Clinical trial NCT05638919: Real World COVID-19 Antiviral Effectiveness Research
Official title: Real-world Effectiveness of Oral Antivirals for Treatment of COVID-19 in Ministry of Health Malaysia Institutions
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Keywords: oral antivirals
high risk patients
Lead sponsor: Clinical Research Centre, Malaysia
Sponsor class: OTHER
First posted: 2022-12-06
Enrollment: 660
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All SARS-CoV-2 positive adult population seen in the Ministry of Health Malaysia institutions

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.

Eligibility criteria: 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

Primary outcomes:
measure: Frequency and proportion of study participants with COVID-19 related Hospitalization
timeFrame: Within 28 days after treatment initiation
measure: Frequency and proportion of of study participants with COVID-19 related all-caused mortality
timeFrame: Within 28 days after treatment initiation
Secondary outcomes:
measure: Frequency and proportion of study participants with of COVID-19 related symptoms
timeFrame: Within 28 days after treatment initiation
measure: Frequency and proportion of study participants with COVID-19 ICU admission
timeFrame: Within 28 days after treatment initiation
measure: Frequency and proportion of study participants with adverse drug reaction
timeFrame: Within 28 days after treatment initiation
measure: Duration of Hospitalization
timeFrame: Within 28 days after treatment initiation
measure: Frequency and proportion of study participants with long-term COVID-19 symptoms
timeFrame: COVID-19 related symptoms lasting more than 4 weeks up to 6 months following COVID-19
Other outcomes:
Locations:
city: Kajang
country: Malaysia
facility: Klinik Kesihatan Kajang
state: Selangor
city: Klang
country: Malaysia
facility: Klinik Kesihatan Banadar Botanik
state: Selangor
city: Klang
country: Malaysia
facility: Klinik Kesihatan Bukit Kuda
state: Selangor
city: Klang
country: Malaysia
facility: Klinik Kesihatan Pandamaran
state: Selangor
city: Petaling Jaya
country: Malaysia
facility: Klinik Kesihatan Seksyen 19
state: Selangor
city: Petaling Jaya
country: Malaysia
facility: Klinik Kesihatan Seksyen 7
state: Selangor
city: Subang Jaya
country: Malaysia
facility: Klinik Kesihatan Puchong Batu 14
state: Selangor
city: Petaling Jaya
country: Malaysia
facility: Klinik Kesihatan Taman Medan
Study officials:
affiliation: Clinical Research Center, Malaysia
name: Ee Vien Low, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: