Real World COVID-19 Antiviral Effectiveness Research
- Conditions
- COVID-19
- Interventions
- Drug: Oral Antiviral
- Registration Number
- NCT05638919
- Lead Sponsor
- Clinical Research Centre, Malaysia
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 660
- All SARS-CoV-2 positive individuals who are eligible for oral antiviral treatment based on current Ministry of Health Malaysia guidelines.
- Individual who received oral antiviral (either nirmatrelvir plus ritonavir or monupiravir) more than 5 days following their positive SARS-CoV-2 test date
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Oral Antiviral Group Oral Antiviral Study participant initiated with oral antiviral (nirmatrelvir plus ritonavir or molnupiravir) for the treatment of COVID-19
- Primary Outcome Measures
Name Time Method Frequency and proportion of of study participants with COVID-19 related all-caused mortality Within 28 days after treatment initiation Any cause of death
Frequency and proportion of study participants with COVID-19 related Hospitalization Within 28 days after treatment initiation Hospital admission due to COVID-19
- Secondary Outcome Measures
Name Time Method Frequency and proportion of study participants with adverse drug reaction Within 28 days after treatment initiation Medication related adverse reaction (eg. rash, itchiness, increased blood pressure, abdominal pain, etc)
Duration of Hospitalization Within 28 days after treatment initiation Number of days hospitalized due to COVID-19
Frequency and proportion of study participants with of COVID-19 related symptoms Within 28 days after treatment initiation 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)
Frequency and proportion of study participants with COVID-19 ICU admission Within 28 days after treatment initiation Admission to Intensive Care Unit (ICU) due to COVID-19
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 COVID-19 related symptoms that last more than 6 weeks
Trial Locations
- Locations (8)
Klinik Kesihatan Puchong Batu 14
🇲🇾Subang Jaya, Selangor, Malaysia
Klinik Kesihatan Seksyen 19
🇲🇾Petaling Jaya, Selangor, Malaysia
Klinik Kesihatan Seksyen 7
🇲🇾Petaling Jaya, Selangor, Malaysia
Klinik Kesihatan Taman Medan
🇲🇾Petaling Jaya, Malaysia
Klinik Kesihatan Kajang
🇲🇾Kajang, Selangor, Malaysia
Klinik Kesihatan Banadar Botanik
🇲🇾Klang, Selangor, Malaysia
Klinik Kesihatan Pandamaran
🇲🇾Klang, Selangor, Malaysia
Klinik Kesihatan Bukit Kuda
🇲🇾Klang, Selangor, Malaysia