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
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
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;
Universitas Hospital
Bloemfontein, Free State, South Africa
Mitchells Plain Hospital
Cape Town, Western Cape, South Africa
Cynthia Nyoni
+27117619279 - 9279
Cynthia.Nyoni@sanbs.org.za
Mpumi Maxebengula, BCom
+27214066497 - 6497
mpumi.maxebengula@uct.ac.za