NCT04480138

Pegylated Interferon - α2b With SARSCoV- 2 (COVID-19)

A Phase II, Multicenter, Open-label, Randomized, Comparator Controlled Study to Evaluate the Efficacy and Safety of Pegylated Interferon - α2b in the Treatment of Adult Patients Diagnosed With SARS-CoV2 (COVID-19)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Zydus Lifesciences Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase II, multicenter, open-label, randomized, comparator-controlled study to evaluate the efficacy and safety of Pegylated Interferon -α2b in the treatment of adult patients diagnosed with SARS-CoV2 (COVID-19).Initial 1 mcg/kg of Pegylated Interferon-α2b will be administered on day 1. After safety evaluation of first dose, next dose (second dose) 1 mcg/kg on day 8 will be administered with recommended standard care during the trial.

Detailed description

This is a phase II, multicenter, open-label, randomized, comparator-controlled study to evaluate the efficacy and safety of Pegylated Interferon -α2b in the treatment of adult patients diagnosed with SARS-CoV2 (COVID-19).Moderate COVID-19 subjects will be randomly assigned to receive test arm or reference arm in a 1:1 ratio.

Conditions

• Covid19

Interventions

Type	Name	Description
DRUG	Pegylated Interferon-α2b	1 mcg/kg on day 1 and day 8 after safety evaluations.
OTHER	Standard of Care	Standard of care as per local authority

Timeline

• Start date: 2020-08-11
• Primary completion: 2021-06-21
• Completion: 2021-06-21
• First posted: 2020-07-21
• Last updated: 2022-07-12

Locations

2 sites across 1 country: Mexico