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Clinical trial

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

ID
Name
NMRR ID-22-00938-2YN
Description
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.
Trial arms
Trial start
2022-12-06
Estimated PCD
2023-07-30
Trial end
2023-07-31
Status
Recruiting
Treatment
Oral Antiviral
Nirmatrelvir plus ritonavir or molnupiravir
Arms:
Oral Antiviral Group
Other names:
Paxlovid, Lagevrio
Size
660
Primary endpoint
Frequency and proportion of study participants with COVID-19 related Hospitalization
Within 28 days after treatment initiation
Frequency and proportion of of study participants with COVID-19 related all-caused mortality
Within 28 days after treatment initiation
Eligibility criteria
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
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 660, 'type': 'ESTIMATED'}}
Updated at
2023-05-23

1 organization

1 product

1 indication

Organization
Clinical Research Centre
Product
Oral Antiviral
Indication
COVID-19