NCT04714515

Brief Summary

The current study aimed to make a therapeutic comparison and effectiveness of Hydroxychloroquine (HCQ) and Montelukast (ML) in COVID-19 patients in addition to the standard of care. The safety and efficacy of HCQ and ML will be assessed as individual therapy and in combination with each other and with the standard of care. Cytokine storm (Interleukin levels) also will be monitored throughout the study to assess treatment progression.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2020

Shorter than P25 for all trials

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 20, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2020

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2020

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 19, 2021

Completed
Last Updated

January 19, 2021

Status Verified

January 1, 2021

Enrollment Period

1 month

First QC Date

September 19, 2020

Last Update Submit

January 15, 2021

Conditions

Covid19SARS-CoV-2 Infection

Keywords

COVID-19Montelukast

Outcome Measures

Primary Outcomes (3)

  • Patients admittance to ICU

    Changes in the number of ICU visits of COVID-19 patients

    2 Week

  • Length of total stay at the hospital

    Changes in the length of total stay of patients at the hospital

    2 weeks

  • Alleviating the symptoms of COVID-19

    Monitoring the changes in disease severity with alleviation of the symptoms

    2 weeks

Secondary Outcomes (1)

  • Interleukin levels

    1 Week

Study Arms (4)

Hydroxychloroquine and Montelukast

Group 1 was given Standard of care (SOC) + HCQ + Montelukast

Drug: MontelukastDrug: Hydroxychloroquine

Montelukast

Group 2 was given Standard of care (SOC) + Montelukast

Drug: Montelukast

Hydroxychloroquine

Group 3 was given Standard of care (SOC) + HCQ

Drug: Hydroxychloroquine

Hydroxychloroquine, Montelukast and Invermectin

Group 4 was given Standard of care (SOC) + Montelukast + HCQ and Ivermectin

Drug: MontelukastDrug: HydroxychloroquineDrug: Ivermectin

Interventions

MontelukastDRUG

An FDA approved medicine to treat asthmatic patients

Hydroxychloroquine and MontelukastHydroxychloroquine, Montelukast and InvermectinMontelukast
HydroxychloroquineDRUG

An FDA approved antiarthritis drug

HydroxychloroquineHydroxychloroquine and MontelukastHydroxychloroquine, Montelukast and Invermectin
IvermectinDRUG

An FDA approved anti-parasitic medicine

Hydroxychloroquine, Montelukast and Invermectin

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients, who were admitted to the hospitals with SARS-CoV-2 contacts (environmental exposure or close contact) or obvious COVID-19 symptoms and were diagnosed with COVID-19 using the PCR tests. Consent was obtained from all patients with a detailed history of any known co-morbidities.

You may qualify if:

  • Patients with diagnosed COVID-19
  • Patients who are not directly admitted to ICU

You may not qualify if:

  • Patients, who were already on immunosuppressants
  • Patients with age \> 80
  • Patient with any known allergies to montelukast

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Critical Care Medicine, Shanghai General Hospital, Shanghai Jiao Tong University, School of Medicine, Shanghai, China

Shanghai, China

Location

Shaukat Khanum Memorial Cancer Hospital & Research Centre, Johar Town, Lahore, Pakistan

Lahore, Punjab Province, 54600, Pakistan

Location

Biospecimen

Retention: SAMPLES WITH DNA

Nasal Swab samples

MeSH Terms

Conditions

COVID-19

Interventions

montelukastHydroxychloroquineIvermectin

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

ChloroquineAminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsMacrolidesPolyketidesLactonesOrganic Chemicals

Study Officials

  • Wei Zhang, MD

    Department of Critical Care Medicine, Shanghai General Hospital, Shanghai Jiao Tong University, School of Medicine, Shanghai, China

    PRINCIPAL INVESTIGATOR

  • Muhammad Rehman Akram, MBBS

    Shaukat Khanum Memorial Cancer Hospital & Research Centre, Johar Town, Lahore, Pakistan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 19, 2020

First Posted

January 19, 2021

Study Start

February 20, 2020

Primary Completion

March 30, 2020

Study Completion

April 20, 2020

Last Updated

January 19, 2021

Record last verified: 2021-01

Locations

PA(1)CN(1)