COVID-19 Clinical Trial
Official 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
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
Status | Recruiting |
Enrollment | 600 |
Est. completion date | July 31, 2022 |
Est. primary completion date | December 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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; |
Country | Name | City | State |
---|---|---|---|
South Africa | Universitas Hospital | Bloemfontein | Free State |
South Africa | Mitchells Plain Hospital | Cape Town | Western Cape |
Lead Sponsor | Collaborator |
---|---|
South African National Blood Service |
South Africa,
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Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24. Erratum in: Lancet. 2020 Jan 30;:. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical Improvement | Proportion of participants with successful treatment outcome, defined as clinical improvement (= 2 points on WHO R&D BOSCI 1) by Day 28 post-randomisation. | Day 28 | |
Secondary | Adverse Events of special interest | 1. Proportion of participants with adverse events of special interest (Transfusion-Associated Circulatory Overload (TACO); Transfusion-Related Acute Lung Injury (TRALI); allergic transfusion reaction). | Day 28 | |
Secondary | Serious Adverse Events | 2. Proportion of participants with serious adverse events. | Day 28 | |
Secondary | Survival | 3. Proportion of participants surviving at Day 28 post-randomisation. | Day 28 | |
Secondary | Invasive mechanical ventilation | 4. Proportion of participants requiring invasive mechanical ventilation. | Day 28 | |
Secondary | Disease severity | 5. Proportion of participants with moderate and severe ARDS. | Day 28 | |
Secondary | Time to outcomes of interest | 6. Time from randomization to death, clinical improvement, ICU admission, and invasive mechanical ventilation. | Day28 | |
Secondary | Length of stay meausures | 7. Duration of hospitalisation, ICU stay, and mechanical ventilation in survivors. | Day28 | |
Secondary | SARS-CoV PCR | 8. Proportion negative SARS-CoV-2 PCR at Day 28; time to viral clearance (PCR-negativity); change in SARS-CoV-2 PCR Ct value. | Day28 | |
Secondary | Inflammatory markers | 9. Proportion with and time to normalisation of inflammatory markers, including CRP, lymphocyte count, D-dimer, ferritin. | Day28 | |
Secondary | Radiography | 10. Worsening of radiographic abnormalities. | Day28 | |
Secondary | Fever & Hypoxia | 11. Proportion with and time to resolution of fever and hypoxia. | Day28 | |
Secondary | patients with HIV infection and other comorbidities | 12. Proportion of patients with HIV infection and other comorbidities (obesity, diabetes, hypertension) with primary efficacy outcome. | Day 28 | |
Secondary | Timing of IP & Efficacy Outcome | 13. Relationship between timing of transfusion from symptom onset and primary efficacy outcome. | Day 28 | |
Secondary | Neutralising Ab | 14. Relationship between convalescent plasma neutralizing antibody titers and primary efficacy outcome | Day28 | |
Secondary | SARS CoV Antibody titre | 15. Comparison of anti-SARS-CoV-2 titer dynamics between treatment arms | Day28 |
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