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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

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.


Condition or disease Intervention/treatment Phase
Neurokinin 1 Receptor, Substance P, Respiratory Illness, Inflammation, Covid-19, Coronavirus Drug: NK-1R antagonist Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: To Determine the Efficacy of Neurokinin 1 Receptor Antagonist as a Therapeutic Tool Against Cytokine Storm and Respiratory Failure in Covid-19 Patients
Actual Study Start Date : June 15, 2020
Estimated Primary Completion Date : July 15, 2020
Estimated Study Completion Date : August 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
matching placebo drug
Drug: NK-1R antagonist
NK-1R antagonist, 80 mg daily once for 3-5 days along with dexamethasone 6 mg daily for 5 days

Experimental: NK-1R antagonist group
80 mg daily
Drug: NK-1R antagonist
NK-1R antagonist, 80 mg daily once for 3-5 days along with dexamethasone 6 mg daily for 5 days




Primary Outcome Measures :
  1. Time to improvement on a 7-point ordinal scale as compared to baseline [ Time Frame: 14 days or discharge ]

Secondary Outcome Measures :
  1. total in-hospital days and the total duration [ Time Frame: 14 days or discharge ]
  2. Treatment and prevention of inflammatory lung injury as measured by change in baseline of interleukin-6 (IL-6) [ Time Frame: 14 days or discharge ]
  3. Rate of Decline of COVID-19 viral load assessed by RT-PCR from nasopharyngeal samples [ Time Frame: 14 days or discharge ]
  4. Reduction from baseline of NRS for cough [ Time Frame: 14 days or discharge ]
  5. Reduction from baseline of NRS for nausea [ Time Frame: 14 days or discharge ]
  6. Time to normalization of fever for at least 48 hours [ Time Frame: 14 days or discharge ]
  7. Time to improvement in oxygenation for at least 48 hours [ Time Frame: 14 days or discharge ]


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04468646


Locations
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Pakistan
Bahria International Hospital Recruiting
Lahore, Punjab, Pakistan, 53720
Contact: Ahad Qayyum, MBBS,MRCP    00924235340135 ext 7    lhrhospital@bahriatown.com.pk   
Contact: Muhammad Asim o Rana, MBBS    00923435807006    lhrhospital@bahriatown.com.pk   
Principal Investigator: Riffat Mehboob, PhD         
Sub-Investigator: Fridoon Jawad Ahmad, PhD         
Sub-Investigator: Ahad Qayyum, MBBS         
Sub-Investigator: Muhammad Asim Rana, MBBS         
Sub-Investigator: Javed Akram, MBBS         
Sponsors and Collaborators
Prof. Dr. Fridoon Jawad Ahmad
University of Lahore
bahria international hospital
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Responsible Party: Prof. Dr. Fridoon Jawad Ahmad, Professor, head of Physiology department, University of Health Sciences Lahore
ClinicalTrials.gov Identifier: NCT04468646    
Other Study ID Numbers: UniversityHSL-NK1R
First Posted: July 13, 2020    Key Record Dates
Last Update Posted: July 13, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Prof. Dr. Fridoon Jawad Ahmad, University of Health Sciences Lahore:
neurokinin 1 receptor
Substance P
Respiratory illness
inflammation
Covid-19
Coronavirus
Additional relevant MeSH terms:
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Coronavirus Infections
Respiratory Insufficiency
Inflammation
Pathologic Processes
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiration Disorders
Respiratory Tract Diseases