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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Moderate Covid19
• Intervention / Treatment: Other: Placebo; Drug: Leukotriene Receptor Antagonist

• Study Type: Interventional
• Enrollment (Anticipated): 66
• Phase: Phase 3

Contacts and Locations

Study Locations

• Saudi Arabia
  • Riyadh, Saudi Arabia, 11426
    • Recruiting
    • King Abdulaziz Medical City, MNGHA
    • Contact: Mohammed Al Ghobain, MD; Phone Number: 14219 009668011111; Email: alghobainmo@NGHA.MED.SA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age of 18 years or above
2. Diagnosed with COVID-19 by PCR confirmed SARS-coV-2 viral infection.
3. Able to sign the consent form and agree to clinical samples collection
4. Moderate symptomatic COVID-19 patients, (any or all of the followings: fever or cough or SOB)
5. Admitted to the hospital (outside the ICU)
6. Patients had to be enrolled within 10 days of symptoms onset.
7. willingness to comply with all study procedures and availability for the duration of the study

Exclusion Criteria:

1. Asthmatic patient using antiasthma medications
2. Being in the hospital or in home isolation for more than 72 hours before the start of the study drug.
3. Known sensitivity/allergy to the study drug
4. Pregnancy
5. Patient refused
6. Chronic liver disease
7. Severe mental disorder
8. Unstable patients requiring ICU admission
9. Participating in other clinical trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; 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; Zafirlukast
Placebo Comparator: Control; placebo plus the standard treatment according to Saudi CDC protocol	Other: Placebo; Placebo

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

Collaborators and Investigators

• Sponsor: King Abdullah International Medical Research Center

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2021
• Primary Completion (Anticipated): September 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: May 1, 2021
• First Submitted That Met QC Criteria: May 1, 2021
• First Posted (Actual): May 4, 2021

Study Record Updates

• Last Update Posted (Actual): May 10, 2021
• Last Update Submitted That Met QC Criteria: May 5, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Asthmatic Agents; Respiratory System Agents; Hormone Antagonists; Leukotriene Antagonists
• Other Study ID Numbers: RC20/206/R

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No