1. Convalescent plasma in the management of moderate covid-19 in adults in India: open label phase II multicentre randomised controlled trial (PLACID Trial)
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Agarwal, Anup, Mukherjee, Aparna, Kumar, Gunjan, Chatterjee, Pranab, Bhatnagar, Tarun, Malhotra, Pankaj, Latha, B, Bundas, Sunita, Kumar, Vivek, Dosi, Ravi, Khambholja, Janak Kumar, de Souza, Rosemarie, Mesipogu, Raja Rao, Srivastava, Saurabh, Dube, Simmi, Chaudhary, Kiran, Subash, S, Anbuselvi, S, Rajendran, V, Sundararajaperumal, A, Balamanikandan, P, Maheswari, R S Uma, Jayanthi, R, Ragunanthanan, S, Bhandari, Sudhir, Singh, Ajeet, Pal, Ashok, Handa, Anjali, Rankawat, Govind, Kargirwar, Ketan, Regi, Joyce, Rathod, Darshana, Pathrose, Edwin, Bhutaka, Nirankar, Patel, Mayur H, Verma, Rahul J, Malukani, Kamal, Patel, Shivani, Thakur, Apurv, Joshi, Satish, Kulkarni, Rashmi, Suthar, Nilay N, Shah, Nehal M, Purohit, Hemang M, Shah, Cherry K, Patel, Monila N, Shah, Saket, Shah, Smit T, Memon, Tehsim, Beriwala, Vishal R, Jashnani, Kusum, Ezzy, Fatema, Agrawal, Simran, Bhadade, Rakesh, Atish, MN, Madke, Tushar, Kavishwar, Vikas, Waghmare, Ramesh, Valvi, Nitin, Chander, B Thrilok, Sekhar, A Vinaya, Maurya, Akhilesh Kumar, Hemanth, K, Nagamani, K, Sudha, K, Chandra, T Ravi, Rao, K Tushara, Vyshnavi, J, Upadhyay, Rashmi, Bahadur, Shalini, Pathak, Rambha, Seth, Shikha, Gupta, Rakesh, Saxena, Rita, Dwivedi, Preksha, Malik, Reeni, Chourasia, Deepti, Lalwani, Jaya, Sharma, UM, Marko, JL, Suri, Amit, Kumar, Vijay, Kaushik, Rajnish, Kodan, Parul, Acharya, Bhabani Prasad, Gaur, Kuldeep Kumar, Gupta, Anubhav, Sachdeva, Prerna, Dogra, Shruti, Jindal, Aikaj, John, M Joseph, Dhanju, Avtar Singh, Khetrepal, Ranjana, Sharma, Neeraj, Kukar, Neetu, Kavita, Divya, Kumar, Rajesh, Mahajan, Rajesh, Singh, Gurpreet, Kaur, Jaspreet, Singh, Raminder Pal, Bassi, Rajni, Parikh, Swapneil, Shrivastav, Om, Shastri, Jayanthi, Desai, Maherra, Udupa, Shreevatsa, Bafna, Varun A, Barge, Vijay, Madane, Rajendra, Yadav, Sheetal, Misra, Sanjeev, Bajpayee, Archana, Garg, M K, Bohra, G K, Nag, Vijaylakshmi, Anne, Puneeth Babu, Nadeem, Mohd, Singh, Pallavi, Niwas, Ram, Khaire, Niranjan Shiwaji, Sharma, Rattiram, Singh, Mini P, Sachdeva, Naresh, Sachdev, Suchet, Hans, Rekha, Suri, Vikas, Yaddanapudi, LN, Lakshmi, PVM, Singh, Neha, Bhushan, Divendu, Kumar, Neeraj, Tambe, Muralidhar, Salvi, Sonali, Kadgi, Nalini, Sangle, Shashikala, Nakate, Leena, Joshi, Samir, Karyakarte, Rajesh, Goyanka, Suraj, Sharma, Nimisha, Verma, Nikhil, Das, Asim, Bahl, Monika, Wadhwa, Nitya, Bhat, Shreepad, Deshmukh, Shweta, Wagh, Vrushali, Kulkarni, Atul, Yardi, Tanvi, Kalgud, Ram S, Reddy, Purushottam, Yevoor, Kavitha, Gajula, Prashanth, Maleyur, Vivek, Medini, S, Mohith, HN, Gurtoo, Anil, Sud, Ritika, Pahuja, Sangeeta, Prakash, Anupam, Gogoi, Parijat, Shukla, Shailja, Reddy, D Himanshu, Chandra, Tulika, Pandey, Saurabh, Maurya, Pradeep, Ali, Wahid, Upadhyay, Kamlesh, Bhatnagar, Nidhi, Shah, Nilima, Shah, Mamta, Patel, Tarak, Jaiswal, Ram Mohan, Jain, Ashish, Sharma, Shweta, Rijhwani, Puneet, Gupta, Naveen, Patel, Tinkal C, Solu, Mahesh G, Patel, Jitendra, Shah, Yash R, Jarag, Mayur, Godbole, Varsha, Shah, Meenakshi, Raj, Rikin, Nagori, Irfan, Jha, Pramod R, Shah, Arti D, Yeeli, Gowtham, Jain, Archit, Gill, Rooppreet Kaur, Babu, KV Sreedhar, Babu, B Suresh, Mohan, Alladi, Vengamma, B, Sekhar, K Chandra, Damam, Srinivasulu, Narsimhulu, K, Aparna, C, Baleswari, G, Reddy, K Ravindranath, Chandrasekhar, P, Panjwani, Sunil Jodharam, Shah, Pragnesh H, Barvaliya, Manish, Desai, Kairavi, Akholkar, Pankaj J, Baldi, Milind, Yadav, Ashok, Gupta, Manoj, Rawat, Nitin, Chawda, Dilip, Natarajan, M, Sintha, M, Kumar, David Pradeep, Rabbani, Fathhur, Khadke, Vrushali Khirid, Patki, Dattatray, Marathe, Sonali, D’Souza, Clyde, Tadha, Vipul, Arora, Satyam, Gupta, Devendra Kumar, Dua, Seema, Chauhan, Nitu, Chahar, Ajeet Singh, Mammen, Joy John, Kumar, Snehil, Daniel, Dolly, Singh, Ravindraa, Dhat, Venkatesh, Agarwal, Yogesh, Arora, Sohini, Pathak, Ashish, Purohit, Manju, Sharma, Ashish, Sharma, Jayashree, Madkaikar, Manisha, Joshi, Kavita, Yadav, Reetika Malik, Bhagwat, Swarupa, Karnik, Niteen D, Gokhale, Yojana A, Naik, Leena, Margam, Sangita, Das, Santasabuj, Turuk, Alka, Kumar, V Saravana, Kanagasabai, K, Sabarinathan, R, Deshpande, Gururaj, Sharma, Sharda, Gunjikar, Rashmi, Shete, Anita, Phagiwala, Darpan, Patil, Chetan, Shingade, Snehal, Jarande, Kajal, Kaushal, Himanshu, Yadav, Pragya, Sapkal, Gajanan, and Abraham, Priya
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Adult ,Male ,medicine.medical_specialty ,Pneumonia, Viral ,India ,030204 cardiovascular system & hematology ,Antibodies, Viral ,Corrections ,law.invention ,Betacoronavirus ,03 medical and health sciences ,0302 clinical medicine ,Randomized controlled trial ,law ,Fraction of inspired oxygen ,Internal medicine ,medicine ,Humans ,Treatment Failure ,Pandemics ,COVID-19 Serotherapy ,030304 developmental biology ,Oxygen saturation (medicine) ,0303 health sciences ,SARS-CoV-2 ,business.industry ,Research ,Immunization, Passive ,Absolute risk reduction ,COVID-19 ,General Medicine ,Middle Aged ,Antibodies, Neutralizing ,Confidence interval ,Clinical trial ,Relative risk ,Disease Progression ,Arterial blood ,Female ,Coronavirus Infections ,business - Abstract
ObjectiveTo investigate the effectiveness of using convalescent plasma to treat moderate coronavirus disease 2019 (covid-19) in adults in India.DesignOpen label, parallel arm, phase II, multicentre, randomised controlled trial.Setting39 public and private hospitals across India.Participants464 adults (≥18 years) admitted to hospital (screened 22 April to 14 July 2020) with confirmed moderate covid-19 (partial pressure of oxygen in arterial blood/fraction of inspired oxygen (PaO2/FiO2) ratio between 200 mm Hg and 300 mm Hg or a respiratory rate of more than 24/min with oxygen saturation 93% or less on room air): 235 were assigned to convalescent plasma with best standard of care (intervention arm) and 229 to best standard of care only (control arm).InterventionsParticipants in the intervention arm received two doses of 200 mL convalescent plasma, transfused 24 hours apart. The presence and levels of neutralising antibodies were not measured a priori; stored samples were assayed at the end of the study.Main outcome measureComposite of progression to severe disease (PaO2/FiO2ResultsProgression to severe disease or all cause mortality at 28 days after enrolment occurred in 44 (19%) participants in the intervention arm and 41 (18%) in the control arm (risk difference 0.008 (95% confidence interval −0.062 to 0.078); risk ratio 1.04, 95% confidence interval 0.71 to 1.54).ConclusionConvalescent plasma was not associated with a reduction in progression to severe covid-19 or all cause mortality. This trial has high generalisability and approximates convalescent plasma use in real life settings with limited laboratory capacity. A priori measurement of neutralising antibody titres in donors and participants might further clarify the role of convalescent plasma in the management of covid-19.Trial registrationClinical Trial Registry of India CTRI/2020/04/024775.
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- 2020