13 cis retinoic acid improved the outcomes of COVID-19 patients. A randomized clinical trial
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Abstract
The COVID-19 pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has infected over 100 million people causing over 2.4 million deaths over the world, and it is still expanding. Given the urgency of the COVID-19 pandemic, the clinical investigation of approved drugs is a promising alternative to find a timely effective treatment. In this randomized trial, we investigated the activity of both oral and aerosolized 13 cis retinoic acid in the treatment of SARS-COV-2 added to standard of care treatment in patients with COVID-19 versus standard of care treatment alone. This was a randomized controlled trial conducted at Kafrelsheikh University’s Quarantine Hospitals, Egypt. After obtaining informed consent, forty patients with a confirmed diagnosis of COVID-19 were enrolled in the study. They were randomly assigned to one of two groups: Group I; 20 patients received aerosolized and oral 13 cis retinoic acid plus standard of care treatment (13 cis RA group) and Group II; 20 patients received only standard care treatment as a control group. The two groups were age and gender matched. There was no statistically significant difference between them in any of the baseline characteristics or laboratory parameters. The results showed that there was a high significant difference between the two groups regarding intensive care unit (ICU) admission, mortality and improvement (P<0.05). Only 10.52 % of patients in the 13 cis retinoic acid group needed ICU admission compared to 28.57 % in the control arm. There was no mortality in the 13 cis retinoic acid group, whereas about 14.35% were died in the group II. All patients who received 13 cis retinoic acid noticed a high improvement (P<0.001), and the mean value for clinical improvement was 16.3±4.5 days. There was no significant difference regarding the laboratory parameters before and after 14 days of treatment in the group of patients received the standard of care treatment (P=0.66). Univariate logistic regression analysis showed overall mortality was significantly related to the patient’s age, serum ferritin, C-reactive protein, oxygen saturation, the presence of diabetes mellitus, obesity, and abdominal pain. We conclude that 13 cis retinoic acid is a promising drug in the treatment of patients with COVID-19 infection, when added to the standard of care treatment.
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SciScore for 10.1101/2022.03.05.22271959: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: This clinical trial was approved by the Research Ethics Committee of the Faculty of Medicine, Kafrelsheikh University.
Consent: Informed and signed consent was obtained from patients or legally authorized representatives.Sex as a biological variable not detected. Randomization Study Design and Patients: We conducted a randomized interventional comparative trial a 1:1 ratio randomized (Two groups) using a computerized random number generator using simple randomization with an equal allocation ratio, comparing and investigating the efficacy of aerosolized and oral 13 cis retinoic acid plus Standard Therapy vs Standard Therapy including for treating COVID-19 among hospitalized adults with … SciScore for 10.1101/2022.03.05.22271959: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: This clinical trial was approved by the Research Ethics Committee of the Faculty of Medicine, Kafrelsheikh University.
Consent: Informed and signed consent was obtained from patients or legally authorized representatives.Sex as a biological variable not detected. Randomization Study Design and Patients: We conducted a randomized interventional comparative trial a 1:1 ratio randomized (Two groups) using a computerized random number generator using simple randomization with an equal allocation ratio, comparing and investigating the efficacy of aerosolized and oral 13 cis retinoic acid plus Standard Therapy vs Standard Therapy including for treating COVID-19 among hospitalized adults with respiratory illness admitted to Kafrelsheikh University’s Quarantine Hospitals with suspected or confirmed COVID-19 in the period between June and August 2020. Blinding not detected. Power Analysis not detected. Table 2: Resources
No key resources detected.
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: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.Results from TrialIdentifier: We found the following clinical trial numbers in your paper:
Identifier Status Title NCT04353180 Not yet recruiting Assessment the Activity Value of Isotretinoin (13- Cis-Retin… 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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