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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Antiviral Group | Study participant initiated with oral antiviral (nirmatrelvir plus ritonavir or molnupiravir) for the treatment of COVID-19 |
| |
| Non Oral Antiviral Group | Study participant not initiated with oral antiviral for the treatment of COVID-19 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral Antiviral | Drug | Nirmatrelvir plus ritonavir or molnupiravir |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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All SARS-CoV-2 positive adult population seen in the Ministry of Health Malaysia institutions
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ee Vien Low, Ph.D. | Contact | +60333628829 | evlow@moh.gov.my | |
| Mohan Dass Pathamanathan, MD | Contact | +60333628628 | drmohandass@moh.gov.my |
| Name | Affiliation | Role |
|---|---|---|
| Ee Vien Low, Ph.D. | Clinical Research Center, Malaysia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinik Kesihatan Kajang | Recruiting | Kajang | Selangor | Malaysia |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000998 | Antiviral Agents |
| C000719967 | nirmatrelvir and ritonavir drug combination |
| C000656703 | molnupiravir |
| ID | Term |
|---|---|
| D000890 | Anti-Infective Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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| 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 |
| Klinik Kesihatan Banadar Botanik | Recruiting | Klang | Selangor | Malaysia |
|
| Klinik Kesihatan Bukit Kuda | Recruiting | Klang | Selangor | Malaysia |
|
| Klinik Kesihatan Pandamaran | Recruiting | Klang | Selangor | Malaysia |
|
| Klinik Kesihatan Seksyen 19 | Recruiting | Petaling Jaya | Selangor | Malaysia |
|
| Klinik Kesihatan Seksyen 7 | Recruiting | Petaling Jaya | Selangor | Malaysia |
|
| Klinik Kesihatan Puchong Batu 14 | Recruiting | Subang Jaya | Selangor | Malaysia |
|
| Klinik Kesihatan Taman Medan | Recruiting | Petaling Jaya | Malaysia |
|
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |