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Efficacy of convalescent plasma therapy in the patient with COVID-19: a randomised control trial (COPLA-II trial).
Bajpai, Meenu; Maheshwari, Ashish; Dogra, Vikas; Kumar, Suresh; Gupta, Ekta; Kale, Pratibha; Saluja, Vandana; Thomas, Sherin S; Trehanpati, Nirupama; Bihari, Chhagan; Agarwal, Reshu; Bharti, Praveen; Shankar, Prabha; Hussain, Javid; Chhabra, Karan; Gupta, Amita; Narayanan, Ashad; Agarwal, Sarika; Jain, Shruti; Bhardwaj, Ankit; Kumar, Guresh; Yadav, Birendra Kumar; Sarin, Shiv Kumar.
  • Bajpai M; Department of Transfusion Medicine, Institute of Liver and Biliary Sciences, New Delhi, India.
  • Maheshwari A; Department of Transfusion Medicine, Institute of Liver and Biliary Sciences, New Delhi, India.
  • Dogra V; Department of Pulmonology, Rajiv Gandhi Super Speciality Hospital, New Delhi, India.
  • Kumar S; Department of Medicine, Maulana Azad Medical College, New Delhi, India.
  • Gupta E; Department of Clinical Virology, Institute of Liver and Biliary Sciences, New Delhi, India.
  • Kale P; Department of Clinical Microbiology, Institute of Liver and Biliary Sciences, New Delhi, India.
  • Saluja V; Department of Anesthesia, Institute of Liver and Biliary Sciences, New Delhi, India.
  • Thomas SS; Department of Clinical Biochemistry, Institute of Liver and Biliary Sciences, New Delhi, India.
  • Trehanpati N; Department of Molecular and Cellular Medicine, Institute of Liver and Biliary Sciences, New Delhi, India.
  • Bihari C; Department of Pathology, Institute of Liver and Biliary Sciences, New Delhi, India.
  • Agarwal R; Department of Clinical Virology, Institute of Liver and Biliary Sciences, New Delhi, India.
  • Bharti P; Department of Medicine, Maulana Azad Medical College, New Delhi, India.
  • Shankar P; Department of Transfusion Medicine, Institute of Liver and Biliary Sciences, New Delhi, India.
  • Hussain J; Department of Pulmonology, Rajiv Gandhi Super Speciality Hospital, New Delhi, India.
  • Chhabra K; Department of Medicine, Maulana Azad Medical College, New Delhi, India.
  • Gupta A; Department of Transfusion Medicine, Institute of Liver and Biliary Sciences, New Delhi, India.
  • Narayanan A; Department of Transfusion Medicine, Institute of Liver and Biliary Sciences, New Delhi, India.
  • Agarwal S; Department of Transfusion Medicine, Institute of Liver and Biliary Sciences, New Delhi, India.
  • Jain S; Department of Pulmonology, Rajiv Gandhi Super Speciality Hospital, New Delhi, India.
  • Bhardwaj A; Department of Clinical Research, Institute of Liver and Biliary Sciences, New Delhi, India.
  • Kumar G; Department of Clinical Research, Institute of Liver and Biliary Sciences, New Delhi, India.
  • Yadav BK; Department of Molecular and Cellular Medicine, Institute of Liver and Biliary Sciences, New Delhi, India.
  • Sarin SK; Department of Hepatology, Institute of Liver and Biliary Sciences, New Delhi, India shivsarin@gmail.com.
BMJ Open ; 12(4): e055189, 2022 04 06.
Article in English | MEDLINE | ID: covidwho-1962215
ABSTRACT
IMPORTANCE No proven treatment is available for severely ill COVID-19. Therapeutic use of COVID-19 convalescent plasma (COPLA) is under investigation.

OBJECTIVE:

To compare the efficacy of COPLA with standard medical therapy (SMT) alone in severe COVID-19 patients. DESIGN, SETTING AND

PARTICIPANTS:

A multicentric, open-labelled, phase-III randomised controlled trial conducted at two treatment centres with COPLA collected at the third dedicated centre in North-India, the coordinating centre during trial from June 2020 to December 2020. The study population comprised 400 participants in the ratio of 11 in each treatment group. INTERVENTION One group received COPLA with SMT (n=200), and another group received SMT only (n=200). MAIN OUTCOME

MEASURES:

Primary outcome was time to clinical improvement measured by a two-point reduction in the ordinal scale. Secondary outcomes included duration of O2 therapy, the proportion of patients on mechanical ventilation at day-7, mortality, SARS-CoV-2 antibody levels, cytokine levels and incidence of adverse events.

RESULTS:

The median time to a two-point reduction in the ordinal scale in both groups was 9 days (IQR=7-13) (p=0.328). The median duration of O2 therapy was 8 days (IQR=6-12) in COPLA and 10 days (IQR=6-12) in SMT group (p=0.64). The PaO2/FiO2 ratio showed significant improvement at 7 days in COPLA group(p=0.036). There was no difference in mortality till 28 days in both groups (p=0.62). However, if COPLA was given within 3 days of hospital admission, a significant reduction in ordinal scale was observed (p=0.04). Neutralising antibody titres in COPLA group (80 (IQR 80-80)) were higher than SMT group (0 (IQR 0-80)) at 48 hours (p=0.001). COPLA therapy led to a significant reduction in TNF-α levels at 48 hours (p=0.048) and D-dimer at 7 days (p=0.02). Mild allergic reactions were observed in 3 (1.5%) patients in COPLA group. CONCLUSION AND RELEVANCE Convalescent plasma with adequate antibody titres should be transfused in COVID-19 patients along with SMT in the initial 3 days of hospitalisation for better clinical outcomes. TRIAL REGISTRATION NUMBER NCT04425915.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Limits: Humans Language: English Journal: BMJ Open Year: 2022 Document Type: Article Affiliation country: Bmjopen-2021-055189

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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Limits: Humans Language: English Journal: BMJ Open Year: 2022 Document Type: Article Affiliation country: Bmjopen-2021-055189