NCT04468646

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

Status unknown Phase 3 Last updated 13 July 2020

What this trial tests

Phase 3 trial testing NK-1R antagonist in Neurokinin 1 Receptor, Substance P, Respiratory Illness, Inflammation, Covid-19, Coronavirus in 100 participants. Status unknown.

Timeline

15 June 2020

Primary endpoint
15 July 2020

30 August 2020

Quick facts

Lead sponsor	Prof. Dr. Fridoon Jawad Ahmad
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	100
Start date	15 June 2020
Primary completion	15 July 2020
Estimated completion	30 August 2020
Sites	1 location across Pakistan

Drugs / interventions tested

• NK-1R antagonist — full drug profile →

Conditions studied

• Neurokinin 1 Receptor, Substance P, Respiratory Illness, Inflammation, Covid-19, Coronavirus — all drugs for Neurokinin 1 Receptor, Substance P, Respiratory Illness, Inflammation, Covid-19, Coronavirus →

Sponsor

Prof. Dr. Fridoon Jawad Ahmad

Who can join

Adults 18 to 90, any sex, with Neurokinin 1 Receptor, Substance P, Respiratory Illness, Inflammation, Covid-19, Coronavirus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. An update on drugs with therapeutic potential for SARS-CoV-2 (COVID-19) treatment.
   Drożdżal S, Rosik J, Lechowicz K, Machaj F, et al · · 2021 · cited 186× · PMID 34991982 · DOI 10.1016/j.drup.2021.100794
2. Systemic corticosteroids for the treatment of COVID-19.
   Wagner C, Griesel M, Mikolajewska A, Mueller A, et al · · 2021 · cited 151× · PMID 34396514 · DOI 10.1002/14651858.cd014963
3. Systemic corticosteroids for the treatment of COVID-19: Equity-related analyses and update on evidence.
   Wagner C, Griesel M, Mikolajewska A, Metzendorf MI, et al · · 2022 · cited 44× · PMID 36385229 · DOI 10.1002/14651858.cd014963.pub2
4. Effectiveness of aprepitant in post-acute COVID19 syndrome.
   Reinoso-Arija R, López-Ramírez C, Jimenez-Ruiz JA, López-Campos JL. · · 2021 · cited 8× · PMID 34567551 · DOI 10.1002/ccr3.4646
5. Potential COVID-19 Therapies from Computational Repurposing of Drugs and Natural Products against the SARS-CoV-2 Helicase.
   Piplani S, Singh P, Winkler DA, Petrovsky N. · · 2022 · cited 7× · PMID 35887049 · DOI 10.3390/ijms23147704
6. Aprepitant as a combinant with Dexamethasone reduces the inflammation via Neurokinin 1 Receptor Antagonism in severe to critical Covid-19 patients and potentiates respiratory recovery: A novel therapeutic approach
   Mehboob R, Ahmad FJ, Qayyum A, Rana MA, et al · · 2020 · cited 1× · DOI 10.1101/2020.08.01.20166678