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To Determine the Efficacy of Neurokinin 1 Receptor Antagonist as a Therapeutic Tool Against Cytokine Storm and Respiratory Failure in Covid-19 Patients

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ClinicalTrials.gov Identifier: NCT04468646
Recruitment Status : Recruiting
First Posted : July 13, 2020
Last Update Posted : July 13, 2020
Sponsor:
Collaborators:
University of Lahore
bahria international hospital
Information provided by (Responsible Party):
Prof. Dr. Fridoon Jawad Ahmad, University of Health Sciences Lahore

Tracking Information
First Submitted Date  ICMJE July 7, 2020
First Posted Date  ICMJE July 13, 2020
Last Update Posted Date July 13, 2020
Actual Study Start Date  ICMJE June 15, 2020
Estimated Primary Completion Date July 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 10, 2020)
Time to improvement on a 7-point ordinal scale as compared to baseline [ Time Frame: 14 days or discharge ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 10, 2020)
  • total in-hospital days and the total duration [ Time Frame: 14 days or discharge ]
  • Treatment and prevention of inflammatory lung injury as measured by change in baseline of interleukin-6 (IL-6) [ Time Frame: 14 days or discharge ]
  • Rate of Decline of COVID-19 viral load assessed by RT-PCR from nasopharyngeal samples [ Time Frame: 14 days or discharge ]
  • Reduction from baseline of NRS for cough [ Time Frame: 14 days or discharge ]
  • Reduction from baseline of NRS for nausea [ Time Frame: 14 days or discharge ]
  • Time to normalization of fever for at least 48 hours [ Time Frame: 14 days or discharge ]
  • Time to improvement in oxygenation for at least 48 hours [ Time Frame: 14 days or discharge ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE To Determine the Efficacy of Neurokinin 1 Receptor Antagonist as a Therapeutic Tool Against Cytokine Storm and Respiratory Failure in Covid-19 Patients
Official Title  ICMJE To Determine the Efficacy of Neurokinin 1 Receptor Antagonist as a Therapeutic Tool Against Cytokine Storm and Respiratory Failure in Covid-19 Patients
Brief Summary

This is a randomized, randomized controlled trial to investigate the efficacy and safety of Neurokinin-1 Receptor (NK-1R) 80 mg orally given daily to treat cytokine storm causing inflammatory lung injury and respiratory failure associated with severe or critical COVID-19 infection. NK-1R is the receptor of Substance P (SP) and responsible for its functionality. Here, we propose that SP via its tachykinin receptor, NK-1R may cause inflammation in Covid-19 infection. It may initiate the cytokine storming via binding to its receptor NK-1 and many inflammatory mediators are released. If SP release is reduced by NK-1R antagonist, it may control the cytokine storming and hence the hyper-responsiveness of the respiratory tract through reduction in cytokine storming It may serve as the treatment strategy for Covid-19 infected patients.

Patients fulfilling the inclusion criteria will be enrolled after giving consent. They wll be randomized to treatment with either NK-1R antagonist or placebo in addition to Dexamethasone as a standard treatment given to both groups for Covid-19 infection as per the protocol at the treating hospital. Inflammatory lab markers as detailed should be collected once per day in the morning, preferably at the same time every morning. All enrolled participants will have whole blood collected for whole genome sequencing.

Detailed Description

Objective:

To evaluate the clinical outcomes of Neurokinin 1 Receptor antagonist in Covid-19 patients against the usual treatments as controls

Dosage Aprepitant capsules may be given to patients from 3-5 days fosaprepitant dimeglumine (Injection 115mg, prodrug form of aprepitant) may be substituted for oral drug in case of critical patients May be taken with or without food

Administration One capsule of Aprepitant once a day for 3-5 days

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Neurokinin 1 Receptor, Substance P, Respiratory Illness, Inflammation, Covid-19, Coronavirus
Intervention  ICMJE Drug: NK-1R antagonist
NK-1R antagonist, 80 mg daily once for 3-5 days along with dexamethasone 6 mg daily for 5 days
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    matching placebo drug
    Intervention: Drug: NK-1R antagonist
  • Experimental: NK-1R antagonist group
    80 mg daily
    Intervention: Drug: NK-1R antagonist
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 10, 2020)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 30, 2020
Estimated Primary Completion Date July 15, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age > 18 yrs
  • Both genders
  • Lab Confirmed COVID-19 infection by PCR or plasma positive of specific antibody against COVID-19
  • In hospital treatment ≥ 72 hours
  • Admitted patients
  • Severe Disease (Respiratory rate >=30/min; or (b) Rest SPO2<=90%; or (c) PaO2/FiO2<=300 mmHg) or
  • Critical Phase (Respiratory failure and needs mechanical ventilation; or Shock occurs; or Multiple organ failure and needs ICU monitoring)

Exclusion Criteria:

  • Patients who are not willing to give consent
  • known HIV,HBV, HCV infection
  • pregnancy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Pakistan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04468646
Other Study ID Numbers  ICMJE UniversityHSL-NK1R
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Prof. Dr. Fridoon Jawad Ahmad, University of Health Sciences Lahore
Study Sponsor  ICMJE Prof. Dr. Fridoon Jawad Ahmad
Collaborators  ICMJE
  • University of Lahore
  • bahria international hospital
Investigators  ICMJE Not Provided
PRS Account University of Health Sciences Lahore
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP