Neurokinin 1 Receptor, Substance P, Respiratory Illness, Inflammation, Covid-19, CoronavirusPhase 3NCT04468646
To Determine the Efficacy of Neurokinin 1 Receptor Antagonist as a Therapeutic Tool Against Cytokine Storm and Respiratory Failure in Covid-19 Patients
A Phase 3 study testing NK-1R antagonist in people with Neurokinin 1 Receptor, Substance P, Respiratory Illness, Inflammation, Covid-19, Coronavirus, run by Prof. Dr. Fridoon Jawad Ahmad at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Neurokinin 1 Receptor, Substance P, Respiratory Illness, Inflammation, Covid-19, Coronavirus
- What is being tested?
- NK-1R antagonist
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jun 2020to 30 Aug 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Patients who are not willing to give consent
- known HIV,HBV, HCV infection
- pregnancy
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Bahria International Hospital
Lahore, Punjab Province, 53720
Ahad Qayyum, MBBS,MRCP, 00924235340135 ext. 7, lhrhospital@bahriatown.com.pk
Muhammad Asim o Rana, MBBS, 00923435807006, lhrhospital@bahriatown.com.pk
About this study
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.
Read the 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
- Being tested
- NK-1R antagonist
- Keywords
- neurokinin 1 receptor, Substance P, Respiratory illness, inflammation, Covid-19, Coronavirus
- Medical subject headings
- Inflammation, COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NK-1R antagonistDrug
NK-1R antagonist, 80 mg daily once for 3-5 days along with dexamethasone 6 mg daily for 5 days
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | matching placebo drug Receives: Drug: NK-1R antagonist |
| NK-1R antagonist group | Experimental | 80 mg daily Receives: Drug: NK-1R antagonist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to improvement on a 7-point ordinal scale as compared to baseline
Measured: 14 days or discharge
Secondary outcomes (7)
total in-hospital days and the total duration
Measured: 14 days or discharge
Treatment and prevention of inflammatory lung injury as measured by change in baseline of interleukin-6 (IL-6)
Measured: 14 days or discharge
Rate of Decline of COVID-19 viral load assessed by RT-PCR from nasopharyngeal samples
Measured: 14 days or discharge
Reduction from baseline of NRS for cough
Measured: 14 days or discharge
Reduction from baseline of NRS for nausea
Measured: 14 days or discharge
Time to normalization of fever for at least 48 hours
Measured: 14 days or discharge
Time to improvement in oxygenation for at least 48 hours
Measured: 14 days or discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2020
- Study start15 Jun 2020
- Primary completion15 Jul 2020 (estimated)
- Study completion30 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurokinin 1 Receptor, Substance P, Respiratory Illness, Inflammation, Covid-19, CoronavirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Fridoon Jawad Ahmad
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lahore, Bahria International Hospital
- Responsible party
- Sponsor-investigator, Prof. Dr. Fridoon Jawad Ahmad, University of Health Sciences Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04468646
- Sponsor's protocol ID
- UniversityHSL-NK1R
- Status last verified
- Jul 2020
- First submitted
- 7 Jul 2020
- Last updated
- 13 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04468646
- Acronym / sponsor ID
- UniversityHSL-NK1R
- Conditions
- Neurokinin 1 Receptor, Substance P, Respiratory Illness, Inflammation, Covid-19, Coronavirus
- Keywords
- neurokinin 1 receptor, Substance P, Respiratory illness, inflammation, Covid-19, Coronavirus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Prof. Dr. Fridoon Jawad AhmadUniversity, hospital or other
- Collaborators
- University of Lahore, Bahria International Hospital
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 15 Jul 2020 (estimated)
- Study completion
- 30 Aug 2020 (estimated)
- First posted
- 13 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: NK-1R antagonistmatching placebo drug |
| NK-1R antagonist group | Experimental | Drug: NK-1R antagonist80 mg daily |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- Patients who are not willing to give consent
- known HIV,HBV, HCV infection
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NK-1R antagonistNK-1R antagonist, 80 mg daily once for 3-5 days along with dexamethasone 6 mg daily for 5 days | Drug | NK-1R antagonist group, Placebo |
Primary outcome
Time to improvement on a 7-point ordinal scale as compared to baseline
Time frame: 14 days or discharge
7 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2020.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NK-1R antagonist in people with Neurokinin 1 Receptor, Substance P, Respiratory Illness, Inflammation, Covid-19, Coronavirus, run by Prof. Dr. Fridoon Jawad Ahmad at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to improvement on a 7-point ordinal scale as compared to baseline (time frame: 14 days or discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2020.