NCT04516811

Therapeutic Use of Convalescent Plasma in the Treatment of Patients With Moderate to Severe COVID-19

A Prospective, Randomized, Placebo-controlled, Double-blinded, Phase III Clinical Trial of the Therapeutic Use of Convalescent Plasma in the Treatment of Patients With Moderate to Severe COVID-19

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: South African National Blood Service · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A prospective, randomized, placebo-controlled, double-blinded, phase III clinical trial of the therapeutic use of convalescent plasma in the treatment of patients with moderate to severe COVID-19

Detailed description

Full Title: A prospective, randomized, placebo-controlled, double-blinded, phase III clinical trial of the therapeutic use of convalescent plasma in the treatment of patients with moderate to severe COVID-19. Short Title: PROTECT-Patient study Aim: Assess the safety and efficacy of COVID-19 convalescent plasma (CCP) as a therapeutic treatment for hospitalised patients with moderate to severe COVID-19 Study Design: Randomised, double-blinded, placebo-controlled, phase III clinical trial Intervention: Randomised 1:1 to either CCP plus standard of care (SOC) or to SOC plus placebo (200 mL normal saline) Active Agent: A single unit of approximately 200-250 mL of CCP that contains anti-SARS-CoV-2 collected by plasmapheresis from a volunteer who recovered from COVID19 with SOC as determined by local practice and guidelines. Placebo: A single unit of 200 mL normal saline with SOC as determined by local practice and guidelines Sample Size: 600 Study Population: Consenting adult inpatients with moderate to severe COVID-19, not requiring invasive ventilation, who are admitted to a participating public or private sector hospital and who are not enrolled in another COVID-19 treatment trial. Settings: Participating public and private sector hospitals in South Africa

Conditions

• COVID-19
• SARS-CoV-2 Infection
• Severe Acute Respiratory Syndrome Coronavirus 2

Interventions

Type	Name	Description
BIOLOGICAL	COVID-19 convalescent plasma (CCP) plus standard of care (SOC)	A single unit of approximately 200-250 mL of CCP that contains anti-SARS-CoV-2 collected by plasmapheresis from a volunteer who recovered from COVID19 with SOC as determined by local practice and guidelines.
BIOLOGICAL	Standard of care (SOC) plus placebo	A single unit of 200 mL normal saline with SOC as determined by local practice and guidelines

Timeline

• Start date: 2020-09-21
• Primary completion: 2021-12-30
• Completion: 2022-07-31
• First posted: 2020-08-18
• Last updated: 2020-09-25

Locations

2 sites across 1 country: South Africa