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

NCT ID: NCT04871828

Last Updated: 2021-05-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-28
• Study Completion Date: 2021-12-31

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.

Conditions

Moderate Covid19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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).

Group Type: EXPERIMENTAL

Leukotriene Receptor Antagonist

Intervention Type: DRUG

Zafirlukast

Control

placebo plus the standard treatment according to Saudi CDC protocol

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo

Interventions

Leukotriene Receptor Antagonist

Zafirlukast

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

King Abdullah International Medical Research Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

King Abdulaziz Medical city, MNGHA

Riyadh, , Saudi Arabia

Site Status: RECRUITING

Countries

Saudi Arabia

Facility Contacts

Mohammed Al Ghobain, MD

Role: primary

alghobainmo@NGHA.MED.SA

009668011111 ext. 14219

Other Identifiers

RC20/206/R

Identifier Type: -

Identifier Source: org_study_id