scholarly journals Efficacy of Convalescent Plasma Therapy compared to Fresh Frozen Plasma in Severely ill COVID-19 Patients: A Pilot Randomized Controlled Trial

Author(s):  
Meenu Bajpai ◽  
Suresh Kumar ◽  
Ashish Maheshwari ◽  
Karan Chhabra ◽  
Pratibha kale ◽  
...  

AbstractBackgroundThe role of convalescent plasma (COPLA) for the treatment of severely ill Corona Virus Disease-2019 is under investigation. We compared the efficacy and safety of convalescent plasma with fresh frozen plasma (FFP) in severe COVID-19 patients.Methods and findingsThis was an open-label, single-centre phase II RCT on 29 patients with severe COVID-19 from India. One group received COPLA with standard medical care (SMC) (n=14), and another group received FFP with SMC (n=15). A total of 29 patients were randomized in the two treatment groups. Eleven out of 14 (78.5%) patients remained free of ventilation at day seven in the intervention arm while the proportion was 14 out of 15 (93.3 %) in the control arm (p= 0.258). The median reductions in RR per min at 48-hours in COPLA-group and FFP group were -6.5 and -3 respectively [p=0.004] and at day seven were -14.5 and -10 respectively (p=0.008). The median improvements in percentage O2 saturation at 48-hours were 6.5 and 2 respectively [p=0.001] and at day seven were 10 and 7.5 respectively (p=0.026). In the COPLA-group, the median improvement in PaO2/FiO2 was significantly superior to FFP at 48-hours [41.94 and 231.15, p=0.009], and also at day-7 [5.55 and 77.01 p<0.001]. We did not find significant differences in hospitalization duration between the groups (0.08).ConclusionCOPLA therapy resulted in rapid improvement in respiratory parameters and shortened time to clinical recovery, although no significant reduction in mortality was observed in this pilot trial. We need larger trials to draw conclusive evidence on the use of Convalescent plasma in COVID-19. This trial is registered with ClinicalTrial.gov (identifier: NCT04346446).

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Manaf AlQahtani ◽  
Abdulkarim Abdulrahman ◽  
Abdulrahman Almadani ◽  
Salman Yousif Alali ◽  
Alaa Mahmood Al Zamrooni ◽  
...  

AbstractConvalescent plasma (CP) therapy in COVID-19 disease may improve clinical outcome in severe disease. This pilot study was undertaken to inform feasibility and safety of further definitive studies. This was a prospective, interventional and randomized open label pilot trial in patients with severe COVID-19. Twenty COVID-19 patients received two 200 ml transfusions of convalescent patient CP over 24-h compared with 20 who received standard of care. The primary outcome was the requirement for ventilation (non-invasive or mechanical ventilation). The secondary outcomes were biochemical parameters and mortality at 28 days. The CP group were a higher risk group with higher ferritin levels (p < 0.05) though respiratory indices did not differ. The primary outcome measure was required in 6 controls and 4 patients on CP (risk ratio 0.67, 95% CI 0.22–2.0, p = 0.72); mean time on ventilation (NIV or MV) did not differ. There were no differences in secondary measures at the end of the study. Two patients died in the control and one patient in the CP arm. There were no significant differences in the primary or secondary outcome measures between CP and standard therapy, although a larger definitive study is needed for confirmation. However, the study did show that CP therapy appears to be safe in hospitalized COVID-19 patients with hypoxia.Clinical trials registration NCT04356534: 22/04/2020.


Transfusion ◽  
2020 ◽  
Author(s):  
Ali B.V. McMichael ◽  
Kanecia O. Zimmerman ◽  
Karan R. Kumar ◽  
Caroline P. Ozment

1981 ◽  
Author(s):  
D C Case

A 25-year old male was admitted for an episode of right sided headache and subsequent generalized seizure. On admission his temperature was 37.6°. He had generalized petechiae and conjunctival hemorrhages. Organomegaly and lymphadenopathy were absent. There was mild left sided weakness. The Hgb. was 6.9 g/dl., reticulocyte count 10%, WBC 11,500/mm3, and platelet count 10,000/mm3. There were numerous schistocytes on the peripheral smear; bone marrow revealed panhyperplasia. Coagulation studies were normal. The BUN was 30, and the creatinine 1.7 mg/dl. Plasma was positive for Hgb. CT scan was negative for gross intracranial bleeding. The diagnosis of T.T.P. was made. On admission, the patient received 10 units of platelets and 2 units of packed red blood cells. He did not require further red cell or platelet transfusions during the rest of his hospital course. He was then started on infusions of fresh-frozen plasma. He then received one unit every 3 hours for 6 days, one unit every 6 hours for 2 days, then one unit every 12 hours for 2 days and finally 1 unit daily for 5 days. The response was immediate. After the infusions were started, the hematologic parameters steadily improved. The patient’s hematuria rapidly improved. Further CNS symptoms did not appear. The patient’s Hgb. was 12 g/dl, and reticulocyte count was 2.5% by the 9th day. His platelet count was normal by the 4th day. The patient was discharged on the 15th day. Infusions of plasma were discontinued at the time of discharge. The patient required plasma therapy 4 weeks later for recurrent thrombocytopenia (50,000/mm3). The patient has remained normal for 9 months since therapy and further plasma has not been required. Primary plasma therapy for T.T.P. as sole treatment should be further studied.


Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 5030-5030
Author(s):  
Abraham Klepfish ◽  
H. Ghoti ◽  
E.A. Rachmilewitz

Abstract Background Chronic lymphocytic leukemia (CLL), a chronic proliferative disorder of mature-looking B-lymphocytes, is the most common leukemia in the Western world. Rituximab (RTX) is a chimeric IgG1 monoclonal antibody that specifically targets the CD20 surface antigen and induces the death of neoplastic B lymphocytes. The mechanisms proposed as causing this effect include complement-dependent cell lysis (CDC), apoptosis, and antibody-dependent cellular cytotoxicity. The response of CLL to RTX is inferior in comparison to other indolent B cell malignancies [Hillmen P. Semin Oncol.2004;31(1 Suppl 2):22]. Abnormalities in the complement system (low levels of complement components and properdin) have been reported in CLL patients, and their magnitude correlated with Rai stage of the disease [Schlesinger M. et al. Leukemia.1996;10:1509]. We report here an attempt to augment the RTX effect in a heavily pretreated patient with advanced CLL by adding complement present in fresh frozen plasma (FFP), which is a well known source of complement elements. Case report 59 year-old woman diagnosed 12 years ago with CLL, was treated over the years with single agent cyclophosphamide (CTX), repeated cycles of fludarabine/CTX, and in the last 9 months - with 6 cycles of RTX combined with modified CHOP-like chemotherapy. Originally the response lasted for 18 months, but during the last 13 months the patient suffers from advanced disease, with malaise, B symptoms, massive lymphadenopathy, splenomegaly, lymphocytosis up to 450x109/l, and LDH up to 2,400 IU/l, in spite of the treatment. Peripheral smears, immunophenotyping and lymph node biopsy were still compatible with CLL. Endoscopic biopsy, performed because of culture-negative diarrhea, revealed involvement of the colon by CLL, with no evidence of infection. Treatment regimen consisted of 2 units of FFP followed by 400 mg/m2 of RTX on day 1, and 2 units of FFP followed by 270 mg/m2 of RTX on day 2. A dramatic response was manifested by improvement of ambulation, cessation of diarrhea, marked reduction of lymphadenopathy, as well as a decrease of lymphocyte count from 270 x109/mcl to 120 x109/mcl on day 2, and to 40x109/mcl on day 6, with decrease of LDH level from 2,400 IU/l to 1,200 IU/l. The analysis of the complement system parameters prior to and following the treatment is currently being performed. Comment To the best of our knowledge, this is the first description of a case where successful induction of a dramatic and rapid improvement of both clinical and laboratory parameters in a patient with advanced CLL previously resistant to RTX-containing chemoimmuno-therapy, was achieved by combining RTX therapy with fresh frozen plasma as a source for complement. This observation has to be verified in additional patients in order to confirm the approach of potentiation of RTX effect by providing increased amount of complement in order to augment CDC.


PEDIATRICS ◽  
1972 ◽  
Vol 50 (5) ◽  
pp. 693-701
Author(s):  
Robert P. Erickson ◽  
Robert Sandman ◽  
William van B. Robertson ◽  
Charles J. Epstein

Patients with Mucopolysaccharidosis II (Hunter's syndrome) were given short-term treatment with large infusions of fresh frozen plasma to evaluate recent claims of clinical and chemical improvement by such therapy. Clinical behavior, urine glycosaminoglycans, and skin, serum, and urine acid hydrolases were evaluated by single-blind techniques. There was no noticeable effect of fresh frozen plasma infusion on the performance of these patients. The total urinary excretion of glycosaminoglycans was not altered by the infusions and there was no change in the size of the glycosaminoglycan fragments. The abnormal skin activity levels of β-galactosidase, β-glucuronidase, and N-acetylglucosaminidase were unaltered three days after fresh frozen plasma infusion and, similarly, the abnormal levels of these enzymes in the serum persisted without significant change during the ten days of evaluation.


PEDIATRICS ◽  
1988 ◽  
Vol 81 (2) ◽  
pp. 272-276
Author(s):  
Charles Peters ◽  
James F. Casella ◽  
Richard A. Marlar ◽  
Robert R. Montgomery ◽  
William H. Zinkham

An infant with severe homozygous protein C deficiency was brought to medical attention because of purpura fulminans and severe bilateral vitreous hemorrhages in the neonatal period. Infusions of fresh frozen plasma were given for 8 months. On two occasions, attempts to decrease the frequency of fresh frozen plasma infusions to less than twice a day led to episodes of microangiopathic hemolysis, fibrinolysis, and acute renal failure. Infarction of skin and subcutaneous tissues did not recur. Both episodes were controlled after reinstitution of fresh frozen plasma. Complications of therapy with fresh frozen plasma included hyperproteinemia and hypertension. Warfarin therapy was instituted when the baby was 8 months of age, followed by a gradual withdrawal of fresh frozen plasma therapy. The dose of warfarin required to maintain the prothrombin time in a range of 1.8 to 2.2 times normal varied considerably during short periods, a phenomenon that may have been due to several factors: hypercatabolism of the drug with prolonged administration, abnormality of liver function, variation in levels of serum albumin, fluctuations in drug dosage secondary to oral administration, and variations in dietary vitamin K. Protein C determinations by immunologic and functional assays consistently showed detectable but reduced protein C antigen levels with undetectable activity levels, suggesting that a dysproteinemia rather than a deficiency of synthesis is responsible for the child's coagulopathy.


1988 ◽  
Vol 3 (6) ◽  
pp. 437-447
Author(s):  
Trevor Leese ◽  
Kevin P. West ◽  
David B. Morton ◽  
Peter R. F. Bell

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