Real World COVID-19 Antiviral Effectiveness Research

NCT05638919 | Unknown FDA Drug

• 1 other identifier: NMRR ID-22-00938-2YN
• Study Type: observational
• Target: 660
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

COVID-19

Keywords

oral antivirals; high risk patients

Outcome Measures

Primary Outcomes (2)

• Frequency and proportion of study participants with COVID-19 related Hospitalization

  Hospital admission due to COVID-19

  Within 28 days after treatment initiation

• Frequency and proportion of of study participants with COVID-19 related all-caused mortality

  Any cause of death

  Within 28 days after treatment initiation

Secondary Outcomes (5)

• Frequency and proportion of study participants with of COVID-19 related symptoms

  Within 28 days after treatment initiation

• Frequency and proportion of study participants with COVID-19 ICU admission

  Within 28 days after treatment initiation

• Frequency and proportion of study participants with adverse drug reaction

  Within 28 days after treatment initiation

• Duration of Hospitalization

  Within 28 days after treatment initiation

• Frequency and proportion of study participants with long-term COVID-19 symptoms

  COVID-19 related symptoms lasting more than 4 weeks up to 6 months following COVID-19

Study Arms (2)

Oral Antiviral Group

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

Drug: Oral Antiviral

Non Oral Antiviral Group

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

Interventions

Oral Antiviral DRUG

Nirmatrelvir plus ritonavir or molnupiravir

Also known as: Paxlovid, Lagevrio

Oral Antiviral Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All SARS-CoV-2 positive adult population seen in the Ministry of Health Malaysia institutions

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Clinical Research Centre, Malaysia: lead

Study Sites (8)

Klinik Kesihatan Kajang

Kajang, Selangor, Malaysia

RECRUITING

Klinik Kesihatan Banadar Botanik

Klang, Selangor, Malaysia

RECRUITING

Klinik Kesihatan Bukit Kuda

Klang, Selangor, Malaysia

RECRUITING

Klinik Kesihatan Pandamaran

Klang, Selangor, Malaysia

RECRUITING

Klinik Kesihatan Seksyen 19

Petaling Jaya, Selangor, Malaysia

RECRUITING

Klinik Kesihatan Seksyen 7

Petaling Jaya, Selangor, Malaysia

RECRUITING

Klinik Kesihatan Puchong Batu 14

Subang Jaya, Selangor, Malaysia

RECRUITING

Klinik Kesihatan Taman Medan

Petaling Jaya, Malaysia

RECRUITING

MeSH Terms

Conditions

COVID-19

Interventions

Antiviral Agents; nirmatrelvir and ritonavir drug combination; molnupiravir

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Ee Vien Low, Ph.D.

  Clinical Research Center, Malaysia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ee Vien Low, Ph.D.

CONTACT

+60333628829; evlow@moh.gov.my

Mohan Dass Pathamanathan, MD

CONTACT

+60333628628; drmohandass@moh.gov.my

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2022
• First Posted: December 6, 2022
• Study Start: December 6, 2022
• Primary Completion: July 30, 2023
• Study Completion: July 31, 2023
• Last Updated: May 23, 2023

Record last verified: 2023-05

Locations

MY (8)