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

Phase 3

• Conditions: Moderate Covid19
• Interventions: Drug: Leukotriene Receptor Antagonist; Other: Placebo

• Registration Number: NCT04871828
• Lead Sponsor: King Abdullah International Medical Research Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-28
• Status Verified: 2021-05
• Study First Submitted: 2021-05-01
• Study First Submitted QC: 2021-05-01
• Study First Posted: 2021-05-04
• Last Update Submitted: 2021-05-05
• Last Update Posted: 2021-05-10
• Primary Completion: 2021-09
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 66

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Leukotriene Receptor Antagonist	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).
Control	Placebo	placebo plus the standard treatment according to Saudi CDC protocol

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Escalate therapy.	28Day	The requirement to escalate therapy.

Trial Locations

Locations (1)

King Abdulaziz Medical city, MNGHA; 🇸🇦 Riyadh, Saudi Arabia