Clinical trial NCT04714515: Montelukast - a Treatment Choice for COVID-19
Official title: Using Montelukast to Treat the Patients Infected With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
SARS-CoV-2 Infection
Keywords: COVID-19
Montelukast
Lead sponsor: University of Sargodha
Sponsor class: OTHER
Collaborators: name: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
name: Shaukat Khanum Memorial Cancer Hospital & Research Centre
name: Shanghai Jiao Tong University School of Medicine
name: Teesside University
First posted: 2021-01-19
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients, who were admitted to the hospitals with SARS-CoV-2 contacts (environmental exposure or close contact) or obvious COVID-19 symptoms and were diagnosed with COVID-19 using the PCR tests. Consent was obtained from all patients with a detailed history of any known co-morbidities.

Brief summary: The current study aimed to make a therapeutic comparison and effectiveness of Hydroxychloroquine (HCQ) and Montelukast (ML) in COVID-19 patients in addition to the standard of care. The safety and efficacy of HCQ and ML will be assessed as individual therapy and in combination with each other and with the standard of care. Cytokine storm (Interleukin levels) also will be monitored throughout the study to assess treatment progression.

Detailed description: To date, no specific medication is available for COVID-19. Many FDA-approved drugs, including antivirals, antibacterials, and anti-inflammatory compositions are being tested with the intention of repurposing against COVID-19. In this study, investigators have evaluated the effectiveness of Hydroxychloroquine (HCQ) and Montelukast (ML) in an individual and combination therapy.

Investigators have performed an observational study of 100 hospitalized COVID-19 patients while assessing the safety and efficacy of HCQ, ML, and IV as individual therapy and in combination with each other. ECG, interleukin levels, LFTs, blood profiles were continuously monitored throughout the study.

The aim was to observe participants treated with ML and monitor the inflammatory markers to see whether they increase or decrease and whether an increase in survival rate is observed. The findings have shown that combinational therapy of ML with continuous observation of liver/kidney profiles and QTc prolongation can provide robust recovery with suppression of cytokines.

Eligibility criteria: Inclusion Criteria:

* Patients with diagnosed COVID-19
* Patients who are not directly admitted to ICU

Exclusion Criteria:

* Patients, who were already on immunosuppressants
* Patients with age \> 80
* Patient with any known allergies to montelukast

Primary outcomes:
measure: Patients admittance to ICU
timeFrame: 2 Week
measure: Length of total stay at the hospital
timeFrame: 2 weeks
measure: Alleviating the symptoms of COVID-19
timeFrame: 2 weeks
Secondary outcomes:
measure: Interleukin levels
timeFrame: 1 Week
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Critical Care Medicine, Shanghai General Hospital, Shanghai Jiao Tong University, School of Medicine, Shanghai, China
city: Lahore
country: Pakistan
facility: Shaukat Khanum Memorial Cancer Hospital & Research Centre, Johar Town, Lahore, Pakistan
state: Punjab
Study officials:
affiliation: Department of Critical Care Medicine, Shanghai General Hospital, Shanghai Jiao Tong University, School of Medicine, Shanghai, China
name: Wei Zhang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shaukat Khanum Memorial Cancer Hospital & Research Centre, Johar Town, Lahore, Pakistan
name: Muhammad Rehman Akram, MBBS
role: PRINCIPAL_INVESTIGATOR
References: