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

Last updated: September 24, 2020
Sponsor: South African National Blood Service
Overall Status: Active - Recruiting

Phase

3

Condition

Covid-19

Corona Virus

Sars-cov-2

Treatment

N/A

Clinical Study ID

NCT04516811
PROTECT-Patient trial
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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 ofpulmonary infiltrates on chest x-ray;

  • Moderate to severe Covid-19 disease, defined as: SpO2 ≤ 93% on room air; plusrequiring non-invasive oxygen therapy (WHO R&D BOSCI 4 or 5

  • Signed informed consent;

  • Pregnant women will be allowed to participate.

Exclusion

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 notexclude critically ill patients who are not, due to resource limitations, candidatesfor critical care admission and/or mechanical ventilation);

  • Known hypersensitivity to immunoglobulin or any components of the formulation;

Study Design

Total Participants: 600
Study Start date:
September 21, 2020
Estimated Completion Date:
July 31, 2022

Study 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

Connect with a study center

  • Universitas Hospital

    Bloemfontein, Free State 9301
    South Africa

    Site Not Available

  • Mitchells Plain Hospital

    Cape Town, Western Cape 7786
    South Africa

    Active - Recruiting

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