Effect of polymerised type I collagen on hyperinflammation of adult outpatients with symptomatic COVID‐19
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SciScore for 10.1101/2021.05.12.21257133: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: The study was approved by the institutional review board of the Instituto Nacional de Ciencias Médicas y Nutrición Salvador
Consent: All participants provided written informed consent.Sex as a biological variable Exclusion criteria were: hypersensitivity to PTIC or any of its excipients; COVID-19 patients that required hospitalization; all pregnant or breast-feeding women; patients with chronic kidney disease (estimated glomerular filtration rate less than 60 for more than 3 months or need for haemodialysis or hemofiltration); decompensated liver cirrhosis; congestive heart failure (New York Heart Association class III or IV); and patients with cerebrovascular disease, autoimmune … SciScore for 10.1101/2021.05.12.21257133: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: The study was approved by the institutional review board of the Instituto Nacional de Ciencias Médicas y Nutrición Salvador
Consent: All participants provided written informed consent.Sex as a biological variable Exclusion criteria were: hypersensitivity to PTIC or any of its excipients; COVID-19 patients that required hospitalization; all pregnant or breast-feeding women; patients with chronic kidney disease (estimated glomerular filtration rate less than 60 for more than 3 months or need for haemodialysis or hemofiltration); decompensated liver cirrhosis; congestive heart failure (New York Heart Association class III or IV); and patients with cerebrovascular disease, autoimmune disease, cancer, multiorgan failure or immunocompromise (solid organ transplant recipient or donor, bone marrow transplant recipient, AIDS, or treatment with biologic agents or corticosteroids). Randomization Study design: This was a single centre, double-blind, placebo-controlled, randomised clinical trial that compared PTIC to placebo in adult outpatients with confirmed COVID-19. Blinding All outcome assessors, investigators and research staff who were in contact with participants were blinded to participant treatment assignment. Power Analysis not detected. Table 2: Resources
Software and Algorithms Sentences Resources The Excel program displayed a random allocation list to the laboratory manager (K.R-R) who was in charge of assigning PTIC or placebo to study subjects. Excelsuggested: NoneFor the Kaplan-Meier curves, we modelled oxygen saturation ≤92%-free survival in the PRISM GraphPad Statistics analysis program. PRISMsuggested: (PRISM, RRID:SCR_005375)GraphPadsuggested: (GraphPad Prism, RRID:SCR_002798)Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:We acknowledge several limitations. This is a small study conducted within a single centre, so findings should be regarded as preliminary until replicated in larger clinical trials with a more heterogeneous study population. Clinical outcomes were only exploratory. The self-reporting symptom severity, or rather, the lack of information to verify compliance, is one of the study’ ss limitation. The possible usefulness of PTIC for treatment of hospitalized and/or patients with invasive ventilation is still unknown. We did not measure viral loads, so a possible effect of PTIC on viral kinetics cannot be ruled out. Finally, the underlying mechanisms for the beneficial effects of PTIC observed in this study need further clarification. In summary, in this clinical trial of adult outpatients with mild to moderate symptomatic COVID-19, intramuscular PTIC was safe and well tolerated, downregulated CRS, efficiently shortened symptom duration, and was associated with better oxygen saturation values when compared to placebo.
Results from TrialIdentifier: We found the following clinical trial numbers in your paper:
Identifier Status Title NCT04517162 Recruiting Intramuscular Effect of Polymerized Type I Collagen on the C… Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
Results from scite Reference Check: We found no unreliable references.
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