Moderate Covid19Phase 3PROMISENCT04871828
The Efficacy of Leukotriene Inhibitor in Adult Patients With Moderate SARS-COV-2 Symptoms (COVID19)
A Phase 3 study testing Leukotriene Receptor Antagonist in people with Moderate Covid19, run by King Abdullah International Medical Research Center at 1 site in Saudi Arabia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Moderate Covid19
- What is being tested?
- Leukotriene Receptor Antagonist
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 28 Feb 2021to Dec 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Severe mental disorder
- Unstable patients requiring ICU admission
- Participating in other clinical trial
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site, 1 recruiting
- Recruiting
King Abdulaziz Medical city, MNGHA
Riyadh, 11426
Mohammed Al Ghobain, MD, 009668011111 ext. 14219, alghobainmo@NGHA.MED.SA
About this study
Official title: The Efficacy of Leukotriene Inhibitor in Adult Patients With Moderate SARS-COV-2 Symptoms (COVID19): (Randomized Clinical Trial)
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
- Being tested
- Leukotriene Receptor Antagonist, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leukotriene Receptor AntagonistDrug
Zafirlukast
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | 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). Receives: Drug: Leukotriene Receptor Antagonist |
| Control | Placebo comparator | placebo plus the standard treatment according to Saudi CDC protocol Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28Day
Secondary outcomes (4)
Escalate therapy.
The requirement to escalate therapy.
Measured: 28Day
PCR test
PCR test negative conversion rate at day 14
Measured: Day14
Length of hospital stay.
Length of hospital stay.
Measured: 28Day
Duration of fever
Duration of fever
Measured: 28Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start28 Feb 2021
- Primary completionSep 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomized placebo-controlled double-blinded clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Abdullah International Medical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04871828
- Sponsor's protocol ID
- RC20/206/R
- Acronym
- PROMISE
- Status last verified
- May 2021
- First submitted
- 1 May 2021
- Last updated
- 10 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Leukotriene Inhibitor in Adult Patients With Moderate SARS-COV-2 Symptoms (COVID19): (Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT04871828
- Acronym / sponsor ID
- PROMISE / RC20/206/R
- Conditions
- Moderate Covid19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- King Abdullah International Medical Research CenterUniversity, hospital or other
- Study start
- 28 Feb 2021 (actual)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 4 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Prospective randomized placebo-controlled double-blinded clinical trial
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Leukotriene Receptor AntagonistZafirlukast 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 comparator | Other: Placeboplacebo plus the standard treatment according to Saudi CDC protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Leukotriene Receptor AntagonistZafirlukast | Drug | Treatment |
| PlaceboPlacebo | Other | Control |
Primary outcome
Time to clinical improvement,
Time frame: 28Day
The time from symptoms resolved: No fever for 72 hours, no cough, no SOB or live discharge from the hospital, whichever came first.
4 secondary outcomes
Escalate therapy.
Time frame: 28Day
PCR test
Time frame: Day14
Length of hospital stay.
Time frame: 28Day
Duration of fever
Time frame: 28Day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2021.
Related trials for Moderate Covid19
Active, not recruitingPhase 1/2
Study of Cord Blood Derived Mesenchymal Stem Cells for Treatment of Moderate, Severe or Critical Pneumonia
COVID-19 Infection, COVID-19-Associated Acute Respiratory Distress Syndrome
RecruitingPhase 2
RCT for Yinqiaosan-Maxingganshitang in the Treatment of COVID-19
COVID-19
Not yet recruitingPhase 1/2
Evaluation of the Safety and Efficacy of XoGlo Pro, a Placental Mesenchymal Stem Cell-derived Extracellular Vesicles in Treating COVID-19 Symptoms
COVID-19
RecruitingPhase 1/2
SARS-CoV-2 CTLS for Mild to Moderate COVID-19 Disease
Covid19
Enrolling by invitationPhase 2
SPI-1005 Treatment in Moderate COVID-19 Patients
Covid19, Corona Virus Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
King Abdulaziz Medical city, MNGHA
Riyadh, Saudi Arabia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Leukotriene Receptor Antagonist in people with Moderate Covid19, run by King Abdullah International Medical Research Center at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to clinical improvement, (time frame: 28Day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2021.