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

Sponsor
King Abdullah International Medical Research Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04871828
Collaborator
(none)
66
Enrollment
1
Location
2
Arms
9.1
Anticipated Duration (Months)
7.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Leukotriene Receptor Antagonist
  • Other: Placebo
 Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
66 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Prospective randomized placebo-controlled double-blinded clinical trialProspective randomized placebo-controlled double-blinded clinical trial
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
The Efficacy of Leukotriene Inhibitor in Adult Patients With Moderate SARS-COV-2 Symptoms (COVID19): (Randomized Clinical Trial)
Actual Study Start Date :
Feb 28, 2021
Anticipated Primary Completion Date :
Sep 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Escalate therapy. [28Day]

    The requirement to escalate therapy.

  2. PCR test [Day14]

    PCR test negative conversion rate at day 14

  3. Length of hospital stay. [28Day]

    Length of hospital stay.

  4. Duration of fever [28Day]

    Duration of fever

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 King Abdulaziz Medical city, MNGHA Riyadh Saudi Arabia 11426

Sponsors and Collaborators

  • King Abdullah International Medical Research Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
King Abdullah International Medical Research Center
ClinicalTrials.gov Identifier:
NCT04871828
Other Study ID Numbers:
  • RC20/206/R
First Posted:
May 4, 2021
Last Update Posted:
May 10, 2021
Last Verified:
May 1, 2021
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
Additional relevant MeSH terms:
COVID-19
Leukotriene Antagonists

Study Results

No Results Posted as of May 10, 2021