NCT05638919

Real World COVID-19 Antiviral Effectiveness Research

Real-world Effectiveness of Oral Antivirals for Treatment of COVID-19 in Ministry of Health Malaysia Institutions

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 660 (estimated)
• Sponsor: Clinical Research Centre, Malaysia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	Oral Antiviral	Nirmatrelvir plus ritonavir or molnupiravir

Timeline

• Start date: 2022-12-06
• Primary completion: 2023-07-30
• Completion: 2023-07-31
• First posted: 2022-12-06
• Last updated: 2023-05-23

Locations

8 sites across 1 country: Malaysia

Regulatory

• FDA-regulated drug study