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

TerminatedPhase 3

Sponsor: South African National Blood Service

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

Interventions: COVID-19 convalescent plasma (CCP) plus standard of care (SOC), Standard of care (SOC) plus placebo

Countries: South Africa

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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;

Locations (2)

Bloemfontein, Free State, South Africa
Cape Town, Western Cape, South Africa