days To study the incidence of serious adverse events and safety of this drug when used in haematological illnesses Additional study outcomes To study the factors that affect viral load reduction To study if the reduction in viral load correlates with improvement in inflammatory parameters To study the incidence of serious adverse events and safety of this drug when used in haematological illnesses
Starting date	27 May 2020
Contact information	Biju George, Professor Christian Medical College Vellore Department of Haematology Vellore Tamil Nadu 632004 India biju@cmcvellore.ac.in
Notes	Recruitment status: not yet recruiting Prospective completion date: NR Planned completion date more than 6 months ago: unclear Date last update posted: 27 May 2020 Sponsor/funding: Christian Medical College Vellore