COVID-19 Clinical Trial
— myRECOVEROfficial title:
Real-world Effectiveness of Oral Antivirals for Treatment of COVID-19 in Ministry of Health Malaysia Institutions
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.
Status | Recruiting |
Enrollment | 660 |
Est. completion date | July 31, 2023 |
Est. primary completion date | July 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Malaysia | Klinik Kesihatan Kajang | Kajang | Selangor |
Malaysia | Klinik Kesihatan Banadar Botanik | Klang | Selangor |
Malaysia | Klinik Kesihatan Bukit Kuda | Klang | Selangor |
Malaysia | Klinik Kesihatan Pandamaran | Klang | 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 Puchong Batu 14 | Subang Jaya | Selangor |
Lead Sponsor | Collaborator |
---|---|
Clinical Research Centre, Malaysia |
Malaysia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Frequency and proportion of study participants with COVID-19 related Hospitalization | Hospital admission due to COVID-19 | Within 28 days after treatment initiation | |
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Duration of Hospitalization | Number of days hospitalized due to COVID-19 | Within 28 days after treatment initiation | |
Secondary | 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 |
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