NCT04425837

Effectiveness and Safety of Convalescent Plasma in Patients With High-risk COVID-19

Effectiveness and Safety of Convalescent Plasma in Patients With High-risk COVID-19: A Randomized, Controlled Study CRI-CP (Coronavirus Investigation - Convalescent Plasma)

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 236 (estimated)
• Sponsor: Fundación Santa Fe de Bogota · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has affected the global population with significant morbidity and mortality. One of the main concerns is the management of the patients since there is no specific treatment for this condition. Therefore, in SARS-CoV-2 patients the compassionate use of off-label therapies has been initiated; such as the use of plasma from convalescent patients. This treatment has been used in other pandemics like SARS-CoV-1, H5N1, H1N1, Ebola, among others. This study is a phase II/III randomized clinical trial to assess the effectiveness and safety of convalescent plasma administration in patients with high-risk SARS-CoV-2.

Detailed description

This is a Phase II/III randomized clinical trial to assess the effectiveness and safety of anti-SARS-CoV-2 convalescent plasma in i) hospitalized adult patients with high-risk of progression SARS-CoV-2 infection and ii) patients in Intensive Care Unit (ICU). Compatible ABO plasma from convalescent patients will be administered at a dose of 400 ml divided into two doses intravenously. Outcomes will be measured as follows: \* Group of patients with critical illness: Primary outcomes (Effectiveness and safety): * Mortality * Safety: Presence of adverse events Secondary outcomes: * Intensive care unit length of stay * Evolution of clinical and paraclinical aspects. * Group of patients at high risk of progression: Primary outcomes (Effectiveness and safety): * Mortality * Safety: Presence of adverse events * Admission to ICU in 30 days * Mechanical ventilation requirement Secondary outcomes: * Hospital/Intensive care unit length of stay * Evolution of clinical and paraclinical aspects.

Conditions

• Sars-CoV2
• Covid-19

Interventions

Type	Name	Description
BIOLOGICAL	SARS-CoV-2 convalescent plasma treatment	Plasma transfusion of convalescent patients from COVID-19 with negative RT-PCR, and antibody titers of 1:160 or greater at a dose of 400ml distributed in two doses administered on the same day intravenous administration
OTHER	Standard care	Standard care according to guidelines and national regulations

Timeline

• Start date: 2020-07-01
• Primary completion: 2021-02-01
• Completion: 2021-02-01
• First posted: 2020-06-11
• Last updated: 2020-06-11

Locations

1 site across 1 country: Colombia