Articles

Impact of a mobile phone-based interactive voice response software on tuberculosis treatment outcomes in Uganda (CFL-TB): a protocol for a randomized controlled trial

Throughout the last decade, tuberculosis (TB) treatment success has not surpassed 90%, the global target. The impact of mobile health interventions (MHIs) on TB treatment outcomes is unknown, especially in low...

Authors: Dathan Mirembe Byonanebye, Hope Mackline, Christine Sekaggya-Wiltshire, Agnes N. Kiragga, Mohammed Lamorde, Elizabeth Oseku, Rachel King and Rosalind Parkes-Ratanshi

Integrating pharmacists into aged care facilities to improve the quality use of medicine (PiRACF Study): protocol for a cluster randomised controlled trial

Medication management in residential aged care facilities is an ongoing concern. Numerous studies have reported high rates of inappropriate prescribing and medication use in aged care facilities, which contrib...

Authors: Sam Kosari, Jane Koerner, Mark Naunton, Gregory M. Peterson, Ibrahim Haider, Emily Lancsar, David Wright, Theo Niyonsenga and Rachel Davey

Evaluation of adherence monitoring system using evriMED with a differentiated response compared to standard of care among drug-sensitive TB patients in three provinces in South Africa: a protocol for a cluster randomised control trial

South Africa has achieved drug-susceptible TB (DS-TB) treatment success of only 77% among people with new and previously treated TB. Alternative approaches are required to improve medication adherence and trea...

Authors: Noriah Maraba, Catherine Orrell, Candice M. Chetty-Makkan, Kavindhran Velen, Rachel Mukora, Liesl Page-Shipp, Pren Naidoo, M. Thulani Mbatha, Katherine L. Fielding and Salome Charalambous

The quality of intervention reporting in trials of therapeutic exercise for hip osteoarthritis: a secondary analysis of a systematic review

Therapeutic exercise is recommended as a core treatment for hip osteoarthritis (HOA). Whilst it is widely accepted that exercise can improve pain and disability, optimal type and dose of exercise are yet to be...

Authors: Louise C. Burgess, Thomas W. Wainwright, Khara A. James, Johan von Heideken and Maura D. Iversen

Auricular acupressure for myopia prevention and control in children and its effect on choroid and retina: a randomized controlled trial protocol

Nowadays, because of the increasing incidence, the prevention and control of myopia has become an urgent issue. In China, auricular acupressure has been commonly used in the clinical treatment of myopia in chi...

Authors: Rong Han, Xie-he Kong, Feng Zhao, Yan-ting Yang, Xiao-qing Dong, Li Zeng, Zhi Chen, Yue Zhao, Guang Yang, Jue Hong, Xing-tao Zhou and Xiao-peng Ma

The cerebral mechanism of acupuncture for chronic insomnia with gastrointestinal disorder: protocol for a randomized controlled trial

Many patients with chronic insomnia disorder (CID) have gastrointestinal (GI) symptoms. First-line insomnia medications do not treat GI problems. Acupuncture has a comprehensive regulative action on both CID a...

Authors: Wei Peng, Xiaojuan Hong, Yaru Huangfu, Zhao Sun, Wei Shen, Fen Feng, Liang Gong, Zhifu Shen, Baojun Guo, Leixiao Zhang, Yanan Wang, Ying Zhao, Tianmin Zhu, Youping Hu and Siyi Yu

SWE and SMI ultrasound techniques for monitoring needling treatment of ankylosing spondylitis: study protocol for a single-blinded randomized controlled trial

Ankylosing spondylitis (AS) is a high-incidence disease in young men that interferes with patients’ physical and mental wellbeing and overall quality of life (QoL). It is often accompanied by arthralgia, stiff...

Authors: Mengyu Wang, Wen Fu, Lingcui Meng, Jia Liu, Lihua Wu, Yingjun Peng and Ziping Li

Prophylaxis for patients at Risk to Eliminate Post-operative Atrial Fibrillation (PREP-AF trial): a protocol for a feasibility randomized controlled study

Postoperative atrial fibrillation (POAF) is a frequent adverse event after thoracic surgery with associated morbidity, mortality, and healthcare costs. It has been shown to be preventable with prophylactic ami...

Authors: Heather A. Smith, Salmaan Kanji, Diem T. T. Tran, Calum Redpath, Dean Ferguson, Tori Lenet, Greg Sigler, Sebastien Gilbert, Donna Maziak, Patrick Villeneuve, Sudhir Sundaresan and Andrew J. E. Seely

Assessing the efficacy of a stepped-care group treatment programme for borderline personality disorder: study protocol for a pragmatic trial

Borderline personality disorder (BPD) is a high prevalence and serious mental health disorder that has historically challenged the finite resources of health services. Despite empirical evidence supporting str...

Authors: Judy A. Pickard, Adam Finch, Elizabeth Huxley, Michelle L. Townsend, Stephanie Deuchar, Kate L. Lewis, Jason Pratt and Brin F. S. Grenyer

Maternal low-intensity psychosocial telemental interventions in response to COVID-19 in Qatar: study protocol for a randomized controlled trial

As COVID-19 is spreading, new psychological health problems are suspected to be emerging among pregnant women. Higher maternal mental health distress, including perinatal anxiety, depression, and COVID-19-spec...

Authors: Sarah Naja, Rowaida Elyamani, Mohamad Chehab, Mohamed Siddig, Abdullah Al Ibrahim, Tagreed Mohamad, Rajvir Singh and Iheb Bougmiza

Letter on “Sharing trial results directly with trial participants and other stakeholders after the SARS-CoV-2 pandemic hit the UK – experience from the ActWELL trial”

After the SARS-CoV-2 pandemic took hold in the UK, the ActWELL trial team’s plans to present the trial results to participants and other stakeholders had to change. Instead of face-face events, three online ev...

Authors: Hanne Bruhn, Annie S. Anderson, Amy Hickman, E. Jane Macaskill and Shaun Treweek

Patient-Reported OUtcome measures in key African languages to promote Diversity in research and clinical practice (PROUD)—protocol for a systematic review of measurement properties

Sub-Saharan Africa is a subcontinent with a proud cultural richness and diversity, yet inexplicably also a region with severe health care challenges and inequity. To challenge this health equity gap and reduce...

Authors: Martin Heine, Lidwine B. Mokkink, Chanel van Zyl, Wayne Derman and Susan Hanekom

A framework for handling missing accelerometer outcome data in trials

Accelerometers and other wearable devices are increasingly being used in clinical trials to provide an objective measure of the impact of an intervention on physical activity. Missing data are ubiquitous in th...

Authors: Mia S. Tackney, Derek G. Cook, Daniel Stahl, Khalida Ismail, Elizabeth Williamson and James Carpenter

Safety and efficacy of Ayurvedic interventions and Yoga on long term effects of COVID-19: A structured summary of a study protocol for a randomized controlled trial

Primary Objective

Authors: Babita Yadav, Amit Rai, Pallavi Suresh Mundada, Richa Singhal, B. C. S. Rao, Rakesh Rana and Narayanam Srikanth

Endoscopic vacuum therapy versus stent treatment of esophageal anastomotic leaks (ESOLEAK): study protocol for a prospective randomized phase 2 trial

Intrathoracic anastomotic leaks represent a major complication after Ivor Lewis esophagectomy. There are two promising endoscopic treatment strategies in the case of leaks: the placement of self-expanding meta...

Authors: Michael Tachezy, Seung-Hun Chon, Isabel Rieck, Marcus Kantowski, Hildegard Christ, Karl Karstens, Florian Gebauer, Tobias Goeser, Thomas Rösch, Jakob R. Izbicki and Christiane J. Bruns

Efficacy and safety of early target-controlled plasma volume replacement with a balanced gelatine solution versus a balanced electrolyte solution in patients with severe sepsis/septic shock: study protocol, design, and rationale of a prospective, randomized, controlled, double-blind, multicentric, international clinical trial

Sepsis is associated with capillary leakage and vasodilatation and leads to hypotension and tissue hypoperfusion. Early plasma volume replacement is required to achieve haemodynamic stability (HDS) and maintai...

Authors: Gernot Marx, Kai Zacharowski, Carole Ichai, Karim Asehnoune, Vladimír Černý, Rolf Dembinski, Ricard Ferrer Roca, Dietmar Fries, Zsolt Molnar, Peter Rosenberger, Manuel Sanchez-Sanchez, Tobias Schürholz, Tamara Dehnhardt, Sonja Schmier, Elke von Kleist, Ute Brauer…

Clinical trial reporting performance of thirty UK universities on ClinicalTrials.gov—evaluation of a new tracking tool for the US clinical trial registry

Clinical trial transparency forms the foundation of evidence-based medicine, and trial sponsors, especially publicly funded institutions such as universities, have an ethical and scientific responsibility to m...

Authors: Sarai Mirjam Keestra, Florence Rodgers, Daphne Lenz, Rhiannon Osborne, Till Bruckner and Sean Lee

Measuring the effectiveness of integrated vector management with targeted outdoor residual spraying and autodissemination devices on the incidence of dengue in urban Malaysia in the iDEM trial (intervention for Dengue Epidemiology in Malaysia): study protocol for a cluster randomized controlled trial

In common with many South East Asian countries, Malaysia is endemic for dengue. Dengue control in Malaysia is currently based on reactive vector management within 24 h of a dengue case being reported. Preventi...

Authors: Mitra Saadatian-Elahi, Neal Alexander, Tim Möhlmann, Carole Langlois-Jacques, Remco Suer, Nazni Wasi Ahmad, Rose Nani Mudin, Farah Diana Ariffin, Frederic Baur, Frederic Schmitt, Jason H. Richardson, Muriel Rabilloud and Nurulhusna Ab Hamid

Acceptability of a COVID-19 pre-exposure prophylaxis trial with hydroxychloroquine in French healthcare workers during the first wave of COVID-19 pandemic

Authors: Amandine Gagneux-Brunon, Clémentine Schilte, Arnauld Garcin, Nathalie Jolly, Muriel Vray, Laura Schaeffer, Xavier Duval, Bruno Hoen and Elisabeth Botelho-Nevers

Fidelity is not easy! Challenges and guidelines for assessing fidelity in complex interventions

Fidelity in complex behavioural interventions is underexplored and few comprehensive or detailed fidelity studies report on specific procedures for monitoring fidelity. Using Bellg’s popular Treatment Fidelity...

Authors: Liane R. Ginsburg, Matthias Hoben, Adam Easterbrook, Ruth A. Anderson, Carole A. Estabrooks and Peter G. Norton

TB research requires strong protections, innovation, and increased funding in response to COVID-19

Authors: B. T. Nyang’wa, A. N. LaHood, C. D. Mitnick and L. Guglielmetti

Chemoprophylaxis trial designs in epidemics: insights from a systematic review of COVID-19 study registrations

Chemoprophylactics against emerging epidemic and pandemic infectious diseases offer potential for prevention but require efficacy and safety analysis before widespread use can be recommended. Chemoprophylaxis ...

Authors: Lakshmi Manoharan, Piero Olliaro, Peter W. Horby and Conall H. Watson

Is postoperative non-weight-bearing necessary? INWN Study protocol for a pragmatic randomised multicentre trial of operatively treated ankle fracture

Postoperative management regimes vary following open reduction and internal fixation (ORIF) of unstable ankle fractures. There is an evolving understanding that extended periods of immobilisation and weight-be...

Authors: Ramy Khojaly, Ruairí Mac Niocaill, Muhammad Shahab, Matthew Nagle, Colm Taylor, Fiachra E. Rowan and May Cleary

Baby-OSCAR: Outcome after Selective early treatment for Closure of patent ductus ARteriosus in preterm babies—a statistical analysis plan for short-term outcomes

The Baby-OSCAR trial is a multi-centre, randomised, placebo-controlled parallel group trial of early treatment of large patent ductus arteriosus (PDA) with ibuprofen in extremely preterm infants. This paper de...

Authors: Jennifer L. Bell, Samir Gupta, Edmund Juszczak, Pollyanna Hardy and Louise Linsell

Individualized, low-cost and accessible pulmonary rehabilitation program based on functional clinical tests for individuals with COPD—a study protocol of a randomized controlled trial

Patients with chronic obstructive pulmonary disease (COPD) present pulmonary and extrapulmonary impairments. The strategies used to mitigate these impairments are pulmonary rehabilitation programs (PRP). Howev...

Authors: Marcela Maria Carvalho da Silva, Juliano Ferreira Arcuri and Valéria Amorim Pires Di Lorenzo

Optimising AVATAR therapy for people who hear distressing voices: study protocol for the AVATAR2 multi-centre randomised controlled trial

AVATAR therapy is a novel intervention targeting distressing auditory verbal hallucinations (henceforth ‘voices’). A digital simulation (avatar) of the voice is created and used in a three-way dialogue between...

Authors: Philippa Garety, Clementine J. Edwards, Thomas Ward, Richard Emsley, Mark Huckvale, Paul McCrone, Mar Rus-Calafell, Miriam Fornells-Ambrojo, Andrew Gumley, Gillian Haddock, Sandra Bucci, Hamish McLeod, Amy Hardy, Emmanuelle Peters, Inez Myin-Germeys and Thomas Craig

The efficacy of repetitive transcranial magnetic stimulation (rTMS) for young individuals with high-level perceived stress: study protocol for a randomized sham-controlled trial

High level of perceived stress may result in negative effects both psychologically and physically on individuals and may predispose onset of mental disorders such as depression, anxiety, and posttraumatic stre...

Authors: Jingsong Wu, Mengyu Han, Youze He, Xiaoting Xie, Jian Song and Xiujuan Geng

VITADIAL “Does correction of 25 OH-VITAmin D with cholecalciferol supplementation increase muscle strength in hemoDIALysis patients?”: study protocol for a randomized controlled trial

Muscle strength decreases as kidney failure progresses. Low muscle strength affects more than 50% of hemodialysis patients and leads to daily life activities impairment. In the general population, numerous stu...

Authors: Stanislas Bataille, Nathalie Pedinielli, Elisa Carreno, Mathilde Prezelin-Reydit, Philippe Chauveau, Guillaume Jean, Thomas Robert, Mickaël Bobot, Guillaume Seret, Elisabeth Jouve, Frederic Lavainne, Marianne Serveaux, Laurence Vrigneaud and Stéphanie Gentile

The UPMC OPTIMISE-C19 (OPtimizing Treatment and Impact of Monoclonal antIbodieS through Evaluation for COVID-19) trial: a structured summary of a study protocol for an open-label, pragmatic, comparative effectiveness platform trial with response-adaptive randomization

The primary objective is to evaluate the comparative effectiveness of COVID-19 specific monoclonal antibodies (mABs) with US Food and Drug Administration (FDA) Emergency Use Authorization (EUA), alongside UPMC...

Authors: David T. Huang, Erin K. McCreary, J. Ryan Bariola, Richard J. Wadas, Kevin E. Kip, Oscar C. Marroquin, Stephen Koscumb, Kevin Collins, Judith A. Shovel, Mark Schmidhofer, Mary Kay Wisniewski, Colleen Sullivan, Donald M. Yealy, Meredith Axe, David A. Nace, Ghady Haidar…

Mediterranean diet, Mindfulness-Based Stress Reduction and usual care during pregnancy for reducing fetal growth restriction and adverse perinatal outcomes: IMPACT BCN (Improving Mothers for a better PrenAtal Care Trial BarCeloNa): a study protocol for a randomized controlled trial

Fetal growth restriction (FGR) affects 7–10% of all pregnancies resulting in a higher risk of perinatal morbidity and mortality, long-term disabilities, and cognitive impairment. Due to its multifactorial etio...

Authors: Francesca Crovetto, Fàtima Crispi, Roger Borras, Cristina Paules, Rosa Casas, Andrés Martín-Asuero, Angela Arranz, Eduard Vieta, Ramon Estruch and Eduard Gratacós

Providing trial results to participants in phase III pragmatic effectiveness RCTs: a scoping review

There is an ethical imperative to offer the results of trials to those who participated. Existing research highlights that less than a third of trials do so, despite the desire of participants to receive the r...

Authors: Hanne Bruhn, Elle-Jay Cowan, Marion K. Campbell, Lynda Constable, Seonaidh Cotton, Vikki Entwistle, Rosemary Humphreys, Karen Innes, Sandra Jayacodi, Peter Knapp, Annabelle South and Katie Gillies

Assessment of a combined strategy of seasonal malaria chemoprevention and supplementation with vitamin A, zinc and Plumpy’Doz™ to prevent malaria and malnutrition in children under 5 years old in Burkina Faso: a randomized open-label trial (SMC-NUT)

Malaria and malnutrition represent major public health concerns worldwide especially in Sub-Sahara Africa. Despite implementation of seasonal malaria chemoprophylaxis (SMC), an intervention aimed at reducing m...

Authors: Paul Sondo, Marc Christian Tahita, Toussaint Rouamba, Karim Derra, Bérenger Kaboré, Cheick Saïd Compaoré, Florence Ouédraogo, Eli Rouamba, Hamidou Ilboudo, Estelle Aïssa Bambara, Macaire Nana, Edmond Yabré Sawadogo, Hermann Sorgho, Athanase Mwinessobaonfou Somé, Innocent Valéa, Prabin Dahal…

Effects of cycling workstation to get tertiary employee moving on their overall health: study protocol for a REMOVE trial

Sedentary behaviour (SB) and low levels of physical activity (PA) are predictors of morbidity and mortality. Tertiary employees spend a considerable amount of their daily time seated and new efficient strategi...

Authors: Terry Guirado, Lore Metz, Bruno Pereira, Audrey Bergouignan, David Thivel and Martine Duclos

Comparative efficacy of a single-session “Empowered Relief” videoconference-delivered group intervention for chronic pain: study protocol for a randomized controlled trial

Chronic pain is naturally aversive and often distressing for patients. Pain coping and self-regulatory skills have been shown to effectively reduce pain-related distress and other symptoms. In this trial, the ...

Authors: Maisa S. Ziadni, Steven R. Anderson, Lluvia Gonzalez-Castro and Beth D. Darnall

Including random centre effects in design, analysis and presentation of multi-centre trials

In large multicentre trials in diverse settings, there is uncertainty about the need to adjust for centre variation in design and analysis. A key distinction is the difference between variation in outcome (ind...

Authors: Kate Edgar, Ian Roberts and Linda Sharples

Efficacy of capacitive resistive monopolar radiofrequency in the physiotherapeutic treatment of chronic pelvic pain syndrome: study protocol for a randomized controlled trial

Chronic pelvic pain syndrome (CPPS) is a multifactorial disorder that affects 5.7% to 26.6% of women and 2.2% to 9.7% of men, characterized by hypersensitivity of the central and peripheral nervous system affe...

Authors: A. Carralero-Martínez, M. A. Muñoz Pérez, R. Pané-Alemany, L. Blanco-Ratto, S. Kauffmann and I. Ramírez-García

The Drinkers’ Intervention to Prevent Tuberculosis (DIPT) trial among heavy drinkers living with HIV in Uganda: study protocol of a 2×2 factorial trial

The risk of tuberculosis (TB) is high among people with HIV (PWH). Heavy alcohol drinking independently increases TB risk and approximately 25% of PWH globally engage in heavy drinking. While isoniazid (INH) prev...

Authors: Sara Lodi, Nneka I. Emenyonu, Kara Marson, Dalsone Kwarisiima, Robin Fatch, Michael G. McDonell, Debbie M. Cheng, Harsha Thirumurthy, Monica Gandhi, Carol S. Camlin, Winnie R. Muyindike, Judith A. Hahn and Gabriel Chamie

Heterogeneity in design and analysis of ICU delirium randomized trials: a systematic review

There is a growing number of randomized controlled trials (RCTs) evaluating interventions to prevent or treat delirium in the intensive care unit (ICU). Efforts to improve the conduct of delirium RCTs are unde...

Authors: Elizabeth Colantuoni, Mounica Koneru, Narjes Akhlaghi, Ximin Li, Mohamed D. Hashem, Victor D. Dinglas, Karin J. Neufeld, Michael O. Harhay and Dale M. Needham

Correction to: A novel preference-informed complementary trial (PICT) design for clinical trial research influenced by strong patient preferences

Authors: Samina Ali, Gareth Hopkin, Naveen Poonai, Lawrence Richer, Maryna Yaskina, Anna Heath, Terry Paul Klassen and Chris McCabe

Different limb lengths in gastric bypass surgery: study protocol for a Swiss multicenter randomized controlled trial (SLIM)

Obesity and type 2 diabetes mellitus are reaching epidemic proportions. In morbidly obese patients, bariatric operations lead to sustained weight loss and relief of comorbidities in the majority of patients. L...

Authors: Marko Kraljević, Romano Schneider, Bettina Wölnerhanssen, Marco Bueter, Tarik Delko and Ralph Peterli

Protective mechanical ventilation with optimal PEEP during RARP improves oxygenation and pulmonary indexes

This trial aimed to evaluate the effects of a protective ventilation strategy on oxygenation/pulmonary indexes in patients undergoing robot-assisted radical prostatectomy (RARP) in the steep Trendelenburg posi...

Authors: Jianwei Zhou, Chuanguang Wang, Ran Lv, Na Liu, Yan Huang, Wu Wang, Lina Yu and Junran Xie

Intraoperative ultrasound-guided compared to stereotactic navigated ventriculoperitoneal shunt placement: study protocol for a randomised controlled study

Ventriculoperitoneal shunt (VPS) placement is one of the most frequent neurosurgical procedures and the operation is performed in a highly standardised manner under maintenance of highest infection precautions...

Authors: Severina Leu, Florian Halbeisen, Luigi Mariani and Jehuda Soleman

Effect of hydroxychloroquine on COVID-19 prevention in cancer patients undergoing treatment: study protocol for a randomized controlled trial

In this study, we will investigate the effect of hydroxychloroquine on the prevention of novel coronavirus disease (COVID-19) in cancer patients being treated.

Authors: H. Rahimi, A. Allahyari, S. Ataei Azimi, M. Kamandi, Z. Mozaheb, F. Zemorshidi, M. Khadem-Rezaiyan, A. Bary, M. Seddigh-Shamsi and M. Moeini Nodeh

Comparison of a fast track protocol and standard care after hip arthroplasty in the reduction of the length of stay and the early weight-bearing resumption: study protocol for a randomized controlled trial

To date, hip arthroplasty is one of the most commonly performed surgical procedures, with growing worldwide demand. In recent decades, major progress made in terms of surgical technique, biomechanics, and trib...

Authors: Martina Rocchi, Cesare Stagni, Marco Govoni, Alessandro Mazzotta, Leonardo Vivarelli, Antonella Orlandi Magli, Mariada Perrone, Maria Grazia Benedetti and Dante Dallari

Parent engagement in co-design of clinical trials: the PARENT trial

Evidence generated from partnering with parents to design and conduct research together may be used to refine, adjust, and modify future research approaches. This study aimed to describe the initial approaches...

Authors: Leigh M. Vanderloo, Shelley M. Vanderhout, Erika Tavares, Jonathon Maguire, Sharon Straus and Catherine S. Birken

Study of Peri-Articular Anaesthetic for Replacement of the Knee (SPAARK): statistical analysis plan for a randomised controlled trial assessing the effectiveness of peri-articular liposomal bupivacaine plus bupivacaine hydrochloride compared with bupivacaine hydrochloride alone

Up to three quarters of surgical patients receive inadequate pain relief, with 40% of patients reporting severe pain following knee replacement, which may indicate the current pain relief strategies using opia...

Authors: Jamie R. Stokes, Ariel Wang, Lisa Poulton, Ines Rombach, Hemant Pandit and Ruth Knight

Updated protocol of the SANO trial: a stepped-wedge cluster randomised trial comparing surgery with active surveillance after neoadjuvant chemoradiotherapy for oesophageal cancer

The Surgery As Needed for Oesophageal cancer (SANO) trial compares active surveillance with standard oesophagectomy for patients with a clinically complete response (cCR) to neoadjuvant chemoradiotherapy. The ...

Authors: Ben M. Eyck, Berend J. van der Wilk, Bo Jan Noordman, Bas P. L. Wijnhoven, Sjoerd M. Lagarde, Henk H. Hartgrink, Peter Paul L. O. Coene, Jan Willem T. Dekker, Michail Doukas, Ate van der Gaast, Joos Heisterkamp, Ewout A. Kouwenhoven, Grard A. P. Nieuwenhuijzen, Jean-Pierre E. N. Pierie, Camiel Rosman, Johanna W. van Sandick…

Nutrition-focused group intervention with a strength-based counseling approach for people with clinical depression: a study protocol for the Food for Mind randomized controlled trial

Depression is a highly prevalent mental disorder with major public health effects globally. It impairs the quality of life and reduces the ability to work and function, leading to increasing costs of sick leav...

Authors: Johanna Roponen, Anu Ruusunen, Pilvikki Absetz, Timo Partonen, Virpi Kuvaja-Köllner, Mika Hujo and Outi Nuutinen

Reconvalescent plasma/camostat mesylate in early SARS-CoV-2 Q-PCR positive high-risk individuals (RES-Q-HR): a structured summary of a study protocol for a randomized controlled trial

Currently, there are no approved treatments for early disease stages of COVID-19 and few strategies to prevent disease progression after infection with SARS-CoV-2. The objective of this study is to evaluate th...

Authors: Verena Keitel, Björn Jensen, Torsten Feldt, Johannes C. Fischer, Johannes G. Bode, Christiane Matuschek, Edwin Bölke, Wilfried Budach, Christian Plettenberg, Kathrin Scheckenbach, Detlef Kindgen-Milles, Jörg Timm, Lisa Müller, Henrike Kolbe, Andreas Stöhr, Christian Calles…

Randomized clinical trial to evaluate safety and efficacy of convalescent plasma use among hospitalized patients with COVID-19 (PERUCONPLASMA): a structured summary of a study protocol for a randomized controlled trial

The general objective of this study is to test the hypothesis that administration of convalescent plasma from donors with previous diagnosis of severe COVID-19 pneumonia is safe and associated with a decrease ...

Authors: Alonso Soto, Fiorella Krapp, Alex Vargas, Lucía Cabrejos, Enrique Argumanis, Patricia L. García, Karina Altamirano, Martín Montes, Pamela R. Chacón-Uscamaita and Patricia J. García