Real World COVID-19 Antiviral Effectiveness Research

Study Overview
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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.

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

Conditions
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COVID-19

Intervention / Treatment
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* Drug: Oral Antiviral


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Oral Antiviral Group<br>Study participant initiated with oral antiviral (nirmatrelvir plus ritonavir or molnupiravir) for the treatment of COVID-19 | Drug: Oral Antiviral<br>* Nirmatrelvir plus ritonavir or molnupiravir<br>* Other names: Lagevrio;|
| Non Oral Antiviral Group<br>Study participant not initiated with oral antiviral for the treatment of COVID-19 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency and proportion of study participants with of COVID-19 related symptoms | Type of COVID-19 related symptoms (Eg. fever or chills, fatigue, shortness of breath, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, diarrhea) | Within 28 days after treatment initiation | 
| Frequency and proportion of study participants with COVID-19 ICU admission | Admission to Intensive Care Unit (ICU) due to COVID-19 | Within 28 days after treatment initiation | 
| Frequency and proportion of study participants with adverse drug reaction | Medication related adverse reaction (eg. rash, itchiness, increased blood pressure, abdominal pain, etc) | Within 28 days after treatment initiation | 
| Duration of Hospitalization | Number of days hospitalized due to COVID-19 | Within 28 days after treatment initiation | 
| Frequency and proportion of study participants with long-term COVID-19 symptoms | COVID-19 related symptoms that last more than 6 weeks | COVID-19 related symptoms lasting more than 4 weeks up to 6 months following COVID-19 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oral antivirals, high risk patients