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

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04871828

Acronym

PROMISE

Enrollment

Registered

2021-05-04

Start date

2021-02-28

Completion date

2021-12-31

Last updated

2021-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate Covid19

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.

Interventions

DRUGLeukotriene Receptor Antagonist

Zafirlukast

OTHERPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Intervention model description

Prospective randomized placebo-controlled double-blinded clinical trial

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Saudi Arabia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026