Convalescent-anti-SARS-CoV-2-plasma/heparin

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An event is serious (based on the ICH definition) when the patient outcome is:

• * death

• * life-threatening

• * hospitalisation

• * disability

• * congenital anomaly

• * other medically important event

A 30-year-old woman exhibited lack of efficacy while receiving treatment with heparin for thrombosis and following an off-label treatment with convalescent-anti-SARS-CoV-2-plasma for COVID-19 pneumonia [not all routes and dosages stated].

The woman (gravida 4, para 2) was admitted to the emergency department at 37 weeks and 5 days of gestational age with fever and an associated cough for 2 days. Her medical history was significant for previous caesarean section, endometriosis following excision of the anterior abdominal wall endometrioma and atypical squamous cells of undetermined significance. She additionally reported reduced fetal movements from one day. She had remission of fever after receiving paracetamol [acetaminophen] 650mg. Thereafter, she was diagnosed with COVID-19 pneumonia and was discharged in a stable condition. She was prescribed oral azithromycin [Zithromax] 500mg on day 1 and 250 mg/day for the next 4 days for community-acquired pneumonia. However, after 5 days, she was admitted with preterm labour and respiratory distress. The laboratory findings showed bilateral infiltrates and oxygen saturation was found to be 75% on room air, which further worsened to 60% on room air. She was then intubated and underwent emergency C-section. Consequently, she delivered a viable female infant. Post-operatively, she remained intubated and was transferred to surgical ICU. On post-operative day 2, she developed a fever. Therefore, she received piperacillin/tazobactam [Zosyn] and vancomycin. However, she had no remarkable improvement in neurological findings and developed worsening hypertension, tachycardia and ventilator dyssynchrony. She required maximum ventilatory support to maintain haemoglobin-oxygen saturations above 90%. Further, she showed elevated D-dimer levels and a heparin drip was added for thrombosis. She also received an off-label treatment with one dose of 200mL convalescent-anti-SARS-CoV-2-plasma [convalescent plasma] for COVID-19 pneumonia. As a result, her respiratory condition improved; however, on day 15 after intubation, her condition worsened. The chest X-ray showed worsening confluent opacities. Despite maximal ventilation and medical treatment with heparin and an off-label treatment with convalescent-anti-SARS-CoV-2-plasma, she was then desaturated to 80% to 86% and was persistently hypotensive and hypoxic without improvement. As a result, lack of efficacy with heparin and an off-label treatment with convalescent-anti-SARS-CoV-2-plasma was considered. After days of C-section and delivering a female infant, she was admitted to surgical ICU, where she died due to cardiac arrest after unsuccessful resuscitation.