1. Convalescent plasma in the management of moderate COVID-19 in India: An open-label parallel-arm phase II multicentre randomized controlled trial (PLACID Trial)
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P Balamanikandan, Pranab Chatterjee, Himanshu Kaushal, Ashish Pathak, Sunil Jodharam Panjwani, Rajendra Madane, Deepti Chourasia, Sohini Arora, Shailja Shukla, Pragya D Yadav, Simmi Dube, Rattiram Sharma, Om Shrivastav, Snehil Kumar, Mayur Jarag, Kairavi Parthesh Joshi, V Saravana Kumar, Pallavi Singh, Ravindranath Reddy K, G Baleswari, Parul Kodan, Clyde D Souza, Medini S, Ketan Kargirwar, Kavita Joshi, Satish Joshi, Purushottam Reddy, Neha Singh, M Sintha, B Latha, Vikash Kavishwar, Tulika Chandra, Pragnesh H Shah, Jayashree Sharma, T Ravi Chandra, Divendu Bhushan, Ravindraa Singh, Puneet Rijhwani, K Chandra Sekhar, Bhabani Prasad Acharya, Rikin Raj, Rekha Hans, Alka Turuk, Pankaj Malhotra, R Sabarinathan, Rajnish Kaushik, Yash Shah, KV Sreedhar Babu, Ram Niwas, Nitin Valvi, Reeni Malik, K Kanagasabai, Vrushali Khirid Khadke, Kavitha Yevoor, Parijat Gogoi, K Tushara Rao, Saurabh Srivastava, Kusum Jashnani, Archit Jain, Vikas Suri, Gowtham Yeeli, Atul Kulkarni, Kamal Malukani, Sheetal Yadav, Anita M. Shete, Anjali Handa, Nirankar Bhutaka, Mamta Shah, Sudhir Bhandari, Govind Rankawat, Jaya Lalwani, M Natarajan, Prerna Sachdeva, Jitendra Patel, Santasabuj Das, Gurpreet Singh, Anil Gurtoo, Sonali Marathe, Maherra Desai, Leena Naik, Nehal M Shah, Gajanan N. Sapkal, Shashikala Sangle, Amit Suri, Milind Baldi, Ajeet Singh, Ram Mohan Jaiswal, Chetan Patil, Vijay Barge, Hemang M Purohit, Tanvi Yardi, Neeraj Kumar, Ashok Yadav, Ashok Pal, Suraj Goyanka, Rajesh Kumar, Asim Das, Darpan Phagiwala, Janak Kumar Khambholja, Niranjan Shiwaji Khaire, Ram S Kalgud, Sangeeta Pahuja, Neeraj Sharma, Saket Shah, Yojana A Gokhale, Mohd Nadeem, Priya Abraham, R Jayanthi, Leena Nakate, Rajesh Karyakarte, UM Sharma, Sonali Salvi, Rakesh Gupta, Pramod R Jha, Monila Patel, D Himanshu Reddy, Rashmi Upadhyay, Mini P Singh, Atish M N, Nikhil Verma, Dattatray Patki, Varun A Bafna, Nilay N Suthar, Ashish Sharma, Anup Agarwal, Smit H Shah, Vipul Tadha, Satyam Arora, K Nagamani, Rashmi Kulkarni, B Suresh Babu, Simran Agrawal, Mayur H Patel, Preksha Dwivedi, B Vengamma, Varsha Godbole, Vijaylakshmi Nag, Divya Kavita, Sanjeev Mishra, Mohith Hn, Raminder Pal Singh, Vinoth Rajendran, Manisha Madkaikar, R S Uma Maheswari, Muralidhar Tambe, Rambha Pathak, K Narsimhulu, Joyce Regi, Shalini Bahadur, Ravi Dosi, Alladi Mohan, Rosemarie de Souza, Akhilesh Kumar Maurya, Kiran Chaudhary, Manoj Kumar Gupta, Rooppreet Kaur Gill, Irfan Nagori, Tushar Madke, Ashish Jain, Rajesh Mahajan, Pankaj J Akholkar, Sunita Bundas, Ritika Sud, Kajal Jarande, Samir Joshi, Anubhav Gupta, Gururaj Rao Deshpande, Manju Purohit, L N Yaddanapudi, Ramesh Waghmare, Pradeep Maurya, Neetu Kukar, Prashanth Gajula, Pvm Lakshmi, Swarupa Bhagwat, Vivek Kumar, Reetika Malik Yadav, Vivek Maleyur, Nitya Wadhwa, Shikha Seth, Tarun Bhatnagar, Mahesh G Solu, Dolly Daniel, P Chandrasekhar, Gunjan Kumar, Devendra K Gupta, David Pradeep Kumar, Nalini Kadgi, Sangita Margam, Swapneil Parikh, Naresh Sachdeva, Venkatesh Dhat, Niteen D Karnik, Fathhur Rabbani, J Vyshnavi, Aparna Mukherjee, Suchet Sachdev, Rashmi Gunjikar, Jayanthi Shastri, JL Marko, Nitu Chauhan, Naveen Gupta, Vrushali Wagh, Shreepad Bhat, Shreevatsa Udupa, Shweta Sharma, Monika Bahl, Ali Wahid, Ranjana Khetrepal, Arti D Shah, M Joseph John, Snehal Shingade, Seema Dua, Kuldeep Kumar Gaur, Archana Bajpayee, Apurv Thakur, Aikaj Jindal, S Ragunanthanan, Ajeet Singh Chahar, Shruti Dogra, Fatema Ezzy, C Aparna, Shivani A. Patel, Srinivasulu Damam, Tehsim Memon, Kamlesh Upadhyay, Nitin Rawat, Rita Saxena, Mahendra Kumar Garg, Tinkal C Patel, Cherry K Shah, B Thrilok Chander, Vishal R Beriwala, Dilip Chawda, Nimisha Sharma, Subash S, Meenakshi Shah, Jaspreet Kaur, Edwin Pathrose, Vijay Kumar, Darshana Rathod, Puneeth Babu Anne, K Hemanth, Shweta Deshmukh, Nidhi Bhatnagar, Anupam Prakash, G K Bohra, Sharda Sharma, Yogesh Agarwal, Nilima Shah, Saurabh Pandey, A Vinaya Sekhar, Rakesh Bhadade, Raja Rao Mesipogu, Manish Barvaliya, Tarak Patel, Rahul J Verma, K Sudha, Joy John Mammen, A Sundararajaperumal, Avtar Singh Dhanju, and Rajni Bassi
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medicine.medical_specialty ,Convalescent plasma ,Standard of care ,Coronavirus disease 2019 (COVID-19) ,business.industry ,Outcome measures ,law.invention ,Clinical trial ,Primary outcome ,Randomized controlled trial ,law ,Internal medicine ,medicine ,Open label ,business - Abstract
ObjectivesConvalescent plasma (CP) as a passive source of neutralizing antibodies and immunomodulators is a century-old therapeutic option used for the management of viral diseases. We investigated its effectiveness for the treatment of COVID-19.DesignOpen-label, parallel-arm, phase II, multicentre, randomized controlled trial.SettingThirty-nine public and private hospitals across India.ParticipantsHospitalized, moderately ill confirmed COVID-19 patients (PaO2/FiO2: 200-300 or respiratory rate > 24/min and SpO2 ≤ 93% on room air).InterventionParticipants were randomized to either control (best standard of care (BSC)) or intervention (CP + BSC) arm. Two doses of 200 mL CP was transfused 24 hours apart in the intervention arm.Main Outcome MeasureComposite of progression to severe disease (PaO2/FiO2< 100) or all-cause mortality at 28 days post-enrolment.ResultsBetween 22ndApril to 14thJuly 2020, 464 participants were enrolled; 235 and 229 in intervention and control arm, respectively. Composite primary outcome was achieved in 44 (18.7%) participants in the intervention arm and 41 (17.9%) in the control arm [aOR: 1.09; 95% CI: 0.67, 1.77]. Mortality was documented in 34 (13.6%) and 31 (14.6%) participants in intervention and control arm, respectively [aOR) 1.06 95% CI: −0.61 to 1.83].InterpretationCP was not associated with reduction in mortality or progression to severe COVID-19. This trial has high generalizability and approximates real-life setting of CP therapy in settings with limited laboratory capacity. A priori measurement of neutralizing antibody titres in donors and participants may further clarify the role of CP in management of COVID-19.Trial registrationThe trial was registered with Clinical Trial Registry of India (CTRI); CTRI/2020/04/024775.
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- 2020