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

Primary Purpose

Moderate Covid19

Status
Unknown status
Phase
Phase 3
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Leukotriene Receptor Antagonist
Placebo
Sponsored by
King Abdullah International Medical Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Moderate Covid19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • King Abdulaziz Medical city, MNGHARecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment

Control

Arm 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).

placebo plus the standard treatment according to Saudi CDC protocol

Outcomes

Primary Outcome Measures

Time to clinical improvement,
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

Escalate therapy.
The requirement to escalate therapy.
PCR test
PCR test negative conversion rate at day 14
Length of hospital stay.
Length of hospital stay.
Duration of fever
Duration of fever

Full Information

First Posted
May 1, 2021
Last Updated
May 5, 2021
Sponsor
King Abdullah International Medical Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT04871828
Brief Title
The Efficacy of Leukotriene Inhibitor in Adult Patients With Moderate SARS-COV-2 Symptoms (COVID19)
Acronym
PROMISE
Official Title
The Efficacy of Leukotriene Inhibitor in Adult Patients With Moderate SARS-COV-2 Symptoms (COVID19): (Randomized Clinical Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 28, 2021 (Actual)
Primary Completion Date
September 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King Abdullah International Medical Research Center

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moderate Covid19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Prospective randomized placebo-controlled double-blinded clinical trial
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm 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).
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
placebo plus the standard treatment according to Saudi CDC protocol
Intervention Type
Drug
Intervention Name(s)
Leukotriene Receptor Antagonist
Intervention Description
Zafirlukast
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Time to clinical improvement,
Description
The time from symptoms resolved: No fever for 72 hours, no cough, no SOB or live discharge from the hospital, whichever came first.
Time Frame
28Day
Secondary Outcome Measure Information:
Title
Escalate therapy.
Description
The requirement to escalate therapy.
Time Frame
28Day
Title
PCR test
Description
PCR test negative conversion rate at day 14
Time Frame
Day14
Title
Length of hospital stay.
Description
Length of hospital stay.
Time Frame
28Day
Title
Duration of fever
Description
Duration of fever
Time Frame
28Day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age of 18 years or above Diagnosed with COVID-19 by PCR confirmed SARS-coV-2 viral infection. Able to sign the consent form and agree to clinical samples collection Moderate symptomatic COVID-19 patients, (any or all of the followings: fever or cough or SOB) Admitted to the hospital (outside the ICU) Patients had to be enrolled within 10 days of symptoms onset. willingness to comply with all study procedures and availability for the duration of the study Exclusion Criteria: Asthmatic patient using antiasthma medications Being in the hospital or in home isolation for more than 72 hours before the start of the study drug. Known sensitivity/allergy to the study drug Pregnancy Patient refused Chronic liver disease Severe mental disorder Unstable patients requiring ICU admission Participating in other clinical trial
Facility Information:
Facility Name
King Abdulaziz Medical city, MNGHA
City
Riyadh
ZIP/Postal Code
11426
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohammed Al Ghobain, MD
Phone
009668011111
Ext
14219
Email
alghobainmo@NGHA.MED.SA

12. IPD Sharing Statement

Learn more about this trial

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

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