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

South African National Blood Service

Status and phase: Unknown; Phase 3

Conditions: COVID-19; SARS-CoV-2 Infection; Severe Acute Respiratory Syndrome Coronavirus 2

Treatments: Biological: Standard of care (SOC) plus placebo; Biological: COVID-19 convalescent plasma (CCP) plus standard of care (SOC)

Study type: Interventional

Funder types: Other

Identifiers

NCT04516811

PROTECT-Patient trial

Details and patient eligibility

About

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

Full 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

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Laboratory confirmed SARS-CoV-2 by positive RT-PCR on any respiratory sample;
• Age ≥ 18 years;
• Require hospital admission for COVID-19 pneumonia as defined by the presence of pulmonary infiltrates on chest x-ray;
• Moderate to severe Covid-19 disease, defined as: SpO2 ≤ 93% on room air; plus requiring non-invasive oxygen therapy (WHO R&D BOSCI 4 or 5
• Signed informed consent;
• Pregnant women will be allowed to participate.

Exclusion criteria

• Current participation in another therapeutic clinical trial for COVID-19;
• Invasive mechanical ventilation;
• Expected survival < 24 hours based on clinical assessment (however, the study does not exclude critically ill patients who are not, due to resource limitations, candidates for critical care admission and/or mechanical ventilation);
• Known hypersensitivity to immunoglobulin or any components of the formulation;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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600 participants in 2 patient groups, including a placebo group

Arm 1

Experimental group

Description:

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.

Treatment:

Biological: COVID-19 convalescent plasma (CCP) plus standard of care (SOC)

Arm 2

Placebo Comparator group

Description:

A single unit of 200 mL normal saline with SOC as determined by local practice and guidelines.

Treatment:

Biological: Standard of care (SOC) plus placebo