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Real World COVID-19 Antiviral Effectiveness Research (myRECOVER)

C

Clinical Research Centre, Malaysia

Status

Enrolling

Conditions

COVID-19

Treatments

Drug: Oral Antiviral

Study type

Observational

Funder types

Other

Identifiers

NCT05638919
NMRR ID-22-00938-2YN

Details and patient eligibility

About

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.

Full description

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.

Enrollment

660 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

660 participants in 2 patient groups

Oral Antiviral Group
Description:
Study participant initiated with oral antiviral (nirmatrelvir plus ritonavir or molnupiravir) for the treatment of COVID-19
Treatment:
Drug: Oral Antiviral
Non Oral Antiviral Group
Description:
Study participant not initiated with oral antiviral for the treatment of COVID-19

Trial contacts and locations

8

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Central trial contact

Mohan Dass Pathamanathan, MD; Ee Vien Low, Ph.D.

Data sourced from clinicaltrials.gov

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