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

NCT04468646 | Unknown Phase 3 DMC

• 1 other identifier: UniversityHSL-NK1R
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurokinin 1 Receptor, Substance P, Respiratory Illness, Inflammation, Covid-19, Coronavirus

Keywords

neurokinin 1 receptor; Substance P; Respiratory illness; inflammation; Covid-19; Coronavirus

Outcome Measures

Primary Outcomes (1)

• Time to improvement on a 7-point ordinal scale as compared to baseline

  14 days or discharge

Secondary Outcomes (7)

• total in-hospital days and the total duration

  14 days or discharge

• Treatment and prevention of inflammatory lung injury as measured by change in baseline of interleukin-6 (IL-6)

  14 days or discharge

• Rate of Decline of COVID-19 viral load assessed by RT-PCR from nasopharyngeal samples

  14 days or discharge

• Reduction from baseline of NRS for cough

  14 days or discharge

• Reduction from baseline of NRS for nausea

  14 days or discharge

Study Arms (2)

Placebo

PLACEBO COMPARATOR

matching placebo drug

Drug: NK-1R antagonist

NK-1R antagonist group

EXPERIMENTAL

80 mg daily

Drug: NK-1R antagonist

Interventions

NK-1R antagonist DRUG

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

NK-1R antagonist group; Placebo

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Patients who are not willing to give consent
• known HIV,HBV, HCV infection
• pregnancy

Sponsors & Collaborators

• Prof. Dr. Fridoon Jawad Ahmad: lead
• University of Lahore: collaborator
• Bahria International Hospital: collaborator

Study Sites (1)

Bahria International Hospital

Lahore, Punjab Province, 53720, Pakistan

RECRUITING

MeSH Terms

Conditions

Inflammation; COVID-19; Coronavirus Infections

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, head of Physiology department

Study Record Dates

• First Submitted: July 7, 2020
• First Posted: July 13, 2020
• Study Start: June 15, 2020
• Primary Completion: July 15, 2020
• Study Completion: August 30, 2020
• Last Updated: July 13, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)