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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| Control | Placebo Comparator | placebo plus the standard treatment according to Saudi CDC protocol |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Leukotriene Receptor Antagonist | Drug | Zafirlukast |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 28Day |
| Measure | Description | Time Frame |
|---|---|---|
| Escalate therapy. | The requirement to escalate therapy. | 28Day |
| PCR test | PCR test negative conversion rate at day 14 | Day14 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King Abdulaziz Medical city, MNGHA | Recruiting | Riyadh | 11426 | Saudi Arabia |
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| ID | Term |
|---|---|
| D020024 | Leukotriene Antagonists |
| ID | Term |
|---|---|
| D006727 | Hormone Antagonists |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
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Prospective randomized placebo-controlled double-blinded clinical trial
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| Other |
Placebo |
|
| Length of hospital stay. | Length of hospital stay. | 28Day |
| Duration of fever | Duration of fever | 28Day |
| D020164 | Chemical Actions and Uses |