Aprepitant as a combinant with Dexamethasone reduces the inflammation via Neurokinin 1 Receptor Antagonism in severe to critical Covid-19 patients and potentiates respiratory recovery: A novel therapeutic approach
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Abstract
Background
Corona virus infection is a respiratory infection, compromising the normal breathing in critical patients by damaging the lungs. Researches are ongoing to find an efficient treatment strategy for this disease by either inactivating the virus or boosting the immune system of patient or by managing the cytokine storm.
Aim
To evaluate the clinical outcomes of Substance P receptor Neurokinin 1 antagonist in Covid-19 patients against the usual treatments as controls.
Patients and Methods
It is a randomized clinical trial, open label, having two arms, one receiving normal management and care while other receiving Neurokinin-1 Receptor antagonist, Aprepitant, in addition. Dexamethasone, a corticosteroid is also administered orally to both the groups. PCR positive, hospitalized patients with more than 18 years of age, both genders, moderate to critical phase were included. 18 patients were randomly allocated in both arms, having 10 in group A and 8 in group B. Lab investigations were performed in both the groups before and after the intervention. We report preliminary results for the comparison of Aprepitant 80 mg given once daily for 3-5 days vs routine management. The primary outcome was total in hospital days and duration of disease.
Results
Mean age of patients in group A was 47.63 ±12.07years while 60.90± 9.75 years in group B. There were 3/8 males in group A and 8/10 in group B. There were 2 critical patients in group A and 5 in group B. Biochemical and hematological parameters in both groups didn’t show much difference except the C-reactive protein reduction in the intervention group, indicative of a reduced inflammation. Oxygen saturation also improved but more patients should be enrolled to get a statistically significant data. One patient was discharged from each group within 5 days and one patient expired in each.
Conclusions
It is a pilot study but the findings give a strong clue for the therapeutic potential of Aprepitant. Patients who received a combination therapy of Aprepitant and Dexamethasone were recovered earlier and showed improved clinical outcomes, laboratory findings and reduced C-reactive protein which is an inflammatory marker. We suggest here a study on larger sample size to get a deeper insight of its potential and efficacy. It may be more effective in severe to critical patients having respiratory difficulties.
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SciScore for 10.1101/2020.08.01.20166678: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IRB: The trial was conducted in accordance with the principles of the International Conference on Harmonization Good Clinical Practice guidelines and approved by the Bahria International Hospital Ethics Committee and informed consent was obtained from the patients.
Consent: The trial was conducted in accordance with the principles of the International Conference on Harmonization Good Clinical Practice guidelines and approved by the Bahria International Hospital Ethics Committee and informed consent was obtained from the patients.Randomization Trial Design and Participants: It is an open label, randomized clinical trial conducted at Bahria International Hospital, … SciScore for 10.1101/2020.08.01.20166678: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IRB: The trial was conducted in accordance with the principles of the International Conference on Harmonization Good Clinical Practice guidelines and approved by the Bahria International Hospital Ethics Committee and informed consent was obtained from the patients.
Consent: The trial was conducted in accordance with the principles of the International Conference on Harmonization Good Clinical Practice guidelines and approved by the Bahria International Hospital Ethics Committee and informed consent was obtained from the patients.Randomization Trial Design and Participants: It is an open label, randomized clinical trial conducted at Bahria International Hospital, Lahore, to evaluate the effects of a combination therapy including Dexamethasone and Aprepitant in hospitalized patients with Covid-19. Blinding Patients and care givers were not blinded to the allocated treatment. Power Analysis not detected. Sex as a biological variable Patients with respiratory diseases other than Covid-19 infection and pregnant females were excluded. 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: We detected the following sentences addressing limitations in the study:So, the limitation of this study is small sample size as the number of patients decreased in Pakistan and we couldn’t enroll more patients. Here, we suggest, to conduct this trial in other populations were there is still surge of Covid-19 and ruling out the confounding variables. But this study gives a strong clue for the effectiveness of this treatment for severe to critical Covid-19 patients.
Results from TrialIdentifier: We found the following clinical trial numbers in your paper:
Identifier Status Title NCT04468646 Recruiting To Determine the Efficacy of Neurokinin 1 Receptor Antagonis… 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.
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