The Efficacy of Leukotriene Inhibitor in Adult Patients With Moderate SARS-COV-2 Symptoms (COVID19)

Study Overview
=================
Brief Summary
-----------------
There is an urgent need to explore therapeutic options for SARS-CoV-2 in order to face the pandemic. The selected intervention was based on that zafirlukast will have dual effect; first it will block the virus replication through inhibiting the COVID19 helicase that is involved in virus replication and secondly by reducing the inflammation through antagonizing the leukotriene receptor. The purpose of this study is to evaluate the clinical efficacy and safety of Leukotriene receptor antagonist in the treatment of moderate cases of COVID-19 patients.

Official Title
-----------------
The Efficacy of Leukotriene Inhibitor in Adult Patients With Moderate SARS-COV-2 Symptoms (COVID19): (Randomized Clinical Trial)

Conditions
-----------------
Moderate Covid19

Intervention / Treatment
-----------------
* Drug: Leukotriene Receptor Antagonist
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age of 18 years or above Diagnosed with COVID-19 by PCR confirmed SARS-coV-2 viral infection. Able to sign the consent form and agree to clinical samples collection Moderate symptomatic COVID-19 patients, (any or all of the followings: fever or cough or SOB) Admitted to the hospital (outside the ICU) Patients had to be enrolled within 10 days of symptoms onset. willingness to comply with all study procedures and availability for the duration of the study Exclusion Criteria: Asthmatic patient using antiasthma medications Being in the hospital or in home isolation for more than 72 hours before the start of the study drug. Known sensitivity/allergy to the study drug Pregnancy Patient refused Chronic liver disease Severe mental disorder Unstable patients requiring ICU admission Participating in other clinical trial

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective randomized placebo-controlled double-blinded clinical trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Zafirlukast plus the standard treatment according to Saudi CDC protocol (combination experimental arm) Description of investigational drug Zafirlukast is leukotriene receptor antagonist (LTRA) for the maintenance treatment of asthma. It is available as a tablet and is usually dosed twice daily. It is approved by USFDA and currently commercially marketed under the name of Accolate 20 mg oral tablet. The drug will be acquired from the pharmacy and will be received by the patient during the hospital admission via research coordinator. The study drug will be stored in at room temperature (15 - 25 c) in the hospital's pharmacy and a delegated pharmacist will be responsible for dispensing and return of any drugs. The study drug will be administrated to the patient in the dose of 20 mg orally twice daily for 10 days (fixed dose with no staring or escalating dose). | Drug: Leukotriene Receptor Antagonist<br>* Zafirlukast<br>|
| Placebo Comparator: Control<br>placebo plus the standard treatment according to Saudi CDC protocol | Other: Placebo<br>* Placebo<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to clinical improvement, | The time from symptoms resolved: No fever for 72 hours, no cough, no SOB or live discharge from the hospital, whichever came first. | 28Day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Escalate therapy. | The requirement to escalate therapy. | 28Day | 
| PCR test | PCR test negative conversion rate at day 14 | Day14 | 
| Length of hospital stay. | Length of hospital stay. | 28Day | 
| Duration of fever | Duration of fever | 28Day |