An Open-Label Parallel-Arm Phase II Multicentre Randomized Controlled Trial (PLACID Trial)

An Open-Label Parallel-Arm Phase II Multicentre Randomized Controlled Trial (PLACID Trial)

medRxiv preprint doi: https://doi.org/10.1101/2020.09.03.20187252; this version posted September 10, 2020. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. All rights reserved. No reuse allowed without permission. Title Page Convalescent plasma in the management of moderate COVID-19 in India: An open-label parallel-arm phase II multicentre randomized controlled trial (PLACID Trial) Anup Agarwal, Aparna Mukherjee, Gunjan Kumar, Pranab Chatterjee, Tarun Bhatnagar, Pankaj Malhotra and PLACID Trial Collaborators The names and affiliations of PLACID Trial Collaborators are provided in Annexure 1 Running title: Convalescent plasma in COVID-19 Corresponding Author: Name: Dr. Aparna Mukherjee MD, PhD Affiliation: Scientist-E, Clinical Trial and Health Systems Research Unit, Indian Council of Medical Research Full Address: Indian Council of Medical Research V. Ramalingaswamy Bhawan PO Box No. 4911 Ansari Nagar, New Delhi – 110029, India Email: [email protected] [email protected] 1 NOTE: This preprint reports new research that has not been certified by peer review and should not be used to guide clinical practice. medRxiv preprint doi: https://doi.org/10.1101/2020.09.03.20187252; this version posted September 10, 2020. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. All rights reserved. No reuse allowed without permission. Name Highest Affiliation Full Address Degree Anup Agarwal MBBS Consultant, Indian Council of Clinical Trial & Health Systems Research Unit, Medical Research. Indian Council of Medical Research (ICMR) V. Ramalingaswami Email – [email protected] Bhawan, P.O. Box No. 4911. Ansari Nagar, New Delhi - 110029, India. Aparna Mukherjee PhD Scientist E, New Delhi - 110029, Clinical Trial & Health Systems Research Unit, India. Indian Council of Medical Research (ICMR), Email – [email protected] Gunjan Kumar MD Scientist C, New Delhi - 110029, Clinical Trial & Health Systems Research Unit, India. Indian Council of Medical Research (ICMR) Email - [email protected] Pranab Chatterjee MD Scientist B, New Delhi - 110029, Translational Global Health Policy and Research Cell, India. Indian Council of Medical Research (ICMR) Email - [email protected] Tarun Bhatnagar PhD Scientist E, Chennai, Tamil, India ICMR School of Public Health, Indian Council of Medical Research -National Institute of Epidemiology Email - [email protected] Pankaj Malhotra MD Professor, Chandigarh, India Department of Internal Medicine, Post Graduate Institute of Medical Education and Research Email – [email protected] B Latha MD Department of Transfusion Medicine, Madras Chennai, Tamil Nadu, Medical College India Email - [email protected] Sunita Bundas MD Professor, Jaipur, Rajasthan, India Department of Immunohaematology and Transfusion Medicine, SMS Medical College and Hospital Email – [email protected] Vivek Kumar EDIC Dept. of Critical Care Medicine, Mumbai, India Sir H N Reliance Foundation Hospital Email - [email protected] Ravi Dosi DNB Professor, Indore, Madhya Department of Respiratory Medicine, Pradesh, India Sri Aurobindo Institute of Medical Sciences Email - [email protected] Janakkumar R MD Professor, Ahmedabad, Gujarat, Khambholja Department of Internal Medicine, India Smt NHL Municipal Medical College Email - [email protected] Rosemarie de Souza MD Professor, Mumbai, Maharashtra, Department of Internal Medicine, India BYL Nair Charitable Hospital & TN Medical College Email - [email protected] 2 medRxiv preprint doi: https://doi.org/10.1101/2020.09.03.20187252; this version posted September 10, 2020. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. All rights reserved. No reuse allowed without permission. Raja Rao Mesipogu MD Professor, Hyderabad, Telangana, Department of Internal Medicine, India Gandhi Medical College Email - [email protected] Saurabh Srivastava Professor, Greater Noida, Uttar Department of Internal Medicine, Government Pradesh, India Institute of Medical Sciences Email - [email protected] Simmi Dube MD Professor, Bhopal, Madhya Department of Internal Medicine, Pradesh, India Gandhi Medical College, Bhopal Email - [email protected] Kiran Chaudhary MCh Department of Transfusion Medicine, New Delhi, India Atal Bihari Vajpayee Institute of Medical Sciences and Ram Manohar Lohia Hospital Email - [email protected] Subash S MD Professor, Chennai, Tamil Nadu, Department of Transfusion Medicine, India Madras Medical College Email - [email protected] S. Anbuselvi Mattuvar MD Professor, Department of Physiology, Madras Chennai, Tamil Nadu, K Medical College India Email - [email protected] V Rajendran MD Department of Internal Medicine, Chennai, Tamil Nadu, Madras Medical College India Email - [email protected] A Sundararajaperumal MD Department of Thoracic Medicine, Chennai, Tamil Nadu, Madras Medical College India Email - [email protected] P Balamanikandan MD Department of Internal Medicine, Chennai, Tamil Nadu, Madras Medical College India Email - [email protected] R S Uma Maheswari MD Department of Internal Medicine, Chennai, Tamil Nadu, Madras Medical College India Email - [email protected] R Jayanthi MD Department of Internal Medicine, Chennai, Tamil Nadu, Madras Medical College India Email - [email protected] S Ragunanthanan MD Department of Internal Medicine, Chennai, Tamil Nadu, Madras Medical College India Email - [email protected] Sudhir Bhandari MD Professor, Jaipur, Rajasthan, India Department of Internal Medicine, SMS Medical College and Hospital Email – [email protected] Ajeet Singh MD Department of Internal Medicine, Jaipur, Rajasthan, India SMS Medical College and Hospital Email - [email protected] Ashok Pal MD Department of Immunohaematology and Transfusion Jaipur, Rajasthan, India Medicine, SMS Medical College and Hospital Email - [email protected] Anjali Handa MD Department of Immunohaematology and Transfusion Jaipur, Rajasthan, India Medicine, SMS Medical College and Hospital 3 medRxiv preprint doi: https://doi.org/10.1101/2020.09.03.20187252; this version posted September 10, 2020. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. All rights reserved. No reuse allowed without permission. Email - [email protected] Govind Rankawat MBBS Department of Internal Medicine, Jaipur, Rajasthan, India SMS Medical College and Hospital Email - [email protected] Ketan Kargirwar EDIC Dept. of Critical Care Medicine, Mumbai, Maharashtra, Sir H N Reliance Foundation Hospital India Email - [email protected] Joyce Regi MD Dept. of Transfusion Medicine, Mumbai, Maharashtra, Sir H N Reliance Foundation Hospital India Email - [email protected] Darshana Rathod MD Dept. of Critical Care Medicine, Mumbai, Maharashtra, Sir H N Reliance Foundation Hospital India Email - [email protected] Edwin Pathrose MBBS Dept. of Critical Care Medicine, Mumbai, Maharashtra, Sir H N Reliance Foundation Hospital India Email - [email protected] Nirankar Bhutaka MBBS Dept. of Critical Care Medicine, Mumbai, Maharashtra, Sir H N Reliance Foundation Hospital India Email - [email protected] Mayur H Patel MD Dept. of Critical Care and Emergency Medicine, Mumbai, Maharashtra, Sir H N Reliance Foundation Hospital India Email - [email protected] Rahul J Verma MRCP Dept. of Academics and Research, Mumbai, Maharashtra, Sir H N Reliance Foundation Hospital India Email - [email protected] Kamal Malukani MD Professor, Indore, Madhya Department of Pathology, Pradesh, India Sri Aurobindo Institute of Medical Sciences Email – [email protected] Shivani Patel DM Department of Hematology, Indore, Madhya Sri Aurobindo Institute of Medical Sciences Pradesh, India Email – [email protected] Apurv Thakur MD Department of Community Medicine, Indore, Madhya Sri Aurobindo Institute of Medical Sciences Pradesh, India Email – [email protected] Satish Joshi DCP Department of Pathology, Indore, Madhya Sri Aurobindo Institute of Medical Sciences Pradesh, India Email – [email protected] Rashmi Kulkarni PhD Department of Forensic Medicine, Indore, Madhya Sri Aurobindo Institute of Medical Sciences Pradesh, India Email - [email protected] Nilay N Suthar MD Professor, Ahmedabad, Gujarat, Department of Internal Medicine, India Smt NHL Municipal Medical College Email: [email protected] Nehal M Shah MD Department of Internal Medicine, Ahmedabad, Gujarat, Smt NHL Municipal Medical College India Email: [email protected] Hemang M Purohit MSc Department of Internal Medicine, Ahmedabad, Gujarat, Smt NHL Municipal Medical College India Email: [email protected] Cherry K Shah MD Professor, Ahmedabad, Gujarat, Department of Pathology, India Smt NHL Municipal Medical College Email: [email protected] 4 medRxiv preprint doi: https://doi.org/10.1101/2020.09.03.20187252; this version posted September 10, 2020. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted

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