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1. Presenting Symptoms and Predictors of Poor Outcomes Among 2,184 Patients with COVID-19 in Lagos State, Nigeria.

Author

Abayomi A, Odukoya O, Osibogun A, Wright O, Adebayo B, Balogun M, Abdus-Salam I, Bowale A, Mutiu B, Saka B, Adejumo M, Yenyi S, Agbolagorite R, Onasanya O, Erinosho E, Obasanya J, Adejumo O, Adesola S, Oshodi Y, Akase IE, Ogunbiyi S, Lajide D, Erinoso F, and Abdur-Razzaq H

Subjects
Adolescent, Adult, Aged, Aged, 80 and over, Child, Child, Preschool, Female, Humans, Infant, Infant, Newborn, Male, Middle Aged, Nigeria epidemiology, Young Adult, COVID-19 mortality, SARS-CoV-2
Abstract

Introduction: Lagos state remains the epicentre of COVID-19 in Nigeria. We describe the symptoms and signs of the first 2,184 PCR-confirmed COVID-19 patients admitted at COVID-19 treatment centers in Lagos State. We also assessed the relationship between patients' presenting symptoms, sociodemographic and clinical characteristics and COVID-19 deaths.., Methods: Medical records of PCR-confirmed COVID-19 patients were extracted and analyzed for their symptoms, symptom severity, presence of comorbidities and outcome., Results: The ages of the patients ranged from 4 days to 98 years with a mean of 43.0(16.0) years. Of the patients who presented with symptoms, cough (19.3%) was the most common presenting symptom. This was followed by fever (13.7%) and difficulty in breathing, (10.9%). The most significant clinical predictor of death was the severity of symptoms and signs at presentation. Difficulty in breathing was the most significant symptom predictor of COVID-19 death (OR:19.26 95% CI 10.95-33.88). The case fatality rate was 4.3%., Conclusion: Primary care physicians and COVID-19 frontline workers should maintain a high index of suspicion and prioritize the care of patients presenting with these symptoms. Community members should be educated on such predictors and ensure that patients with these symptoms seek care early to reduce the risk of deaths associated with COVID-19., (Copyright © 2020 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Published
2021
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2. Association between convalescent plasma treatment and mortality in COVID-19: a collaborative systematic review and meta-analysis of randomized clinical trials

Author

Axfors, Cathrine, Janiaud, Perrine, Schmitt, Andreas M., van’t Hooft, Janneke, Smith, Emily R., Haber, Noah A., Abayomi, Akin, Abduljalil, Manal, Abdulrahman, Abdulkarim, Acosta-Ampudia, Yeny, Aguilar-Guisado, Manuela, Al-Beidh, Farah, Alejandria, Marissa M., Alfonso, Rachelle N., Ali, Mohammad, AlQahtani, Manaf, AlZamrooni, Alaa, Anaya, Juan-Manuel, Ang, Mark Angelo C., Aomar, Ismael F., Argumanis, Luis E., Averyanov, Alexander, Baklaushev, Vladimir P., Balionis, Olga, Benfield, Thomas, Berry, Scott, Birocco, Nadia, Bonifacio, Lynn B., Bowen, Asha C., Bown, Abbie, Cabello-Gutierrez, Carlos, Camacho, Bernardo, Camacho-Ortiz, Adrian, Campbell-Lee, Sally, Cao, Damon H., Cardesa, Ana, Carnate, Jose M., Castillo, German Jr. J., Cavallo, Rossana, Chowdhury, Fazle R., Chowdhury, Forhad U. H., Ciccone, Giovannino, Cingolani, Antonella, Climacosa, Fresthel Monica M., Compernolle, Veerle, Cortez, Carlo Francisco N., Costa Neto, Abel, D’Antico, Sergio, Daly, James, Danielle, Franca, Davis, Joshua S., De Rosa, Francesco Giuseppe, Denholm, Justin T., Denkinger, Claudia M., Desmecht, Daniel, Díaz-Coronado, Juan C., Díaz Ponce-Medrano, Juan A., Donneau, Anne-Françoise, Dumagay, Teresita E., Dunachie, Susanna, Dungog, Cecile C., Erinoso, Olufemi, Escasa, Ivy Mae S., Estcourt, Lise J., Evans, Amy, Evasan, Agnes L. M., Fareli, Christian J., Fernandez-Sanchez, Veronica, Galassi, Claudia, Gallo, Juan E., Garcia, Patricia J., Garcia, Patricia L., Garcia, Jesus A., Garigliany, Mutien, Garza-Gonzalez, Elvira, Gauiran, Deonne Thaddeus V., Gaviria García, Paula A., Giron-Gonzalez, Jose-Antonio, Gómez-Almaguer, David, Gordon, Anthony C., Gothot, André, Grass Guaqueta, Jeser Santiago, Green, Cameron, Grimaldi, David, Hammond, Naomi E., Harvala, Heli, Heralde, Francisco M., Herrick, Jesica, Higgins, Alisa M., Hills, Thomas E., Hines, Jennifer, Holm, Karin, Hoque, Ashraful, Hoste, Eric, Ignacio, Jose M., Ivanov, Alexander V., Janssen, Maike, Jennings, Jeffrey H., Jha, Vivekanand, King, Ruby Anne N., Kjeldsen-Kragh, Jens, Klenerman, Paul, Kotecha, Aditya, Krapp, Fiorella, Labanca, Luciana, Laing, Emma, Landin-Olsson, Mona, Laterre, Pierre-François, Lim, Lyn-Li, Lim, Jodor, Ljungquist, Oskar, Llaca-Díaz, Jorge M., López-Robles, Concepción, López-Cárdenas, Salvador, Lopez-Plaza, Ileana, Lucero, Josephine Anne C., Lundgren, Maria, Macías, Juan, Maganito, Sandy C., Malundo, Anna Flor G., Manrique, Rubén D., Manzini, Paola M., Marcos, Miguel, Marquez, Ignacio, Martínez-Marcos, Francisco Javier, Mata, Ana M., McArthur, Colin J., McQuilten, Zoe K., McVerry, Bryan J., Menon, David K., Meyfroidt, Geert, Mirasol, Ma. Angelina L., Misset, Benoît, Molton, James S., Mondragon, Alric V., Monsalve, Diana M., Moradi Choghakabodi, Parastoo, Morpeth, Susan C., Mouncey, Paul R., Moutschen, Michel, Müller-Tidow, Carsten, Murphy, Erin, Najdovski, Tome, Nichol, Alistair D., Nielsen, Henrik, Novak, Richard M., O’Sullivan, Matthew V. N., Olalla, Julian, Osibogun, Akin, Osikomaiya, Bodunrin, Oyonarte, Salvador, Pardo-Oviedo, Juan M., Patel, Mahesh C., Paterson, David L., Peña-Perez, Carlos A., Perez-Calatayud, Angel A., Pérez-Alba, Eduardo, Perkina, Anastasia, Perry, Naomi, Pouladzadeh, Mandana, Poyato, Inmaculada, Price, David J., Quero, Anne Kristine H., Rahman, Md. M., Rahman, Md. S., Ramesh, Mayur, Ramírez-Santana, Carolina, Rasmussen, Magnus, Rees, Megan A., Rego, Eduardo, Roberts, Jason A., Roberts, David J., Rodríguez, Yhojan, Rodríguez-Baño, Jesús, Rogers, Benjamin A., Rojas, Manuel, Romero, Alberto, Rowan, Kathryn M., Saccona, Fabio, Safdarian, Mehdi, Santos, Maria Clariza M., Sasadeusz, Joe, Scozzari, Gitana, Shankar-Hari, Manu, Sharma, Gorav, Snelling, Thomas, Soto, Alonso, Tagayuna, Pedrito Y., Tang, Amy, Tatem, Geneva, Teofili, Luciana, Tong, Steven Y. C., Turgeon, Alexis F., Veloso, Januario D., Venkatesh, Balasubramanian, Ventura-Enriquez, Yanet, Webb, Steve A., Wiese, Lothar, Wikén, Christian, Wood, Erica M., Yusubalieva, Gaukhar M., Zacharowski, Kai, Zarychanski, Ryan, Khanna, Nina, Moher, David, Goodman, Steven N., Ioannidis, John P. A., and Hemkens, Lars G.

Published
2021
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3. Detection of SARS-CoV-2 in Nigeria: laboratory preparedness and report of index case.

Author

James, Ayorinde Babatunde, Salu, Olumuyiwa Babalola, Shaibu, Joseph Ojonugwa, Onwuamah, Chika, Mutiu, Bamidele Paul, Amoo, Olufemi, Orenolu, Mercy Remilekun, Okwuraiwe, Azuka, Ndodo, Nnaemeka, Saka, Babatunde Akeem, Anyanwu, Roosevelt Amaobichukwu, Bankole, Munir Akinwale, Ige, Fehintola, Abdullah, Mariam Abiodun, Abdus-Salam, Ismail Adeshina, Audu, Rosemary Ajuma, Osibogun, Akin, Abayomi, Akin, Ihekweazu, Chikwe, and Salako, Babatunde Lawal

Subjects
COVID-19 pandemic, HEALTH facilities, POLYMERASE chain reaction, EVOLUTIONARY algorithms, VACCINES
Abstract

Introduction: heightened surveillance of the severe acute respiratory syndrome coronavirus-2 (SARSCoV-2) 2019 outbreak in Wuhan, China activated several collaborative laboratory drills on its detection by health institutions in Nigeria. We hereby detail the laboratory detection and confirmation of the novel SARS-CoV-2 virus of the index case imported into Nigeria. Methods: viral RNA from sputum sample of the index case was tested for SARS-CoV-2 envelope (E) and RNA dependent RNA polymerase (RdRp) genes using quantitative reverse transcription-polymerase chain reaction (qRT-PCR). Genetic analysis using a partial sequence of RdRp gene was used for laboratory confirmation, evolutionary inferences, and relatedness to previous strains of betacorona viruses in Nigeria. Results: both qRT-PCR for the E and RdRp genes indicated the presence of the SARSCoV-2 RNA by showing cycle threshold (ct) values of 20.27 and 25.26 respectively. On successful completion of the sequencing run, data aligned with >98% similarity of the 2019 circulating strain of Coronavirus SARS-CoV-2. Evolutionary algorithms revealed that the sequence (RdRp gene) of the outbreak circulating strains were more conserved unlike previous coronavirus outbreaks. Data showed that some coronaviruses belonging to the BetaCoV genus had earlier been reported in bats and camels in Nigeria indicating the possibility of sero-protection in exposed populations. Conclusion: pre-laboratory drills prompted early diagnosis and confirmation of SARS-CoV-2 index case in Nigeria initiating rapid case-definition, contact tracing, and successful epidemiological management of the outbreak. Rapid sequencing of the viral genome during strategic points of the outbreak curve and making libraries of new variants for improved vaccine development are recommended. [ABSTRACT FROM AUTHOR]

Published
2021
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4. Association between convalescent plasma treatment and mortality in COVID-19: a collaborative systematic review and meta-analysis of randomized clinical trials

Author

Axfors, Cathrine, Janiaud, Perrine, Schmitt, Andreas M, Van't Hooft, Janneke, Smith, Emily R, Haber, Noah A, Abayomi, Akin, Abduljalil, Manal, Abdulrahman, Abdulkarim, Acosta-Ampudia, Yeny, Aguilar-Guisado, Manuela, Al-Beidh, Farah, Alejandria, Marissa M, Alfonso, Rachelle N, Ali, Mohammad, AlQahtani, Manaf, AlZamrooni, Alaa, Anaya, Juan-Manuel, Ang, Mark Angelo C, Aomar, Ismael F, Argumanis, Luis E, Averyanov, Alexander, Baklaushev, Vladimir P, Balionis, Olga, Benfield, Thomas, Berry, Scott, Birocco, Nadia, Bonifacio, Lynn B, Bowen, Asha C, Bown, Abbie, Cabello-Gutierrez, Carlos, Camacho, Bernardo, Camacho-Ortiz, Adrian, Campbell-Lee, Sally, Cao, Damon H, Cardesa, Ana, Carnate, Jose M, Castillo, German Jr J, Cavallo, Rossana, Chowdhury, Fazle R, Chowdhury, Forhad UH, Ciccone, Giovannino, Cingolani, Antonella, Climacosa, Fresthel Monica M, Compernolle, Veerle, Cortez, Carlo Francisco N, Costa Neto, Abel, D'Antico, Sergio, Daly, James, Danielle, Franca, Davis, Joshua S, De Rosa, Francesco Giuseppe, Denholm, Justin T, Denkinger, Claudia M, Desmecht, Daniel, Díaz-Coronado, Juan C, Díaz Ponce-Medrano, Juan A, Donneau, Anne-Françoise, Dumagay, Teresita E, Dunachie, Susanna, Dungog, Cecile C, Erinoso, Olufemi, Escasa, Ivy Mae S, Estcourt, Lise J, Evans, Amy, Evasan, Agnes LM, Fareli, Christian J, Fernandez-Sanchez, Veronica, Galassi, Claudia, Gallo, Juan E, Garcia, Patricia J, Garcia, Patricia L, Garcia, Jesus A, Garigliany, Mutien, Garza-Gonzalez, Elvira, Gauiran, Deonne Thaddeus V, Gaviria García, Paula A, Giron-Gonzalez, Jose-Antonio, Gómez-Almaguer, David, Gordon, Anthony C, Gothot, André, Grass Guaqueta, Jeser Santiago, Green, Cameron, Grimaldi, David, Hammond, Naomi E, Harvala, Heli, Heralde, Francisco M, Herrick, Jesica, Higgins, Alisa M, Hills, Thomas E, Hines, Jennifer, Holm, Karin, Hoque, Ashraful, Hoste, Eric, Ignacio, Jose M, Ivanov, Alexander V, Janssen, Maike, Jennings, Jeffrey H, Jha, Vivekanand, King, Ruby Anne N, Kjeldsen-Kragh, Jens, Klenerman, Paul, Kotecha, Aditya, Krapp, Fiorella, Labanca, Luciana, Laing, Emma, Landin-Olsson, Mona, Laterre, Pierre-François, Lim, Lyn-Li, Lim, Jodor, Ljungquist, Oskar, Llaca-Díaz, Jorge M, López-Robles, Concepción, López-Cárdenas, Salvador, Lopez-Plaza, Ileana, Lucero, Josephine Anne C, Lundgren, Maria, Macías, Juan, Maganito, Sandy C, Malundo, Anna Flor G, Manrique, Rubén D, Manzini, Paola M, Marcos, Miguel, Marquez, Ignacio, Martínez-Marcos, Francisco Javier, Mata, Ana M, McArthur, Colin J, McQuilten, Zoe K, McVerry, Bryan J, Menon, David K, Meyfroidt, Geert, Mirasol, Ma Angelina L, Misset, Benoît, Molton, James S, Mondragon, Alric V, Monsalve, Diana M, Moradi Choghakabodi, Parastoo, Morpeth, Susan C, Mouncey, Paul R, Moutschen, Michel, Müller-Tidow, Carsten, Murphy, Erin, Najdovski, Tome, Nichol, Alistair D, Nielsen, Henrik, Novak, Richard M, O'Sullivan, Matthew VN, Olalla, Julian, Osibogun, Akin, Osikomaiya, Bodunrin, Oyonarte, Salvador, Pardo-Oviedo, Juan M, Patel, Mahesh C, Paterson, David L, Peña-Perez, Carlos A, Perez-Calatayud, Angel A, Pérez-Alba, Eduardo, Perkina, Anastasia, Perry, Naomi, Pouladzadeh, Mandana, Poyato, Inmaculada, Price, David J, Quero, Anne Kristine H, Rahman, Md M, Rahman, Md S, Ramesh, Mayur, Ramírez-Santana, Carolina, Rasmussen, Magnus, Rees, Megan A, Rego, Eduardo, Roberts, Jason A, Roberts, David J, Rodríguez, Yhojan, Rodríguez-Baño, Jesús, Rogers, Benjamin A, Rojas, Manuel, Romero, Alberto, Rowan, Kathryn M, Saccona, Fabio, Safdarian, Mehdi, Santos, Maria Clariza M, Sasadeusz, Joe, Scozzari, Gitana, Shankar-Hari, Manu, Sharma, Gorav, Snelling, Thomas, Soto, Alonso, Tagayuna, Pedrito Y, Tang, Amy, Tatem, Geneva, Teofili, Luciana, Tong, Steven YC, Turgeon, Alexis F, Veloso, Januario D, Venkatesh, Balasubramanian, Ventura-Enriquez, Yanet, Webb, Steve A, Wiese, Lothar, Wikén, Christian, Wood, Erica M, Yusubalieva, Gaukhar M, Zacharowski, Kai, Zarychanski, Ryan, Khanna, Nina, Moher, David, Goodman, Steven N, Ioannidis, John PA, and Hemkens, Lars G

Subjects
Meta-analysis, Convalescent plasma, Treatment Outcome, SARS-CoV-2, Immunization, Passive, COVID-19, Humans, COVID-19 Serotherapy, 3. Good health, Randomized Controlled Trials as Topic
Abstract

Funder: laura and john arnold foundation, BACKGROUND: Convalescent plasma has been widely used to treat COVID-19 and is under investigation in numerous randomized clinical trials, but results are publicly available only for a small number of trials. The objective of this study was to assess the benefits of convalescent plasma treatment compared to placebo or no treatment and all-cause mortality in patients with COVID-19, using data from all available randomized clinical trials, including unpublished and ongoing trials (Open Science Framework, https://doi.org/10.17605/OSF.IO/GEHFX ). METHODS: In this collaborative systematic review and meta-analysis, clinical trial registries (ClinicalTrials.gov, WHO International Clinical Trials Registry Platform), the Cochrane COVID-19 register, the LOVE database, and PubMed were searched until April 8, 2021. Investigators of trials registered by March 1, 2021, without published results were contacted via email. Eligible were ongoing, discontinued and completed randomized clinical trials that compared convalescent plasma with placebo or no treatment in COVID-19 patients, regardless of setting or treatment schedule. Aggregated mortality data were extracted from publications or provided by investigators of unpublished trials and combined using the Hartung-Knapp-Sidik-Jonkman random effects model. We investigated the contribution of unpublished trials to the overall evidence. RESULTS: A total of 16,477 patients were included in 33 trials (20 unpublished with 3190 patients, 13 published with 13,287 patients). 32 trials enrolled only hospitalized patients (including 3 with only intensive care unit patients). Risk of bias was low for 29/33 trials. Of 8495 patients who received convalescent plasma, 1997 died (23%), and of 7982 control patients, 1952 died (24%). The combined risk ratio for all-cause mortality was 0.97 (95% confidence interval: 0.92; 1.02) with between-study heterogeneity not beyond chance (I2 = 0%). The RECOVERY trial had 69.8% and the unpublished evidence 25.3% of the weight in the meta-analysis. CONCLUSIONS: Convalescent plasma treatment of patients with COVID-19 did not reduce all-cause mortality. These results provide strong evidence that convalescent plasma treatment for patients with COVID-19 should not be used outside of randomized trials. Evidence synthesis from collaborations among trial investigators can inform both evidence generation and evidence application in patient care.

5. Association between convalescent plasma treatment and mortality in COVID-19: a collaborative systematic review and meta-analysis of randomized clinical trials

Author

Axfors, Cathrine, Janiaud, Perrine, Schmitt, Andreas M, Van't Hooft, Janneke, Smith, Emily R, Haber, Noah A, Abayomi, Akin, Abduljalil, Manal, Abdulrahman, Abdulkarim, Acosta-Ampudia, Yeny, Aguilar-Guisado, Manuela, Al-Beidh, Farah, Alejandria, Marissa M, Alfonso, Rachelle N, Ali, Mohammad, AlQahtani, Manaf, AlZamrooni, Alaa, Anaya, Juan-Manuel, Ang, Mark Angelo C, Aomar, Ismael F, Argumanis, Luis E, Averyanov, Alexander, Baklaushev, Vladimir P, Balionis, Olga, Benfield, Thomas, Berry, Scott, Birocco, Nadia, Bonifacio, Lynn B, Bowen, Asha C, Bown, Abbie, Cabello-Gutierrez, Carlos, Camacho, Bernardo, Camacho-Ortiz, Adrian, Campbell-Lee, Sally, Cao, Damon H, Cardesa, Ana, Carnate, Jose M, Castillo, German Jr J, Cavallo, Rossana, Chowdhury, Fazle R, Chowdhury, Forhad UH, Ciccone, Giovannino, Cingolani, Antonella, Climacosa, Fresthel Monica M, Compernolle, Veerle, Cortez, Carlo Francisco N, Costa Neto, Abel, D'Antico, Sergio, Daly, James, Danielle, Franca, Davis, Joshua S, De Rosa, Francesco Giuseppe, Denholm, Justin T, Denkinger, Claudia M, Desmecht, Daniel, D��az-Coronado, Juan C, D��az Ponce-Medrano, Juan A, Donneau, Anne-Fran��oise, Dumagay, Teresita E, Dunachie, Susanna, Dungog, Cecile C, Erinoso, Olufemi, Escasa, Ivy Mae S, Estcourt, Lise J, Evans, Amy, Evasan, Agnes LM, Fareli, Christian J, Fernandez-Sanchez, Veronica, Galassi, Claudia, Gallo, Juan E, Garcia, Patricia J, Garcia, Patricia L, Garcia, Jesus A, Garigliany, Mutien, Garza-Gonzalez, Elvira, Gauiran, Deonne Thaddeus V, Gaviria Garc��a, Paula A, Giron-Gonzalez, Jose-Antonio, G��mez-Almaguer, David, Gordon, Anthony C, Gothot, Andr��, Grass Guaqueta, Jeser Santiago, Green, Cameron, Grimaldi, David, Hammond, Naomi E, Harvala, Heli, Heralde, Francisco M, Herrick, Jesica, Higgins, Alisa M, Hills, Thomas E, Hines, Jennifer, Holm, Karin, Hoque, Ashraful, Hoste, Eric, Ignacio, Jose M, Ivanov, Alexander V, Janssen, Maike, Jennings, Jeffrey H, Jha, Vivekanand, King, Ruby Anne N, Kjeldsen-Kragh, Jens, Klenerman, Paul, Kotecha, Aditya, Krapp, Fiorella, Labanca, Luciana, Laing, Emma, Landin-Olsson, Mona, Laterre, Pierre-Fran��ois, Lim, Lyn-Li, Lim, Jodor, Ljungquist, Oskar, Llaca-D��az, Jorge M, L��pez-Robles, Concepci��n, L��pez-C��rdenas, Salvador, Lopez-Plaza, Ileana, Lucero, Josephine Anne C, Lundgren, Maria, Mac��as, Juan, Maganito, Sandy C, Malundo, Anna Flor G, Manrique, Rub��n D, Manzini, Paola M, Marcos, Miguel, Marquez, Ignacio, Mart��nez-Marcos, Francisco Javier, Mata, Ana M, McArthur, Colin J, McQuilten, Zoe K, McVerry, Bryan J, Menon, David K, Meyfroidt, Geert, Mirasol, Ma Angelina L, Misset, Beno��t, Molton, James S, Mondragon, Alric V, Monsalve, Diana M, Moradi Choghakabodi, Parastoo, Morpeth, Susan C, Mouncey, Paul R, Moutschen, Michel, M��ller-Tidow, Carsten, Murphy, Erin, Najdovski, Tome, Nichol, Alistair D, Nielsen, Henrik, Novak, Richard M, O'Sullivan, Matthew VN, Olalla, Julian, Osibogun, Akin, Osikomaiya, Bodunrin, Oyonarte, Salvador, Pardo-Oviedo, Juan M, Patel, Mahesh C, Paterson, David L, Pe��a-Perez, Carlos A, Perez-Calatayud, Angel A, P��rez-Alba, Eduardo, Perkina, Anastasia, Perry, Naomi, Pouladzadeh, Mandana, Poyato, Inmaculada, Price, David J, Quero, Anne Kristine H, Rahman, Md M, Rahman, Md S, Ramesh, Mayur, Ram��rez-Santana, Carolina, Rasmussen, Magnus, Rees, Megan A, Rego, Eduardo, Roberts, Jason A, Roberts, David J, Rodr��guez, Yhojan, Rodr��guez-Ba��o, Jes��s, Rogers, Benjamin A, Rojas, Manuel, Romero, Alberto, Rowan, Kathryn M, Saccona, Fabio, Safdarian, Mehdi, Santos, Maria Clariza M, Sasadeusz, Joe, Scozzari, Gitana, Shankar-Hari, Manu, Sharma, Gorav, Snelling, Thomas, Soto, Alonso, Tagayuna, Pedrito Y, Tang, Amy, Tatem, Geneva, Teofili, Luciana, Tong, Steven YC, Turgeon, Alexis F, Veloso, Januario D, Venkatesh, Balasubramanian, Ventura-Enriquez, Yanet, Webb, Steve A, Wiese, Lothar, Wik��n, Christian, Wood, Erica M, Yusubalieva, Gaukhar M, Zacharowski, Kai, Zarychanski, Ryan, Khanna, Nina, Moher, David, Goodman, Steven N, Ioannidis, John PA, and Hemkens, Lars G

Subjects
Meta-analysis, Convalescent plasma, SARS-CoV-2, COVID-19, 3. Good health, Research Article
Abstract

Funder: laura and john arnold foundation; doi: http://dx.doi.org/10.13039/100009827, BACKGROUND: Convalescent plasma has been widely used to treat COVID-19 and is under investigation in numerous randomized clinical trials, but results are publicly available only for a small number of trials. The objective of this study was to assess the benefits of convalescent plasma treatment compared to placebo or no treatment and all-cause mortality in patients with COVID-19, using data from all available randomized clinical trials, including unpublished and ongoing trials (Open Science Framework, https://doi.org/10.17605/OSF.IO/GEHFX ). METHODS: In this collaborative systematic review and meta-analysis, clinical trial registries (ClinicalTrials.gov, WHO International Clinical Trials Registry Platform), the Cochrane COVID-19 register, the LOVE database, and PubMed were searched until April 8, 2021. Investigators of trials registered by March 1, 2021, without published results were contacted via email. Eligible were ongoing, discontinued and completed randomized clinical trials that compared convalescent plasma with placebo or no treatment in COVID-19 patients, regardless of setting or treatment schedule. Aggregated mortality data were extracted from publications or provided by investigators of unpublished trials and combined using the Hartung-Knapp-Sidik-Jonkman random effects model. We investigated the contribution of unpublished trials to the overall evidence. RESULTS: A total of 16,477 patients were included in 33 trials (20 unpublished with 3190 patients, 13 published with 13,287 patients). 32 trials enrolled only hospitalized patients (including 3 with only intensive care unit patients). Risk of bias was low for 29/33 trials. Of 8495 patients who received convalescent plasma, 1997 died (23%), and of 7982 control patients, 1952 died (24%). The combined risk ratio for all-cause mortality was 0.97 (95% confidence interval: 0.92; 1.02) with between-study heterogeneity not beyond chance (I2 = 0%). The RECOVERY trial had 69.8% and the unpublished evidence 25.3% of the weight in the meta-analysis. CONCLUSIONS: Convalescent plasma treatment of patients with COVID-19 did not reduce all-cause mortality. These results provide strong evidence that convalescent plasma treatment for patients with COVID-19 should not be used outside of randomized trials. Evidence synthesis from collaborations among trial investigators can inform both evidence generation and evidence application in patient care.

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