No benefit seen in 2 published inpatient RCTs (but had limitations). Press release from inpatient Recovery trial with large number of endpoints showed no benefit. CCP collected from survivors of original strain infection had no neutralisation

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

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;

Where available and applicable, the results of this study will be reported to the appropriate scientific and management divisions of participating institutions. In addition, interim results may be communicated to lay press if doing so is deemed appropriate and relevant by the Study Management Committee. Interim and final results will be presented at various scientific congresses, meeting and in appropriate peer-reviewed scientific journals. Under no circumstances will personal identifier be revealed to any party not legally entitled to such information.

Undecided

undecided

Neither participants nor the investigators will be aware of the participant's treatment allocation until the end of the study (double blinding). Blinding will be maintained by local blood bank preparing the appropriate IP and Placebo. Unmasking procedures are detailed by SOP