Real World COVID-19 Antiviral Effectiveness Research

NCT ID: NCT05638919

Last Updated: 2023-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

660 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-06

Study Completion Date

2023-07-31

Brief Summary

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This study is a prospective observational cohort study to evaluate the benefit of oral antivirals (nirmatrelvir plus ritonavir or molnupiravir) in Ministry of Health institutions. In this study, we will observe the progress of COVID-19 study participants seen in the health clinic up to 90 days from their initial visit to the health clinic.

Detailed Description

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This protocol is a prospective, multi-center, observational cohort study to evaluate the benefit of oral antivirals (nirmatrelvir plus ritonavir or molnupiravir) in Ministry of Health institutions in preventing progression of COVID-19 to severe COVID-19.

In this study, we will observe the clinical outcomes (COVID-19 symptoms, hospitalization admission, mortality, long term COVID-19 symptoms) of COVID-19 study participants seen in the health clinic up to 90 days from their initial visit to the health clinic . The hypothesis is that oral antiviral is beneficial in preventing disease progression and reducing long term COVID-19 symptoms.

Conditions

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COVID-19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Oral Antiviral Group

Study participant initiated with oral antiviral (nirmatrelvir plus ritonavir or molnupiravir) for the treatment of COVID-19

Oral Antiviral

Intervention Type DRUG

Nirmatrelvir plus ritonavir or molnupiravir

Non Oral Antiviral Group

Study participant not initiated with oral antiviral for the treatment of COVID-19

No interventions assigned to this group

Interventions

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Oral Antiviral

Nirmatrelvir plus ritonavir or molnupiravir

Intervention Type DRUG

Other Intervention Names

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Paxlovid Lagevrio

Eligibility Criteria

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Inclusion Criteria

* All SARS-CoV-2 positive individuals who are eligible for oral antiviral treatment based on current Ministry of Health Malaysia guidelines.

Exclusion Criteria

* Individual who received oral antiviral (either nirmatrelvir plus ritonavir or monupiravir) more than 5 days following their positive SARS-CoV-2 test date
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clinical Research Centre, Malaysia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ee Vien Low, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Clinical Research Center, Malaysia

Locations

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Klinik Kesihatan Kajang

Kajang, Selangor, Malaysia

Site Status RECRUITING

Klinik Kesihatan Banadar Botanik

Klang, Selangor, Malaysia

Site Status RECRUITING

Klinik Kesihatan Bukit Kuda

Klang, Selangor, Malaysia

Site Status RECRUITING

Klinik Kesihatan Pandamaran

Klang, Selangor, Malaysia

Site Status RECRUITING

Klinik Kesihatan Seksyen 19

Petaling Jaya, Selangor, Malaysia

Site Status RECRUITING

Klinik Kesihatan Seksyen 7

Petaling Jaya, Selangor, Malaysia

Site Status RECRUITING

Klinik Kesihatan Puchong Batu 14

Subang Jaya, Selangor, Malaysia

Site Status RECRUITING

Klinik Kesihatan Taman Medan

Petaling Jaya, , Malaysia

Site Status RECRUITING

Countries

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Malaysia

Central Contacts

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Ee Vien Low, Ph.D.

Role: CONTACT

+60333628829

Mohan Dass Pathamanathan, MD

Role: CONTACT

+60333628628

Facility Contacts

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Lih Bing Lau

Role: primary

Mohan Dass Pathmanathan

Role: backup

Salbiah Mohamed Isa

Role: primary

Cheng Lee Ooi

Role: backup

Siti Fairuz

Role: primary

Ee Vien Low

Role: backup

Zienna Zufida Zainol Rashid

Role: primary

Cheng Lee Ooi

Role: backup

Mohammad Ariff Fahmi Ahmad Zawawi

Role: primary

Cheng Lee Ooi

Role: backup

Azah Abdul Samad

Role: primary

Cheng Lee Ooi

Role: backup

Izwan Effendy Ismail

Role: primary

Ee Vien Low

Role: backup

Suet Yin Chow

Role: primary

Ee Vien Low

Role: backup

Other Identifiers

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NMRR ID-22-00938-2YN

Identifier Type: -

Identifier Source: org_study_id

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