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.
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
Drug: NK-1R antagonist
NK-1R antagonist, 80 mg daily once for 3-5 days along with dexamethasone 6 mg daily for 5 days
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
Bahria International Hospital
Lahore, Punjab, Pakistan
Investigator: Ahad Qayyum, MBBS,MRCP
Contact: 00924235340135
lhrhospital@bahriatown.com.pk
Investigator: