Trial | NCT04516811  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    600
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 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
Study Started
Sep 21
2020
Primary Completion
Dec 30
2021
Anticipated
Study Completion
Jul 31
2022
Anticipated
Last Update
Sep 25
2020

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

Arm 1 Experimental

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.

Arm 2 Placebo Comparator

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

Criteria 

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;
No Results Posted