COVID-19
Conditions
Keywords
oral antivirals, high risk patients
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.
Interventions
DRUGOral Antiviral
Nirmatrelvir plus ritonavir or molnupiravir
Sponsors
Clinical Research Centre, Malaysia
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency and proportion of study participants with COVID-19 related Hospitalization | Within 28 days after treatment initiation | Hospital admission due to COVID-19 |
| Frequency and proportion of of study participants with COVID-19 related all-caused mortality | Within 28 days after treatment initiation | Any cause of death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Duration of Hospitalization | Within 28 days after treatment initiation | Number of days hospitalized 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 |
| 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) |
| 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) |
Countries
Malaysia
Contacts
Primary ContactEe Vien Low, Ph.D.
Backup ContactMohan Dass Pathamanathan, MD
Outcome results
None listed