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

NCT ID: NCT04468646

Last Updated: 2020-07-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-15
• Study Completion Date: 2020-08-30

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

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo

matching placebo drug

Group Type: PLACEBO_COMPARATOR

NK-1R antagonist

Intervention Type: 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

80 mg daily

Group Type: EXPERIMENTAL

NK-1R antagonist

Intervention Type: DRUG

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

Interventions

NK-1R antagonist

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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Lahore

OTHER

Sponsor Role: collaborator

Bahria International Hospital

UNKNOWN

Sponsor Role: collaborator

Prof. Dr. Fridoon Jawad Ahmad

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Fridoon Jawad Ahmad

Professor, head of Physiology department

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Bahria International Hospital

Lahore, Punjab Province, Pakistan

Site Status: RECRUITING

Countries

Pakistan

Facility Contacts

Ahad Qayyum, MBBS,MRCP

Role: primary

lhrhospital@bahriatown.com.pk

00924235340135 ext. 7

Muhammad Asim o Rana, MBBS

Role: backup

lhrhospital@bahriatown.com.pk

00923435807006

Other Identifiers

UniversityHSL-NK1R

Identifier Type: -

Identifier Source: org_study_id