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

King Abdullah International Medical Research Center

Status and phase: Unknown; Phase 3

Conditions: Moderate Covid19

Treatments: Other: Placebo; Drug: Leukotriene Receptor Antagonist

Study type: Interventional

Funder types: Other

Identifiers

NCT04871828

RC20/206/R

Details and patient eligibility

About

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.

Enrollment: 66 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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66 participants in 2 patient groups, including a placebo group

Treatment

Experimental group

Description:

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).

Treatment:

Drug: Leukotriene Receptor Antagonist

Control

Placebo Comparator group

Description:

placebo plus the standard treatment according to Saudi CDC protocol

Treatment:

Other: Placebo