Status:
UNKNOWN
Therapeutic Use of Convalescent Plasma in the Treatment of Patients With Moderate to Severe COVID-19
Lead Sponsor:
South African National Blood Service
Conditions:
COVID-19
SARS-CoV-2 Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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
Detailed 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 C...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
September 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2022
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT04516811
Start Date
September 21 2020
End Date
July 31 2022
Last Update
September 25 2020
Active Locations (2)
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1
Universitas Hospital
Bloemfontein, Free State, South Africa, 9301
2
Mitchells Plain Hospital
Cape Town, Western Cape, South Africa, 7786