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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

Primary Purpose

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

Status

Unknown status

Phase

Phase 3

Locations

Pakistan

Study Type

Interventional

Intervention

NK-1R antagonist

About this trial

This is an interventional treatment trial for Neurokinin 1 Receptor, Substance P, Respiratory Illness, Inflammation, Covid-19, Coronavirus focused on measuring neurokinin 1 receptor, Substance P, Respiratory illness, inflammation, Covid-19, Coronavirus

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Bahria International HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

NK-1R antagonist group

Arm Description

matching placebo drug

80 mg daily

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

total in-hospital days and the total duration

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

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

Reduction from baseline of NRS for cough

Reduction from baseline of NRS for nausea

Time to normalization of fever for at least 48 hours

Time to improvement in oxygenation for at least 48 hours

Full Information

NCT ID

NCT04468646

First Posted

July 7, 2020

Last Updated

July 10, 2020

Sponsor

Prof. Dr. Fridoon Jawad Ahmad

Collaborators

University of Lahore, Bahria International Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04468646

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Unknown status

Study Start Date

June 15, 2020 (Actual)

Primary Completion Date

July 15, 2020 (Anticipated)

Study Completion Date

August 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Prof. Dr. Fridoon Jawad Ahmad

Collaborators

University of Lahore, Bahria International Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

matching placebo drug

Arm Title

NK-1R antagonist group

Arm Type

Experimental

Arm Description

80 mg daily

Intervention Type

Drug

Intervention Name(s)

NK-1R antagonist

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

14 days or discharge

Secondary Outcome Measure Information:

Title

total in-hospital days and the total duration

Time Frame

14 days or discharge

Title

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

Time Frame

14 days or discharge

Title

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

Time Frame

14 days or discharge

Title

Reduction from baseline of NRS for cough

Time Frame

14 days or discharge

Title

Reduction from baseline of NRS for nausea

Time Frame

14 days or discharge

Title

Time to normalization of fever for at least 48 hours

Time Frame

14 days or discharge

Title

Time to improvement in oxygenation for at least 48 hours

Time Frame

14 days or discharge

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Bahria International Hospital

City

Lahore

State/Province

Punjab

ZIP/Postal Code

53720

Country

Pakistan

Individual Site Status

Recruiting

Facility Contact: