Neurokinin 1 Receptor, Substance P, Respiratory Illness, Inflammation, Covid-19, Coronavirus Clinical Trial
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
| Verified date | July 2020 |
| Source | University of Health Sciences Lahore |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Recruiting |
| Enrollment | 100 |
| Est. completion date | August 30, 2020 |
| Est. primary completion date | July 15, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 90 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Pakistan | Bahria International Hospital | Lahore | Punjab |
| Lead Sponsor | Collaborator |
|---|---|
| Prof. Dr. Fridoon Jawad Ahmad | bahria international hospital, University of Lahore |
Pakistan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Time to improvement on a 7-point ordinal scale as compared to baseline | 14 days or discharge | ||
| Secondary | total in-hospital days and the total duration | 14 days or discharge | ||
| Secondary | Treatment and prevention of inflammatory lung injury as measured by change in baseline of interleukin-6 (IL-6) | 14 days or discharge | ||
| Secondary | Rate of Decline of COVID-19 viral load assessed by RT-PCR from nasopharyngeal samples | 14 days or discharge | ||
| Secondary | Reduction from baseline of NRS for cough | 14 days or discharge | ||
| Secondary | Reduction from baseline of NRS for nausea | 14 days or discharge | ||
| Secondary | Time to normalization of fever for at least 48 hours | 14 days or discharge | ||
| Secondary | Time to improvement in oxygenation for at least 48 hours | 14 days or discharge |