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.
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.
Study Type
OBSERVATIONAL
Enrollment
660
Nirmatrelvir plus ritonavir or molnupiravir
Klinik Kesihatan Kajang
Kajang, Selangor, Malaysia
RECRUITINGKlinik Kesihatan Banadar Botanik
Klang, Selangor, Malaysia
RECRUITINGKlinik Kesihatan Bukit Kuda
Klang, Selangor, Malaysia
Frequency and proportion of study participants with COVID-19 related Hospitalization
Hospital admission due to COVID-19
Time frame: Within 28 days after treatment initiation
Frequency and proportion of of study participants with COVID-19 related all-caused mortality
Any cause of death
Time frame: Within 28 days after treatment initiation
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)
Time frame: 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
Time frame: 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)
Time frame: Within 28 days after treatment initiation
Duration of Hospitalization
Number of days hospitalized due to COVID-19
Time frame: 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
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Klinik Kesihatan Pandamaran
Klang, Selangor, Malaysia
RECRUITINGKlinik Kesihatan Seksyen 19
Petaling Jaya, Selangor, Malaysia
RECRUITINGKlinik Kesihatan Seksyen 7
Petaling Jaya, Selangor, Malaysia
RECRUITINGKlinik Kesihatan Puchong Batu 14
Subang Jaya, Selangor, Malaysia
RECRUITINGKlinik Kesihatan Taman Medan
Petaling Jaya, Malaysia
RECRUITINGTime frame: COVID-19 related symptoms lasting more than 4 weeks up to 6 months following COVID-19